LabMedica International March 2022 by Globetech

V I S I T

WORLD’S CLINICAL LABORATORY NEWS LEADER ISSN 1068-1760

Vol. 39 No.1 • 2-3/2022

Marker Predicts Sepsis in Critical Patients

epsis has been reported as a major cause of increased morbidity, length of stay and mortality among patients hospitalized in Intensive Care Units (ICUs) for any cause. The survival of patients developing sepsis in the ICU is strictly related to an early

DAILY CLINICAL LAB NEWS

Novel Protein Biomarkers Evaluate Prostate Cancer Aggressiveness

rostate cancer is the most commonly diagnosed cancer in men and is among the top five causes of cancer-related death. In most cases, prostate cancer can be successfully treated but there is a group of patients who suffer an aggressive course and often

fatal outcome. In order to be able to treat prostate cancer more efficiently, it is necessary to understand the complex processes in the tumor at the molecular level. Though multiple genomic and transcriptomic-based analyses have been

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Simple Rapid Test Identifies Genetic Mutations in Cancer Cells for Personalized Therapy

nvestigators have developed an extremely sensitive test to detect and quantify, from a routine blood sample, DNA fragments containing rare genetic mutations in cancer cells. Faster and cheaper than current methods, the assay can be performed on widely available instruments. See article on page 4

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Rapid Antigen Screening for Bladder Cancer

rinary bladder cancer (BC) is the tenth most prevalent cancer affecting mainly the elderly and men. The suspicion of BC often arises after the detection of microscopic or macroscopic (gross) hematuria during a patient’s examination. An accurate urinary marker for BC could be valuable in identifying high-risk patients and reducing the number of control Cont’d on page 12

D-Serine Clearance Helps Measure Kidney Function

valuation of kidney function is essential in daily clinical practice. The measured glomerular filtration rate (mGFR) using exogenous inulin has been considered as the gold standard of kidney function, though this procedure is labor intensive, time consuming, and expensive. D-Serine is a candidate biomarker of kidney function. D-Serine circulates the blood Cont’d on page 10

INSIDE

Smartphone App with LAMP Kit Rapidly Detects COVID -19 / Flu Virus

COVID-19 Update. . . . . 5

n a potential game changer for COVID-19 pandemic control efforts, a new cell phone app and lab kit have transformed a smartphone into a COVID-19/flu detection system. The detection system developed by a team of research scientists at UC Cont’d on page 14

Sensitive Protein Assay Differentiates Parkinson’s from Other Synucleinopathies

team of British researchers adapted a sensitive analytical method to evaluate the diagnostic value of a real-time quaking-induced conversion (RT-QuIC) assay for assessing disease progression, stratification, and conversion in synucleinopathies such as

Parkinson’s disease. Synucleinopathies (also called alpha-synucleinopathies) are neurodegenerative diseases characterized by the abnormal accumulation of aggregates of alpha-synuclein protein in neurons, nerve fibers, or glial cells. There are three Cont’d on page 24

Clinical News. . . . . . 4-26 IFCC News. . . . . . . . . . 25 Product News . . . . . 6-28 Industry News . . . . . . . 29 Events Calendar . . 30-31

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LabMedica International

Simple Rapid Test Identifies Genetic Mutations in Cancer Cells for Personalized Therapy

A rapid, cheaper test can identify specific genetic mutations in a patient’s cancer cells for effective targeted therapy. Using a routine blood sample, investigators from the Public Health Research Institute of the New Jersey Medical School of Rutgers University (Newark, NJ, USA; www.rutgers. edu) have developed an extremely sensitive assay to detect and quantify DNA fragments containing rare genetic mutations in a patient’s cancer cells. This assay uses “SuperSelective” PCR primers that virtually ignore abundant closely related non-mutant DNA fragments derived from patients’ normal cells. The new assay is faster and considerably cheaper than current methods and can be performed on widely available instruments. Current techniques for analyzing liquid biopsies involve either next-generation sequence analysis, which is expensive, lengthy, and has limited sensitivity; or use a PCR technique in which both the mutant DNA fragments and the closely related wild-type DNA fragments are amplified, limiting sensitivity when the mutant DNA fragments are rare. The unique design of SuperSelective PCR primers, on the other hand, enables the amplification of the mutant DNA fragments, while effectively preventing the amplification of the abundant closely related wild-type DNA fragments. Consequently, the SuperSelective PCR assays are very sensitive. Multiplex SuperSelective PCR assays, utilizing frequent non-invasive liquid biopsies, enable the choice and subsequent modification of an effective targeted therapy for the treatment of an individual’s cancer. Furthermore, after treatment, these assays may help monitor the patient to detect the presence of minimal residual disease, enabling further intervention if necessary. To demonstrate the clinical potential of their approach, six DNA samples from the plasma of patients with cancer were assayed. The samples from five of the patients were blinded. Multiplex SuperSelective PCR assays

were performed to confirm the presence or absence of particular human epidermal growth factor receptor (EGFR) mutations in each sample. These mutations were chosen because their presence determines which targeted therapy is most likely to be effective against non-small-cell lung cancer. Four samples were positive for different EGFR target mutations and two samples did not give signals for EGFR target mutations. After the blinded samples were unblinded, it was revealed that the two negative samples were from patients who did not have EGFR mutations, and those samples were purposely provided as a control. The assays identified the previously known mutations in the other samples. Significantly, the assay also identified a very rare resistance mutation in one blinded sample that was not previously known to be present, suggesting that the patient’s targeted therapy needed to be changed. The researchers note that this technology might have other medical applications, such as the identification of rare antibiotic-resistant bacteria and the identification of rare mutant genes found in fetal cells circulating in a mother’s plasma. Thus, the availability of sensitive multiplex SuperSelective PCR assays is likely to have wide clinical utility. “The long-term goal of this research is to develop highly multiplex assays that enable both the early detection of mutations relevant to cancer before any symptoms have occurred and the application of an effective early treatment,” explained lead investigators Diana Yaneth Vargas, MS, and Fred Russell Kramer, PhD, from the Public Health Research Institute of the New Jersey Medical School of Rutgers University, Newark, NJ, USA. “These assays will use noninvasive liquid biopsies (routine blood samples) taken during a person’s annual medical checkup, and the DNA fragments transiently present in the blood sample (originating from cells that have died) will then be analyzed by highly multiplex real-time or digital PCR techniques.”

Regulatory and Other Rheumatoid Factors Analyzed in RA Patients

heumatoid arthritis (RA) is a long-term autoimmune disorder that primarily affects joints. It typically results in warm, swollen, and painful joints. Pain and stiffness often worsen following rest. Most commonly, the wrist and hands are involved, with the same joints typically involved on both sides of the body. Despite numerous studies, the only properties definitively established for rheumatoid factor (RF) are that RF is an antibody to the Fc portion of modified IgG, and that elevated RF levels are a diagnostic marker for RA. Both the mechanisms by which RF level is elevated in autoimmune and infectious diseases and the role that RF plays in

healthy and disease states remain speculative. Immunologists at the Udmurt State University (Izhevsk, Russian Federation; https://udsu.ru) studied a total of 32 patients with an established diagnosis of rheumatoid arthritis. Of those, 22 patients had high to moderate rheumatoid arthritis activity. Several of the patients had systemic manifestations, such as anemia, rheumatoid nodules, Sjögren’s syndrome. The duration of disease in the sample of RA patients studied was 2 to 20 years, with a mean of 8 ± 5.9 years and 35% of patients were receiving combination therapy. The RF direct latex test (VedaLab, Alençon, France; www.vedalab.com) was used to detect Cont’d on page 16

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ISSN 1068-1760

Vol.39 No.1. Published, under license, by Globetech Media LLC; Copyright © 2020. All rights reserved. Reproduction in any form is forbidden without express permission. Opinions expressed are solely those of the authors, and do not represent an endorsement, or lack thereof, by the Publisher of any products or services. Teknopress Yayıncılık ve Ticaret Ltd. Şti. adına İmtiyaz Sahibi: M. Geren • Yazı işleri Müdürü: Ersin Köklü Müşir Derviş İbrahim Sok. 5/4, Esentepe, 34394 Şişli, İstanbul P. K. 1, AVPIM, 34001 İstanbul • E-mail: Teknopress@yahoo.com Baskı: Postkom A.Ş. • İpkas Sanayi Sitesi 3. Etap C Blok • 34490 Başakşehir • İstanbul Yerel süreli yayındır. Yılda sekiz kere yayınlanır, ücretsiz dağıtılır.

LabMedica International February-March/2022

COVID -19 Diagnostics Update

he report that follows provides a selection of news and advances announced from October 16, 2021 to January 31, 2022. For a recap of earlier developments, the reader is invited to refer to previous issues of LabMedica or visit our website at www.LabMed ica.com. Newly-Launched Portable Molecular Diagnostic Platform Detects COVID -19 at POC within 30 Minutes A new portable molecular diagnostic platform and its compatible diagnostic test for the detection of SARS-CoV-2 from BIOPIX-T (Voutes, Greece; www.biopix-t.com) delivers results within 30 minutes at the Point-of-Care (POC). BIOPIX-T has launched its portable molecular diagnostic platform, the PEBBLE qcLAMP Platform, along with its compatible diagnostic test for the detection of the SARS-CoV-2 virus. PEBBLE is the first Greek portable molecular diagnostic device based on LAMP technology (Isothermal PCR), which can be used at the POC. PEBBLE as well as COV19 qcLAMP kit, the corresponding diagnostic kit to be used together with the diagnostic instrument for the detection of SARS-CoV-2, are now CE Marked.

(DTH) technology is the world’s first low cost, disposable, diagnostic to identify a T-cell immune response to the presence of SARS-CoV-2. Data for this form of testing suggests it may even be more accurate than current methods, by measuring the immune system’s active infection response.

End-to-End Diagnostic Platform could be Game Changer for En-Masse, Rapid and Precise COVID -19 Diagnosis A new diagnostic platform from Dotz Nano Ltd. (Kefar-Sava, Israel; www.dotz.tech) could be a game-changing, end-to-end solution for en-masse, rapid and precise diagnosis of COVID-19 and other viruses at the point-of-care (POC). The Dotz Mega-Diagnostic Platform is an all-in-one solution that consists of proprietary DOTZ Test Kits, an integrated diagnostic system, and a results-management system. The Dotz Mega-Diagnostic Platform is based on RT-LAMP (Loop-Mediated Isothermal Amplification) technology with >95% true positive rate for viral loads of 1250 copies per mL; and 100% specificity.

Novel Sensor Detects SARS-CoV-2 without Antibodies in Minutes Using specialized carbon nanotubes, a team of scientists at the Massachusetts Institute of Technology (MIT; Cambridge, MA, USA; www. web.mit.edu) has designed a novel sensor that can detect SARS-CoV-2 without any antibodies, giving a result within minutes. The new sensor is based on technology that can quickly generate rapid and accurate diagnostics, not just for COVID-19 but also for future pandemics.

New Viral Panel Enables Simultaneous Testing for SARS-CoV-2 and Common Respiratory Viruses Researchers at Augusta University (Augusta, GA, USA; www.augusta.edu) along with Illumina (San Diego, CA, USA; www.illumina.com) have developed a viral panel that enables the simultaneous testing for SARS-CoV-2 along with numerous common respiratory viruses, that tells us whether Cont’d on page 6

New Glycan-Based Flow-Through Device Detects SARS-COV-2 Using Sugars Rather than Antibodies A collaborative study by the University of Warwick (Coventry, UK; www. warwick.ac.uk), Iceni Diagnostics Ltd. (Norwich, UK; www.icenidiagnostics. com) and UHCW NHS Trust (Coventry and Warwickshire, UK; www.uhcw.nhs. uk) has demonstrated a new technology to detect SARS-COV-2 using sugars rather than antibodies. The new research showed that glycans (sugars) can be used to detect COVID-19 infection from swab samples. The proof of concept demonstrated that next generation glycan-based rapid diagnostics can be deployed in real world situations.

New Flow Control Technology Turns Simple COVID -19 Dipstick Tests into Complex Biomedical Assays A team of researchers at the Georgia Institute of Technology (Atlanta, GA, USA; www.gatech.edu) attempting to overcome the limitations of dipsticks have developed a flow control technology that can turn these simple tests into complex biomedical assays. The researchers have applied the new technology in a toolkit to diagnose the novel coronavirus, as well as influenza.

World’s First Low Cost, Disposable COVID-19 Diagnostic Test to Identify T-Cell Immune Response to SARS-CoV-2 A new test is being jointly developed by BioVaxys Technology Corp. (Vancouver, Canada; www.biovaxys. com) and WuXi Biologics (Jiangsu, China; www.wuxibiologics.com) to screen for a T-cell-mediated immune response to SARS-CoV-2 instead of just testing for the virus itself. The test called CoviDTH based on Delayed-Type Hypersensitivity

LabMedica International February-March/2022

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MOLECULAR DIAGNOSTIC SYSTEM

REAL TIME PCR PLATFORM

WHOLE SALIVA COLLECTION DEVICE

The VERSANT kPCR Molecular System delivers accurate, reliable results with optimal productivity and flexibility, enabling laboratories to meet emerging challenges as well as routine needs in molecular diagnostic testing.

The VIASURE V-Lab96 Real Time PCR Platform is an open platform for in vitro diagnostics that allows for the analysis of 96 samples simultaneously for qualitative and quantitative PCR.

The SDNA saliva collection device is a self-contained saliva collection system that provides critical sample consistency while suspending and neutralizing viral RNA transcripts post-collection for sensitive and specific analysis.

SIEMENS HEALTHINEERS

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CERTEST BIOTEC

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COVID -19 Diagnostics Update Cont’d from page 5

other viruses also are at play in patients hard hit by COVID. The new genetic epidemiology tool provides detailed genetic information about the viruses present when packaged with a molecular immunology model called Nextstrain. It also enables researchers to assess the novel viral variants that are circulating in a state or nation and patterns for their spread with the goal of helping predict and mitigate future outbreaks.

Rapid Saliva Tests as Good as PCR Tests for Diagnosing COVID -19 in Early Phase of Infection Researchers from Lund University (Lund, Sweden; www.lunduniversity. lu.se) investigating whether rapid antigen testing can be used on saliva instead of swabbing the nasal cavity have found that saliva could be good enough for diagnosing COVID-19 in the early phase of infection. The researchers believe that rapid saliva tests are a good alternative to standard PCR testing, and can also supplement these methods as screening needs increase.

Molecular COVID -19 Diagnostic System Aims to Provide PCR Lab in the Palm of Your Hand A new molecular diagnostic system from Anavasi Diagnostics (Seattle, WA, USA; www.anavasidx.com) offers a significant advancement in rapid, precise and affordable diagnostic testing for the SARS-CoV-2 virus and is expected to provide results equivalent to lab-based PCR testing in less than 30 minutes. The AscencioDx uses sophisticated LAMP (loop-mediated isothermal amplification) molecular diagnostic chemistry and hardware technology to detect HIV viral variants. Now, the same approach is poised to make COVID-19 testing easier and more accurate for everyone.

Newly-Developed Paper-Based Blood Test Detects COVID -19 Immunity within 10 Minutes Researchers at Singapore-MIT Alliance for Research and Technology (SMART; Singapore; www.smart.mit.edu) have successfully developed a new rapid point-of-care test for the detection of SARS-CoV-2 neutralizing antibodies (NAbs). This simple test, only requiring a drop of blood from a fingertip, can be performed within 10 minutes without the need for a laboratory or specially trained personnel.

Ultra-Fast COVID -19 PCR Test to Achieve High Accuracy at Speed 20 Times Faster than Lab-Based PCR Tests miDIAGNOSTICS (Leuven, Belgium; www.midiagnostics.com) has developed a rapid COVID-19 PCR test that has the potential to achieve an excellent accuracy at a speed 20 times faster than ‘classic’ PCR machines in labs. The test, based on the company’s highly innovative diagnostics platform, involves the transfer of a nasopharyngeal swab sample on a PCR test card, from which the results are read by a compact reader.

THERMO FISHER SCIENTIFIC

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New Test Measures Both T-Cell and Antibody Response to SARS-CoV-2 in Single Blood Sample A new test developed by scientists at Cardiff University (Cardiff, UK; www. cardiff.ac.uk) in collaboration with biotechnology company ImmunoServ Ltd. (Wales, UK; www.immunoserv.com) can measure both the T-cell and antibody response to SARS-CoV-2 in a single blood sample. The unique approach can also be used to measure the immune response brought about by vaccination and previous infection.

New Device Detects Viruses like COVID -19 in the Body as Fast as Rapid Tests With 95% Accuracy Researchers at the University of Central Florida (UCF; Orlando, FL, USA; www.ucf.edu) have developed a device that detects viruses like COVID-19 in the body as fast as and more accurately than current, commonly used rapid detection tests. The optical sensor uses nanotechnology to accurately identify viruses in seconds from blood samples. Researchers say the device can tell with 95% accuracy if someone has a virus, a significant improvement over current rapid tests that experts warn could have low accuracy.

Compact CRISPR System Enables Portable COVID -19 Testing A new form of CRISPR technology developed by bioengineers at King Abdullah University of Science and Technology (KAUST; Makkah, Saudi Arabia; www.kaust.edu.sa) that takes advantage of a compact RNA-editing protein could lead to improved diagnostic tests for COVID-19. The platform relies on a miniature form of the Cas13 protein that some microbes use to defend themselves from viruses. This RNA-cutting enzyme can be designed to cleave any target sequence, including parts of the genome from SARSCoV-2.

New 1-Minute COVID -19 Saliva Test Enables Swift Diagnosis of SARS-CoV-2 Infection A new 1-minute COVID-19 saliva test for identifying individuals infected by SARS-CoV-2 has been designed by Abionic SA (Lausanne, Switzerland; www.abionic.com) for use at schools, events, companies, hotels, or airports, where swift diagnosis is key. Abionic has obtained the CE Mark (Conformité Européenne) for its new 1-minute COVID-19 saliva test using its cutting-edge testing platform, abioSCOPE. This allows Abionic to commercialize its ultra-fast test for identifying individuals infected by SARS-CoV-2 throughout the European Union.

New COVID -19 Rapid Test Identifies Antibody Effectiveness against Multiple SARS-CoV-2 Variants A new test devised by biomedical engineers at Duke University (Durham, NC, USA; www.duke.edu) can quickly and easily assess how well a person’s neutralizing antibodies fight infection from multiple variants of COVID-19 such as Delta and the newly discovered Omicron variant. The test could potentially tell doctors how protected a patient is from new variants and those currently circulating in a community or, conversely, which monoclonal antibodies to treat a COVID-19 patient. Cont’d on page 8 LabMedica International February-March/2022

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PRODUCT NEWS

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CARDIAC PANEL

COVID-19 AG SELF TEST CTK BIOTECH

FULLY AUTOMATED ELISA/CLIA ANALYZER MONOCENT

The Triage Cardiac Panel is a rapid, point of care fluorescence immunoassay used with the Triage MeterPro. This test is designed to determine the level of creatine kinase MB (CK-MB), myoglobin and troponin I.

The OnSite COVID-19 Ag Self Test is a single-use lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab specimens from individuals suspected of COVID-19.

The MONOLYZE AX1100 is a fully automated ELISA and CLIA analyzer with a patented dual-function reader that automatically switches between absorbance and chemiluminescence reading.

QUIDEL

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COVID -19 Diagnostics Update Cont’d from page 6

Rapid COVID -19 Test Compares Solidly With PCR Detection in Largest Field Hospital Study In what is believed to be the largest prospective study of its kind to date, researchers at Johns Hopkins Medicine (Baltimore, MD, USA; www.hopkins medicine.org) and collaborators have reported that a rapid antigen detection test for SARS-CoV-2 proved more effective than expected when compared with virus detection rates using the established standard test, the polymerase chain reaction (PCR) assay. The study involved some 6,000 patients seen at the Baltimore Convention Center Field Hospital (BCCFH) during a 10-day period around the beginning of 2021.

New Test Developed Using AI Proves Almost 100% Accurate In Detecting COVID -19 Antibodies A new test developed by scientists at the University of Aberdeen (Aberdeen, UK; www.abdn.ac.uk) using AI-assisted technology has proven to be almost 100% accurate in detecting COVID antibodies.  The Universal EpitoGen SARSCov-2-test passed the penultimate round of quality assurance assessments by the NIBSC with a reported accuracy that would outperform existing COVID tests.

Sugar-Coated COVID -19 Test Strip Detects All Known Coronavirus Variants Researchers at the University of North Carolina at Chapel Hill (Chapel Hill, NC, USA; www.unc.edu) and University of California San Diego (La Jolla, CA, USA; www.ucsd.edu) have taken advantage of the coronavirus’ sweet tooth by designing a sugar-coated COVID-19 test strip that has proved effective at detecting all known variants of the virus, including delta. In the next few weeks, researchers will determine if the self-test known as GlycoGrip can detect infections caused by the omicron variant as well.

Light-Activated Enzymes Could Significantly Improve PCR-Based COVID -19 Diagnostic Tests

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sensor that has the potential to speed sample turn-around time while maintaining the sensitivity and specificity parameters that make molecular testing powerful.

Novel Approach to COVID -19 Testing May Lead to Much Faster, Less Expensive and More Accurate Tests Using mathematical simulations, researchers at the Massachusetts Institute of Technology (MIT; Cambridge, MA, USA; www.web.mit.edu) have shown that it would be possible to design a sensor, based on quantum physics that could detect the SARS-CoV-2 virus. This novel approach to testing for the presence of the virus that causes COVID-19 may lead to tests that are faster, less expensive, and potentially less prone to erroneous results than existing detection methods.

Highly Accurate, POC Test Measures Level of Neutralizing Antibodies (NAb) to COVID -19, Including Variants A new, highly accurate, point-of-care (POC) test developed by scientists at the Burnet Institute (Melbourne, Australia; www.burnet.edu.au) and the Peter Doherty Institute for Infection and Immunity (Melbourne, Australia; www. doherty.edu.au) can measure the level of neutralizing antibodies (NAb) to COVID-19, including variants. The test that provides a readout from a fingerprick of blood in less than 20 minutes is the first of its type globally, and could also be useful to indicate when a vaccine booster may be required.

Radiolabeled Antibody Saliva Test for Detecting SARSCoV-2 Delivers Rapid, Accurate and High Volume Results International Isotopes Inc. (INIS; Idaho Falls, ID, USA; www.intisoid.com) has entered into an exclusive licensing agreement with Memorial Sloan Kettering Cancer Center (MSK; New York, NY, USA; www.mskcc.org) for developing an accurate, inexpensive, portable, high volume, rapid and non-invasive saliva-based testing kit to detect SARS CoV-2 using radiolabeled antibodies. The company believes the technology could have much broader applications to address other viruses or the next emerging pandemic infection.

Isothermal Amplification Based COVID -19 Test System Could Detect Any Coronavirus Variant

A new approach developed by biochemists at the Ludwig Maximilian University of Munich (LMU; Munich, Germany; www.lmu.de) that uses enzymes triggered by light pulses could help to significantly improve COVID-19 diagnostic tests based on PCR. The approach is expected to help produce better enzymes for biotechnological and diagnostics use.

Researchers at the HSE University (Moscow, Russia; www.hse.ru) have developed a strategy to create a cheap and rapid COVID-19 test based on isothermal amplification that will make it possible to create universal test systems for any of the COVID-19 variants. The strategy will decrease the cost of COVID-19 tests considerably and speed up the process, since no specially trained professionals or expensive equipment will be needed.

New Methodology to Detect SARS-CoV-2 that Produces Reliable Results More Quickly Could Be a Game-Changer

Game-Changing Diagnostic Test for SARS-CoV-2 Rapidly Differentiates Between COVID -19 and Influenza

Researchers at the Binghamton University (Binghamton, NY, USA: www. binghamton.edu) have developed a new methodology to detect SARS-CoV-2 that can produce reliable results more quickly than other methods could be a game-changer in COVI-19 testing. The team has developed a nucleic acid

An interdisciplinary team of researchers at the University of Florida (Gainesville, FL, USA; www.ufl.edu) has developed a game-changing diagnostic test for SARS-CoV-2 that is fast, reliable, low-cost and capable of differentiating Cont’d on page 10 LabMedica International February-March/2022

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SARS-COV-2 / INFLUENZA TEST

WHOLE BLOOD GLUCOSE QC

MOLECULAR DIAGNOSTICS SYSTEM

The Actim SARS-CoV-2+Actim Influenza A&B is a qualitative immunochromatographic test based on monoclonal antibodies. It distinguishes between respiratory infections with only a single respiratory sample required for both tests.

The CueSee Glucose WB (PT) is an unassayed glucose QC material designed for application in Proficiency Testing (PT) / External Quality Assessment Schemes (EQAS) to verify the precision and accuracy of blood glucose meters.

The cobas 5800 is a compact, fully-automated real-time PCR diagnostics system that offers expanded on board capacity, allowing labs to test multiple assays simultaneously and delivers up to 144 results in an eight-hour shift.

MEDIX BIOCHEMICA

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EUROTROL

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COVID -19 Diagnostics Update Cont’d from page 8

between COVID-19 and influenza. The researchers also demonstrated its ability to detect two viruses in 50 minutes without using bulky or sophisticated laboratory equipment or power supply, and with detection sensitivity that is on par with that of the gold-standard RT-PCR (reverse transcription polymerase chain reaction) assay.

New Molecular Diagnostic Platform Developed Using Gold Nanoparticles Shortens COVID -19 Diagnosis Time Researchers at the Chung-Ang University (Seoul, South Korea; www. neweng.cau.ac.kr) have used gold nanoparticles to develop a new molecular diagnostic platform that considerably reduces the time required for COVID-19 detection. The novel nanotechnology-based platform could also create a paradigm shift in the field of molecular diagnostics, revolutionizing how we detect infectious diseases and tackle future epidemics.

cont’d from cover

ROCHE DIAGNOSTICS

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New Rapid Test Simultaneously Diagnoses COVID -19 Infection and Predicts Disease Course Researchers at the Paul Scherrer Institute (PSI; Switzerland; www.psi.ch) and the University of Basel (Basel, Switzerland; www.unibas.ch) have developed a COVID-19 rapid test based on a novel functional principle that promises reliable and quantifiable results concerning a patient’s disease and its course. The test can also provide evidence concerning other diseases and COVID variants that may be present.

Lab-In-A-Backpack Offers Fast, Affordable, Reliable COVID -19 Testing Scientists from Queen Mary University of London (London, UK; www. qmul.ac.uk) have created a simple COVID-19 testing lab that fits into a backpack providing a cheap and effective solution for low income or remote areas. In a new study, the team has shown that their lab-in-a-backpack approach is as effective as commercially available COVID-19 tests at detecting SARS-CoV-2. The compact kit is relatively inexpensive to make, costing USD 51 in total.

D-Serine Clearance Helps Measure Kidney Function

stream in the body and is delivered to the kidney. D-Serine is then filtrated through the glomerulus and excreted in the urine. When kidney function is impaired, the urinary excretion of D-serine decreases, and its blood level increases. Medical Scientists at the Osaka University (Osaka, Japan; www.osaka-u.ac.jp) and their colleagues carried out a cross-sectional observational study of 200 living kidney transplant donors and recipients enrolled between July 2019 and December 2020, for whom GFR was measured by clearance of inulin (C-in). The clearance of D-serine (C-DSer) was calculated based on blood and urine levels of D-serine, as measured by two-dimensional high-performance liquid chromatography. Analytical performance was assessed by calculating biases. Utilizing data from 129 participants, the team developed equations for C-in based on C-DSer and C-cre using a linear regression model, and the performance was validated in 68 participants. Creatinine in serum and urine was measured enzymatically (Determiner L CRE, Hitachi Chemical, Tokyo, Japan; www. hitachi.com), and serum cystatin C (sCys) was

measured using an immunological turbid metric assay (Nescoat GC Cystatin C, Alfresa Pharma, Osaka, Japan; www.alfresa-pharma.co.jp). The investigators reported that in the overall cohort, the mean values of serum creatinine, cystatin C, and plasma D-serine were 0.86 mg/dL, 1.1 mg/L, and 2.3 μM, respectively. The mean clearances of inulin, creatinine, and D-serine were 66.7, 98.2, and 55.7mL per minutes per 1.73m2 of body surface area, respectively. The levels and clearances of D-serine in plasma and serum were almost identical and so they used plasma level of D-serine in the analysis. In the total cohort population, C-DSer was significantly and strongly correlated with C-in (R = 0.91), like C-cre (R = 0.93). Remarkably, the clearance of D-serine agreed well with GFR. The low bias as a measure of GFR was an advantage for the D-serine clearance. The degree of bias against GFR was smaller than that of the creatinine clearance. Additionally, the combinational analysis of clearances of D-serine and creatinine could measure GFR with high performance. Tomonori Kimura, MD, PhD, the senior author of the study, said, “D-Serine turned out to be of great clinical importance. D-Serine

may solve the problem of kidney disease with more than 800 million patients in the world. Measuring D-serine is applicable in a wide range of clinical fields and for drug development.” The authors concluded that the combination of C-DSer and C-cre can measure the GFR with precision and minor biases. The current method using endogenous molecules may reduce clinical burdens for measuring GFR. The new method is precise across the tested range of GFR and has the potential to facilitate key clinical decisions in various clinical situations. The study was published on December 4, 2021 in the journal EClinicalMedicine. LabMedica International February-March/2022

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The Novodiag System is a molecular diagnostic platform that offers a simple and fast way to pinpoint patients most at risk with targeted and syndromic on-demand testing.

The HumaLoop M is especially designed as a consolidated platform based on the easy-to-use Loopamp technology for sample preparation, amplification, and easy visual result reading.

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Rapid Antigen Screening for Bladder Cancer

cystoscopies. The broad spectrum of pointof-care (POC) urinary analysis tests currently available facilitates the rapid, non-invasive, and cost-efficient determination of urinary markers, but have a high rate of false positives. A large international team of Urologists and their colleagues led by those at the Charité - Universitätsmedizin Berlin (Berlin, Germany; www.charite.de) analyzed data from 1,787 patients from 13 participating centers tested between 2012 and 2020, including 763 patients with BC. Urine samples were analyzed with the UBC Rapid Test (IDL Biotech, Bromma, Sweden; www.idlbiotech. com). The results were quantified by the Concile Ω 100 POC reader (Concile, Freiburg, Germany; www.concile.de).

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The nomograms were developed using data from 320 patients and externally validated using data from 274 patients. The diagnostic accuracy of the UBC Rapid Test was evaluated using receiver operating characteristics analysis. Brier scores and calibration curves were chosen for validation. Biopsy-proven BC was predicted using multivariate logistic regression. The investigators reported that the sensitivity, specificity, and area under the curve for the UBC Rapid Test were 46.4%, 75.5%, and 0.61 for low-grade (LG-) BC, and 70.5%, 75.5%, and 0.73 for high-grade (HG-) BC, respectively. Age, UBC Rapid Test results, smoking status, and hematuria were identified as independent predictors of primary BC. After external validation,

nomograms based on these predictors resulted in an area under the curve of 0.79 and 0.95 in predicting LG-BC and HG-BC, respectively, showing excellent calibration associated with a higher net benefit than the UBC Rapid Test alone for low and medium risk levels in decision curve analysis. The authors concluded that the UBC Rapid Test alone has limited clinical utility for predicting the presence of BC. However, its combined use with BC risk factors including age, smoking status, and hematuria provides a fast, highly accurate, and non-invasive tool for screening patients for primary LG-BC and especially primary HGBC. The study was published on December 20, 2021 in the British Journal of Urology.

Marker Predicts Sepsis in Critical Patients

diagnosis, as well as a prompt start of appropriate medical interventions. Among biomarkers of sepsis, procalcitonin (PCT) is acknowledged as the single best parameter for patients at the ICU. However, even with serial PCT measurements, the level of sensitivity and specificity achieved for the prediction of sepsis was at best equal to 75%. Recent findings suggested using Monocyte Distribution Width (MDW), a relatively simple proxy of innate monocyte response to bacterial or fungal bloodstream invasion, as a biomarker for the early recognition of sepsis. A multidisciplinary team of medical scientists led by those at the University of Chieti (Chieti, Italy) performed an observational, prospective study to estimate the analytical performance of MDW in detecting sepsis or septic shock in patients hospitalized at the ICU of the General Hospital of Pescara (Abruzzo, Italy).

Sepsis and septic shock were diagnosed according to the diagnostic criteria of the Sepsis-3 classification. Microbiology identification and sensitivity assays were performed, using the Vitek2 system (bioMérieux, Marcy l’Etoile, France; www.biomerieux.com), Accelerate Pheno Test (Accelerate Diagnostics, Tucson, AZ, USA; www.acceleratediagnostics.com), GeneXpert (Cepheid, Sunnyvale, CA, USA; www.cepheid.com), as well as disc diffusion methods and agar MIC determinations by antibiotic discs and MIC test strips (Liofilchem, Roseto degli Abruzzi, Italy; www.liofilchem.com). Blood cell counts including MDW were determined with the UniCel DxH800 hematologic analyzer system (Beckman Coulter, Inc., Brea, CA, USA; www.beckman.com). The investigators reported that a total of 211 patients were observed, 129 of whom were included in the final sample due to the suspect of ensuing sepsis; of

these, 74 (57%) had a confirmed diagnosis of sepsis, which was best predicted with the combination of MDW > 23.0 and PCT > 0.5 ng/mL (Positive Predictive Value, PPV: 92.6, 95% CI: 82.1–97.9). The best MDW cut-off to rule out sepsis was ≤20.0 (Negative Predictive Value, NPV: 86.4, 95% CI: 65.1–97.1). Multivariate analyses using both MDW and PCT found a significant association for MDW > 23 only (OR:17.64, 95% CI: 5.53–67.91). The authors concluded that MDW can be used as a novel sustainable biomarker of ensuing sepsis at the ICU, alone or in combination with PCT. Values of MDW ≤ 20 can be used to rule out sepsis (sensitivity = 95.9%, NPV = 86.4%). On the other hand, MDW > 23 can be used to rule in sepsis (PPV = 90.2%), with a slight gain when used in combination with PCT > 0.5 ng/mL (PPV = 92.6%). The study was published on November 22, 2021 in the journal BMC Emergency Medicine. LabMedica International February-March/2022

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The Mispa MagenTa is a fully automated compact RNA extraction unit based on magnetic beads technology for high throughput applications providing the highest yield. The instrument can purify up to 32 samples simultaneously.

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Smartphone App with LAMP Kit Rapidly Detects COVID-19 / Flu Virus

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Santa Barbara (Santa Barbara, CA, USA) and Santa Barbara Cottage Hospital (Santa Barbara, CA, USA) is among the most rapid, sensitive, affordable and scalable tests known - and can be readily adapted for other pathogens with pandemic potential including deadly variants of COVID and flu. It also provides a platform for inexpensive home-based testing. The system succeeded in achieving rapid and accurate diagnosis of COVID-19, COVID variants, and flu viruses. The app uses a smartphone’s camera to measure a chemical reaction and determines a diagnosis in 25 minutes - at a fraction of the cost of current diagnostic methods. The app and methodology are free and

openly available to all. The process, termed smaRT-LAMP, is simple and straightforward. A small volume of the patient’s saliva is collected and analyzed by the smartphone app using the phone’s camera and the diagnostic kit. No additional specialty materials are required. The lab kit can be produced for less than USD 100, and it requires little more than a smartphone, a hot plate and LED lights. The screening tests can be run for less than USD 7 each versus USD 10 to USD 20 per rapid antigen test and USD 100 to USD 150 per PCR test. PCR tests are the gold standard due to their sensitivity and accuracy, but they are slow, expensive and not portable. LAMP tests

match the sensitivity and accuracy of PCR - at a fraction of the time and cost. Further, LAMP occurs at constant temperature, which is suitable for point-of-care and home-based testing. The simple lab test can detect and differentiate COVID-19 and the flu, which show very similar respiratory disease symptoms and can lead to misdiagnosis. “As new COVID variants emerge globally, testing and detection remain essential to pandemic control efforts,” said lead author Michael Mahan of UC Santa Barbara. “Nearly half the world’s population has a smartphone, and we believe that this holds exciting potential to provide fair and equal access to precision diagnostic medicine.”

Novel Protein Biomarkers Can Evaluate Prostate Cancer Aggressiveness

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conducted, the results have not yet contributed to an improvement of diagnostics and therapy of Prostate cancer (PCa) patients. Clinical Scientist at the Medical University of Vienna (Vienna, Austria; www.meduniwien. ac.at) and their colleagues acquired formalin-fixed and paraffin-embedded (FFPE) prostate material from 88 patients with primary PCa and seven patients with bladder cancer. Human tissue-microarray (TMA) generation as well as sample selection and preparation for laser microdissection were conducted. Immunohistochemistry was conducted on FFPE TMAs using consecutive sections. Staining was performed using the BenchMark ULTRA automated staining system (Roche Diagnostics, Rotkreuz, Switzerland; www.dia gnostics.roche.com). The samples were analyzed using an Olympus system (Tokyo, Japan; www.olympus-lifescience.com). Proteomic Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS) Analysis was also performed.

The investigators reported that retrospective data analysis identified 153 proteins differentially expressed between STAT3-low and STAT3-high samples. Out of these, 46 proteins were associated with mitochondrial processes including oxidative phosphorylation (OXPHOS), and 45 proteins were upregulated, including NDUFS1/ATP5O. In a STAT3 independent PCa cohort, high expression of NDUFS1/ATP5O was confirmed by immunocytochemistry (IHC) and was significantly associated with earlier biochemical recurrence (BCR). mRNA expression levels for these two genes were significantly higher in intra-epithelial neoplasia and in PCa compared to benign prostate glands. NDUFS1/ATP5O levels are increased both at the mRNA and protein level in aggressive PCa. The authors noted that further analyses of the transcriptome, which comprises all genes that are transcribed in the cell at a certain point in time, also showed a rectified shift in the concentration of messenger ribonucleic acid (mRNA). This means that there is a direct

correlation between the genetic transcripts and the proteins produced. The study represents an important step in establishing a link between NDUFS, ATP5O and cancer aggressiveness. NDUFS1 and ATP5O could therefore serve as additional immunohistochemical markers for aggressive prostate tumors and, at the same time, as new targets for cancer treatment. The study was published on November 30, 2021 in the journal Cancers. Image: A) NDUFS1 immunohistochemistry staining of prostate cancer (PCa) tissue microarray (TMA) samples and B) ATP5O immunohistochemistry staining of PCa TMA samples. Staining intensity as per number. Scale bar = 100 µm (Photo courtesy of Medical University of Vienna) LabMedica International February-March/2022

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Long-Term Storage Stability of Corticotropin Investigated

orticotropin (adrenocorticotropic hormone, ACTH) is a 39-residue polypeptide tropic hormone secreted by the anterior pituitary gland following hypothalamic corticotropin-releasing hormone release. Corticotropin is notorious for its instability. Cortisol regulates ACTH release via a negative feedback loop. Measurements of plasma ACTH are crucial for differential diagnosis of endocrine disorders including Cushing’s syndrome and adrenal insufficiency but can be complicated by both preanalytical and analytical factors. Clinical Biochemists at Amsterdam University (Amsterdam, The Netherlands; www.uva.nl) and their colleagues investigated the long-term storage stability of corticotropin in ethylenediaminetetraacetic acid containing plasma. Plasma specimens were obtained from 20 healthy American subjects that were either neat or spiked with ACTH (22–1,866 pg/ ml). Plasma specimens were also obtained from Dutch patients visiting the Amsterdam University Medical Centers (UMC, Amsterdam, The Netherlands; www.amsterdamumc. org), between 2012 and 2013 for various indications. Individual specimens were assayed on the day of processing (month 0) and five times (at 1, 3, 9, 12, and 18 months) following storage at both −20 °C and −70 °C in five replicates each. Specimens were thawed once on the laboratory countertop at room temperature, mixed by gentle inversion and centrifuged at 3,000×g for 5 minutes Afterwards they were kept at room temperature and quickly analyzed. ACTH results were generated on the ARCHITECT i2000SR automated immunoassay instrument system (Abbott Laboratories, Abbott Park, IL, USA; www.abbott.com). The team also used a chemiluminescence immunoassay (CLIA) that uses two monoclonal antibodies of which the Liaison capture antibody that is coated to magnetic particles and the detection antibody is linked to an isoluminol derivative (Diasorin, Salugia, Italy; www.diasorin.com). The team reported that storing human plasma specimens for up to one and a half years at −20 °C or −70 °C had limited influence on the ACTH levels in these specimens measured by the ARCHITECT ACTH assay. In both neat and spiked specimens at the two storage conditions, ACTH levels remained relatively stable over time

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with only minimal changes in ACTH levels (<11%). Storing specimens for up to four or six years did significantly reduce detectable ACTH levels in native patient plasma specimens. After four years of storage at −20 °C, ACTH levels were 74.8%, whereas after six years of storage ACTH levels were only 46.2% of the original ACTH levels measured using the Liaison immunoassay. The authors concluded that corticotropin levels are stable in plasma when stored at −20 °C for one and a half years using the Abbott assay, but with longer storage time a significant reduction in corticotropin levels can be expected. Once specimens are stored for future corticotropin measurements, one should consider storage time, storage tem-

perature and assay differences. The study was originally published on October 13, 2021 in the journal Clinical Chemistry and Laboratory Medicine. Image: The ARCHITECT i2000SR automated immunoassay instrument system (Photo courtesy of Abbott Laboratories)

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Cystic Pancreatic Lesion Bacteria Are Precursors to Pancreatic Cancer

ancreatic cancer (PC) is one of the most aggressive and lethal types of cancer. The 5-year survival rate at the time of diagnosis is about 10%, as approximately 80%–85% of patients present either unresectable or metastatic disease. PC accounts for roughly 459,000 new cases and 432,000 deaths. Cystic lesions, including intraductal papillary mucinous neoplasms (IPMNs), of the pancreas are common. Because they are known as precursors to pancreatic cancer, many patients need regular, lifelong checkups, and a few can also require surgery. It would be valuable for the individual and for the healthcare to know more about the carcinogenic risk factors. Medical Scientists at the Karolinska Institutet (Stockholm, Sweden; www.ki.se) investigated the possibility to cultivate pancreatic microbiome from pancreatic cystic lesions associated with invasive cancer. Between February 2018 and November 2019, patients undergoing pancreatic surgery due to pancreatic cystic neoplasms (PCN) with cancer suspicion confirmed by radiologi-

cal and clinical examinations participated in this study. Surgically removed pancreata were sampled for cyst fluid immediately upon resection in strict sterile conditions and cultured in aerobic and anaerobic blood culture bottles (BacT/ALERT 3D, bioMerieux, Marcy l’Étoile, France; www.bio merieux.fr). The culture-positive samples were streaked repetitively to obtain pure monocultures for a subsequent strain identification by MALDI-TOF MS profiling (MALDI Biotyper System, Bruker, Billerica, MA, USA; www.bruker.com). The investigators reported that 29 cases (24%) exhibited bacterial growth. Pancreas pathology revealed that all seven culture-positive cases had IPMN, of which five were in the high-grade dysplasia (HGD) stage or associated with invasive cancer (5/7; 71.4%). The culture-negative cases included only six malignant cases (6/21; 27.3%), the others were low-risk tumors such as IPMN-low grade dysplasia and serous cystic tumors (SCNs), and three cases also had signs of concomitant pancreatitis. MALDI-TOF MS profiling analysis shows Gammaproteobacteria

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and Bacilli dominate among individual bacteria isolates. Among cultivated bacteria, Gammaproteobacteria, particularly Klebsiella pneumoniae, but also Granulicatella adiacens and Enterococcus faecalis, demonstrate consistent pathogenic properties in pancreatic cell lines tested in ex vivo co-culture models. Margaret Sällberg Chen, DDS, PhD, a Professor and senior author of the study said, “Some bacteria could cause double-stranded DNA breakage which is considered the first step of cellular lesion and cancer. We also found that antibiotics could prevent the damage to the DNA. Our findings not only confirm that bacteria play an important part in the development of cancer, they also illuminate new ways to attack the process.” The authors concluded that their results showed an over-representation of Gammaproteobacteria and another class of bacterium called Bacilli. These bacteria reside normally in the digestive tract and have previously been shown to promote cancer drug resistance by interfering the effect of gemcitabine, a cytostatic drug used in pancreatic cancer treatment. The study showed that these bacteria were present in IPMNs and culturable in 24% of the cases. The study was published on November 24, 2021 in the journal Gut Microbes.

Regulatory and Other Rheumatoid Factors Analyzed in RA Patients

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rheumatoid factor in the sera of arthritis patients. The regulatory rheumatoid factor (regRF) titer was determined in an agglutination test using human IgG-loaded tanned human erythrocytes. RegRF depletion from rheumatoid arthritis sera was also performed. Lyophilized human IgG was used to prepare an agglutination test system for detecting regRF. Size exclusion chromatography was performed using a Sephacryl S 100 26/400 column (Cytiva, Marlborough, MA, USA; www. cytivalifesciences.com). A Genesys 10S UV-Vis Spectrophotometer (Thermo Fisher Scientific,

Waltham, MA, USA; www.thermofisher.com) was used for the analysis. The investigators reported that patients in remission had regRF levels higher than in healthy subjects. The regRF in remission was characterized by tight binding to its antigen, as in healthy subjects. The regRF levels in patients with active RA varied dramatically, and regRF binding to its antigen was weak. The exacerbation of Still’s disease coincided with low regRF levels and affinity, while an improvement in patient condition was associated with an increase in regRF levels and affinity. The RF specific to RA, which

was detected by the RF latex-fixation method, was a nonhomogeneous population of antibodies that included RF to lyophilized IgG, to IgG immobilized on polystyrene, and to rabbit IgG. The authors concluded the RA remission is associated with an increase in regRF levels and affinity. Results of an analysis of a clinical case of Still’s disease were consistent with the results obtained when patients with active rheumatoid arthritis were compared with those in remission. The study was published on December 24, 2021 in the Journal of Clinical Laboratory Analysis. LabMedica International February-March/2022

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Parkinson’s Disease Patients Have More Inflammatory Bacteria in their Noses

arkinson’s disease (PD) is a complex neurodegenerative disease characterized by nigrostriatal degeneration resulting in bradykinesia, rigidity, tremor, and gait dysfunction. Non-motor symptoms are also typically present, including depression, constipation, and alteration of smell. Diminished sense of smell (hyposmia), is a common hallmark of prodromal PD. PD gut dysbiosis is characterized by increased putative pro-inflammatory microbes, belonging to the phylum Proteobacteria, and a reduction in putative beneficial short chain fatty acids (SCFAs)-producing bacteria. Given the loss of olfaction that has been associated with pre-motor PD in 75%–95% of early cases, the nasal cavity may be a secondary site (in addition to the gut) triggering neuroinflammation in PD. Medical Scientists at the Rush University Medical Center (Chicago, IL, USA; www. rush.edu) analyzed bacteria in the deep nasal sinus cavity of 30 people with Parkinson’s. The team noted that the deep nasal sinus cavity, far up in the nose, is close to the olfactory bulb, a brain structure involved in the sense of smell. The team also analyzed bacteria in the deep nasal sinus cavities of 11 of the patients’ spouses who did not have Parkinson’s. Spouses were chosen in order to account

for environmental factors (e.g., bacteria that happen to live in a person’s house). Bacteria from 17 non-spousal healthy controls also were analyzed. The scientists used deep nasal swabbing under nasal anterior endoscopy by a trained rhinologist. Total genomic DNA was extracted from the swabs using the FastDNA Spin Kit for Soil (MP Biomedicals, Santa Ana, CA, USA; www.mpbio.com). PCR amplified and sequenced on an Illumina MiniSeq sequencer (Illumina, San Diego, CA, USA; www.illu mina.com). 16S rRNA gene amplicon library preparation was performed using two parallel techniques. To provide superior resolution at the species taxonomic level, a multi-amplicon workflow was conducted employing the Swift Amplicon 16S + ITS Panel (Swift Biosciences, Madison, WI, USA; www.swiftbiosci.com). The investigators reported that, compared to the controls, people with Parkinson’s tended to have higher amounts of certain bacteria that are likely to have pro-inflammatory effects. For example, many patients had high abundances of Moraxella catarrhalis, which is known to be an opportunistic pathogen, a bacteria that usually does not cause disease, but can under certain circumstances. The team noted that M. catarrhalis was not always linked with Parkinson’s. indeed, some patients had no de-

tectable amounts of this type of bacteria. But microbiomes with the highest abundances of these bacteria consistently came from people with Parkinson’s. In addition to high levels of pro-inflammatory bacteria, Parkinson’s patients also tended to have lower amounts of bacteria with anti-inflammatory properties, including Blautia wexlerae, Lachnospira pectinoschiza, and Propionibacterium humerusii. The authors concluded that their data indicated the presence of a dysbiotic and potentially pro-inflammatory deep nasal sinus cavity microbiota environment in PD subjects as compared to control subjects. Within PD subjects there was a positive correlation between putative pro-inflammatory bacteria, including M. catarrhalis, and PD clinical features. The study was published on December 8, 2021 in the journal npj Parkinson’s Disease. Image: FastDNA Spin Kit for Soil quickly and efficiently isolates PCR-ready genomic DNA (Photo courtesy of MP Biomedicals)

Association Between Helicobacter Pylori With Nonalcoholic Fatty Liver Disease Assessed

on-alcoholic fatty liver disease is closely linked to various metabolic disorders such as obesity, type 2 diabetes, and cardiovascular disease, and has been considered as a hepatic manifestation of metabolic syndrome. Helicobacter pylori (Hp) is a Gramnegative microorganism that infects more than half of the global population. While Hp is considered to play a causative role in many gastrointestinal diseases such as chronic gastritis, peptic ulcers and gastric cancer, its role in extra-gastric diseases including metabolic syndrome, hematologic and cardiovascular diseases has also been studied. Gastroenterologists at the Seoul National University Hospital (Seoul, Korea; www. snuh.org) conducted a retrospective cohort study of apparently healthy individuals who underwent liver Fibroscan during health screening tests between January 2018 and December 2018 and 1,784 subjects were included in the final analysis. Laboratory tests included serum total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, fasting glucose, and glycated hemoglobin (HbA1c). Diagnosis of Hp infection was based on the results of a serum anti-Hp IgG antibody

LabMedica International February-March/2022

test using a commercially available chemiluminescent microparticle immunoassay kit, the Immulite 2000 CMIA (Siemens Healthcare GmbH, Erlangen, Germany; www. siemens-healthineers.com). This is a solidphase, two step chemiluminescent enzyme immunoassay. The Hp IgG in diluted serum sample bound with antigen-coated bead enclosed within a test unit. After removing unbound serum by centrifugation, an alkaline phosphatase-labeled anti-human IgG is introduced. Values higher than 1.10 IU/mL were considered positive. The Hp IgG kit has a sensitivity of 91% and a specificity of 100%. The scientists reported that among the 1,784 subjects (mean age 55.3 years, 83.1% male), 708 (39.7%) subjects showed positive results of Hp serology. In the multivariate analysis, obesity (body mass index ≥25) (odds ratio [OR] 3.44, triglyceride (OR 2.31), and the highest tertile of liver stiffness measurement (OR 2.08) were found to be associated with NAFLD, defined by controlled attenuation parameter (CAP) ≥248 dB/m, while Hp-seropositivity showed no association with NAFLD. Serum levels of HDL cholesterol significantly decreased in subjects with Hp-seropositivity compared to HP-seronegativity in both groups with and

without NAFLD. The authors concluded that while Hp seropositivity was not associated with CAPdefined NAFLD, serum HDL cholesterol level were negatively associated with Hpseropositivity in both groups with and without NAFLD. As various Hp antigens are associated differently with metabolic conditions, it would be better to verify multiple Hp antigen using multiplex serology. The study was published on December 13, 2021 in the journal PLOS ONE. Image: The Immulite 2000 XPI System is an easy to use, continuous random-access immunoassay analyzer with one of the largest automated immunoassay menus available (Photo courtesy of Siemens Healthcare)

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Certain Protein Ectodomains in Cerebrospinal Fluid Are Diagnostic Biomarkers for Autism

bnormally low levels of a protein biomarker, which can be detected in the cerebrospinal fluid (CSF), have the potential to be the basis for diagnosis of autism and related neurological disorders. Mutations in the contactin-associated protein-like 2 (CNTNAP2) gene had been related to autism combined with epilepsy. Autism, which has a highly genetic component, affects about 17% of children in the United States, and from 30% to 50% of these children also have epilepsy. The CNTNAP2 gene encompasses almost 1.6% of chromosome seven and is one of the largest genes in the human genome. It has been associated with autism spectrum disorder but accounts for very few cases. Investigators at Northwestern University

(Chicago, IL, USA; www.northwestern.edu) recently reported that the ectodomain (the portion of the protein extending beyond the cell membrane) of CNTNAP2 (CNTNAP2ecto), was a prominent neurodevelopmental disorder (NDD) risk factor. As such, CNTNAP2-ecto was determined to be an important constituent of the population of brain proteins shed into the CSF, also known as the neuronal sheddome. Transmembrane proteins sometime undergo ectodomain shedding upon proteolytic cleavage, but only a few such cases have been studied. Using unbiased global proteomic approaches, the investigators discovered that a large number of neuronal membrane proteins undergo ectodomain shedding. This “sheddome” was detectable

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in the cerebrospinal fluid and was enriched in synaptic proteins and disease risk factors. Unexpectedly, such ectodomains were found to have novel biological functions in regulating cellular and network level properties of brain circuits. In the current study, the investigators found that CNTNAP2-ecto levels were reduced in the CSF of individuals with autism spectrum disorder. Using mass spectrometry, the investigators identified the plasma membrane Ca2+ ATPase (PMCA) extrusion pumps as novel CNTNAP2-ecto binding partners. CNTNAP2-ecto enhanced the activity of PMCA2 and regulated neuronal network dynamics in a PMCA2-dependent manner. “We can replace CNTNAP2,” said senior author Dr. Peter Penzes, professor of psychiatry and behavioral sciences at Northwestern University. “We can make it in a test tube and should be able inject it into children’s spinal fluid, which will go back into their brain.” The study was published in the December 17, 2021 online edition of the journal Neuron. Image: The synaptic sheddome: protein ectodomains shed into the cerebrospinal fluid (Photo courtesy of Dr. Peter Penzes, Northwestern University) LabMedica International February-March/2022

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Biomarker FR+CTC Explored for Breast Cancer Diagnosis

he prognosis of breast cancer is dramatically improved owing to progress on the early diagnosis and effective therapy, and the survivor number is higher than any other types of cancers. However, the number of new breast cancer cases reached 2.26 million in 2020, accounted for 11.7% of all new tumor cases. Folate receptor (FR) is a glycosylated phosphatidylinositol-coupled protein with high affinity and endocytosis and transport capacity for its natural ligand folic acid. It is a cell surface protein that has been proven to be an ideal tumor marker for non-small cell lung cancer. The clinical significance of folate receptor-positive circulating tumor cells (FR+CTC) has been explored. Clinical Laboratorians at the Renmin Hospital of Wuhan University (Wuhan, China; www.whu.edu.cn) enrolled in a study 60 breast cancer female patients with a mean age of 52 years (range, 27–75 years) and 32 healthy controls with an age of 52 (range, 40–66 years), from January 2019 to January 2021,. The diagnosis for the patients was confirmed by cytology or histopathology. Peripheral blood was collected for isolation of circulating tumor cells (CTC) on the diagnosis in all patients of the cohort. The 27 patients underwent radical mastectomy, and the peripheral blood was also collected in two weeks after the operation. Circulating tumor cells was isolated with folate receptor-positive (FR+) CTC isolation method using CytoploRare kit (GenoSaber Biotech Co., Ltd., Shanghai, China; www.

genosaber.com). The method includes negative enrichment of FR+ circulating tumor cells with immunomagnetic beads to deplete leukocytes first, then CTC level was quantitated by ligand-targeted PCR. First, leukocytes and mononuclear macrophages were removed by anti-CD45 and anti-CD14 magnetic beads. Then, the cells were activated and washed to free up the folate binding site. The carcinoembryonic antigen (CEA), cancer antigen 125 (CA125), and cancer antigen 153 (CA153) were measured by chemiluminescent immunoassay. The investigators reported that the levels of FR+CTC were significantly higher in breast cancer patients compared with healthy controls. The levels of FR+CTC in breast cancer patients and healthy people were 10.95 (7.28– 14.15) FU/3 mL and 6.93 (5.46–8.19) FU/3 mL, respectively. The detection rate of FR+CTC was decreased in 19 of 27 patients underwent the surgery in two weeks post-operation compared with pre-operation; statistical analysis showed the difference was significant. They also found that the combination of FR+CTC, CEA, CA125, and CA153 can significantly improve the diagnostic efficiency for breast cancer. The authors concluded that the detection of FR+CTCs in peripheral blood is simple, noninvasive methods with high sensitivity and specificity. It can be used as a potential biomarker for auxiliary diagnosis and early detection in breast cancer patients. The study was published on December 17, 2021 in the Journal of Clinical Laboratory Analysis.

Image: A colored scanning electron micrograph (SEM) of a breast cancer cell (Photo courtesy of Case Western Reserve University School)

Serum High Sensitivity C-Reactive Protein Associated with Pre-Diabetes

ndividuals with pre-diabetes are at a higher risk for progression to diabetes and are also known to be associated with an increased risk of cardiovascular disease. Also, pre-diabetes is known to be associated with obesity and an abnormal lipid profile. C-reactive protein (CRP) is an acutephase protein that is increased in infections, inflammatory conditions, and even cancers. Low-grade inflammation is said to be associated with pre-diabetes and high sensitivity CRP (hsCRP) is an indicator of inflammation. Clinical Scientists at the Jawaharlal Nehru Medical College (Wardha, India; www.dmimsu.edu.in) carried out a cross-sectional study from October 2018 to August 2020 to determine whether hsCRP can be used as a biomarker in the early diagnosis of pre-diabetes in a rural population. A total of 200 participants, including 100 diabetics and 100 controls who were age- and gender-matched, were enrolled. Blood investigations included blood glucose levels, lipid profile, and high sensitivity CRP. The hsCRP levels were tested by an ultrasensitive CRP kit, and were measured

LabMedica International

LabMedica International February-March/2022

by the spectrophotometric method using an enzyme-linked immunosorbent assay (ELISA) Turbichem-Hs-CRP kit, (Genuine Biosystem, Chennai, India; www.indiamart. com). The test was based on the two-site sandwich enzyme immunoassay principle. The investigators reported that the mean value of high sensitivity CRP for cases was 2.17 ± 0.72 mg/L. The mean value of high sensitivity CRP for controls was 0.66 ± 0.22 mg/L and therefore high sensitivity CRP for diabetics was significantly higher than controls. High sensitivity CRP was significantly and positively correlated to age, body mass index (BMI), total cholesterol, low-density lipoprotein, cholesterol, and waist-hip ratio. The authors concluded that Hs-CRP, which is a marker of inflammation, was also found to be correlated with abnormal lipid profiles and oral glucose tolerance tests. The Hs-CRP can be used as an early predictor of inflammation in pre-diabetes and can be a marker of underlying abnormal sugar levels and lipid profile in pre-diabetics unaware of their health status. The study was published on October 28, 2021 in the journal Cureus. LINKXPRESS COM

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Near Normal Aminotransferase Levels Reported in Alcoholic Cirrhosis Patients

lcoholic cirrhosis affects around 1 in 400 adults in the USA. It is an advanced form of liver disease, which occurs when chronic ethanol use leads to inflammation and cirrhosis or scarring of the liver. Less than 50% of people diagnosed with advanced liver disease due to cirrhosis survive for one year, and so early diagnosis is crucial. Although cirrhosis is generally not a reversible condition, early diagnosis provides physicians with an opportunity to encourage cessation of drinking and offer treatment that can reduce symptoms and increase life expectancy. A common method to diagnose patients with alcoholic cirrhosis is to look for elevated levels of enzymes known as aminotransferases in the liver. Specialists in Hepatology at the Medical University of South Carolina (Charleston, SC, USA; www.musc.edu) carried out a retrospective cohort analysis, and identified consecutive patients with documented alcoholic cirrhosis who were admitted between January 1 2016 and December 1 2018. They examined clinical outcomes of 78 patients as a function of whether the aspartate transaminase (AST) or alanine aminotransferase (ALT) was normal or abnormal. In the cohort of patients with alcoholic cirrhosis (age 55, 26-75; 58% male) 70 had a normal ALT

and 12 had a normal AST. The average AST for all patients was 59U/L ± 34U/L (Upper Limit of Normal [ULN] = 35U/L), and the average ALT was 27U/L ± 13U/L (ULN = 45U/L). The average INR was 1.5 ± 0.5 and total bilirubin was 3.7mg/dL ± 4.9mg/ dL, and 20 patients had a normal bilirubin level, including only one with an abnormal ALT level. The average model for end-stage liver disease (MELD) score was 19 ± 8 and 32% of patients died during the follow-up time period of five months. Decompensating events were identified in 78 (100%) patients. There was no correlation between complications or death and aminotransferase levels. Don C. Rockey, MD, a Professor of Medicine and the senior author of the study, said, “We would see these patients with advanced disease and complications, yet their liver tests seemed to be normal. So, if you just looked at their liver tests, you’d say, ‘Oh no problem,’ but in fact, that wasn’t the case.” The authors concluded that aminotransferase levels are often unremarkable in patients with alcohol related cirrhosis and bear no relationship to clinical events or outcomes. Clinicians should be cautious when interpreting aminotransferases in patients with alcoholic cirrhosis. The study was published on October 4, 2021 in The American Journal of the Medical Sciences. LabMedica International February-March/2022

To view this issue in interactive digital magazine format visit LabMedica.com

Calprotectin Levels Vary When Measured in Different Matrices for COVID-19

everal risk scores, diagnostic imaging and biomarkers have been evaluated and compared to help predict severe complications and outcome in COVID-19 patients. Nevertheless, early prediction of COVID19 severity remains difficult, emphasizing the need for additional biomarkers in daily practice. Calprotectin (CLP) is typically expressed and secreted by neutrophils, monocytes, and activated macrophages, but can also be expressed and secreted by other cell lines including but not limited to dendritic cells, endothelial cells, keratinocytes and squamous mucosal epithelium. Circulating CLP (cCLP) has gained recent attention as a biomarker of neutrophil-related inflammation and chronic inflammatory disorders. Medical Laboratory Scientists at the OLV Hospital (Aalst, Belgium; www.olvz.be) prospectively included patients with primary diagnosis of SARS-CoV-2, confirmed by real-time reverse transcription polymerase chain reaction (rRT-PCR)) who presented at the emergency department (ED) requiring hospitalization. One hundred and thirty-six SARS-CoV-2 positive patients were included (70 hospitalized at a non-ICU ward; 66 at an ICU ward), next to 40 SARS-CoV-2 negative control patients (20 nonICU; 20 CV-ICU). The primary biomarkers of interest concerning the inflammatory response to COVID-19

were cCLP (measured in heparin, EDTA and citrate plasma and serum), C-reactive protein (CRP), Interleukin-6 (IL-6), lactate dehydrogenase (LDH) and procalcitonin (PCT). After routine laboratory analysis, including CRP, LDH and PCT analysis, was performed on blood samples taken at the ED, aliquots of serum, heparin plasma, EDTA plasma and citrate plasma were stored at -20 °C. Batch analyses of cCLP using the EliA Calprotectin 2 assay on a Phadia 200 instrument (Thermo Fisher Scientific, Waltham, MA, USA; www.thermofisher.com) and IL-6 (Elecsys IL-6 on cobas c801, Roche Diagnostics, Rotkreuz, Switzerland; www.diagnostics.roche. com) were performed on stored aliquots. The investigators reported that for the 136 COVID-19 patients, cCLP levels were higher compared to the respective control populations, with significantly higher cCLP levels in serum and heparin than in EDTA or citrate. Higher cCLP levels were obtained for COVID-19 patients with i) severe/critical illness (n=70), ii) ICU admission (n=66) and iii) need for mechanical ventilation/extracorporeal membrane oxygenation (ECMO) (n=25), but iv) not in patients who deceased within 30 days (n=41). The authors concluded that cCLP has a high power to discriminate severe or critical COVID-19 cases versus patients presenting with asymptomatic, mild or moderate disease, to

predict the need for ICU admission and the need for mechanical ventilation or ECMO. The study was published on December 14, 2021 in the journal Clinica Chimica Acta. Image: The Phadia 200 instrument is capable of diagnostic testing menu of more than 700 different ImmunoCAP and EliA tests to aid in the diagnosis of allergy and autoimmune diseases (Photo courtesy of Thermo Fisher Scientific)

Tissue Counterpart to Monoclonal B-Cell Lymphocytosis Characterized

onoclonal B-cell lymphocytosis (MBL) was initially proposed to recognize patients with a monotypic B-cell population identified by peripheral blood (PB) flow cytometry (FC) that did not meet numerical criteria for chronic lymphocytic leukemia (CLL). While MBL is defined in the blood, pathologists encounter rare cases in which a monotypic B-cell population is detected in biopsy tissue undergoing FC without obvious morphologic involvement by lymphoma. B-cell clones discovered in tissue biopsies, without overt lymphoma, may represent a tissue counterpart to peripheral blood monoclonal B-cell lymphocytosis (MBL), herein termed tMBL. Hematopathologists at the Cleveland Clinic (Cleveland, OH, USA; www.my.cleveland clinic.org) searched for all cases from 2009 to 2019 with FC analysis demonstrating a monotypic B-cell population in which a corresponding lymphomatous infiltrate was not evident by re-review of the routine hematoxylin-eosin (H&E)–stained sections. Flow cytometry was performed in-house on 31 cases (BD FACSCanto, BD Biosciences, San Diego, CA, USA; www. bdbiosciences.com). At a minimum, all cases had immunohistochemical (IHC) stains for CD3, CD5, CD19, CD20, lymphoid enhancer-binding factor 1 (LEF1), and cyclin-D1. In cases with a clinical history of a CD10+ lymphoma, immunostaining with CD10, BCL2, and BCL6 was

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LabMedica International February-March/2022

also performed. The scientists reported that 54 cases were identified (35 lymph node, three splenic, and 16 soft tissue/viscera). Forty-six cases were chronic lymphocytic leukemia (CLL)-type, two were atypical CLL, and six were non-CLL. tMBL was detectable by immunohistochemistry in 14 cases (26%, all CLL-type). Concurrent blood flow cytometry, available in 10 cases, showed four with low-count MBL (three CLL-type, one with non-CLL–type), five with high-count MBL (all CLL-type), and one case negative for clonal population. With median follow-up of 51 months, two patients had progression of disease (CLL, 68.7 months; and diffuse large B-cell lymphoma, 5.9 months). Patients with immunohistochemistry-detectable tMBL had increased monoclonal B cells per total lymphocyte events, morphologic evidence of bone marrow involvement, higher white blood cell count, and increased absolute lymphocyte count. The authors concluded that tMBL spans an immunophenotypic spectrum similar to MBL, is detectable by immunohistochemistry in a minority of cases (often CLL immunophenotype), and is likely systemic in most cases. Development of overt lymphoma is uncommon but may occur, warranting clinical follow-up. The study was published in the December 2021 issue of the journal Archives of Pathology and Laboratory Medicine. LINKXPRESS COM

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Benchtop Cell Sorter Validated in Biosafety Containment Setting

luorescent-activated cell sorting (FACS) is often the most appropriate technique to obtain pure populations of a cell type of interest for downstream analysis. The ability to sort pure populations of immune cells is a critical tool for immunologists. Aerosol droplets can be generated during the sort, which poses a biosafety risk when working with samples containing risk group 3 pathogens such as Francisella tularensis, Mycobacterium tuberculosis, Yersinia pestis, and severe acute respiratory syndrome coronavirus 2. Pulmonary pathogen specialists at the Rocky Mountain Laboratories (Hamilton, MT, USA; www.niaid.nih.gov) performed aerosol testing as part of the biosafety evaluation of the MACSQuant Tyto (Miltenyi Biotec, Bergisch Gladbach, Germany; www.miltenyibiotec.com) a completely closed, cartridge-based cell sorter. They also established quality control procedures to routinely evaluate instrument performance. Aerosol testing was performed on FACSAria II (BD Biosciences, San Diego, CA, USA; www.bdbiosciences.com) with the Aerosol Management System disabled as a positive control for

aerosol generation. The scientists reported that before usage of the Tyto on the benchtop to sort cells at BSL-3, it was necessary to empirically determine if aerosols were generated during the cell sort procedure. They utilized a novel method using internally fluorescent 1.0 μm beads to perform aerosol testing on the Tyto. These beads were uniform in size and intensely fluorescent in the fluorescein isothiocyanate (FITC) channel. As a positive control, they detected aerosols generated by the in-house FACSAria II when the Aerosol Management System was disabled, and the flow stream disrupted. As expected, beads were detected on the coverslip after only a 30-second exposure. The MACSQuant Tyto did not produce aerosols as part of the sort procedure. The scientists established a purity of >96%, depletion yield of >80%, and sort efficiency of >85% as benchmarks that must be met during quality control testing. The authors concluded that they utilized the Tyto cell sorter in their BSL-3 laboratory. This instrument not only has a small footprint but most importantly does not generate aerosols during the sort procedure. The use of this technology will improve current immunological studies in containment laboratories by allowing a greater number of scientific groups to isolate cell types involved in the immune response to high-consequence pathogens for downstream applications. The study was published on November 24, 2021 in the journal Applied Biosafety. Image: The MACSQuant Tyto Cell Sorter can be used safely in at BSL-3 laboratory facilities (Photo courtesy of Miltenyi Biotec)

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Epigenetic Biomarkers for Early Rheumatoid Arthritis Detection

NA methylation alterations, termed epimutations, have demonstrated the potential to be used as a biomarkers for rheumatoid arthritis to improve the detection and clinical management of the disease. Rheumatoid arthritis (RA) is a long-term autoimmune disorder that primarily affects joints. Most commonly, the wrist and hands are involved, with the same joints typically involved on both sides of the body. The disease may also affect other parts of the body, including skin, eyes, lungs, heart, nerves, and blood. Often, symptoms emerge gradually over a period of weeks or months. RA affects between 0.5 and 1% of adults in the developed world with between five and 50 per 100,000 individuals newly developing the condition each year. Onset is most frequent during middle age, and women are affected 2.5 times as frequently as men. Current drug treatments have limited efficacy in many RA patients, although some studies have shown that treatments begun in early stages of the disease can cause remission of symptoms. Mutations have been assumed to be the primary factor in the development of RA, but they account for only a minority of the variance in disease risk. In contrast to genetic influences, the environment can have dramatic impacts on the epigenetics that associate with origin of the disease. Epigenetic mechanisms are affected by several factors and processes including development in utero and in childhood, environmental chemicals, drugs and pharmaceuticals, aging, and diet. DNA methylation occurs when methyl groups tag DNA, which can activate or repress genes. Histones are proteins around which DNA can wind for compaction and gene regulation. All of these factors and processes can have an effect on people’s health and potential for disease development. To examine the role of epigenetic factors in the development of RA and to assess their value in diagnosing the disease, investigators at Washington State University (Pullman, WA, USA; www.wsu.edu) used buccal cells and purified blood monocytes from two different clinical cohorts involving Caucasian or African American female populations with or without arthritis. The differential DNA methylation regions (DMRs) between the control and RA populations were identified with an epigenome-wide association study. Results revealed distinctive DMRs (epimutations) common to both the buccal cells and monocytes. The DMR associated genes were identified and many had previously been shown to be associated with arthritis. Therefore, DNA methylation epimutation RA biomarkers were cell type specific and similar findings were observed with the two racial background populations. The current study confirmed the existence of buccal cell RA epigenetic biomarkers and hinted that a relatively non-invasive diagnostic cheek

LabMedica International February-March/2022

swab test could be developed to screen for the disease. “Surprisingly, most of the DNA methylation sites we found that were consistent among patients with the disease were associated with genes previously known to be involved in rheumatoid arthritis,” said senior author Dr. Michael Skinner, professor of biological sciences at Washington State University. “If we can identify these patients ten years earlier before the disease

develops, it opens up a whole arena of preventative medicine that we did not have access to before.” The study was published in the December 10, 2021, online edition of the journal Scientific Reports. Image: How epigenetic mechanisms can affect health (Photo courtesy of [U.S.] National Institutes of Health)

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Sensitive Protein Assay Differentiates Parkinson’s from Other Synucleinopathies

cont’d from cover

main types of synucleinopathy: Parkinson’s disease (PD), dementia with Lewy bodies (DLB), and multiple system atrophy (MSA). Real-time quaking-induced conversion (RT-QuIC) is a highly sensitive assay that originally was developed for prion detection. The “quaking” in the name of the technique refers to the fact that samples in the RT-QuIC assay are literally subjected to shaking. This action breaks apart aggregates of prion protein (PrP) that are then further incubated, amplifying the amount of misfolded PrP to detectable levels. Recently, the RT-QuIC method has been adapted to measure levels of alpha-synuclein, primarily from Lewy bodies, in cerebrospinal fluid (CSF). A Lewy body is composed of the protein alpha-synuclein associated with other proteins, such as ubiquitin, neurofilament protein, and alpha B crystallin. Tau proteins may also be present, and Lewy bodies may occasionally be surrounded by neurofibrillary tangles. Previous studies have confirmed that the alpha-synuclein real-time quaking-induced conversion (alpha-Syn-RT-QuIC) assay had high sensitivity and specificity for Parkinson’s disease. However, whether the assay could be used as a robust, quantitative measure to monitor disease progression, stratify different synucleinopathies, and predict disease conversion in patients with idiopathic REM sleep behavior disorder remains undetermined.

REM sleep behavior disorder (RBD) is a syndrome in which individuals with RBD lose the paralysis of muscles (atonia) that is normal during rapid eye movement (REM) sleep, and act out their dreams or have other abnormal movements or vocalizations. Abnormal sleep behaviors may appear decades before any other symptoms, often as an early sign of a synucleinopathy. Investigators at the University of Oxford (United Kingdom; www.ox.ac. uk) conducted a study designed to assess the diagnostic value of CSF aSynRT-QuIC in regard to disease progression, stratification, and conversion in synucleinopathies. To this end, they performed alpha-Syn-RT-QuIC on CSF samples from 74 Parkinson’s disease, 24 multiple system atrophy, and 45 idiopathic REM sleep behavior disorder patients as compared to 55 healthy controls. Results of the assay revealed 89% sensitivity for correctly identifying individuals with Parkinson’s disease and 96% specificity for correctly identifying those without the condition. The assay was also able to distinguish individuals with MSA from those with Parkinson’s and helped to identify those with RBD who had abnormal alpha-synuclein and later developed Parkinson’s disease. The assay could also distinguish different clinical subtypes of Parkinson’s disease. There was no link between the test results and severity of symptoms in Parkinson’s disease, but in MSA the test results were linked to the severity of the condition. Senior author Dr. Laura Parkkinen, associate professor of clinical neurosciences at the University of Oxford, said, “The most exciting finding of the study is that the detected clumps of alpha-synuclein differed between different clinical Parkinson’s subtypes and between people with Parkinson’s and MSA. These differences could represent distinct “strain profiles” which could not only provide a way to distinguish between different neurodegenerative disorders (MSA versus Parkinson’s) but also provide a way to distinguish variations within a single condition. How the “strain profiles” vary within Parkinson’s and how they relate to clinical subtypes will need to be investigated further. We now need to understand what the differences are in the clumping of alpha-synuclein between Parkinson’s, dementia with Lewy bodies, and MSA. By getting these answers, we will hopefully be able to create a blueprint for effective diagnosis and therapeutics for these conditions.” The study was published in the December 11, 2021, online edition of the journal Brain. Image: Positive alpha-synuclein staining of a Lewy body from a patient who had Parkinson’s disease (Photo courtesy of Wikimedia Commons) LabMedica International February-March/2022

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

NEWS

New IFCC Task Force to Focus on Global Reference Interval Database

By Dr Jakob Zierk; Chair, TF-GRID; Universitätsklinikum Erlangen Kinder-und Jugendklinik; Erlangen, Germany

n December 1, 2021, the newly-created IFCC Task Force on Global Reference Interval Database (TF-GRID), chaired by Jakob Zierk (Erlangen, Germany) came together for their first meeting in a virtual conference call. The task force’s overarching goal is the establishment and dissemination of digital IFCC reference interval resources to be used by scientists and clinicians worldwide. Specifically, the task force has identified five major tasks within their scope and mandate, which will be led by small subgroups within the task force: • First, an IFCC website which provides an overview of all major global and local reference interval studies and initiatives will be developed. The aim of this website is to provide an IFCC-sponsored entry point to clinicians and scientists looking for reference intervals. This task will be led by M. K. Bohn (Member/YS, CA), P. Ridefelt (Member, SE), R. Müller (Corp. Rep., Abbott, DE), J.M. Rhea-McManus (Corp. Rep., US, Siemens), A. Al-Farwi (Corr. Member, SCLA), S. Sharma (Corr. Member, ACBI), and E. C. Cheung Wong (Member, US) • Second, the task force will create a global IFCC reference interval database. This database will give end users access to specific reference intervals, stratified by the relevant covariates and also allow comparison of patient’s test results to existing reference intervals. (Both websites from the first and second task will be mobile-friendly.) The members leading this task are M. K. Bohn (Member/YS, CA), P. Ridefelt (Member, SE), P. Christensen (Corr. Member, DSKB), J.M. Rhea-McManus (Corp. Rep., Siemens, US), E. C. Cheung Wong (Member, US), and E. Kupatadze (Corr. Member GLMA). • Third, the task force will create web-based tools to allow end-users to calculate reference intervals using various direct and indirect methods. This task is led by A. B. Leichtle (Member, CH), A. Coskun (Member, TR), L. Franszon (Corr. Member, ISLM), and H. Marques Tiburcio (Corr. Member, DSKB) • Fourth, the task force will analyze existing global reference interval data to assess opportunities for reference interval harmonization, and to identify areas where reference interval studies are needed most. N. Mayanskiy (Member, RU), E. A. Chaler (Corr. Member, CUBRA) and R. Müller (Corp Rep, Abbott, US) are leading this task. • Fifth, a workshop on indirect reference intervals is planned, with the aim to disseminate both theoretic and practical knowledge on indirect reference interval approaches. This task is led by A. B. Leichtle (Member, CH), A. Coskun (Member, TR), and A. Al-Farwi (Corr. Member, SCLA).

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The task force’s first in-person meeting is currently scheduled for the Euromedlab meeting in Munich, until then the group is having monthly virtual meetings. For further information about the TF activities, please visit: https://www.ifcc.org/executive-board-and-council/eb-task-forces/ task-force-on-global-reference-interval-database-tf-grid/

NEWS

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

Editorial

By Katherina Psarra, MSc, PhD

Dear colleagues, lready at the end of the second month of 2022 we would like to wish you a belated happy new year. It will be full of in person much anticipated meetings to which our president Prof K Adeli welcomes our whole community. Let’s hope and

A IN MEMORIAM

believe that they will be realized. In this issue we are (as always) celebrating laboratory medicine. Don’t forget to go through Dr Per Hyltoft Petersen’s life, a life dedicated to analytical quality. Dear colleagues, celebrate Laboratory medicine in your own ways and go through our news to honour it even more.

Dr Per Hyltoft Petersen: An Appreciation

adly, Dr Per Hyltoft Petersen from Odense in Denmark, passed away on 15 January 2022. Ever since the early 1980s, Dr Petersen was involved in investigations on how the analytical quality achieved affected clinical outcomes, and this continued throughout his professional life. In the 1990s, along with many others interested in this particular aspect of Laboratory Medicine, including Mogens Horder, Callum Fraser, Jim Westgard, Rainer Haeckel, Carmen Ricos, Sverre Sandberg, and many other internationally well-known collaborators, Dr Petersen continued his work on setting analytical goals and generating and applying data on the components of biological variation. Throughout this period, definition of what was then generally termed analytical goals was addressed by several professional groups including the European Group on Evaluation of Laboratory Tests (EGE-Lab) and the European External Quality Assessment (EQA) Organisers Working Groups, of which Dr Petersen was a very active member. Much controversy grew about the appropriate means to set analytical goals and he, along with Drs Callum Fraser, Anders Kallner and Desmond Kenny organised the 1999 Stockholm Consensus Conference on Setting Global Analytical Quality Specifications in Laboratory Medicine, inviting all colleagues who had published on this topic to present (and publish) their views. The consensus achieved was a hierarchy of the known strategies for setting analytical quality specifications with the effect of performance on clinical decision-making as the best and the state-of-the-art achieved as the least advantageous. This hierarchy was based on the proposal advocated in an Editorial by Fraser and Petersen in Clinical Chemistry. The hierarchy was widely adopted throughout Laboratory Medicine.

By Callum G. Fraser, Sverre Sandberg

However, by the 2010s, it became clear that the hierarchy warranted review. In consequence the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) held the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine in 2014. Dr Petersen was a member of the organising group, presented a summary of his work on analysis of the effect of analytical performance on clinical decision-making using his well-known and highly regarded graphical approaches, and participated in the preparation of the consensus statement, a simplification of the hierarchy established by the Stockholm Conference, a paper which has been cited more than 350 times already. Much interest was generated at the Strategic Conference on the assessment and uses of data on biological variation, a subject to which Dr Petersen had contributed much over his career. His inspiration has contributed to the impressive body of work done in the last decade by the EFLM groups con-

cerned with biological variation, which have contributed so much to contemporary Laboratory Medicine. Since the Strategic Conference, Dr Petersen and colleagues from Scandinavia and Scotland have published a series of papers up to 2019 on the assessment of means to develop reference change values, another long-held interest of Dr Petersen to which he contributed significant insights. Although Dr Petersen was situated in Odense, for more than 20 years he was engaged in the work of the Norwegian organisation for quality improvement of laboratory examinations (Noklus) and worked as an Adjunct Professor at the University of Bergen. In NOKLUS he engaged, inspired, and supervised many PhD and MSc students and all looked forward to his visits in Bergen with anticipation. In addition to his publications, Dr Petersen was a captivating speaker and was invited to present his work at many conferences and meetings too countless to detail, but from every country in Scandinavia, through Milan, Antwerp, Padua, Jackson Hole: Wyoming (at the invitation of the College of American Pathologists), Kobe: Japan (resulting in a book “Maintaining a Healthy State within the Individual”), Bratislava, Barcelona, Kuwait (giving a two-week course in selection and evaluation of analytical methods for the Ministry of Health, with Callum Fraser), and many others, including Australia. Together with Linda Thienpont, Dietmar Stöckl, Kristian Linnet and Sverre Sandberg, over many years, he toured around the world presenting a comprehensive course in medical statistics. A great scientist, innovator, and communicator, who contributed so much to the development of the numerical aspects of Laboratory Medicine, Per Hyltoft Petersen had great ambitions for the discipline: in contrast, his ambitions on his own behalf were small. LabMedica International February-March/2022

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

NEWS

MESSAGE FROM THE PRESIDENT By Khosrow Adeli

•

President, IFCC

appy New Year to everyone in the IFCC family! Moving into 2022, the IFCC is eager to continue its mission of “advancing excellence in laboratory medicine for better healthcare worldwide”. Several major events are planned this year by IFCC including the EuroMedLab conference in Munich in early April, the WorldLab Congress in Seoul in June, and the IFCC General Conference in Brussels in October. I am optimistic that we will be able to come together again and hold successful in person/ hybrid events as pandemic restrictions are likely to ease in many parts of the world after Spring. Now that the framework for several new initiatives has been built (and the new taskforces are already active), we will be taking a fresh look at divisional activities and planning for the future. To this end, IFCC Division Chairs will come together with the IFCC Executive Board soon for an in person/hybrid IFCC Strategic Meeting to discuss divisional structure and strategic planning. A key goal is to carefully evaluate each functional group (committees, working groups, taskforces), reviewing their mandate and progress to-date, ensuring that the IFCC structure is appropriately positioned to meet its scientific, educational, and global responsibilities over the coming years. IFCC has also launched a new important initiative, the IFCC Global Lab Medicine Week (GLMW), to celebrate the pivotal role of laboratory medicine and laboratory professionals in both public health and patient care. The 2022 focus/theme will be “The

Till next time ☺ Khosrow

New IFCC Corporate Member: Autobio Diagnostics (China)

utobio Diagnostics Co., Ltd was founded in 1998, headquartered in Zhengzhou, China. As a leading provider of comprehensive solutions for medical laboratories, Autobio specializes in R & D, production, marketing and service of clinical diagnostic products. Focusing on immunoassay, molecular, microbiology and POCT fields, Autobio helps healthcare professionals tailor treatment with fast, reliable and accurate diagnosis solution for various diseases and dysfunctions. Autobio has a strategic vision to establish a world class technology-based operation that is committed to manufacturing and marketing products that adhere to global standards in both quality and care. Currently, Autobio has 529 product registration certificates, 322 CE marked and 528 patents. In overseas markets, Autobio’ s products have performed enormous potential, exporting to over 80 countries and regions. Always taking product quality and sophisticated manufacturing as the first priority, Autobio’s fully Automated Chemiluminescence Immunoassay (CLIA) Analyzer and Assays have entered more than ten thousands medical institutions all over the world. From ELISA to CLIA system based on Microparticles, Autobio is among the top IVD enterprises capable of providing comprehensive immunoassay solutions. With profound accumulation in microbiology field, Autobio also takes a predominant position in blood culturing, identification, and antibiotic susceptibility testing. Among them, the Automated Mass Spectrometry Microbial Identification System Autof ms1000 ranks first in growth rate in China and maintains a vigorous upward trend in overseas market by virtue of the ability to obtain identification results within 0.1 seconds. The

Laboratory’s Vital Role in the Global Fight Against the COVID-19 Pandemic”. A Global Lab Week Working Group has been formed with representations from IFCC regional federations and they are hard at work planning the official launch of this program in April of this year during the EuroMedLab Congress in Munich. For this initiative, IFCC would like to collaborate closely with regional federations, national societies, and corporate members to support their activities around the world. To this end, calls for nominations have been circulated for 1) IFCC Corporate Member Representatives to serve on a Corporate Member Advisory Group to the Global Lab Week and 2) National Lab Week Champions to assist with the promotion of GLMW and the vital role our profession plays in their country/region. In other news, IFCC has been working to create a request for proposals to identify a new IT partner to redevelop/upgrade the current IFCC website and associated platforms as well as provide ongoing technical and operational support. In an increasingly virtual world, it is more important than ever to further establish and improve IFCC’s online presence, increasing engagement, knowledge translation, satisfaction, and so much more within the IFCC community and beyond. This will be particularly useful to support initiatives such as GLMW, eAcademy, Global Reference Interval Database (GRID), Global Lab Quality (GLQ), and others. We are also planning the development of an IFCC Virtual Platform for all future virtual and hybrid events, both smaller meeting and larger conferences. Stay tuned! As always, please feel free to email me at president@ifcc.org with any feedback, questions, or concerns you may have.

LabMedica International February-March/2022

function of Autof ms1000 system is mainly to collect the ribosomal protein fingerprints of cultured microorganisms, and to diagnose the pathogenic microorganisms that cause infection through analysis and database comparison. In the field of molecular detection, Autobio has launched the automatic nucleic acid purification and real-time fluorescent PCR analysis systems AutoMolec 3000 and AutoMolec 1600, which innovatively realizes random access and full automation of extraction and amplification. The SARS-CoV-2 reagent has obtained the CE certification. In addition, other molecular detection reagents such as respiratory tract and HPV will also be launched this year. In the future, Autobio will put more investment into the R&D of random automated molecular detection devices and broader assays. The analyzer improves the way in molecular diagnostics and makes your molecular diagnostic more accurate, convenient and flexible. Visit https://en.autobio.com.cn/ for more info.

IFCC OFFICE Via Carlo Farini 81, 20159 Milan, ITALY

Tel: (39) 02-6680-9912 • E-mail: ifcc@ifcc.org • Web: www.ifcc.org Staff Members: Paola Bramati, Silvia Cardinale, Silvia Colli-Lanzi, Smeralda Skenderaj The views and positions expressed in the IFCC News section are those of the IFCC or the individual authors, and do not necessarily represent the views or positions of LabMedica magazine or its publishers.

LabMedica International

To view this issue in interactive digital magazine format visit LabMedica.com

Beta-Lactamase Detecting Reagent Rapidly Diagnoses Urinary ESBL-Producing Pathogens

he increasing prevalence of extended-spectrum beta-lactamase (ESBL)-producing Enterobacterales is recognized as a significant health threat worldwide. In addition, long-term colonization by ESBL-producing Enterobacterales has recently been reported not only in patients undergoing antimicrobial therapy but also in healthy individuals. As Enterobacterales are among the most common pathogenic bacteria causing urinary tract infection (UTI), the rapid spread of ESBL-producing Enterobacterales makes it difficult to select appropriate initial antimicrobial therapy in patients with UTI. Urine culture is the gold standard for confirming the causative organisms of UTI, it takes at least 48–72 hour to obtain the results of antimicrobial susceptibility tests. Clinical Scientists at the Osaka General Medical Center (Osaka, Japan; www.gh.opho.jp) conducted a prospective observational study from July 2019 to November 2019 in a tertiary care hospital in Japan. Patients were eligible if they underwent urine culture tests, and Gram-negative pathogens of at least one per field of view under a 1000× microscope were detected from their urine samples. The reference standard was ESBL-producing Enterobacterales isolated from urine culture and all urine samples were cultured. Bacterial isolates were further identified by MALDI Biotyper (Bruker, Billerica, MA, USA; www.bruker.com). All antibiotic susceptibility tests, including those for ESBL production, were confirmed by a BD Phoenix automated identification and susceptibility testing system (Becton, Dickinson and Company, Franklin, NJ, USA; www. bd.com). Each urine sample was centrifuged, and the pellet was mixed with Cica-beta reagent (Kanto Chemical, Tokyo, Japan; www. kanto.co.jp). The test was considered positive when the enzymatic reaction turned from yellow to red or orange. The investigators reported that 350 patients with Gram-negative bacteriuria were included in the study, and the Cica-beta test

was performed directly on their urine samples. Among these 350 patients, 214 were diagnosed with UTI. Escherichia coli (n=223; 63.7%) was the most frequently isolated bacteria, followed by Klebsiella pneumoniae (n=56; 16.0%) and Pseudomonas aeruginosa (n=34; 9.7%). ESBL-producing pathogens were isolated from 79 samples (22.6%). In total 80 ESBL-producing pathogens were isolated during the study period. The Cica-beta test was positive in 65 (18.6%) samples; non-ESBL-producing pathogens were identified in two cases by culture. E. coli resistant to ampicillin, piperacillin and cefazoline was identified in one case, and Proteus mirabilis resistant to ampicillin and cefazoline was identified in the other case. In most cases, the results of the Cica-beta test were available on the day after the urine samples were collected, or sooner. The authors concluded that the Cica-beta test appeared to be an efficient test for the detection of ESBL-producing pathogens in urine. As it can provide immediate information about ESBLs without complex interpretation, the Cica-beta test may represent a point-of-care test to predict causative pathogens and guide appropriate antibiotic therapy in patients with UTI. The study was published on December 1, 2021 in the International Journal of Infectious Diseases. Image: BD Phoenix automated identification and susceptibility testing system (Photo courtesy of Becton, Dickinson and Company)

Sex Hormone–Binding Globulin a Biomarker for Cardiovascular Disease Risk Independent of Total Testosterone Concentration

he blood protein sex hormone–binding globulin (SHBG) has been shown to be a biomarker that predicts greater risk of myocardial infarction and lower risk of ischemic stroke and heart failure in men between the ages of 40 and 69. Investigators at University of Western Australia (Perth; www.uwa. edu.au) conducted a study to analyze associations of serum total testosterone and SHBG with incident cardiovascular events in men. Testosterone circulates in the bloodstream, with about 54% loosely bound to serum albumin and about 44% bound tightly to SHBG. Only a very small fraction (1 to 2%) is unbound, or “free,” and thus biologically active and able to enter a cell and activate its receptor. Thus, bioavailability of sex hormones is influenced by the level of SHBG. For this study, the investigators analyzed serum samples obtained from 210,700 men aged 40 to 69 for a period of nine years. During this time, outcomes of incident myocardial infarction (MI), hemorrhagic stroke (HS), ischemic stroke (IS), heart failure (HF), and major adverse cardiovascular events (MACE) were observed and associated with measured levels of testosterone and SHBG and calculated levels of free testosterone. Results revealed that 4.2% (8790) of the men had an incident cardiovascular event during the nine year course of the study. Lower testosterone concentrations were not associated with incident MI, HS, IS, HF, or MACE after adjustment for key variables. The incidence of MACE was significantly lower for men with lower calculated free testosterone val-

ues. Lower SHBG concentrations were associated with higher incidence of MI and lower incidence of IS and HF, but not with HS or MACE. These results allowed the investigators to conclude, “Men with lower SHBG concentrations have higher risk for MI but lower risk for HF, indicating a role for SHBG as a biomarker for various cardiovascular risks, independently of total testosterone concentrations.” The study was published in the December 28, 2021, online edition of the journal Annals of Internal Medicine. Image: Crystallographic structure of sex hormone binding globulin (SHBG) (Photo courtesy of Wikimedia Commons) LabMedica International February-March/2022

To view this issue in interactive digital magazine format visit LabMedica.com

AACC and Life Diagnostics Partner to Relaunch AACC Middle East

he American Association for Clinical Chemistry (AACC Washington, D.C., USA; www.aacc.org) has announced a new collaboration with Life Diagnostics (Abu Dhabi, UAE) to relaunch AACC Middle East which will bring AACC’s world-renowned education and scientific programs paired with a dynamic exhibit to Dubai, UAE, November 5-6, 2022. AACC will work closely with Life Diagnostics in order to relaunch AACC Middle East for this purpose. The event’s scientific program will feature experts from the

Industry News

US and the Middle East who will share gold standard, actionable information about the latest in clinical testing. Attendees will be able to come together safely and in-person with leaders in the field to share lessons learned from the pandemic to date. In addition, the exposition floor of AACC Middle East will feature the latest innovations in every area of clinical testing, including coronavirus testing, artificial intelligence (AI), mobile health, molecular diagnostics, mass spectrometry, next-generation sequencing (NGS), point of care (POC), and automation.

Becton Dickinson Acquires Clinical Flow Cytometry Firm in Spain

Becton, Dickinson and Company (BD Franklin Lakes, NJ, USA) has completed the acquisition of Cytognos (Salamanca, Spain; www.cytognos. com) from Vitro S.A. (Seville, Spain; www. vitro.bio). The acquisition of Cytognos, which specializes in flow cytometry solutions for blood cancer diagnosis, minimal residual disease (MRD) detection and immune monitoring research for blood diseases, accelerates BD’s strategy to support chronic disease management by expanding its portfolio of blood cancer diagnostics, immune assessment tests and informatics to address patient, clinician

and care provider needs to better understand the immune system, immune response and MRD. By monitoring for MRD, lab managers and physicians can detect low levels of cancer cells following treatment that alerts them if the disease is still present or if there is a signal of recurrence. This is a key element of the patient care continuum that helps clinicians and physicians recognize when cancer recurs and aids in the timely treatment of patients. Cytognos’ key products are expected to increase BD’s comprehensive portfolio of diagnostic and research solutions for certain types of cancers that use flow cytometry as

the primary means of discovery, diagnosis and understanding, including lymphoma, leukemia and multiple myeloma. With the acquisition of Cytognos, BD gains exclusive access to advanced assays licensed from the EuroFlow Consortium, a scientifically independent network in the fields of hematology and immunology with scientists and researchers from more than 20 European universities and hospitals. BD has existing license agreements with EuroFlow for multiple other assays and the addition of the Cytognos assays further strengthens BD’s 12-year licensing collaboration with EuroFlow.

Illumina and Boehringer Ingelheim in Alliance for Cancer Companion Diagnostics

llumina Inc. (San Diego, CA, USA; www.illumina.com) has entered into a partnership with Boehringer Ingelheim (Ingelheim am Rhein, Germany; www.boehringer-ingelheim.com) to develop companion diagnostics (CDx) for several programs in the latter’s oncology pipeline. The partnership aims to accelerate the development of therapy selection and precision medicines for patients with advanced cancer.

The partnership spans current and future CDx programs, with plans to add CDx claims to an in vitro diagnostic test Illumina is developing that is based on the content of TruSight Oncology 500 (TSO 500). The first program will co-develop a CDx for a Boehringer Ingelheim investigational medicine. TSO 500 is a Research Use Only comprehensive pan-cancer assay designed to identify 523 known and emerging tumor biomarkers.

TSO 500 utilizes both DNA and RNA from tumor samples to identify key variants critical for cancer development and progression, such as small DNA variants, fusions, and splice variants. Based on the content of TSO 500, Illumina will be adding an in vitro diagnostic test to the TruSight Oncology product family. This comprehensive tumor profiling assay will have similar chemistry and analytics to TSO 500.

Thermo Fisher and Oncocyte to Jointly Develop IVD Test Kits and Companion Diagnostics in Precision Oncology

ncocyte Corporation (Irvine, CA, USA; www.oncocyte.com) has entered into a development and co-marketing agreement for two distributed in vitro diagnostic (IVD) assays on Thermo Fisher Scientific’s (Waltham, MA, USA; www.ther mofisher.com) Ion Torrent Genexus System. The agreement also grants Oncocyte rights to develop future companion diagnostics on the Genexus System. The first-of-its-kind Genexus System is designed to be used in any lab and delivers comprehensive next-generation sequencing (NGS) results in as little as a single day – the same timeframe as single-gene tests, such as immunohistochemistry (IHC) assays. The Genexus system’s flexible batching makes it an attractive solution for hospital labs with low and medium testing volume by reducing the need to wait several days until

LabMedica International February-March/2022

a lab has a sufficient number of samples to test. The integrated purification system and sequencer enable sample preparation and processing with only 20 minutes of hands-on time and minimal user intervention, allowing for the democratization of NGS to community and regional cancer centers globally. Under the terms of the collaboration, Oncocyte will clinically validate Thermo Fisher’s existing Oncomine Comprehensive Assay Plus on the Genexus System, paving the way toward IVD clearance for use in tumor profiling and future submissions as a companion diagnostic. As an IVD, the >500-gene assay will initially be able to provide physicians with information about patients’ tumors in accordance with established clinical evidence, applicable clinical trials, and future approval may assist

with the selection of targeted therapies. Oncocyte will also develop its 27-gene expression DetermaIO test as a distributed kit on the Genexus. DetermaIO may predict response to immuno-oncology therapies based on data demonstrating potential pan-cancer utility and improvement over current standard-of-care tests.

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