LabMedica May 2017

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W O R L D ’ S C L I N I C A L L A B O R AT O R Y N E W S L E A D E R ISSN 1068-1760

Vol. 34 No. 3 • 5/ 2017

DAILY CLINICAL LAB NEWS

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Blood Test Predicts Cancer Survival

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Serological Test Differentiates Zika from Dengue Infections

urvival evaluations can determine whether or not pharmacological treatment should be given. Cytotoxic chemotherapy would rarely be prescribed in a patient unlikely to survive beyond several weeks because of unpleasant side effects.

The sedative midazolam is used for symptom relief in palliative care

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ika virus (ZIKV) is an emerging mosquito-transmitted flavivirus currently causing large epidemics in South and Central America as well as in the Caribbean, presenting a global public health emergency.

Zika is increasingly posing a risk in other parts of the world and it is difficult to differentiate clinically from in-

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fections with dengue and chikungunya viruses, which are endemic in the same geographical regions. In laboratory testing, serology is an important supplement to direct detection and provides a much longer diagnostic window. European scientists led by those at the Institute for Experimental Immunology (EUROIMMUN AG,

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Image: Courtesy of Stanford University Medical Center

Panel of Blood Biomarkers Predicts Aging Health

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New Automated Periostin Immunoassay Developed eriostin is being investigated as a potential biomarker for T-helper2 (Th2)-driven asthma or eosinophilic inflammation and may help to identify patients more likely to benefit from interleukin-13-targeted treatments.

The use of serum interleukin-13 (IL-13) itself as a biomarker is challenging because it is expressed locally in inflamed tissue, resulting in very low concentrations in serum and concentrations of serum IL-13 appear

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Blood Test for Earlier Lung Cancer Detection new blood test has been developed that can accurately detect antibodies to lung cancer cells at an early stage, potentially up to five years before traditional scans show any damage.

In the UK, only one in six lung cancer patients have surgery which is low compared to other countries, but this audit reveals that early survival rate is very high, with 96% of patients living beyond 90 days, which is very

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panel of 19 biomarkers in the blood was utilized to create molecular signatures that are able to predict how well an individual is aging and how severe the likelihood that he or she will develop an aging-related disease.

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New Integrated Hematology Analyzer Introduced urrently, hematology testing requires a larger blood sample from a given patient, which needs to be run across several different systems in order to get the full set of results. This is labor- and time-intensive, and potentially provides

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Modified Smartphone-Based System Automatically Determines Antibiotic Resistance icrobiology researchers have described a modified smartphone that functions as an automated diagnostic test reader for the determination of antimicrobial resistance.

Routine antimicrobial susceptibility testing (AST) can prevent deaths due to bacteria and reduce the spread of multi-drug-resistance, but cannot be

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regularly performed in resource-limited-settings due to technological challenges, high-costs, and lack of trained professionals.

A team of investigators at the University of California, Los Angeles (USA; www.ucla.edu) has reported the development of a cellphone-based 96-well Cont’d on page 8

Clinical News . . . . . . . . . 4-26 IFCC News . . . . . . . . . . . . . 27 Product News . . . . . . . 14-24 Industry News . . . . . . . . . .33 International Calendar . . . 34 PUBLISHED IN COOPERATION WITH

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LabMedica International

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Blood Test Predicts Cancer Survival

panel of 19 biomarkers in the blood was utilized to create molecular signatures that are able to predict how well an individual is aging and how severe the likelihood that he or she will develop an aging-related disease.

To establish these signatures, investigators at Boston University (MA, USA; www.bu.edu) measured 19 blood biomarkers that included constituents of standard hematological measures, lipid biomarkers, and markers of inflammation and frailty in 4704 participants of the Long Life Family Study (LLFS). The biomarkers were selected based upon their noted quantitative change with age and specificity for inflammatory, hematological, metabolic, hormonal, or kidney functions.

The LLFS is a family-based study that enrolled 4935 participants including subjects and siblings (30%), their offspring (50%), and spouses (20%), with ages between 30 and 110 years. Approximately 40% of enrolled participants were born before 1935 and had a median age at enrollment of 90 years and 45% participants were male. Almost 55% of participants from the subject generation (birth year prior to 1935) have died since enrollment, with a median age at death of 96 years. Mortality in the generation born after 1935 is lower (3%) and among these few that have died, median age at death is currently 69 years.

The investigators used an agglomerative algorithm to analyze distribution of the 19 biomarkers and then

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Graham Beastall United Kingdom Claus Christiansen Denmark Hernán Fares Taie Argentina Bernard Gouget France Jocelyn M. Hicks United States Anders Kallner Sweden Tahir S. Pillay South Africa Christopher Price United Kingdom Andreas Rothstein Colombia Dmitry B. Saprygin Russia Rosa I. Sierra-Amor Mexico Peter Wilding United States Andrew Wootton United Kingdom A GLOBETECH PUBLICATION

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predicting prognosis improves end-of-life care for cancer patients and their caregivers.” The study was presented on December 18, 2016, at the European Society for Medical Oncology Asia 2016 congress held in Singapore.

Image: Midazolam, a drug used to give symptom relief in palliative care to terminal patients (Photo courtesy of WebMD).

Panel of Blood Biomarkers Predicts Aging Health

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labmedica.com EDITORIAL BOARD

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settings, but tolerance can develop if administered for two weeks or longer. Chronic midazolam treatment could therefore be recommended only for patients likely to die within a few weeks, and be contraindicated when predicted survival was longer than a month.

Scientists from Kyoto University (Japan; www. kyoto-u.ac.jp) tested the predictive value of the models in cancer patients receiving palliative care. It was designed as a sub-analysis of the Japan prognostic assessment tools validation (J-ProVal) study, which compared the ability of four models to predict survival of advanced cancer patients in the real world. This subanalysis included 1,015 patients, of whom 385 were based with palliative care teams in hospital, 464 were in palliative care units, and 166 were receiving palliative care services at home.

The current Six Adaptable Prognostic (SAP) models use three laboratory measurements, albumin, neutrophil, lactate dehydrogenase, which are routinely monitored in daily clinical practice with a blood test. The models can be used at any time point after the initiation of treatment, an important feature since a patient’s condition can change. The team found that the SAP models showed a good performance for predicting the death occurrence within one to three months. The prediction was accurate in 75% to 80% of cases.

Yu Uneno, MD, an oncologist and lead author of the study, said, “Patients with advanced cancer and their families have to make decisions about treatment, where to spend the end-of-life, and when to discontinue palliative chemotherapy. Continuing ineffective therapy increases life-threatening adverse events, reduces quality of life, delays hospice referral, and deprives patients of the chance to die in their preferred place. Accurately

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grouped LLFS participants into clusters that yielded 26 different biomarker signatures.

To test whether these signatures were associated with differences in biological aging, the investigators correlated them with longitudinal changes in physiological functions and incident risk of cancer, cardiovascular disease, type II diabetes, and mortality using longitudinal data collected in the LLFS. One signature was found to be associated with significantly lower mortality, morbidity, and better physical function relative to the most common biomarker signature in LLFS, while nine other signatures were associated with less successful aging, characterized by higher risks for frailty, morbidity, and mortality.

“Many prediction and risk scores already exist for predicting specific diseases like heart disease,” said first author Dr. Paola Sebastiani, professor of biostatistics at Boston University. “Here, though, we are taking another step by showing that particular patterns of groups of biomarkers can indicate how well a person is aging and his or her risk for specific age-related syndromes and diseases. These signatures depict differences in how people age, and they show promise in predicting healthy aging, changes in cognitive and physical function, survival, and age-related diseases like heart disease, stroke, type II diabetes, and cancer.”

The study was published in the January 6, 2017, online edition of the journal Aging Cell.

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Serological Test Differentiates Zika from Dengue Infections cont’d from cover

Lübeck, Germany; www.euroimmun.com) analyzed serum samples from 27 patients who had tested positive for ZIKV RNA by reverse transcription polymerase chain reaction (RTPCR); Samples from a further 85 patients had been pre-characterized by EUROIMMUN’s anti-ZIKV indirect immunofluorescence assay based on whole virus antigen, showing reactivity for anti-ZIKV immunoglobulin M (IgM) and/or IgG; 26 travelers returning from endemic area; and 59 residents in ZIKV-endemic areas. Anti-Zika Virus IgM and IgG enzyme-linked immunosorbent assay ELISA (EUROIMMUN) were tested.

In 17 RT-PCR confirmed Zika specimens collected at least six days after symptom onset, the ELISA sensitivity amounted to 59%, for IgM, 88% for IgG and 100% for IgM/IgG. In the suspected Zika cases, the combined sensitivity was 90%. In an additional investigation using samples from 31 patients with RT-PCR confirmed Zika virus infections (follow-up samples taken 7-10 days after positive RT-PCR result); the ELISA demonstrated a sensitivity of 100% for IgM/IgG. The specificity of the ELISA with respect to the blood donors was 99.8%. Cross reactivity with high-level anti-dengue virus antibodies was not detectable. Among 252 patients with potentially cross-reactive antibodies, overall anti-Zika positive rates were 0.8% for IgM and 0.4% for IgG. The authors concluded that the ELISA provided exceptionally high specificity and avoids the cross reactivity typically associated with tests based on whole virus antigens or viral glycoproteins. The anti-Zika virus ELISA is suitable for acute diagnostics as well as for monitoring purposes, e.g., in prenatal diagnostics, screening of donated blood and epidemiological studies. With its high-throughput format and automatability, the ELISA can be employed in routine laboratories in endemic settings. The study was published on December 16, 2016, in the journal Eurosurveillance.

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Image: The enzyme-linked immunosorbent assay (ELISA) for ZIKA virus (Photo courtesy of EUROIMMUN).

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Blood Test for Earlier Lung Cancer Detection cont’d from cover

encouraging for both patients and health professionals alike. Over 46,000 people are diagnosed with lung cancer in the UK each year according to cancer registration statistics. This makes it the third most common form of cancer in the UK, after breast and prostate cancer, although it kills more people. The disease kills over 35,500 people a year and is the biggest cause of death from both cancer and lung disease for men and women.

The largest ever randomized trial for lung cancer screening using the blood test in a population of approximately 12,000 high risk participants has been under taken with adults aged 50 to 75 years who are at high risk of lung cancer due to smoking heavily for 20 years or more, or due to a family history of lung cancer. Of these, 6,000 had the blood test for autoantibodies, and 6,000 received regular diagnosis and care. The study is now following study

participants over a two year period to find out if this test can reduce the incidence of patients with late stage lung cancer (Stage III or IV) compared with routine care.

The blood test is called Early CDT-Lung (Oncimmune, De Soto, KS, USA; www.oncimmune.com).

The early results show that that nearly 1 in 10 (9.8%) of the group who received the blood test (approximately 6,000 people at higher risk of lung cancer) had results indicating antibodies present.

These individuals were then investigated further with a chest x-ray and serial computerized tomography (CT) scans to look for signs of lung cancer. To date, 16 cases of lung cancer have been diagnosed; three quarters of these were at an early stage. This is higher than expected from current clinical experience. Although these results are encouraging, it is too early to say whether the study will change clinical practice as the final results will only be available

once data from participants in the control group are available and economic analysis is performed.

Stuart Schembri, MD, Honorary Senior Lecturer, University of Dundee (UK; www.dundee.ac.uk) and Co-Chief Investigator of the study, said, “Lung cancer is a serious and life threatening illness and our best hope for successful treatment is to detect it as early as possible. This test allows us to scan from a much more informed position and removes the stress around many patients unnecessarily having to go through a CT scan. But most importantly, we feel it may help us to detect lung cancer in its earliest stages when we have an improved chance of successful treatment.” The study was presented on December 9, 2016, at the British Thoracic Society (BTS) Winter Meeting held in London, UK. Image: The Early CDT-Lung is a simple blood test for risk assessment and detection of early lung cancer (Photo courtesy of Oncimmune).

Modified Smartphone-Based System Automatically Determines Antibiotic Resistance cont’d from cover

microtiter-plate (MTP) reader, capable of performing AST without the need for trained diagnosticians.

The proposed system includes a three dimensionalprinted smartphone attachment that holds and illuminates the MTP using a light-emitting-diode array.

An inexpensive optical fiber-array enables the capture of the transmitted light of each well through the smartphone camera. A custom-designed application sends the captured image to a server to automatically determine well turbidity, with results returned to the smartphone in about one minute.

The investigators tested this mobile-reader on clinical isolates of Klebsiella pneumoniae containing highly resistant antimicrobial profiles using MTPs prepared with 17 antibiotics targeting Gram-negative bacteria. Using 78 patient isolate test-plates, they demonstrated that the mobile-reader met the [U.S.] Food and Drug Administration-defined AST criteria, with a well-turbidity detection accuracy of 98.21%, minimum-inhibitory-concentration accuracy of 95.12%, and a drug-susceptibility interpretation accuracy of 99.23%, with no very major errors.

“This work is extremely important and timely, given that drug-resistant bacteria are increasingly becoming a global threat rendering many of our firstline antibiotics ineffective,” said senior author Dr. Aydogan Ozcan, professor of electrical engineering and bioengineering at the University of California, Los Angeles. “Our new smartphone-based technology can help put laboratory-quality testing into much wider adoption, especially in resource-limited regions.”

The smartphone AST system was described in the December 15, 2016, online edition of the journal Scientific Reports.

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New Automated Periostin Immunoassay Developed cont’d from cover

to be similar between healthy controls and subjects with asthma. Scientists at Abbott Laboratories (Abbott Park, IL, USA; www.abbott.com) and their colleagues assessed the company’s ARCHITECT Periostin Immunoassay performance in terms of precision, sensitivity, linearity, interference from classical immunoassay interferents and representatives of common asthma medications, specimen handling, and isoform reactivity. The assay has been developed for use with the ARCHITECT Immunoassay i System.

Samples from subjects with idiopathic pulmonary fibrosis, subjects with asthma used in periostin concentration assessments, and normal samples from healthy volunteers were obtained. The test is a monoclonal antibody (mAb) sandwich twostep immunoassay for the quantitative determination of periostin in human serum using chemiluminescent magnetic immunoassay technology. Pe-

riostin, the analyte, is captured by microparticles coated with an anti-periostin mAb and subsequently detected with a second anti-periostin mAb conjugated with Acridinium.

The team reported that the percentage of coefficient of variation (CVs) for five-day total precision, assessed using two instruments was less than 6% across two controls and one serum-based panel.

Limit of quantitation was 4 ng/mL, using dilution adjusted concentration, suiting the needs for the application. Dilution analysis yielded linear results and no endogenous sample or drug interferences were observed. All known periostin isoforms expressed in the mature human lung were detected by the assay.

The authors concluded that their analysis of periostin concentration in serum samples appeared to show slightly elevated mean periostin concentrations in samples from subjects with uncontrolled asthma compared with apparently healthy volun-

teers. This is consistent with reports of elevated serum periostin concentration in subjects with asthma, particularly those with Th2-driven asthma or eosinophilic inflammation. The study was published in the January 2017 issue of the journal Clinica Chimica Acta.

Image: The ARCHITECT i1000SR immunoassay analyzer (Photo courtesy of Abbott).

New Integrated Hematology Analyzer Introduced

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inconsistent results, as slide images are difficult to interpret. A new integrated hematology analyzer addresses the challenges of hematology testing by combining the three components of the process: a digital morphology analyzer, cell counter and classifier into one streamlined solution which prepares, stains and analyses microscopy blood slides.

The cobas m 511 (Roche, Basel, Switzerland; www. roche.com) provides greater accuracy and consistency of results, compared to current technologies, by identifying, counting, isolating and categorizing white blood cells, red blood cells and platelets, then presenting the digital images of all these cell types. Medical technologists can now concentrate their time on finding and classifying abnormal cells within patient samples. This automation and digitalization reduces the need for resource-intensive manual microscope reviews, supports clinicians to share challenging cases around the world and enables the delivery of quicker results, which ultimately aid patient diagnoses.

The cobas m 511, uses a unique approach to enter the new field of digital hematology through patented Bloodhound technology for printing, staining and imaging. This technology uses only 30μL of blood to print a monolayer onto the slide, stains with an improved method for further analysis of the morphology and enables classification of cells displayed on a Viewing Station. Based on these direct images, the Bloodhound technology counts, analyses morphology and then classifies every cell in the viewing area to provide a standard complete blood count (CBC) and 5-part differential and reticulocyte count.

The cobas m 511 integrated hematology analyzer, is now available for countries accepting the CE Mark. Roland Diggelmann, CEO of Roche Diagnostics, said, “With this launch, patients will benefit from a faster and more accurate diagnosis of blood diseases, as diverse as anemia and leukemia. We are entering a new area of innovation with Roche in hematology testing, supporting customers with integrated and efficient laboratory solutions, which deliver increased medical value.”

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Novel Device Enables Rapid Identification of Brain Cancer Type device has been developed for quick, accurate identification of a mutation strongly associated with a cancer that affects the central nervous system, potentially enabling accurate removal of the entire tumor during an operation.

Gliomas are tumors occurring in the brain or spinal cord and are difficult to treat as they lack a clear edge, which complicates full surgical removal, which leads to high levels of recurrence and mortality. A particular mutation that is very common in gliomas has been identified, but is rare in other cancers and in normal tissue.

Scientists at the Nagoya University (Japan; www.nagoya-u.ac.jp) collected fresh tumor samples, 5â&#x20AC;&#x201C;10 mm in diameter intraoperatively from 10 patients whose tumors were resected in 2015. The location of each sample was recorded stereotactically in an intraoperative navigation system. Each tumor tissue was dissected into three pieces for the immuno-wall assay, immunohistochemistry, and DNA sequencing.

The scientists used various techniques including cell lines expressing mutated or wild type isocitrate dehydrogenase 1 (IDH1), protein lysates, Western blotting, direct sequencing for IDH1 mutation were carried out using an ABI 3100 Genetic Analyzer (Applied Biosystems, Forest City, CA, USA; www.appliedbiosystems.com). Detection and calculation of the frequency of the mutant allele was performed using pyrosequencing technology (Pyrosequencing AB, Uppsala, Sweden; www. qiagen.com). An immuno-wall assay was developed using immuno-wall chips with 40 microchannels (1 mm width, 40 m height and 8.5 mm length each) in a cyclic-olefin-polymer substrate were constructed using photolithography.

The device features a chip with an attached highly specific antibody, which binds to the protein produced by the gene in which the mutation has occurred. When a sample containing the mutated protein is added to the device, the protein binds to the antibody, which is then specifically detected by a source of fluorescence. In contrast, if the sample is from normal tissue without this mutation, or is from a tumor other than a glioma, no fluorescence occurs. The small sample size required for the device reduces the invasiveness of sample harvesting.

In fact the process takes only 15 minutes, enabling completion during an operation. The immuno-wall could markedly increase success of glioma treatment by rapidly providing data to inform the course of the operation and tissue to remove.

The authors commented that the immuno-wall determines whether a sample is positive for a specific mutation in the isocitrate dehydrogenase 1 gene, which is present in around 70%-80% of grade II and III gliomas. Our results for a range of cancerous cell lines and actual tumor samples both positive and negative for this mutation were very promising. The device was proven highly accurate, as confirmed by complete sequencing of the gene in question in each sample. The study was published on October 4, 2016, in the journal Science and Technology of Advanced Materials.

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Image: Immuno-wall chips with the photo reactive polymer in the center of the 40 microchannels are made with a biotinylated anti-R132H-IDH1 antibody (HMab-2), an anti-wild-type IDH1 antibody (RcMab-1), and fluorescent antibodies. It shows sensitive and specific fluorescence from mutant IDH1 (Photo courtesy of Nagoya University).

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The DxC 700 AU reduces the number of test-processing steps by 30%, allowing operators to streamline workflows. It is designed to meet increasing demands for larger test volumes, and reduces total cost of ownership for hospital laboratories and integrated delivery networks.

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First Epigenetic Signature Test to Classify Metastasis Tumors of Unknown Origin multicentre, retrospective study has shown that an innovative new test could be used for epigenetic profiling to classify cancer of unknown primary (CUP) origin, which would enable doctors to develop more specific treatments.

Initial cancer diagnosis most often includes detection of the primary tumor and the presence or absence of metastases. However, in 5-10% of human tumors this process is done otherwise, as CUPs: metastasis is diagnosed, but the primary tumor is not detected despite various diagnostic testing.

The study, led by Prof. Dr. Manel Esteller, of Bellvitge Biomedical Research Institute (IDIBELL; Barcelona, Spain; www.idibell.cat) and University of Barcelona (Barcelona, Spain; www.ub.edu/web/ub/en), showed that it is possible to use the EPICUP test to determine the type of primary tumor responsible for the metastasis in the patient. EPICUP has helped identify up to 87% of cases of CUPs. “A few years ago, we became aware that chemical patterns that regulate activity of genes (the epigenome) are specific to each tissue. For example, they are different in a pancreatic cell compared to a lung cell,” said Dr. Manel Esteller, “We have analyzed these particular epigenetic signatures for each type of cancer in more than 10,000 human tumors. When we now study the

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DNA of the metastasis of a patient with a tumor of unknown origin, the photograph of the epigenome that we get will tell us that it belongs to the family of pancreatic cancer, lung, colon, breast, etc. In other words, we will give a diagnosis of the origin of the tumor.

“From now on, the patient will not be treated blindly, since we will be able to provide a much more specific therapy for this tumor type; actually, initial data shows that survival is doubled”, explained Dr. Esteller, “Something very important to keep in mind is that this is not a discovery to be developed in the coming years; our collaboration with Ferrer laboratories made it possible for this test to be applied from this very moment.”

The study, by Moran S et al, was published August 27, 2016, in the journal Lancet Oncology.

Image: The EPICUP test is designed to classify a metastasis tumor from an unknown primary origin (Photo courtesy of IDIBELL).

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Rare Inflammatory Disease Identified in Children rare, deadly inflammatory disease among young children, known as otulipenia has been discovered, and it is caused by the malfunction of OTULIN, a gene on chromosome 5 that regulates the development of new blood vessels and the mobilization of infection-fighting cells and proteins. Four children from Pakistani and Turkish families have been identified with the disease, which is characterized by a problem processing the small protein ubiquitin and is accompanied by inflammation that leads to skin rashes and inflamed joints. The abnormal OTULIN gene is part of the innate immune system, which is present at birth with cells and proteins to fight infections.

An international team of scientists in collaboration with those at the US National Human Genome Research Institute (Bethesda, MD, USA; www. genome.gov) identified two missense and one frameshift mutations in one Pakistani and two Turkish families with four affected patients. Patients presented with neonatal-onset fever, neutrophilic dermatitis/panniculitis, and failure to thrive, but with-

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out obvious primary immunodeficiency.

The scientists performed whole-exome sequencing in two patients and their family members, candidate-gene sequencing in the third patient and her parents, and mutation-specific genotyping in 1,630 DNA samples from the Turkish population. To study protein function, they used short hairpin ribonucleic acid (shRNA) knockdowns in Human Embryonic Kidney 293 (HEK293) cells and NF- B luciferase assay, and Met1-linked linear polyubiquitin deubiquitination assay in the same cells. Immunoprecipitation and immunoblotting, flow cytometry, Nanostring, intracellular cytokine staining, and cytokine profiling were performed on samples from the patients and healthy controls. Gene expression analysis was conducted using the nCounter Analysis System (NanoString Technologies, Seattle, WA, USA; www.nanostring.com).

The investigators found that HEK293 cells transfected with mutated OTULIN had decreased enzyme activity relative to cells transfected with wildtype (WT) OTULIN, and showed a substantial de-

fect in the linear deubiquitination of target molecules. Stimulated patients’ fibroblasts and peripheral blood mononuclear cells showed evidence for increased signaling in the canonical NF- B pathway and accumulated linear ubiquitin aggregates. Levels of proinflammatory cytokines were significantly increased in the supernatants of stimulated primary cells and serum samples. They effectively used anti-tumor necrosis factor drugs (TNF inhibitors), which are used to treat other chronic inflammatory diseases such as rheumatoid arthritis, to treat the children with otulipenia.

Daniel L Kastner, MD, PhD, a senior author of the study, said, “The results have been amazing and life changing for these children and their families.

We have achieved the important goal of helping these young patients and made progress in understanding the biological pathways and proteins that are important for the regulation of the immune system’s responses.” The study was published on August 22, 2016, in the journal Proceedings of the National Academy of Sciences.

Desalinated Water Linked to Cases of Iodine Deficiency study suggests and warns that relying on desalinated seawater as a population’s main source of drinking water can dramatically increase the prevalence of inadequate iodine intake, recommending individuals use iodized salt or other supplement and monitoring until an effective population-level solution has been found.

Iodine deficiency is a most important cause of preventable brain damage and mental deficiency.

With surging population growth and water scarcity, seawater desalination is increasingly used to meet increased demand for water. Currently an estimated 300 million people worldwide rely on over 17,000 desalination plants in 150 countries for water.

On one hand “desalination is a blessing. Howev-

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er, we need to be mindful of unintended consequences,” said Dr. Aron Troen, Hebrew University (Jerusalem, Israel; http://new.huji.ac.il), “Desalination removes minerals from the water and could conceivably diminish intake of minerals such as iodine that serve as essential micronutrients.”

This initial (small but telling sample of 74 participants, including controls) study assessed the relationship between iodine intake and thyroid function in an area where drinking water is supplied from iodine-poor desalinated water. It found a surprisingly high prevalence of insufficient iodine intake and a strong association of thyroid dysfunction among adults with low iodine intake.

The study was conducted in the city of Ashkelon

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on the southern Mediterranean coast of Israel – a country with the highest percentage of desalinated water consumption in the world, where 5 desalination plants produce about 50% of its water. In collaboration with Dr. Dov Gefel and PhD student Yaniv Ovadia, Barzilai University Medical Center (Ashkelon, Israel; www.barzilaimc.org.il/eng), the researchers used an Iodine Food Frequency Questionnaire to model the effect of depleting iodine content in drinking water on the distribution of iodine intake. Thyroid function was rigorously assessed by clinical examination, ultrasound, and blood tests, including serum thyroglobulin (Tg) and autoimmune antibodies. The study, by Ovadia YS et al, was published online May 2016 in the journal Public Health Nutrition.

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Novel Turbidimetric Immunoassay Evaluated for Fecal Calprotectin alprotectin is a multifunctional protein that plays an important role in the diagnosis and follow-up of inflammatory bowel disease and high levels of calprotectin in stool samples are associated with inflammation of the intestinal tract. Fecal calprotectin assays are widely used to exclude inflammatory bowel disease (IBD) in patients with suspected IBD, but the problem with most of the fecal calprotectin assays is the rather long test-turnaround times, before the results are available to the physician.

Scientists at Uppsala University (Sweden; www. uu.se) optimized a particle enhanced turbidimetric immunoassay (PETIA) for fecal calprotectin and vali-

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dated the assay for two clinical autoanalyzers using routine fecal samples. They compared the PETIA with a commercial enzyme-linked immunosorbent assay (ELISA), known as the Bühlmann fCAL ELISA (Bühlmann Laboratories, Schönenbuch, Switzerland; www.buhlmannlabs.ch). This new latex based turbidimetric calprotectin assay applies particles coated with anti-human calprotectin (MRP8/14) antibodies: the agglutination is proportional to the calprotectin concentration.

The fecal calprotectin PETIA was validated on two chemistry analyzers, the Mindray BS-380 (Mindray, Shenzhen, China; www.mindray.com) and the Cobas 501 (Roche Diagnostics, Basel,

Switzerland, www.roche.com). The assay is linear in the range 11 g/g to 2,000 g/g, with a limit of quantitation of approximately 10 g/g. No antigen excess hook effect was observed up to 10,000 g/g to 15,000 g/g depending on the instrument used. The turbidimetric method showed a good agreement with the Bühlmann ELISA. The authors concluded that the fecal calprotectin PETIA, fCal Turbo, is well suited for rapid analysis of fecal calprotectin on Mindray BS-380 or Cobas 501 clinical chemistry analyzers. The test results are concordant with the Bühlmann fecal MRP8/14 ELISA. The study was published in the September 2016 issue of the Journal of Clinical Laboratory Analysis.

Coronavirus Linked to Neurological Disease case-study of fatal encephalitis has, for the first time, led researchers to discover a direct association with strain OC 43 of the human coronavirus (HCoV), providing confirmatory evidence for the hypothesis that this respiratory virus can cause certain neurological diseases of unknown origin such as multiple sclerosis, Alzheimer’s disease, Parkinson’s disease, and encephalitis.

A co-leader of the study was Prof. Pierre Talbot, of Institut Armand-Frappier Centre at Institut National de la Recherche Scientifique (INRS; Québec, QC, Canada; www.inrs.ca/english/homepage), who had first demonstrated the virus’s ability to invade the human central nervous system and suggested neuropathological effects. Other researchers conducting the study were also from University College London (UK) and from Great Ormond Street Hospital for Children NHS Foundation Trust (UK).

They studied the case of a very young patient, an 11-month-old boy, who died from encephalitis. He had presented severe immunodeficiency and received a stem cell transplant. Although most cases of encephalitis are caused by viruses or bacteria, pinpointing the cause can be particularly difficult in immunodeficient patients. In this case it was not possible to identify the pathogen using conventional techniques.

The researchers used various other methods that allowed them to irrefutably identify the presence of human coronavirus strain OC-43 in the young patient’s brain tissue.

“Among the methods used, deep sequencing of biopsy materials provides an important tool for the diagnosis of unexplained encephalitis, particularly in immunodeficient patients who have undergone stem cell transplantation,” said Prof. Talbot.

This breakthrough is significant because it will make it possible to use specific treatments better tailored to patient conditions.

The study, by Morfopoulou S et al, was published August 2016 in the New England Journal of Medicine.

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HEMATOLOGY ANALYZER

BLOOD GAS ANALYZER

Nova Biomedical

Dymind Biotechnology

Radiometer

The Stat Profile Prime offers a 10-test critical care menu, and has a throughput of up to 45 samples per hour. It delivers test results in 60 seconds, and is so compact that it can be located virtually anywhere in the hospital or operated on a mobile cart with a battery backup.

The DH76 is a 5-part differentiation auto hematology analyzer that offers three counting modes: whole blood, capillary blood and pre-diluted. It has a throughput of up to 80 samples per hour, a storage capacity of up to 100,000 samples, and uses only a 20µl sample volume.

The ABL80 FLEX is designed for measuring blood gas, electrolytes, and glucose with automatic quality control that operates fully on battery. Easy-touse test cassettes and a small footprint make it ideal for use in low- to mid-volume clinical areas, and sharing among several departments.

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Prognostic Protein Biomarker Found for Esophageal Adenocarcinoma odocalyxin-like protein (PODXL) is a cell surface transmembrane glycoprotein, the expression of which has been associated with poor prognosis in a range of malignancies including glioblastoma multiforme, breast cancer, bladder cancer, periampullary and pancreatic adenocarcinoma and colorectal cancer.

Esophageal and gastric cancers are among the most common types of cancer worldwide in terms of incidence and mortality. The majority of esophageal cancers were squamous cell carcinomas, but in the last four decades there has been a drastic increase in the incidence of adenocarcinoma, especially in many Western countries.

Scientists associated with Skåne University Hospital (Lund, Sweden; www.skane.se), studied a cohort consisting of a consecutive series of 174 patients with esophageal (including the gastroesophageal junction) or gastric adenocarcinoma, surgically treated between 2006 and 2010 and not subjected to neoadjuvant treatment. Immunohistochemical expression of PODXL was assessed in tis-

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sue microarrays with cores from primary tumors, lymph node metastases, intestinal metaplasia and adjacent normal epithelium. Survival analyses were performed on patients with no distant metastases and no macroscopic residual tumor.

Tissue microarrays (TMAs) were constructed using a TMArrayer semi-automated arraying device (Pathology Devices, Westminster, MD, USA; www.pathologydevices.com). From all 174 primary tumors, duplicate cores of 1 mm from separate donor blocks were obtained. In 81 cases lymph node metastases were sampled in duplicate cores, each from a separate metastasis if more than one. Single core samples from 96 adjacent normal esophageal squamous epithelium cases and 131 normal gastric columnar epithelium cases were also retrieved. For immunohistochemical analysis of PODXL expression, 4 m TMA-sections were automatically pre-treated using the PT Link system, and then stained in an Autostainer Plus (DAKO, Glostrup, Copenhagen, Denmark; www.dako.com).

The team found that in the majority of cases, expression of PODXL was significantly higher in cancer cells compared to normal epithelial cells and was significantly associated with lymph node metastases and high grade tumors. In esophageal adenocarcinoma, statistical analyses revealed that patients with PODXL negative tumors had a superior time to recurrence (TTR) and overall survival (OS) compared to patients with PODXL positive tumors. In esophageal and gastric adenocarcinoma combined, the prognostic significance of PODXL expression on TTR was confirmed.

The authors concluded that that PODXL is commonly expressed in esophageal and gastric adenocarcinoma and associated with lymph node metastases and high grade tumors. Furthermore, PODXL is an independent prognostic biomarker for reduced time to recurrence and poor overall survival, but in the subgroup of patients with PODXL negative tumors the prognosis appears to be excellent. The study was published on July 29, 2016, in the journal BMC Clinical Pathology.

Urine Tests for Dehydrated Older Adults Questioned ater-loss dehydration happens when people do not drink enough fluid and urine tests are widely used by doctors, nurses and other health professionals to screen for waterloss dehydration among older people.

Water-loss dehydration is associated with poor health outcomes such as disability and mortality in older people and urine specific gravity (USG), urine color, and urine osmolality have been widely advocated for screening for dehydration in older adults.

Scientists at the University of East Anglia (Norwich, UK; www.uea.ac.uk) and their colleagues assessed 383 men and women aged over 65 living in residential care, nursing homes, or in their own homes in Norfolk and Suffolk. The team tested the participants by measuring serum osmolality to as-

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sess whether they were drinking enough to stay hydrated and compared the results with urine samples taken at the same time. They tested urine for color, cloudiness, specific gravity, osmolality, volume, glucose, and pH. Directly measured serum osmolality was assessed in all samples and was measured by depression of freezing point using a Model 2020 osmometer (Advanced Instruments; Norwood, MA, USA; www.aicompanies.com) with a repeatability of ±3 mOsm/kg (±1 SD) in the 0–400-mOsm region.

Urine measures included urine specific gravity (USG), determined by dipstick and refractometer; urine color; cloudiness; volume; other dipstick tests including glucose, ketones, blood, pH, protein, nitrite, and leukocytes.

The scientists found that the diagnostic accuracy

of urine tests is too low to be useful and that the tests should not be used to indicate hydration status in older people. Lee Hooper, PhD, the lead author of the study said, “Dark urine and high urine specific gravity have long been described as clinical indicators of dehydration, with nursing and medical text books, reviews, guidelines and public websites all advocating their use. We wanted to test their accuracy. Urinary tests rely on normal kidney function.

While urine tests do seem to be able to indicate hydration status in children and younger adults, ageing is associated with impaired kidney function. As we get older we cannot concentrate our urine as well as younger people, so urine tests are not useful in older adults for indicating hydration.” The study was published on May 25, 2016. in the The American Journal of Clinical Nutrition.

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Images Identified for Breast Cancer Cell Histopathology reast cancer is the most prevalent form of cancer for women worldwide. Current breast cancer clinical practice and treatment mainly relies on the evaluation of the disease’s prognosis using the Bloom-Richardson grading system.

The advent of digital pathology and fast digital slide scanners has opened the possibility of automating the prognosis by applying image-processing methods and while this undoubtedly represents progress, image-processing methods have struggled to analyze high-grade breast cancer cells as these cells are often clustered together and have vague boundaries, which make successful detection ex-

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tremely challenging.

An international team comprising engineers, mathematicians and doctors led by those at Trinity College Dublin (Ireland; www.tcd.ie) have has applied a technique used for detecting damage in underwater marine structures to identify cancerous cells in breast cancer histopathology images. This detection framework estimates a nuclei saliency map using tensor voting followed by boundary extraction of the nuclei on the saliency map using a Loopy Back Propagation (LBP) algorithm on a Markov Random Field (MRF).

The method was tested on both whole-slide images and frames of breast cancer histopathology im-

ages. The investigators considered the likelihood of every point in a histopathology image either being near a cell center or a cell boundary and using a belief propagation algorithm, the most suitable cell boundaries were then traced out.

Maqlin Paramanandam, PhD, the lead author of the study said, “The potential for this technology is very exciting and we are delighted that this international and inter-disciplinary team has worked so well at tackling a real bottle-neck in automating the diagnosis of breast cancer using histopathology images.” The study was published on September 20, 2016, in the journal Public Library of Science ONE.

Mosquito-Borne Rift Valley Fever Virus Linked to Miscarriage ift Valley fever virus (RVFv) has been linked to miscarriage in a cross-sectional study of pregnant Sudanese women with fever, which indicated a 7 times greater risk of miscarriage for infected women.

“In parts of Africa where there are RVF outbreaks, human miscarriages have never been linked to this particular viral infection, until now,” said co-author Magnus Evander, professor at Umeå University Faculty of Medicine (Umeå, Sweden; www.medfak.umu. se), “With these results, we can add miscarriage to the list of known complications from RVF. This discovery is important for maternal health and for our efforts to develop preventive measures to minimize miscarriages, which are a big health problem for women in the affected areas of Africa.” The study was a collaboration between researchers at Umeå University, the Swedish Defense Research Agency (FOI), and clinicians in Sudan.

RVFv, mostly in Africa and on the Arabian Peninsula, regularly causes large outbreaks with hundreds of thousands of infected people and animals (e.g. cows, sheep, goats). RVF usually produces mild, influenza-like symptoms in humans, but in about 8% of cases, infected people develop serious symptoms, such as liver damage, serious eye infection, internal and external bleeding, meningitis, and death. In animals it often leads to death and as well as pregnancy miscarriages. The new results are based on a study of 130 pregnant women with fever in Sudan, where outbreaks are a large and recurring health problem. Of the 130 patients, 27 had a miscarriage and 4 had premature births. The women infected with RVFv had a 7 times greater risk of miscarriage. ”Because RVF is caused by a mosquitoborne virus, there is a potential risk of global spread, which has been the case with the Zika virus. The fact that RVF could lead to miscarriage is very worrying,” said Prof. Evander. The study was published September 27, 2016, in the journal Lancet Global Health.

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PRODUCT NEWS DIABETIC MARKER

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HEMOGLOBIN TESTING SYSTEM

MOLECULAR DIAGNOSTIC SYSTEM

DiaSys Diagnostic Systems

Erba Mannheim

Meridian Bioscience

The ß-Hydroxybutyrate is an important marker to detect and monitor diabetic ketoacidosis (DKA), a serious condition in diabetes mellitus. The ß-Hydroxybutyrate 21 FS can be used on common clinical analyzers, and shows improved performance and excellent stabilities.

The Hb Vario uses the HPLC method for HBA1c measurement, and CLE technology enables complete elimination of labile glycoprotein to ensure accurate results with HbA2 and HbF flagging. The benchtop system requires no sample preparation, and is designed for small- to medium-sized labs.

The Illumigene can provide results for up to 10 samples in less than an hour, with a hands-on time per sample of less than two minutes. It allows the addition of molecular assays and is highly flexible, making it possible for any laboratory to implement molecular diagnostic capabilities.

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Proteins Predict Alzheimer’s Risk in Patients with Mild Cognitive Disorder blood test that measures a panel of three complement proteins was shown to predict which individuals with a mild cognitive disorder would most likely progress to develop Alzheimer’s disease (AD).

The growing appreciation of the importance of inflammation in early AD has focused attention on inflammatory biomarkers in cerebrospinal fluid or plasma; however, the measurement of non-specific inflammation markers has not shown great success.

For this reason, investigators at Cardiff University (United Kingdom; www.cardiff.ac.uk) and other institutions in the United Kingdom adopted a targeted approach, centered on an inflammatory pathway already implicated in the disease.

The investigators analyzed five complement proteins and four activation products in blood samples taken from 292 individuals with the earliest signs of memory impairment. They found that only one complement analyte, clusterin, differed significant-

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ly between controls and plasma from patients who had gone on to develop AD. Clusterin (apolipoprotein J) is a protein associated with the clearance of cellular debris and apoptosis. In humans, clusterin is encoded by the CLU gene on chromosome eight. It is a molecular chaperone responsible for aiding protein folding of secreted proteins, and its three isoforms have been differentially implicated in pro- or antiapoptotic processes. Through this function, CLU is involved in many diseases related to oxidative stress, including neurodegenerative diseases, cancers, inflammatory diseases, and aging.

A model combining clusterin with relevant covariables was found to be highly predictive of AD risk. Three analytes (clusterin, factor I, and terminal complement complex) were significantly different between individuals with mild cognitive impairment who had progressed to AD one year later compared to those that did not. A model combining

these three analytes with informative co-variables was highly predictive of AD risk.

“Senior author Dr. B. Paul Morgan, professor of infection and immunity at Cardiff University, said, “Alzheimer’s disease affects around 520,000 people in the United Kingdom and this number is continually growing as the population ages. As such it is important that we find new ways to diagnose the disease early, giving us a chance to investigate and instigate new treatments before irreversible damage is done. Our research proves that it is possible to predict whether or not an individual with mild memory problems is likely to develop Alzheimer’s disease over the next few years. We hope to build on this in order to develop a simple blood test that can predict the likelihood of developing Alzheimer’s disease in older people with mild, and possibly innocent, memory impairment.”

The study was published in the August 2016 online edition of the Journal of Alzheimer’s Disease.

Biomarker Outperforms Current Gold Standard to Detect Brain Shunt Infections hildren treated with cerebrospinal fluid (CSF) shunts to manage hydrocephalus frequently develop shunt failure and/or infections, conditions that present with overlapping symptoms. The potential life-threatening nature of shunt infections requires rapid diagnosis; however, traditional microbiology is time consuming, expensive, and potentially unreliable. A quick and accurate test for bacterial infection in brain shunts or meningitis would improve the quality and efficiency of patient care and patient outcomes. Such a test would also lower health care expenses by avoiding needless hospitalization and treatment.

Scientists at the University of Alabama (Birmingham, AL, USA; www.uab.edu) prospectively enrolled 198 consecutive undergoing evaluation and treatment for newly diagnosed hydrocephalus, shunt infection, and versus malfunction. Study samples were collected at the same time as routine lab

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specimens to provide corresponding laboratory results for each specimen (glucose, protein, hematology indices, gram stain, and culture). Samples were labeled and stored at –20 °C and/or –80 °C for a period of one week on average prior to analysis.

Cerebrospinal fluid (CSF) CSF was assayed for the soluble membrane attack complex (sMAC) by enzyme-linked immunosorbent assay (ELISA) in patients with suspected shunt failure or infection. CSF was obtained at the time of initial surgical intervention. Statistical analysis was performed to assess the diagnostic potential of sMAC in pyogenic-infected versus non-infected patients. Soluble MAC was quantitated using the MicroVue complement sC5b9 Plus enzyme immunoassay (Quidel Corporation, Athens, OH, USA; www.quidel.com). The lower limit of detection for the assay was 3.7 ng/mL. The team used appropriately adjusted cutoff values for maximum sensitivity and specificity, and the

sMAC was able to detect 14 of 15 infections in the 248 patients, while the current diagnostic gold standard of bacterial culture was less accurate, detecting only 11 of the 15 infections. At the best cutoff value, the test had excellent diagnostic capability with a sensitivity of 93% and a specificity of 86%. Children with pyogenic shunt infection had significantly increased sMAC levels compared with non-infected patients (3,211 ± 1,111 ng/mL versus 26 ± 3.8 ng/mL).

In infected patients undergoing serial CSF draws, sMAC levels were prognostic for both positive and negative clinical outcomes. Children with delayed, broth-only growth of commensal organisms such as Propionibacterium acnes, Staphylococcus epidermidis had the lowest sMAC levels (7.96 ± 1.7 ng/mL), suggesting contamination rather than shunt infection. The study was first published online on July 7, 2016, in the Journal of Clinical Investigation Insight.

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Low-Cost Sensor Developed for Cystic Fibrosis Diagnosis and Monitoring iomaterials scientists have developed an inexpensive method for detecting salt concentrations in sweat or other bodily fluids with a fluorescent sensor derived from citric acid molecules. The sensor is highly sensitive and highly selective for chloride, the key diagnostic marker in cystic fibrosis (CF). “Salt concentrations can be important for many health-related conditions,” said team leader Jian Yang, professor at Penn State University (University Park, PA, USA; www.psu.edu), “Our method uses fluorescent molecules based on citrate, a natural molecule that is essential for bone health.” Compared to other chloride detection methods, the citrate-based fluorescent material is much more sensitive to chloride and can detect it over a far wider range of concentrations.

In the new study, the citrate-based sensor was compared in a clinical lab against the gold standard sweat test – the results from both were found to be similar.

The new material is also sensitive to bromide, which even in trace amounts can interfere with the results of traditional clinical laboratory tests. With the citrate-based sensor, Prof.

Yang’s group can distinguish between chloride and bromide. The group is also working to establish a possible new standard for bromide detection in diagnosis of the disease.

In collaboration with Penn State electrical engineer Prof. Zhiwen Liu, the team is building a handheld device that can measure salt concentrations in sweat using the citrate-based material and a cell phone, which could be especially useful in areas with limited access to expensive analytical equipment. “We are developing a platform material for sensing that is low cost, can be automated, requires no titration by trained staff or expensive instrumentation as in hospitals, and provides fast, almost instantaneous, results,” said Prof. Liu. “Beyond CF, our platform can also be used for many other diseases, such as metabolic alkalosis, Addison’s disease, and amyotrophic lateral sclerosis (ALS). All of those diseases display abnormal concentrations of chloride in the urine, serum, or cerebral spinal fluid,” said Prof. Yang.

“According to recommendations from the CF Foundation (Bethesda, MD; USA) all patients undergoing evaluation for possible diagnosis of CF should have sweat testing performed,” said Robert Vender, a pulmonary specialist at Penn State Health Milton S. Hershey Medical Center, “To date, measurements of sweat chloride – in millimoles per liter – are only used for diagnostic purposes. However, given the recent scientific and medical advances in CF patientdirected therapy and the development and FDA approval of therapies specifically designed to modify CF transmembrane conductance regulator protein function, serial measurements of sweat chloride may have potential as a therapeutic surrogate indicator of drug effect, and is currently measured in many pharmaceutical-industry-sponsored studies as a response to these novel treatments. The link between the surrogate marker of sweat chloride and actual objective clinical outcomes such as improved lung function still remains to be determined.”

Jimin P. Kim, lead author and Yang lab graduate student, said, “Our citrate-based platform for designing fluorescent sensors provides us with great versatility in tailoring sensors to specific applications. We hope to produce more sensors with interesting applications in the near future” The study, by Kim JP et al, was published online August 30, 2016, in the journal Chemical Science.

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Image: A new citrate-based material, made with naturally fluorescing polymer nanoparticles, can now be used for highly sensitive detection of chloride, a key marker of cystic fibrosis (Photo courtesy of the Yang Laboratory, Penn State University).

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URINE CHEMISTRY ANALYZER

REAL-TIME PCR

HORIBA Medical

Erba Mannheim

QUIDEL

The Yumizen H550 features continuous loading, automatic sample mixing, positive identification of samples, and a manual mode for STAT samples for both open and closed tubes. The automatic system is designed to provide full walkaway capabilities in a variety of clinical environments.

The Laura XL features auto-recognition of 16 urine sediment elements, with the whole process automated for accuracy and reproducibility of results.

Cross-contamination is prevented by automatic cleaning, and humidity protection is ensured by a special dessicating system.

The QuantStudio Dx enables the creation of new assays in 96-well plates in IVD mode, while qPCR microfluidic card formats provide interchangeable thermal cycling blocks to accommodate throughput. A simplified instrument and workflow makes the entire test efficient and cost-effective.

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Immunoassay for Human Cystic Echinococcosis Evaluated ystic echinococcosis (CE) is a neglected disease caused by the larval stage of the tapeworm Echinococcus granulosus complex affecting both humans and livestock. The disease is considered one of the world’s major zoonoses, and represents a public health problem.

The early phase of infection is generally asymptomatic. Small, well encapsulated, viable cysts or old cysts with pseudosolid content typically do not induce major pathology, and patients may remain asymptomatic for years or even permanently. At present, no marker of cyst viability and therapy efficacy exists, and serology may remain positive for years even after successful therapy. As a consequence, long-term follow-up with imaging is required for the clinical management of patients. A team of scientists led by those at Porto Conte Ricerche (Tramariglio, Italy; www.portocontericerche.it) examined a total of 327 sera from CE patients with heterogeneous conditions for cyst stage, cyst number, organ localization, drug therapy, and surgical intervention,

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together with 253 sera from healthy controls. The sera were first analyzed by an enzyme-linked immunosorbent assay (ELISA) based on the antigen 5 (Ag5) preparation in two different setups and, in parallel, by a commercial ELISA routinely used in clinical laboratories for CE serodiagnosis.

Sera were tested in duplicate in the parasitology diagnostic laboratory by laboratory personnel with long standing experience in diagnostic parasitology, using a commercial ELISA test (RIDASCREEN Echinococcus immunoglobulin G (IgG), (R-Biopharm, Darmstadt, Germany; www.rbiopharm.com) for the detection of Echinococcus specific total IgG. Tests were read at 450 nm in a spectrophotometer, and a Sample Index (SI) was calculated and interpreted for each serum.

ELISA was considered positive for SI greater than 1.1, negative for SI less than 0.9, and borderline for 0.9 ≤SI ≤1.1. Sera were tested with the Ag5 ELISAs based on their Ag5 enriched preparation following two alternative setups. The absorbance was read at 620 nm after one-hour incubation using a Tecan Sun-

rise microplate reader (Tecan Group, Ltd.; Männedorf, Switzerland; www.tecan.com).

The Ag5 ELISAs revealed different sensitivity, 88.3% versus 95.3%, without significant differences in specificity, 94.1% versus 92.5%, for the two setups, respectively. Moreover, possible relationships between the Ag5 ELISA absorbance results and clinical variables were investigated. Chi squared test, bivariate logistic regression and multiple regression analyses highlighted differences in the serology reactivity according to pharmacological treatment, cyst activity, and cyst number.

The authors concluded that the good diagnostic sensitivity and the high reliability of the Ag5 preparation method make this antigen a promising candidate for the serodiagnosis of CE. Further studies will be needed to evaluate the ability of our test to provide useful information on specific CE clinical traits. The study was published on March 29, 2016, in the journal Public Library of Science Neglected Tropical Diseases.

Highly Sensitive Detection Method Monitors HDL Kinetics igh-density lipoprotein (HDL) is often referred to as good cholesterol, and high levels of HDL are associated with lower risk of cardiovascular disease, but many clinical outcome trials for drugs that raise HDL levels have failed to show significant benefits for trial participants. Current HDL detection methods usually measure only total HDL cholesterol, but a more sensitive detection method could allow investigators to measure the subfractions of HDL, and more precisely pinpoint which of these subfractions should be raised to help protect against cardiovascular events.

Scientists at Brigham and Women’s Hospital (Boston, MA, USA; www.brighamandwomens.org) and their colleagues studied three participants, two female and one male who were ages 25, 33, and 49 years old; were overweight or obese with a body mass index (BMI) of 26, 31, and 31 kg/m2; and had

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low HDL-C levels of 48, 37, and 24 mg/dl, respectively. The three participants ate a controlled, highunsaturated-fat diet for 32 days, 28 days prior to the kinetic study, and four days during the kinetic study.

Total plasma leucine (D3-Leu labeled and endogenous) was isolated from 0.2 mL of plasma from different time points and measured using a Gas Chromatograph/ Mass Spectrometer (GC/MS) 6890 GC, 5973 MS, (Agilent Technologies, Santa Clara, CA, USA; www.agilent.com). HDL was separated by size using nondenaturing polyacrylamide gel electrophoresis (ND-PAGE). Spectral counting was used for the relative quantification of the apolipoproteins. Peptide samples were analyzed with the Q Exactive mass spectrometer fronted with a Nanospray FLEX ion source, and coupled to an Easy-nLC1000 High performance liquid chromatography (HPLC) pump (Thermo Fisher Scientif-

ic, Bremen, Germany; www.thermofisher.com).

The investigators were able to identify 58 proteins in HDL that were shared among three participants. They followed up on seven of these proteins, monitoring their kinetics to better understand apolipoprotein metabolism and the formation of HDL particles. Their results suggest that the traditional view of the role of HDL in reverse cholesterol transport may oversimplify the roles and contributions of various components of HDL. The authors concluded that their study demonstrated the feasibility of closer monitoring of HDL kinetics. This approach not only revealed novel evidence for the formation of HDL particles, but also found that each HDL subfraction has a unique proteome, which may help to discover new therapeutic targets. The study was published on April 1, 2016 in Journal of Lipid Research.

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Quantitative Fetomaternal Hemorrhage Assessed with Lab Tests etomaternal hemorrhage (FMH) assessment is usually used to determine anti-D immunoglobulin dose in postpartum prophylaxis of the hemolytic disease of the fetus and newborn (HDFN). In maternal blood, fetal red blood cells (RBCs) can be identified due to the differences between them and adult RBCs and these are fetal hemoglobin (HbF) presence, lack of the carbonic anhydrase (CA), and the presence of particular group antigen.

Scientists at the Centre of Postgraduate Medical Education (Warsaw, Poland; www.cmkp.edu.pl) collected blood samples on EDTA as follows: 20 RhD-negative blood donors samples to evaluate test specificity, 18 RhD-negative blood donors and 18 RhDpositive cord blood samples to prepare mixtures imitating FMH from 0.1% to 5%, and 14 weak D blood donors samples to evaluate test specificity with anti-D antibodies and to perform 20 suspensions with the RBCs of 10 RhD-positive blood donors. Blood samples from 98 women were tested: 74 from women just before labor and in 1 to 2 hours after it, 10 only before childbirth, including five before 40 weeks of pregnancy, due to fetal anemia, and 14 only after labor.

The amount and parameters of RBCs were measured with the COULTER AcT diff/diff2 Hematology Analyzer (Beckman Coulter, Brea, CA, USA; www.beckman coulter.com ) to prepare RBCs mixtures with the known percentage of fetal cells. The team used three flow cytometry methods including Antigen D staining, Hemoglobin F (HbF) staining and HbF and carbonic anhydrase (CA) staining. The flow cytometer was calibrated correctly and in all samples, 50,000 RBCs were analyzed using FACSCanto II and FACSDiva software (Becton, Dickinson and Company, Franklin Lakes, NJ, USA; www.bd.com). The scientists also carried out Kleihauer–Betke test (KBT), which is based on HbF resistance to acid elution while HbA is removed from cells.

The hematologists found that in all artificial mixtures with known concentrations, FCTs and KBT with counting 10,000 RBCs had similar satisfying sensitivity and specificity. KBT with counting 2000 RBCs had to be disqualified because of significant discrepancies between expected and measured values of FMH. The test procedure with anti-D was easier and shorter than the remaining tests, but it can be only used for FMH assessment in RhD-negative mothers with RhD-positive newborns. In one clinical sample, it was impossible to distinguish fetal RBCs from maternal F cells in KBT and FC with anti-HbF but other tests were useful.

The authors concluded that the methods that use flow cytometry and anti-HbF, anti-D, and anti-HbF + anti-CA antibodies, as well as microscopic Kleihauer–Betke test detecting HbF-positive blood cells, with counting 10 000 of RBCs, have similar satisfying sensitivity and specificity. In the four tests, correlation between expected and obtained results was appropriate. Each test had some advantage and limitation in any clinical situation. Therefore, it is best to have opportunity to perform two or three assays in the laboratory. The study was published in the August 2016 issue of the International Journal of Laboratory Hematology.

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PRODUCT NEWS HEMATOLOGY ANALYZER

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The Genesis S1000 can handle 1-48 samples per run and has a throughput of 1,000 samples by continuous operation with five units per day (8 hours). It can be setup in five minutes with six-strip formats and can be used with GB RealQuant RTand GB RealQuant HBV, HCV, HIV PCR kits.

The AUTION ELEVEN AE-4022 provides standardized results by automatically reading the AUTION sticks 10EA to eliminate potential errors. Its high throughput makes it ideal as a stand-alone analyzer in medium- to high-volume labs, and as a back-up option for fully automated analyzers.

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Point-of-Care Testing Compared to Automated Blood Glucose Analysis

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iabetes mellitus is a metabolic disease that is characterized by hyperglycemia and blood glucose (BG) levels are helpful for the diagnosis and treatment of diabetes and an important part of the management of diabetes.

Point-of-care testing (POCT) is generally used by patients themselves or medical personnel to monitor BG. As it is simple to use and supplies rapid results, it might accelerate clinical decision-making and improve patients’ prognosis.

Scientists at the Guangxi Medical University (Nanning, China; www. gxmu.edu.cn) carried out a retrospective study comprising 162 volunteers (97 males and 65 females; median age, 47 years; range, 14 to 67 years).

Blood samples were collected with anticoagulation tubes for which hematocrit values ranged between 34.5% and 54% and the range of glucose concentrations were 1.60–21.30 mmol/L. Each sample was divided into two parts; one was separated by centrifugation and measured by the central laboratory system, and the other was measured by the POCT system in whole blood.

The team tested three types of BG meter: They were the ACCU-CHEK Performa and the ACCU-CHEK Active (Roche Diagnostics, Basel, Switzerland); www.roche.com), and the OneTouch UltraVue (Johnson & Johnson Medical Ltd, Shanghai, China; www.onetouch.com). The clinical laboratory measurement system used the Glucose GOD-PAP

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method with a Hitachi 7600-120 analyzer (Hitachi Corporation, Tokyo, Japan; www.hitachi.com) as a reference system.

The investigators showed that BG concentrations measured by venous whole blood was comparable with the reference method. Although the POCT can provide rapid measurement results, the type of specimen, interference factors, environmental conditions, and hematocrit may affect the results. The measurement accuracy of the POCT systems, being 94.9%, 92.6%, and 96.7% for ACCUCHEK Performa, ACCU-CHEK Active, and OneTouch UltraVue, respectively, did not all meet the requirements. The same result was found for BG concentrations equal to or greater than 5.55 mmol/L (100 mg/dL).

With BG concentrations of less than 5.55 mmol/l (100 mg/dL), the accuracy of all POCT systems meet the criteria.

The authors concluded that their study indicated that the POCT system could only be used as a screening test for continuous, qualitative, or semi-quantitative detection as a complement emergency measure to the central laboratory, instead of being used as a standard result in clinical diagnosis. If the POCT system is used in testing too low or too high BG concentrations in clinical diagnosis, it may mislead the diagnosis and treatment. The study was published on August 25, 2016, in the Journal of Clinical Laboratory Analysis.

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Handheld Coagulation Analyzer Recieves FDA Clearance or the first time, the US Food & Drug Administration (FDA) has given 510(k) clearance for a point-of-care (POC) Prothrombin Time / International Normalized Ratio (PT/INR) device based on the new rules published in March 2016. Winner of multiple design awards (e.g. Red Dot Award and iFDesign Award), the device includes a number of innovations and features not found on most other POC analyzers.

The handheld portable Xprecia Stride coagulation analyzer, from Siemens Healthineers (or Siemens Healthcare; Erlangen, Germany; www.healthcare. siemens.com), delivers fast, reliable PT/INR testing for POC monitoring and management of oral anticoagulation therapy with the vitamin K antagonist warfarin. Results are available within minutes. Features promote safety, accuracy, and ease of use. â&#x20AC;&#x153;Among the many challenges of POC testing, accuracy and safety have become paramount to both the user and patient.

With the Xprecia Stride analyzer, Siemens Healthineers delivers on the promise to bring a safe and lab-accurate test directly to the patient,â&#x20AC;? said Michael Sampson, senior vice president, Point of Care, Siemens Healthineers, North America, Millions of PT/INR tests are administered worldwide each year as part of therapy monitoring for patients with a host of conditions, including atrial fibrillation, heart valve replacement surgery, deep vein thrombosis, and congenital heart defects, among others. Xprecia Stride was designed to meet the growing demand for PT/INR results in physician offices and walk-in clinics to help healthcare professionals make informed decisions about patient care.

No bigger than a smartphone and weighing just 10.5 oz, Xprecia Stride can be held at virtually any angle and brought directly to the patientâ&#x20AC;&#x2122;s finger for efficient and comfortable blood sample application. Only a small sample volume is required, obtained by fresh capillary (fingerstick) draw of whole blood. Results are expressed as INR. Xprecia Stride utilizes the same Dade Innovin reagent used by Siemens Healthineers central lab analyzers to minimize potential for variability.

Studies have shown the performance to be equivalent to a reference laboratory hemostasis system (White Paper available online).

To further address challenges, the Xprecia Stride analyzer was designed to provide intuitive user interface and features such as an integrated barcode scanner (enters lot calibration information and operator and patient IDs) to simplify data capture and improve patient workflow. Data such as patient and QC results can be transferred via USB port. Xprecia Stride uses simple icons and animation in a color display more commonly found in mobile devices than medical instruments.

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Safety features include a first-of-its kind test strip eject button that allows the user to eject and easily dispose of a used test strip without touching it, minimizing potential biohazard exposure.

Taken together, these innovations enable better care for the growing number of patients receiving anticoagulation therapy.

Image: The Xprecia Stride coagulation analyzer brings hemostasis testing accuracy and quality from lab to simple point-of-care. Color-coded caps can be used to designate users or locations (Photo courtesy of Siemens Healthineers).

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LabMedica International

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Performance of Malaria Rapid Diagnostics Tests Evaluated Post-Treatment he performance of different malaria rapid diagnostic tests (RDT) may be influenced by transmission intensity and by the length of time each test requires to become negative after treatment and patient’s recovery. The number of different RDTs on the market has increased considerably over the past few years and most malaria RDTs are designed to detect a single parasite antigen, the histidine-rich protein 2 (HRP2) or the Plasmodium lactate dehydrogenase (pLDH), while others are designed to detect both antigens in a single test.

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Scientists at the Epicentre Mbarara Research Centre (Uganda; www.epicentre.msf.org) recruited consecutively all children who presented to any of the participating health centers, were under five years of age, weighed 5 kg or more, and had a fever. Blood samples obtained by finger prick from children whose parent or guardian provided written consent were tested in parallel at the corresponding study health center with the three different RDTs and with microscopy. At each site, a subset of 212 children was selected for the time to become negative analysis.

The following RDTs were evaluated: SD Bioline Malaria Antigen P.f (HRP2) (Standard Diagnostic Inc, Suwon, South Korea; www.standardia.com), CareStart Malaria HRP2 (Pf), and CareStart Malaria pLDH (PAN) (Access Bio, Somerset, NJ, USA; www.accessbio.net). For microscopy, thick and thin blood smears were prepared on the same slide and stained with a 10% Giemsa solution (pH 7.2) for 15 minutes. Reading was performed using a 100× magnification lens with oil immersion. Parasite density was estimated based on a hypothetical leukocyte density of 8,000 WBC/μL. The presence of gametocytes was recorded, although a slide with gametocytes but no asexual parasite forms was scored as negative.

The team reported that the median time to become negative was 35 and 42 days for the SD Bioline HRP2 in two different sites, and two days for the CareStart pLDH at both sites. For the CareStart HRP2 test, the median time could not be calculated because it exceeded 42 days, the maximum follow-up time for patients in the study. In the two settings, sensitivities ranged from 98.4% to 99.2% for the HRP2 tests and 94.7% to 96.1% for the pLDH test. Specificities were 98.9% and 98.8 % for the HRP2 tests and 99.7 % for the pLDH test in the low-transmission setting and 79.7%, 80.7% and 93.9 %, respectively, in the high-transmission setting.

The authors concluded that the ideal malaria RDT, a test that is both highly sensitive and highly specific in all epidemiological contexts is not yet available.

A choice is to be made between an HPR2 test, with the risk of over diagnosing malaria and thereby overlooking other possible causes of fever, and using a pLDH test, which carries the risk of missing true malaria cases with low parasitemia. The study was published on October 4, 2016, in the Malaria Journal.

Image: The CareStart Malaria rapid diagnostic tests that diagnose malaria infection from whole blood of patients in 20 minutes (Photo courtesy of Access Bio).

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Edited by Tahir Pillay MBChB, PhD, FRCPath(Lon), FCPath(SA)

NEWS

IFCC members may send news to: Tahir Pillay MBChB, PhD, Head, Dept of Chemical Pathology, Faculty of Health Sciences, University of Pretoria, Private Bag Bag x323, Arcadia, 0007, South Africa Tel: (27) 012-319-2114; Fax: (27) 012-328-3600; Email: enews@ifcc.org

2018-2020 IFCC Secretary and Treasurer Elected he IFCC Nominations Committee (B. Gouget, Chair; P. Laitinen, Past-Chair; G. Beastall, R. Christenson, AL Maselli, members) is pleased to announce that Dr. David Kinniburgh (Canada) has been elected IFCC Secretary and Prof. Tomris Ozben (Turkey) has been elected IFCC Treasurer. We congratulate them both and wish them a fruitful term in the promotion of clinical chemistry and laboratory medicine world-wide. The elections have been conducted via an electronic system in order to ensure the wider participation in this important moment in the IFCC life.

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Dr. David Kinniburgh, IFCC Secretary

cine, promote the value of laboratory medicine, and improve quality are the hallmarks of the IFCCâ&#x20AC;&#x2122;s importance and its success as an organization. As elected Secretary, Dr. Kinniburgh will work to maintain and to grow these vital activities.

His experience on the IFCC Executive Board has allowed him to gain an overall understanding of the IFCC structure and operations, including the challenges faced. The IFCC Executive Board has been progressive in its efforts to ensure that it is aware of the expectations of its members and in responding Contâ&#x20AC;&#x2122;d on page 28

David Kinniburgh IFCC Secretary

Dr. David Kinniburgh has been nominated by the Canadian Society of Clinical Chemists (CSCC) as a candidate for Secretary of the IFCC Executive Board.

He is the Director of the Alberta Centre for Toxicology at the University of Calgary and a Clinical Professor with the Department of Laboratory Medicine and Pathology at the University of Alberta and an Adjunct Associate Professor in Pharmacology and Therapeutics with the University of Calgary. His professional work experience includes hospital, academic and reference laboratories and he has been active both as a clinical scientist and a senior administrator.

He is the President of the IFCC North American Federation of Clinical Chemistry and Laboratory Medicine (NAFCC) and as such sits as a non-voting representative to the IFCC Executive Board (2015-2017). He is the Past President of the Canadian Society of Clinical Chemists and served previously as Treasurer. Dr. Kinniburgh is the President of the Alberta Association of Clinical Laboratory Doctoral Scientists, and he has served as President of the Alberta Society for Human Toxicology and the Alberta Society of Clinical Chemists.

He has served on a number of committees related to laboratory medicine in Alberta and Canada and currently sits on the Canadian Leadership Council on Laboratory Medicine and the LabCANDx Steering Committee, an organization established to promote the value of laboratory medicine. He is a member of the American Association for Clinical Chemistry Education Committee and he has also served on several committees organizing local, national and international scientific conferences. Over his career, he has been fortunate to meet and work with many laboratory medicine professionals throughout and beyond North America and this experience has broadened his awareness of laboratory medicine globally.

The IFCC plays a singularly vital role in promoting quality and standardization of laboratory medicine on a global basis. The many activities of the IFCC that serve to educate and train clinical biochemists and laboratorians, standardize and harmonize laboratory testing, advance the science of laboratory medi-

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Tomris Ozben IFCC Treasurer

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NEWS

News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information

2018-2020 IFCC Secretary and Treasurer Elected Cont’d from page 27 to those expectations. He has been involved in the strategic planning sessions and subsequent efforts to formulate responsive strategies, including: providing value to all members, responding to financial challenges, establishing collaborations with clinical organizations and other laboratory medicine organizations, expanding Spanish language programs and encouraging more involvement of young scientists, to highlight a few. In his position, Dr. Kinniburgh will continue to support these important initiatives.

His past experience and his skills will allow him to make a meaningful contribution to the IFCC Executive Board. The IFCC is glad to welcome Dr. David Kinniburgh as IFCC Secretary on the Board.

Prof. Tomris Ozben, IFCC Treasurer Prof. Tomris Ozben is a full professor since 1990 at the Dept. of Clinical Biochemistry, Faculty of Medicine, Akdeniz University, Antalya, Turkey. She obtained her Bachelor of Science from the American University “Robert College”, Istanbul, Turkey, Ph.D. in Biochemistry from Ege University, Izmir, Turkey and Specialty in Clinical Biochemistry from Marmara University, Istanbul Turkey.

She is serving actively the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) since 2001, as the Chair of the IFCC Congresses and Conferences Committee (C-CC) (for two consecutive terms; seven years); previously as Full Member (three years) and Corresponding Member (three years) of C-CC. In 2014, she was elected by the IFCC Council with over 60% of the votes to the position of IFCC Treasurer (2015-2017).

Prof. Ozben served as the Organising Committee Member of several EuroMedLabs (Glasgow 2005; Innsbruck 2009; Berlin 2011; Milan 2013; Paris 2015); WorldLabs (Fortaleza 2008; Berlin 2011; Istanbul 2014); IFCC General Conferences (Antalya 2008; Corfu 2010; and Kuala Lumpur 2012); Steering Committee Member of IFCC-Roche Bergmeyer Conferences (2008-2015); Member of the International Advisory Board of the 18th ICCCLM 2002, Kyoto, Japan; IFCC&AACC 2005, Orlando, USA. Since 2016, she is a member of the Board of Directors of the IFCC Foundation for Emerging Nations

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(FEN), a non-profit Charitable Trust devoted to improve the quality and delivery of laboratory medicine services, particularly in emerging nations.

In 2016, she received the “Distinguished Abstract for Scientific Excellence” award of AACC’s National Academy of Clinical Biochemistry (NACB), presented also oral as a hot topic in Clinical Chemistry.

She has been the President (2000-2003), Past- President (2003-2006) and Executive Board member (2006present) of the Balkan Clinical Laboratory Federation (BCLF); Advisory Board member of Forum of European Societies of Clinical Chemistry and Laboratory Medicine (FESCC; IFCC-Europe; 2001-2008); Advanced Courses Committee member of the Federation of European Biochemical Societies (FEBS; 1997-2001); American Biographical Institute, Research Board of Advisors since 2001.

During her tenure at Akdeniz University, Prof.

Ozben has been the Vice Rector, Director of Research Funds, Chairman of the Dept. of Clinical Biochemistry and Founding Director of the Central Laboratory at Akdeniz University Hospital which includes Clinical Chemistry, Microbiology, Virology, Toxicology, Haematology, Immunology, Coagulation, Therapeutic Drug Monitoring, Emergency, Pre-analytical and Point-of-Care Services. She has worked for more than 10 years in the Ethical Committee of Akdeniz University Hospital and Medical Faculty on themes concerning drug research in clinical trials. She has served as the Commission Member of the Turkish Ministry of Health for restructuring Medical Education and Teaching, and Member-Elect of the Turkish High Educational Council for four years. Prof. Ozben has been appointed as the National Representative by the Scientific and Technological Research Council of Turkey (TUBITAK) with the approval of the Ministry of Foreign Affairs since 2008. Teaching Clinical Laboratory Medicine to medical and non-medical students, residents, and fellows has been a primary activity in her career, delivering lectures on a variety of topics to clinicians and laboratory scientists, and serving as a mentor to numerous graduate students and take part at Post-Graduate Education Programmes (Specialty and PhD) at Akdeniz University. Currently, she is one of the Directors at Akdeniz University Hospital Central Laboratory and principal investigator of many research projects. In 2003, she received “Akdeniz

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University Outstanding Contribution” award, and in 2006 “Akdeniz University Science” award.

She is the author of 240 peer-reviewed manuscripts, 14 book chapters and editor of 3 books published by the International Publishers (Plenum Press, New York; IOS Press, Amsterdam). She attended more than 200 international congresses as an invited speaker and have organised several International Congresses, Courses, Workshops, Young Scientists Forums and Meetings supported by IFCC-FEBSIUBMB-BCLF-NATO-TUBITAK. Prof. Ozben is a member of the Editorial and Advisory Boards of many Scientific Journals, reviewer for several journals, and scientific projects evaluator for the Italian Ministry for University Education and Research (MIUR; 2003-present), Ministry of Science and Environmental Protection of Republic of Serbia (2005-present) and Israel Science Foundation (2012-present).

In her role of IFCC Treasures she will aim to: to maintain and improve IFCC as a valid and credible reference resource of expertise for standardization, harmonization accreditation, quality assurance standards, education, innovation, novel applications, evidenced base practise, clinical and cost effectiveness with novel and multiplex diagnostic technologies and pursuing global recognition of the importance of laboratory medicine and improvement of healthcare through laboratory medicine; to strengthen and re-target the financial situation of IFCC to achieve the most efficient outcomes, providing financial stability and robustness of income, and a healthy balance between income and expenses; to prepare to the arising financial difficulties regarding the new MedTech Europe Code of Ethical Business Practice which have already caused global policy changes in companies; revising the relationship with corporate members, by seeking compliance with the Ethical MedTech Conference Vetting System (CVS), and by focusing on specific projects and educational activities; to enhance cooperation and create a common discussion platform with IFCC Regional Federations and member societies; to maintain and enhance the privileges of IFCC full member societies and to increase the number of IFCC affiliate/corporate members; to enhance cooperation of IFCC with other clinical laboratory disciplines, and set up joint promotional activities with international organizations and corporate members; to promote professional development of clinical laboratory scientists at all levels and meet IFCC members’ expectations and professional needs recognizing the needs of both developed and developing countries; to promote publications and products from IFCC activities, to improve e-learning activities; to strengthen collaboration between laboratory professionals and companies active in laboratory medicine and related fields (e.g. in vitro diagnostics, pharma, IT, biotechnology, biotech networks, commercial lab services) to promote IFCC through international and regional congresses.

Her past experience and her skills will allow her to improve and maintain the functions and activities of IFCC. The IFCC is glad to welcome Prof Tomris Ozben as IFCC Treasurer on the Board.

The next IFCC election will be for the Corporate Member of the Executive Board and will take place electronically from 1st June- 30th June 2017. Results will be announced by 15th July 2017. IFCC corporate members constitute the voting members.

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News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information

NEWS

Winners of the Eight 2017 IFCC Distinguished Awards Announced FCC is pleased to announce the names of the winners of the eight 2017 IFCC Distinguished Awards.

The IFCC Distinguished Awards are bestowed to laboratory medicine professionals to recognize their outstanding achievements, publicize their exceptional research and contributions to medicine and healthcare, and encourage the overall advancement of clinical chemistry and laboratory medicine.

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Prof. Yuk M. Dennis Lo (Hong Kong) 2017 IFCC Distinguished Clinical Chemist Award, sponsored by IFCC This award recognizes specifically an individual who has made outstanding contributions to the science of Clinical Chemistry and Laboratory Medicine or the application of Clinical Chemistry to the understanding or the solution of medical problems.

Prof. Lo is the first to report the presence of high concentrations of cell-free fetal DNA in maternal plasma (Lo et al. Lancet 1997; 350: 485). This discovery has created a revolution in non-invasive prenatal diagnosis. He discovered a new biological phenomenon and over a period of 20 years has demonstrated innovation, stamina and vision to lead the field translating this discovery into a new platform technology for non-invasive prenatal diagnosis, which has created a paradigm shift in prenatal medicine. As a result, the number of invasive tests, with their associated risks, has been greatly reduced in many centres making prenatal testing safer and less traumatic for pregnant women and their families.

In addition, the success of non-invasive prenatal testing has shown the world a glimpse of the power of plasma DNA analysis, thus directly triggering the recent global interest in liquid biopsies for cancer detection and monitoring as well as translation to areas such as organ transplantation and autoimmune diseases. In recognition of Prof. Lo’s contribution to the area of non-invasive prenatal diagnosis, he has been given numerous prestigious awards and holds many foundational patents in non-invasive prenatal testing.

tor. Worthy of special merit is her work on behalf of developing countries as an IFCC leader and lecturer, fundraiser and most importantly as a mentor who hosted many individuals from developing countries at her home institution. Dr. Hicks has truly been an “ambassador to the world”: she has not just contributed to the promotion of Clinical Chemistry and Laboratory Medicine; she has brought an understanding of the field to a world community in unique ways.

Prof. Nader Rifai (United States) 2017 IFCC Award for Distinguished Contributions in Education, sponsored by Abbott Diagnostics This award recognizes specifically an individual who has made extraordinary contributions in establishing and developing educational materials for the Clinical Chemistry discipline to improve training and educational programs worldwide or in a region.

Prof. Rifai has made numerous contributions towards the education of individuals worldwide and

Dr. Jocelyn M. B. Hicks (United States) 2017 IFCC Henry Wishinsky Award for Distinguished International Services, sponsored by Siemens This award, recognizes specifically an individual who has made unique contributions to the promotion and understanding of Clinical Chemistry and Laboratory Medicine throughout the world.

Throughout her distinguished career Dr. Hicks has made highly significant contributions globally to the field of laboratory medicine. Her contributions to paediatric laboratory medicine are well recognized, as are her contributions to the stature and influence of the IFCC: she has been the only woman President in 65 years, since IFCC was founded. She has contributed her time and expertise toward the advancement of clinical chemistry and laboratory medicine. She has volunteered her time through active leadership and participation in the programs of many professional societies including, AACC, IFCC, NACB, CLSI and IAPLM. She has given lectures in forty seven countries as a member of IFCC, and is well known as an outstanding educa-

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has pioneered many innovative education tools. As the Editor-in Chief of Clinical Chemistry he has expanded the international reach of the journal as an educational tool. To date, over 1600 articles have been translated to one of 15 languages. He was the driving force behind many new educational tools that benefit training programs and students. He created the Clinical Chemistry Trainee Council, a web-based, and free of charge educational program for trainees and mentors in laboratory medicine. As Editor of the current edition of the Tietz Textbook of Clinical Chemistry, he is pioneering a modern experience to textbook publishing and usage by linking the textbook to cloud-based electronic learning tools.

Cont’d on page 30

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News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information

Winners of the Eight 2017 IFCC Distinguished Awards Announced Cont’d from page 29

Assoc. Prof. Susan Branford (Australia) 2017 IFCC Award for Significant Contributions in Molecular Diagnostics, sponsored by Abbott Molecular This award recognizes specifically an individual who has made unique contributions to the promotion and understanding of molecular biology and its applications in Clinical Chemistry and Laboratory Medicine worldwide.

Prof. Branford has made significant contributions to health outcomes and management of patients with Chronic Myeloid Leukaemia (CML). She developed molecular techniques to assess treatment response and drug resistance. These results correlate with patient outcome and such data now govern therapeutic decisions. She is a leader in international efforts for molecular method standardisation and reporting on a common scale, which have been adopted internationally and incorporated into international clinical practice guidelines to optimise patient outcomes. Prof. Branford is recognised as a leading national and international authority in molecular monitoring for patients with CML.

Dr. Eleftherios Diamandis (Canada) 2017 IFCC Distinguished Award for Laboratory Medicine and Patient Care, sponsored by Sekisui Diagnostics This award recognizes specifically an individual who has made unique contributions in Laboratory Medicine, its application in improving patient care, and having a worldwide impact in clinical medicine.

During his career Dr. Diamandis has made significant contributions to patient care through the discovery, validation and implementation of cancer biomarkers for early diagnosis, prognosis and prediction of therapeutic response. He developed major advances in the identification and application of proteomics, resolving the scope of the Kallikrein gene/enzyme family in human development and disease as well as the initiation and

progression of cancer. Recently he has new projects in male infertility, neurodegenerative disorders and autoimmune diseases. Through Dr. Diamandis’ leadership, training programs in research and clinical chemistry have been developed and the Division of Clinical Biochemistry at the University of Toronto is flourishing. Novel disease biomarkers and diagnostic tests have been developed and commercialized for the benefit of patients and scores of scientists, physicians and healthcare providers have been educated.

Dr. Diamandis has been recognized on several occasions by both the Canadian Society of Clinical Chemist and the American Association for Clinical Chemistry (AACC) with major awards related to research and education.

Prof. Mathias M. Müller (Austria) 2017 IFCC-Robert Schaffer Award for Outstanding Achievements in the Development of Standards for Use in Laboratory Medicine, co-sponsored by NIST and CLSI This award recognizes specifically an individual who has made outstanding and unique contributions to the advancement of reference methods and/or reference materials for laboratory medicine to facilitate improved quality of clinical diagnostics and therapies, which would in turn lead to reduced costs and improved patient care.

Prof. Müller has greatly contributed to the promotion of reference methods and materials in his roles as Chair of the Scientific Division of IFCC and later as its President. He was largely responsible for assembling infrastructure for the adaption of metrological principles to laboratory medicine including the collaboration agreements between the former Institute of Reference Materials and Methods (IRMM) and CLSI with the IFCC so that each of these organizations could work in tandem leveraging the unique strengths of each working together. He was also a driving force in supporting the Joint Committee for Traceability in Laboratory Medicine (JCTLM) which furthers meaningful standardization work in our domain. His article played a key role in developing and articulating the principles of sound metrological principles and a plan of action to improve analytical accuracy in medical laboratories.

Dr. Jack H. Ladenson (United States) 2017 IFCC Distinguished Award for Contributions to Cardiovascular Diagnostics, sponsored by HyTest This award honours an individual who has undertaken remarkable scientific work with cardiac markers or immunodiagnostic applications to improve cardiac disease diagnosis. It will be presented for the first time on occasion of the WorldLab Congress to be held in Durban in 2017.

Dr. Ladenson is one of the researchers who helped bring the field of cardiovascular diagnostics to its current state, being instrumental in the development of diagnostic tests for myocardial infarction and other cardiac diseases. He developed the first monoclonal antibody for the quantification of CK-MB, which was used by almost all commercial CK-MB measurement procedures and was for many years the gold standard biomarker of myocardial infarction. He then went on to develop the first monoclonal antibody and immunoassay for quantifying Troponin I the current gold standard biomarker for myocardial infarction. He used this assay to prove the clinical importance of this biomarker for evaluating myocardial infarction. His Troponin I assay is used in several current FDA-approved assays.

Dr. Rojeet Shrestha (Nepal) 2017 IFCC Young Investigator Award, sponsored by IFCC This award recognizes and encourages the academic and professional development of a young investigator (under 40 years of age) who has demonstrated exceptional scientific achievements in Clinical Chemistry and Laboratory Medicine in his/her career.

Dr. Shrestha started his career in laboratory medicine in his early 20’s involved in research work related to the immunological and molecular aspect of mycobacterial diseases. He worked in the clinical trial to improve the diagnosis of leprosy collaborating with world-renowned international institutions like Centre for Diseases Control and Prevention (CDC). He has demonstrated outstanding performance throughout his professional career and inspired other young medical scientists with several publications as a lead author in prestigious journals in the field and has been recognized with several prestigious awards. These include the National Academy of Clinical Biochemistry’s distinguished abstract award (2013), Japanese Society of Clinical Chemistry (JSCC)’s paper award (2015), American Association for Clinical Chemistry (AACC) Division Award for Excellence in Research (2015), and Asia-Pacific Federation for Clinical Biochemistry (APFCB)’s Young Scientist Award (2016). He is an associate fellow from US National Academy of Clinical Biochemistry (NACB).

He also active member in several academic and professional societies and editor of several journals.

Prof. Howard Morris, IFCC President Elect, Chair IFCC Awards Committee, said: "We are delighted in electing these colleagues for the 2017 IFCC Awards.

The Awardees are a witness of the contribution that IFCC gives to advancement of excellence in laboratory medicine for better healthcare worldwide. I’m happy that so many National Societies submitted excellent candidates: we had a very hard task selecting the Awardees among them. It has been a privilege considering them and we are sure that the Awardees will inspire a new generation of clinician-scientists worldwide".

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News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information

NEWS

VIEWPOINT

A New Type of Convergence Between Biology and Technologies: NBIC

by Dr. Bernard Gouget Counselor for Public Health FHF; Chair-Human Health Care Committee-COFRAC; IFCC Chair-Nominations Committee; General Secretary of the International Francophone Federation Of Clinical Biology and Laboratory Medicine (FIFBCML)

he 21st century is shaping up to be the century of the infinitely small. Biotechnology is advancing at a tremendous speed and will totally transform our relationship with the world in a few generations, changing our economy and reducing death. We have entered a new world filled with increasingly advanced technologies that surpass humans in many respects. We live in a new era where IT, biology and the sciences give meaning to life and offer infinite possibilities for evolution. Human beings have been able to accept and take advantage of these advanced technologies to push the limits of the body and develop ultra-connected tools designed to make everyday life easy. The result is a world where everything is within reach, where people live increasingly longer and are less sick and where the definition of well-being and speed keeps evolving.

According to Laurent Alexandre, surgeon and president of DNAVision, the origin of this revolution is NBIC. This acronym designates the connection of four scientific fields at the origin of the greatest medical, scientific and technological discoveries of the past few years: Nanotechnology, Biology, IT and Cognitive science (artificial intelligence and brain sciences). This synergy increases the power of research tenfold. The four components of the NBIC revolution fertilize each other and are leading us toward humanity 2.0. Genetics benefits from the explosion of computer calculation capacities and nanotechnologies vital for reading and modifying the DNA molecule. Nanotechnology will benefit from progress in IT and cognitive science, which itself will consist of three other components. Cognitive science uses genetics, biotechnology and nanotechnology to understand how to “enhance” the brain and to build increasingly sophisticated forms of artificial intelligence, eventually directly connected to the biological human brain!

Reparative nanomedicine is a good example.

Nanorobots can circulate throughout our bodies, able to move around and repair our defective molecules and genes. These nanotechnologies will allow producing and replacing any defective body part or organ and act in a very targeted manner in the heart of the cell.ll. Nanovectors will be able to transport the therapy into the right cells or even into certain compartments of the cell (nucleus, mitochondria, etc.).

Preliminary forms of nanovectors are already being tested to deliver chemotherapy in order to reduce the doses and affect only cancer cells.

Progress in genetic engineering allows us to glimpse a world where children can be augmented by manipulation of their genome. DNA sequencing is becoming more democratic. The cost of enzymes enabling DNA modification has been decreased 10,000 fold in ten years, which opens the way to DIY genomics. The genome industry will become the leading global industry during the 21st century. It is growing very quickly, from the production of sequencers to biochips and including gene repair techniques. Many genomic start ups are arising: synthetic biology is becoming a pillar of the global economy. Medicine will be completely transformed: it will become personalized medicine and many diseases will be eradicated.

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Electronic tools enhancing our sensory capacity have taken their first steps: Google Glasses and Facebook and Microsoft virtuality glasses. More long term, the interface of our brains with AI would be possible. Google supports Singularity University, which trains NBIC specialists. The term “Singularity” means the moment where the human mind will be exceeded by IA, which is expected to grow exponentially. Ray Kurzweil, an IA chief engineer at Google and a leader in trans-humanism, who believes that a citizen is an autonomous being who alone decides the changes they wish to make to themselves as science progresses, is convinced that NBIC will be able to dramatically reduce death in the next decades. Humanity becomes a perpetually evolving field for experimentation, which can be improved and modified. L. Alexandre asserts that we will progress from repaired humans to augmented humans. In the face of these developments, considerable ethical and moral problems will arise.

Should a young person be told about a predisposition to a future handicap when there is no treatment yet? On the other hand, can citizens be forbidden to know their genetic destiny? What are the limits of science and human dignity: do we have the right to modify the human species to increase its capacities and reduce aging and death? Should an international agency be responsible for compliance by all countries with limits to genetic transgression?

This is a unique moment in the history of technological creations; the improvement of human performance becomes possible by the integration of technology. The grand NBIC convergence will upset our entire philosophical framework in a few generations; its main use will being fighting disease since the aversion to death is universal. Humanity is going to have to deal with decisions that are probably irreversible in the field of genetic manipulation and artificial intelligence. The modification of the human species is a potential technical possibility. This change of perspective is dizzying, when we project for the long and very long term. Choosing to modify our genome or the functioning of our consciousness, orienting artificial intelligence, will lead to a lot of passion, ideological radicalization and even a risk of conflict. The question of regulation will become crucial, even vital. Allowing everything would be frightening; forbidding everything would not make sense, as long as it is not a question of making monsters but rather improving humanity, for example by increasing healthy longevity.

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News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information

14th International Congress of Paediatric Laboratory Medicine (ICPLM), Durban, South Africa, Oct. 20-22, 2017 n behalf of the Organizing Committee of the 14th International Congress of Paediatric Laboratory Medicine (ICPLM) and the Task Force on Paediatric Laboratory Medicine (TF-PLM) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), the IFCC invites you to the Congress in Durban, South Africa on October 20-22nd 2017.

The Congress will be organized in cooperation with the African Federation of Clinical Chemistry, the South African Association for Clinical Biochemistry and Laboratory Medicine, the Medical Research Council (SA) and the National Research Foundation (NRF), SA. The Congress will focus on the latest scientific and technological achievements in all areas of paediatric clinical and diagnostic laboratory medicine and we are certain that all participants will be enthused by the program. Taking place immediately before the IFCC World Lab Durban 2017, the Congress offers you the unique opportunity to gather the latest information in laboratory medicine for children as well as for adult patients.

The scientific programme will cover a wide range of topics and includes sessions on genetically determined diseases in children, metabolic disorders, newborn

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IFCC OFFICE Via Carlo Farini 81, 20159 Milan, ITALY Tel: (39) 02-6680-9912 • Fax: (39) 02-6078-1846 E-mail: ifcc@ifcc.org • Web: www.ifcc.org Office Hours: 8.30-13.00 and 13.30-17.30 Staff Members: Paola Bramati, Silvia Cardinale, Silvia Colli-Lanzi

IFCC PoCT Satellite Meeting, Durban, South Africa, Oct. 21, 2017 n behalf of the Organizing Committee of the IFCC PoCT Satellite Meeting and the Task Force on Point of Care Testing (TF-POCT) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), the IFCC invites you to the IFCC PoCT Satellite Meeting that will be held in Durban, South Africa on October 21st 2017.

Among the speaker Rosy Tirimacco, IFCC Chair of the Task Force on PoCT will highlight the “Important Points to Consider when Implementing PoCT” and the “Use of PoCT and Decision Support Software to Manage Atrial Fibrillation”.

Gerald Kost will focus on “Environmental Factors that can affect PoCT” and Sverre Sandberg on “How to Validate PoCT Equipment with Laboratory Equipment” and “Clinical Indications of PoCT”.

Other presentations by Adil Khan, Anne Skurup, Norman Moore, Trevor Allison, and Evan Ntrivalas will give indications respectively on: “How to Set Up a Quality Framework for PoCT”; “Avoiding Errors in Blood Gas Analysis”; “Use of PoCT for Diagnosis of HIV”; “PoCT for the Early Detection of Renal Disease”; “Supporting Management of Sepsis”.

During the meeting Rajiv Erasmus, Rosy Tirimacco and Sverre Sandberg will Debate about: “Who Should Take Ownership of PoCT - The Laboratory; The Health Service; - Combination of Laboratory and Health Service”.

We look forward to meeting you in Durban on 21st October 2017. For further information and registration, visit: www.durban2017.org/page/programme/satellite

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screening, allergy testing, nutrition, endocrinology, paediatric reference intervals, infectious diseases, challenges of the paediatric laboratory, and many other topics. We would also like to encourage you to submit your latest scientific research results to be presented in scientific poster sessions. The program will attract a wide variety of participants including laboratory physicians, pathologists, scientists and technologists, as well as practicing clinicians in paediatrics, neonatology, infectious disease and family medicine.

Durban, which is the third largest city in South Africa, is a natural paradise known for its gorgeous, safe swimming beaches and subtropical climate, warm Indian Ocean, variety of restaurants and rich cultural diversity.

Durban is situated on the eastern coast of Africa, in Kwazulu Natal province, where summer is all year long.

We look forward to hosting you in Durban in October 2017. For further information visit: www.icplm2017.org

LabMedica International May/2017

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Streck Enters Distribution Agreement with Dow Biomedica treck, Inc. (La Vista, NE, USA; www.streck.com), which develops and manufactures products for clinical and research laboratories, has entered into a distribution agreement for its cell stabilization, molecular and flow cytometry products with Dow Biomedica (Seoul, South Korea; www.dowbiomedica. co.kr), a distributor of diagnostic products specializing in immunology, microbiology and QC materials.

Streck’s products for clinical and research laboratories include automated erythrocyte sedimentation rate instruments, and blood collection tubes that standardize methods for sample collection, stabilization

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and transportation during clinical research studies, drug discovery and diagnostic assay development. The company’s product lines also include flow cytometry, body fluids and urinalysis, as well as rapid diagnostic tools being developed for molecular diagnostics. Streck is also developing a library of diagnostics tools that will soon be available in Korea and the rest of the world.

“We are pleased to partner with a company that will allow Streck increased market penetration,” said Connie Ryan, President and CEO at Streck. “In addition, Dow Biomedica will be able to provide excellent local support to our Korean customers.”

Greiner Bio-One to Serve Spain and Portugal through Distribution Subsidiaries reiner Bio-One (Kremsmünster, Austria; www.gbo.com) has acquired its long-standing distribution partners, VacuetteEspaña and Vacuette Portugal, which will now allow the medical technology company to serve its customers in Spain and Portugal directly through its own distribution subsidiaries.

Greiner Bio-One, a part of the Greiner Group, specializes in the development, production and distribution of high-quality plastic products for laboratory use. The company is a technology partner for hospitals, laboratories, universities, research institutes, the diagnostic and pharmaceu-

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tical industry and biotechnology.

For over 20 years, the Greiner Group has worked with VacuetteEspaña, S.A. and Vacuette Portugal Importação e Exportação de Material Hospitalar, S.A., both of which were previously exclusive distributors for Greiner Bio-One International on the Iberian Peninsula. Towards the end of February 2017, Greiner Bio-One entered into official acquisition agreements with both of its distribution partners that came into effect on March 1, 2017. The two subsidiaries in Madrid and Porto will now continue to supply directly to their customers in both the markets.

Global Analyzer Market to Reach USD 16 Billion by 2025 he global market for clinical chemistry analyzers is expected to reach USD 16.0 billion by 2025, driven by their increased adoption due to the growing prevalence of chronic diseases, fueled further by an increasing geriatric and bariatric population, which is highly susceptible to chronic diseases. The resulting high sample volume requiring high capability analyzing devices will drive the growth of the global clinical chemistry analyzers market, going forward.

These are the latest findings of Grand View Research, Inc., (San Francisco, CA, USA; www.grandview research.com), a market research and consulting company.

The increasing prevalence of chronic diseases, such as diabetes, is

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one of the key growth drivers of the global clinical chemistry analyzers market, as companies are producing advanced analyzers on a large scale to aid diagnosis. Moreover, technological innovations in clinical chemistry analyzers have led to early disease detection and specialized diagnosis in oncology, gynecology, & endocrinology and enabled testing on a larger scale.

Advancements such as advanced modeling & parameter estimation, better resolution, improved pattern recognition, computer-assisted interpretation, and artificial intelligence are providing various benefits, including automatic data acquisition, greater process control allowing real-time automation, efficient parameter monitoring, and automatic variable adjustment.

Industry News

Global Volume of IVD Procedures Exceeded 21 Billion in 2016 he global volume of in vitro diagnostic (IVD) procedures, excluding the over-the counter (OTC) point of care (POC) market and professional POC glucose monitoring activity, reached 21.4 billion in 2016. Currently, an estimated 80% of all conditions diagnosed by physicians worldwide are based at least partially on the results of IVD procedures.

These are the latest findings of Kalorama Information, (New York, NY, USA; www.kaloramainformation.com), an independent medical market research firm.

Over the past few years, significant progress has been made in IVD testing technology due to advances in functional genomics and proteomics, coupled with innovations in automated instruments, bioinformatics, and telecommunications. As a result of developments in IVD testing technology, new tools are becoming available for the detection and analysis of major health problems across the world, such as cancer, diabetes, heart disorders, and infectious diseases.

Evolving global epidemiological patterns, coupled with changing patient care approaches, are driving de-

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mand for a full range of routine and esoteric IVD procedures. Medical providers select IVD procedures based on various factors such as nature of the healthcare activity involved, presence or absence of obvious patient symptoms, patient characteristics and history, and, increasingly, cost and third-party reimbursement eligibility. Based on broad detection capabilities, core laboratories – which consolidate routine tests from multiple disciplines, chemistry, immunoassay, urinalysis, microbiology, coagulation, HPV cytology – held the largest share of global IVD procedure volume in 2016.

Going forward, medical providers across the world are expected to depend increasingly on POC and clinical laboratory tests to identify patient health problems in early stages and prescribe appropriate therapies. Increasing applications in testing of hospital patients, patients undergoing physical examinations and periodic healthcare checkups, and patients suspected of ingesting toxic substances will drive the volume of core laboratory procedures implemented across the world.

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JUNE 2017 EuroMedLab 2017. June 11-15; Athens, Greece; Web: www.ifcc.org FOCIS 2017 - Federation of Clinical Immunology Societies. June 14-17; Boston, MA, USA; Web: www.focisnet.org EAACI 2017 - European Academy of Allergy and Clinical Immunology .

June 17-21; Helsinki, Finland; Web: www.eaaci.org 2017 BIO International Convention.

June 19-22; San Diego, CA, USA; Web: http://convention.bio.org JULY 2017 ESHRE 2017 - European Society for Human Reproduction and Embryology Annual Meeting. Jul 2-5; Geneva, Switzerland; Web: www.eshre.eu FEMS 2017- 7th Cong. of European Microbiologists. July 9-13; Valencia, Spain; Web: www.fems-microbiology2017.kenes. com AACC 2017 – 68th Annual Meeting of American Association for Clinical Chemistry. July 30-Aug 1; San Diego, CA, USA; www.aacc.org AUGUST 2017 FIME 2017 - Florida International Medical Exhibition. Aug 1-3; Miami, FL, USA; Web: www.fimeshow.com SEPTEMBER 2017 ESP 2017 - 29th European Congress of

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