Inside Diagnostics - Spring/Summer 2014 (EN) by nal von minden GmbH

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Inside Diagnostics Spring/Summer 2014

MECHANISATION

Rapid tests and the shift towards automatic analysis

CHLAMYDIA

The advantages of a clear diagnosis

CROCODILE

The most dangerous drug in the world is on the move

In this issue

P R I Z E D R AagW e 12

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Inside Diagnostics Vorwort

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Inside Diagnostics

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Dear Readers, This issue highlights a big change in the way we explore our topics. From now on, we are taking a new direction with the information that we provide. We have made the decision to be more diagnostics focused, and to involve more of our readers with the opportunity to participate in our competition to win a coffee machine, or to follow the adventures of â&#x20AC;&#x2DC;Medical Manâ&#x20AC;&#x2122;! In this issue, we look at the progress in the field of in-vitro diagnostics and the emerging technologies associated with reading lateral flow rapid tests. We give

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you a detailed view of what is going on in this area, and the future of rapid tests. Moreover, in the topic of drugs of abuse, we speak (finally) about EtG testing and the upcoming and lethal Krokodil drug. We also go into depth on the topic of Legal Highs and the political situation in Europe and across the world. As always, the Inside Diagnostics team hope you enjoy reading our magazine and welcome any questions or suggestions. Yours faithfully, Nicolas Kennof

Click here and subscribe in one easy step! Executive editor: Inside Diagnostics Nicolas Kennof Tel.: 0941 29010-36 inside-diagnostics@nal-vonminden.com

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Inside Diagnostics Contents

Contents

CARTOON | Page 19

Experience Medical Man‘s first adventure. Read more on page 19.

Themes EtG �� 5 Mechanisation �� 6 Crocodile �� 8 New Psychoactive Substances �� 10 Borreliosis �� 14 Chlamydia �� 17 nvm Inside Prize Draw ��12 Short News & Cartoon ��19

Flag Contact: nal von minden GmbH Nicolas Kennof Friedenstraße 32 93053 Regensburg Chief Editor: Nicolas Kennof

MECHANISATION | Page 6

Nowadays, electronic analytical devices, with partial or total automation, are set standards in almost all laboratories. However, in comparison, rapid tests, particularly lateral flow tests, are still performed mostly manually with results read by the eye. This area of diagnostics has therefore been characterised for some time, as a newly emerging market in the direction of mechanisation. More on page 6.

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Editors: Torsten Winkler, Kristina Sambs, Raffaela Seiband, Christopher Beiderbeck, Anne Kaiser, Andrea Kreuzer, Franziska Stöckinger, Jodie Baker, Martina Kastenmaier, India Cooper, Alexandre Lages, Miguel Estevez, Lukas Eder inside-diagnostics@nal-vonminden.com Layout: Martina Kastenmaier, Kasia Orlowska

www.istockphoto.com © Vladislav Ociacia, GlobalStock

Inside Diagnostics nal von minden GmbH Customer Magazine

Rapid Tests EtG

EtG

Detect alcohol consumption in urine 2 - 4 days with the nal von minden Drug-Screen® for Ethylglucuronid rapid test The abuse of alcohol is a widespread problem. Fortunately today there are tests available for specific alcohol markers which enable the detection of consumption. The need for indicators, that can show abusive or chronic consumption of alcohol, is growing steadily. The direct measurement of Ethanol in blood, breath, urine, sweat or saliva is the easiest and most specific way to prove recent alcohol consumption. Yet a negative result does not exclude chronic consumption.

www.istockphoto.com © Avesun

Ethylglucuronide (EtG) is a direct metabolite of ethanol, which is formed from hepatic glucuronidation and excreted via the kidneys. EtG has a slow rate of excretion, which means it can be detected in urine for up to four days. In comparison, when testing for alcohol directly the detection period is much shorter. Depending on the amount of alcohol consumed, alcohol itself only detectable for 10-20 hours after consumption (decomposition rate from 0.10 – 0.15 ‰ per hour.) The nal von minden Drug-Screen® Ethylglucuronide rapid test is a chromatographic immunoassay for fast and qualitative detection of the alcohol specific biomarker Ethylglucuronide in human urine with a cut-off of 300 ng/ml. It can be used as a tool to support the introduction or successful maintainance of ther apeutic measures. The rapid test is an invitro diagnostic device for pro fessional use.

What are the benefits of the test? EtG can be detected in urine for two to four days after alcohol consumption. The direct detection of alcohol in urine and blood is only possible for several hours. Thus EtG can be used as a biomarker for alcohol tests in rehabilitation programmes, where a longer detection time period is advantageous. Patients discharged temporarily for the weekend, can be tested on the spot immediately when they return. Here an indication of alcohol consumption for the past 2 – 4 days can be obtained. It is not necessary to send the sample to laboratory, time is saved, and the test is significantly less expensive than other alternatives. What is the target group? Those interested in the test are usually from therapeutic institutions, hospitals with an emphasis on alcohol and drug abuse or prisons. Depending on the reason for testing, the tests can be used to evaluate alcohol consumption or monitor consumer behaviour. AK For the detection of EtG the following products are available as rapid tests: product number: 101044 test strip, 50 pieces per package product number: 102044 Test cassette, 30 pieces per package

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Laboratory Products Mechanisation

Mechanisation

Readers and their application in Point of Care (POC) in vitro diagnostics Nowadays, electronic analytical devices, with partial or total automation, are set standards in almost all laboratories. From blood sugar and antibody titers to automatic de-capping, sample distribution, analysis and LIMS transmission, the options for electrical analysis are limitless. However, in comparison, rapid tests, particularly lateral flow tests, are still performed mostly manually with results read by the eye. This area of diagnostics has therefore been characterised for some time, as a newly emerging market in the direction of mechanisation.

example, it would be beneficial to have an estimate of urine pH and creatinine levels, in order to detect manipulated samples. Even an estimate of drug concentration, or other parameters, such as the weeks of pregnancy, CrP concentration, and the volume of occult blood present in the stool, would be of interest to many users. Lateral flow rapid tests can be used in this way, with a corresponding analysis system, but in some cases where the estimation of analyte concentrations is insufficient, quantitative evaluation at a laboratory would also be necessary.

When lateral flow rapid tests were first invented, they were conceived to be purely qualitative tests, displaying only positive or negative results. A positive finding will cause both lines to appear (sandwich assays e.g. pregnancy tests) or one line to disappear (competitive tests e.g. drug tests). The desire for a rough estimate of the concentration was then enabled by means of a so-called semi-quantitative multi-line test. Multi line tests display several test lines applied in succession on a test strip, where each line has a dedicated cut-off, which appears at different concentrations. Depending on how many lines appear on the test, an approximate concentration value can be determined. This principle is still used, for example, in the semi-quantitative CRP test application.

Quantitative Evaluation

Qualitative Evaluation In the case of biophysical parameters, the line intensity will increase or decrease gradually, thus it is inevitable that there will be a transitionary period when the line can appear to be weak. In such cases, it can be difficult to determine the presence of a line, or not. In such scenarios, it is easier to transfer the decision to a qualitative rapid test analyser, where the result can be objectified. The RSS II has been available for many years for this very purpose. It provides a reliable qualitative reading, where the result is also documented and archived, allowing the result to be accessed at a later date, for statistical purposes, as well as quality management. Semi-Quantitative Evaluation It is often desirable to obtain semi-quantitative results for different parameters in addition to a qualitative evaluation. For

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The step from a semi-quantitative to a quantitative use of rapid tests is much greater than of qualitative tests to semiquantitative. For quantitative tests such as a troponin I test, it is necessary to distinguish reliably between 0.4 ng / ml and 0.6 ng / ml. With increasing demands on accuracy the signal used for interpretation (i.e. the test line) must be more stable, reproducible and sensitive, in order to make even the small differences in concentration quantifiable. In addition, the analyser must be able to detect such small differences effectively. Furthermore no quantification can occur without correctly stored calibration data. This calibration data must be created and stored for each specific test lot. Further questions then automatically arise on distribution of calibration data and calibration stability. The rapid test is suddenly no longer just a fast and affordable way to create a yes-no answer but instead becomes an advanced â&#x20AC;&#x17E;laboratory methodâ&#x20AC;&#x153;. However through the qualification of a test, other regulations are often applied (e.g. in Germany RiliBĂ&#x201E;K). Even with this, for many parameters quantification makes sense, especially for all cardiac markers such as troponin I, D-dimer and NTproBNP and even with drugs (in urine together with a reading for creatinine), CrP, hormones and antibody titers, it is possible to generate an exact concentration value. Quantification does not always make sense However, one should also acknowledge the other side to this continuously growing desire for even more data, information and accuracy. One should make sure that things do not get out of control.

Laboratory Products Mechanisation

For some parameters, it does not make sense to specify an exact value, either because the symptoms do not correlate with the concentration of a marker or that in the pre-analysis phase already such differences will arise if a quantitative value is compared without knowledge of other factors. For example, the quantitative values of IgG and IgM antibodies after or during Lyme disease do not give a clear understanding of the infection, or highlight the severity of the disease or therapeutic success. In some patients only IgG are formed and

in certain cases all antibodies will have disappeared within weeks of successful therapy and in other cases one or both of the antibodies will persist for years or decades. To summarise, reader systems can provide significant enrichments to the interpretation of rapid tests. It is possible to interpret results objectively and reproducibly, and can expand areas of application and overall available information. However, first it must always be distinguished if all this extra information really is necessary. TW

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Rapid Tests Crocodile

Crocodile

The most dangerous drug in the world is on the move

What is Krokodil? The drug family Krokodil is the street name of “desomorphine”, a synthetic opiate that can be synthetised from codeine, red phosphorous and iodine. In other words, Krokodil is just a synthetic morphine derivative. Used as a drug, it is much more powerful than heroin and is created from a complex chain of mixing chemical reactions. The recipe Made out of codeine, gasoline, paint thinner, hydrochloric acid, iodine and red phosphorous from matchstick heads, the result is a highly impure and corrosive substance. The effects on the user are similar to that of heroin but they are reduced from 4-8 hours for heroin to 1-1.5 hours for desomorphine. The name Due to its impure nature, the side effects of the drug are horrific. Among others, they give a stench and reptilian structure to the skin of the user; easy then to understand why the street name of desomorphine is Krokodil. Other devastating effects are, for example, phlebitis and gangrene. The user´s body li-

terally rots from the inside out leaving bones exposed. After the first injection, it is believed that a user´s life expectancy is only 2-3 years. The context of its emergence In 2010, there was a blip in the global production of opioids caused by a disease of the opium poppy in Afghanistan. That crop failure had an important impact on the major illicit markets for opiates and a heroin shortage was observed across South-Eastern Europe and Russia. This shortage led to an increase in the price of heroin and thus difficulties for users to satisfy their needs. In that context, Krokodil began to emerge. Synthesised from unrestricted products freely available on the market and being ten to thirty times cheaper than heroin, it appeared like a very good alternative to a lack of heroin. Moreover, Krokodil can be cooked at home in 30 minutes, further adding to its appeal. Where does Krokodil take its victims? Russia is definitely in the top position, with an estimated one million addicts to Krokodil. Most commonly addicts are outside the big cities, where it is harder to find heroin and where the people are poorer. It started in this environment around 4 years ago. Many countries are now afraid to see the deadliest drug ever from entering their borders. Some signs show that the drug could have already entered the US with two cases reported and presenting the same symptoms in Arizona. An isolated case also appeared in the UK.

In 2010, there was a

blip in the global production of opoids.

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www.istockphoto.com © Andrew Burgess

With high popularity in the media and on the internet, the drug “Krokodil” raises lots of questions and fears. Here below, we tried to summarise the issue and to answer the question of early detection. What is Krokodil? Why is it consumed? What does it do to its victims? And, last but not least, how can it be detected? Find the answers to your questions below.

Rapid Tests Crocodile

How to detect it? The clearly visible side effects of Krokodil consumption make detection at an advanced stage of addiction quite easy. This together with the presence of an iodine smell, due to the fabrication process, makes a user very easy to detect. The problem is that these characteristics are not necessarily detectable from first time injection and need time before they appear. Moreover, they are not scientifically proven. In order to appeal to a relevant detection method, the use of a rapid test is recommended. Yet what kind of test actually works to detect the abuse of desomorphine? As discussed before, desomorphine is a synthetic morphine derivative, and thus the use of a simple

morphine rapid test can be revealing. This test will determine if morphine or one of its derivatives (codeine, heroine, oxycodone, hydromoprhone, hydrocodonem oxymorphone, buprenorphine, dihydromorphone, dihydrocodeine, hydrocodone or desomoprhine) is present in a sample. However, in order to differentiate between all these derivatives, the sample must then be sent in a laboratory that will be able to identify the specific substance. The laboratory must though be notified that you require to test specifically to identify the presence of desomorphine in your sample. Early detection of the abuse of desomorphine can therefore be determined in for a krokodil user whose life expectancy is unlikely to exceed two or three years. NK

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Rapid Tests Legal Highs

Controlling New Psychoactive Substances

Prevention and Damage Limitation New Psychoactive Substances (NPS), also known as Legal Highs, are a wide spread problem across the world. Whilst it is difficult to obtain exact figures on the impact on mortality, due to concentrations of other drugs also present in toxicology reports, it is clear that an increasing number of deaths have been caused by NPS, with a 600% increase from 2009 to 2012 noted. The rise in their popularity is also noted through their expanding social presence, something which does not look set to ease any time soon. An obvious danger of these drugs is the effect it has on the user. The aim of these drugs is to mimic the effect of illegal drugs, an effect that is often incapacitating, with ‘black-outs’ being common. An added threat lies in the uncertainty of their contents, as they are often a combination of untested synthetic substances. The possible effects are therefore largely unknown. To avoid testing regulations and to make such substances legal for sale, “Not for human consumption” must be visible on the packaging. As the manufacture is not regulated, the potency of such drugs can vary hugely, resulting in undetermined and varied reactions from one consumer to the next. This is hugely dangerous for users and makes it very difficult for them to determine their own tolerance limits. There is also the possibility that contained within these NPS are illegal drugs, which would obviously change the legality of the substance, regardless of whether the user is aware of this or not. Examples of New Psychoactive Substances are: • A range of drugs with names such as ‘Mary Jane’, ‘Marshmallow’, ‘Charge+’, ‘Green Dream’, and ‘Blurberrys’ are being advertised currently. • NBOMe, which has an effect similar to LSD (now temporarily banned in the UK.) • Benzo Fury, which simulates the effects of amphetamines (now temporarily banned in the UK.) • Spice, a mixture of synthetic cannabinoids, which mimics the effect of cannabis. Now an illegal and controlled substance under the Misuse of Drugs Act in the UK. • Perhaps the most famous ‘Legal High’ and the start of the epidemic, Mephedrone is a synthetic amphetamine and has been illegal across the EU since December 2010.

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Marketing of New Psychoactive Substances The aim is to mislead the user into a false sense of security about the safety and legality of the substance. Street names, like ‘Spice’ and ‘Mary Jane’, make the drug seem more commonplace. They are marketed globally online, meaning that anyone can buy them, including minors. The packaging of these products is bright and appeals to the younger audience, which these drugs are primarily aimed at. With new products on the market, you can sometimes even receive free samples so the experienced user would be able to compare it to their current high. Information about the drugs on the websites of online head shops do not provide details on the effects (supposed or actual) of the drugs, instead they make light of it and some even state that the descriptions are for ‘novelty purposes only’. So how are young buyers supposed to make an informed choice without any true description as to what they are buying? New Psychoactive Substances in Use New Psychoactive Substances are currently a popular media topic in the UK, as we become increasingly aware of the dangers associated with them. They are often used on the ‘clubbing and festival’ scene to maintain high energy levels, and to manipulate a sense of euphoria. Due to the nature of this environment, it is teenagers and young people who are the predominant users of legal club drugs, often also enticed to buy due to the affordability of the substances compared with illegal drugs. Synthetic cannabis, however, captures a broader audience and tends to be used more regularly, whereby its usage mimics the broader use of cannabis across society. Use of NPSs within prisons is also expected to increase. Within the space of one month, two separate incidences of hospitalisation and violence were recorded through consumption of legal highs in prisons. Due to the new status of these drugs, testing is not yet a part of standard drug screen tests; for example Spice/K2 is not a common parameter offered by drug test suppliers. Especially in prisons, the usage of narcotics could be severely underestimated as a result of not testing for legal highs. Politics In Ireland, a general blanket ban on all new substances has been introduced, but government policy in the UK remains

Rapid Tests Legal Highs

unclear on the subject. Legislation is expected to be brought in, in response to the increasing number of deaths, and for this reason the UK has chosen to opt out of the European Commission rules on NPS. They believe the issue can be dealt with faster and more efficiently internally and there remains strong objections to some claims made by the EU on the topic. The UK currently has some of the strictest regulations surrounding this matter in Europe, in which the Home Secretary can temporarily ban substances for 1 year, allowing time for the drug to be investigated by the Advisory Council on the Misuse of Drugs. This makes the supply of such drugs immediately illegal, whereby possession remains tolerated. The European Commission plans to enforce something similar, but will only criminalise the most harmful substances, but not all. In New Zealand, the issue has been addressed differently. Instead of having to prove that a substance is harmful for it to be banned, a license must be obtained, which proves that the substance poses a ‘low risk of harm’. Whilst this highly controversial method of controlling NPSs could be seen as encouraging their sale, they will not be available to vulnerable customers, and it ensures the most dangerous products never reach the market. Working Against New Psychoactive Substances Additional to government efforts, many organisations are working to increase awareness of these substances and the associated dangers. Some campaigns are designed to reach out to the people exposed to legal highs, such as the ‘Don’t be in the dark about legal highs’ campaign. On 3rd May 2014, twenty-four UK festivals halted all social media presence for 24 hours. Instead their websites only displayed a black screen,

alongside a grey light bulb highlighting the name of the campaign. This was a united stance from some of the UK’s biggest festivals, including Glastonbury and T in the Park, that legal highs are dangerous, should not be consumed and will not be tolerated at their events. Another method introduced by Wales NHS to educate people on the topic, is the Wedinos Project. This is aimed at health workers, but not exclusive to them, and allows people to send in samples of drugs anonymously to find out the exact contents of the substance. The results are then published online with the idea that health workers will be better equipped to help users, when they are aware of the type of substance being consumed. It also aims to enlighten people about the contents of a supposed ‘legal high’. Some instances have shown that the purchase intent was for a legal high, but actually contained illegal drugs, such as MDMA. Testing As it is now well established that Legal Highs can be as damaging to health as controlled substances, it is important to start including them in standard drug testing screens, especially amongst existing drug users and vulnerable groups. Testing is necessary because of the obvious implications of consuming these Legal Highs. The impairment of judgment is arguably equally as dangerous as any physical effects. At nal von minden, we currently offer a rapid test for Spice/ K2. This is in the form of a single strip, but we can also custom make and integrate this parameter into a Multi-Dip, or Cup test upon request. For further information, please contact us. IC

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Rapidinside nvm Tests Prize Substitution Draw

Join in & win! Dear readers,

In this issue you will have the chance to take part in the prize draw and win a Bosch Tassimo T42 coffee machine in red. Just answer to the following question and send the right answer via Fax to +49 941 29010 50 or send the filled form to nal von minden GmbH, Christopher Beiderbeck, Friedenstraße 32, 93053 Regensburg, Germany. Furthermore you can participate by Email. Send the right answer including your complete address with the subject „Prize Draw“ to gewinnspiel@nal-vonminden.com. The winner will be drawn from all of the correct entries received. Closing date is 15.08.2014.

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Good luck! Your Inside Diagnostics team Tassimo Coffee You can win a Bosch maker in red ... riety DISC technology (va ... With patented T atic tom au ly ful n), sca de recognition by barco (T DISCs), les su cap O IM n for TASS 1-button operatio tion. tec pro stand and splash SSIMO exchangeable cup TA n, sig de t ac mp and co ality. Besides the trendy qu e caf at rage diversity offers you hot beve er coffee, filt tic ma aro m fro se For example choo cino, Latte ffe Crema, Cappuc strong Espresso, Ca or tea. Macchiato, Cocoa

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Rapid nvm Tests insideSubstitution Prize Draw

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Signature Conditions of Participation 1. The Promoter is nal von minden GmbH. 2. To enter simply fill in your details on the form here above and fax it to +49 941 290 10-50 or send it by post to: nal von minden GmbH, Christopher Beiderbeck, Friedenstrasse 32, 93053 Regensburg, Germany. Participation is also possible by email; please send an email with your answer and your complete address with the subject line as “Prize Draw” to gewinnspiel@nal-vonminden.com. The winner will be chosen at random and be drawn from those who have entered the correct answer. 3. This prize draw is open to European residents aged 18 years or over, with the exception of employees of the Promoter, their families, agents and anyone else connected with this promotion. Only one entry per person. No entrant may win more than one prize. 4. No purchase necessary to enter the prize draw and the participation is free. By entering the prize draw each entrant agrees to be bound by these terms and conditions. Entries must be received by the 15th August 2014. 5. The winner will be notified via email or post and will receive the prize by post. 6. Prizes are subject to availability. In the event of unforeseen circumstances, the Promoter reserves the right (a) to substitute alternative prizes of equivalent or greater value and (b) in exceptional circumstances to amend or foreclose the promotion without notice. No correspondence will be entered into. 7. The prize is a Bosch coffee machine. No cash or prize alternatives will be offered. The winner‘s entitlement to the prize is not transferable. 8. The Promoter shall not be responsible for damages, losses or liabilities of any kind, including without limitation, direct, indirect or consequential loss or damages arising out of or in relation to the prize draw. 9. Any liability for damages of nal von minden GmbH and their officers, employees and agents in connection with the competition, irrespective of the legal reason, is, as far as legally permissible, limited to cases of intent or gross negligence. 10. The promoter’s decision in respect of all matters to do with the competition will be final and no correspondence will be entered into. Legal recourse is excluded.

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Bacteriology Borreliosis

Lyme Borreliosis

„A clinical and diagnostic chameleon“

Whilst Lyme Borreliosis can be treated easily with antibiotics, misdiagnosis can lead to complicated and often delayed side effects. These can be devastating, sometimes leading to multiorgan failures and damage to the central nervous system of the infected patient. Diagnosis can be difficult because symptoms do not always occur, or mimic those of other common illnesses. The unfortunate result is that more individuals are forced to endure the painful effects of Lyme disease, when frankly they should not. Early diagnosis and treatment with antibiotics usually results in successful recovery and the risk of chronic side effects is greatly reduced. It is therefore important to inform and educate on topics surrounding this disease. Here, we summarise for you the most important information about the infection, symptoms, treatment and various diagnostic methods to detect and thus treat the disease as fast as possible. Transfer of the infection and removal of the tick The Borrelia bacteria are situated in the stomach and the bowel of the tick and will be transferred through the saliva to the host only 12 to 24 hours after first becoming attached. In any case you should remove the tick as fast as possible, without manipulating or squeezing it´s body, to avoid becoming infected. Current guidelines recommend to remove the tick immediately even if there is no appropriate tool available. In such cases, parts of the tick can remain in the skin, but this can be removed later by a doctor to avoid inflammation. Ideally

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the tick should be seized close to the skin with pointed tweezers, tick pincers, a tick loop or a tick card. You should then loosen the tick and slowly remove it before disinfecting the puncture area. Progression of the disease The progression of the disease and clinical side effects of Lyme Borreliosis are divided into an early stage diagnosis (acute and disseminated infection) and a late stage diagnosis (persistent infection). During the clinical course of the disease, all symptoms can occur isolated or in different combinations. An episodical response to the disease is also characteristic, as well as symptoms affecting different parts of the body. Clinical Symptoms Early stage: days to months after the tick bite Erythema chronicum migrans, an initial rash occurs in about 50% of cases. A circular reddening can appear around the puncture site, which then later fades from the centre and becomes a ring-like reddening that can spread all over the body. Flu-like symptoms: headaches, fatigue, exhaustion, fever, joint and rheumatic pains, swelling of the lymph nodes. Further symptoms: lymphocytoma (a reddish or pale bluish thickening of the earlobes, nipples, elbows or scrotum – can occur but is rare), Bannwarth-syndrome (paralysis of face and eye muscles, strong back pain during the night, prickling of the skin), accelerated resting heart rate, headaches radiating from the neck, dizziness, impaired vision and inflammation of the heart muscle. Late stage, also known as ´chronic Lyme Borreliosis´: months to years after the tick bite

www.istockphoto.com © Astrid Gast

Lyme Borreliosis is a bacterial infection transmitted to humans by infected ticks. It is caused by Borrelia burgdorferi, an agile, spiral bacterium, for which there is no existing immunisation. Unfortunately, due to the mild winter, and expanding tick populations, the risk of contracting this infection, has recently increased. In Germany, the Robert-Koch Institute has already reported that the number of Borrelia infections this year, has doubled that of last year and in the UK, Lyme Borreliosis is the most common vector-borne human infection. In Germany it is estimated that 5-35 % of all ticks are vectors for the bacteria.

Bacteriology Borreliosis

Lyme arthritis: swollen and painful joints Neuroborreliosis: paralysis, movement- and sensational of arms and legs is often still possible Enzephalomyelitis: chronic inflammation of the brain and medulla can occur, combined with severe effects to the central nervous system. Acrodermatitis chronica atrophicans â&#x20AC;&#x201C; ACA: the skin on hands, feet and joints can swell, is tinted blue-red and feels like parchment. All symptoms are often combined with a chronic exhaustion. Laboratory diagnostics A thorough laboratory investigation is always necessary, with the help of medical history and clinical evidence. Here, one generally differentiates between direct and indirect detection of causative organisms. The appropriate analysis material for microbiological diagnosis depends on the clinical manifestation, but can be serum, skin biopsy or cerebrospinal fluid. Direct Detection Testing for causative organisms directly depends on certain parameters, and is very complex and exhibits only limited sensitivity. Two different methods are used: Cultivation of Borrelia cultures. Advantages: Positive results indicate the active disease and the isolated Borrelia sample is available for further testing. Disadvantages: Long cultivation period and all Borrelia subgroups may not grow equally. Sampling procedure and transportation can influence the sensitivity. Detection of Borrelia DNA via Polymerase Chain Reaction (PCR) Advantages: Effective process and quick results within 1-2 days. Disadvantages: Low sensitivity, especially with late manifestations. Negative results do not necessary exclude Lyme disease and positive results can still appear after successful treatment. Indirect detection In practice, a laboratory investigation is almost always indirect, performed by determining the presence of specific antibodies (IgM & IgG) in a patientÂ´s serum or cerebrospinal fluid. In Borrelia serology a two-stage test system exists: where an ELISA test is used as an initial screening indication and a Western blot test as a confirmatory test. The interpretation of laboratory results must always be considered alongside other clinical symptoms of the individual patient.

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Bacteriology Borreliosis

ELISA-Tests

Rapid Test

ELISA tests (Enzyme-linked-immunosorbent assays) are used as screening tests and detect IgG and IgM antibodies against B. Burgdorferi quantitatively. Due to the large number of possible Borrelia sub species, the ELISA is composed of recombinant antigens, to achieve the highest possible sensitivity and specificity. All major antigens such as the outer surface Protein C (OspC) or the VlsE protein are included. In the case of border line or positive results, confirmation with a Western Blot test is required.

There are two different rapid tests. The first tests the actual tick for Borrelia, giving fast and reliable information as to whether there is any danger of infection. The second rapid test detects IgG and IgM antibodies against Borrelia in the patientÂ´s blood qualitatively. A positive result here gives a quick indication of infection, highlighting the need for further investigations.

Immunoblot (Westernblot) Test Used as a confirmatory test and for further differentiation, the Western Blot test detects specific IgG and IgM reactions to recombinant antigens, with results visible as separate bands. From this process, lots of important information is derived, which is useful for individual reports. Advantages: Very high specificity antibody test, very sensitive. Disadvantages: A negative result does not always exclude the disease. CSF analysis (Cerebrospinal fluid) An examination of cerebrospinal fluid is only undertaken in the case of serologically proven Lyme disease and suspected impairment to the central nervous system. The interpretation of cerebrospinal fluid is only possible with a parallel study using simultaneously obtained serum. For the diagnosis of Neuroborreliosis, the detection of intrathecally synthesised antibodies is required. The CFS / Serum index is determined by measuring specific antibodies in the blood and cerebrospinal fluid. It determines the total IgG concentration of serum and cerebrospinal fluid and the concentration of serum and cerbrospinal fluid albumin.

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Treatment Treatment of Lyme disease with antibiotics should begin as early as possible. However it is not recommended to prescribe directly after a tick bite. The favoured drugs for treatment are currently Tetracyclines such as Doxycycline. In children and pregnant women amoxicillin or cerfuroxime is recommended instead. The duration of recovery varies from 2 weeks with an early diagnosed infection to 3-4 weeks in the case of prolonged infections.

Would you like more information on the NADALÂŽ Lyme Borreliose Rapid Tests? Contact us on: 0941/29010-0 o or by Email: info@nal-vonminden.com

http://www.borreliose-gesellschaft.de/Texte/Leitlinien.pdf http://www.bfbd.de/de/bund/1.html http://www.lgl.bayern.de/suche/index.htm?q=borreliose http://www.rki.de/DE/Content/Infekt/EpidBull/Merkblaetter/Ratgeber_LymeBorreliose.html

Gynecology Chlamydia

Chlamydia

If undetected, this bacterial infection can cause long-term damage to your health

A Chlamydia infection is a bacterial disease and is usually detected through testing a swab taken from the infected tissue. Mucous membranes may be affected in the eyes, respiratory tract or the genital area. Chlamydia is one of Europe‘s most common sexually transmitted diseases and in most cases symptoms do not appear. Thus the diagnosis of a Chlamydia infection is often an incidental finding. If the infection has progressed, sometimes symptoms can occur and in such cases most will go and see a specialist, where by the doctor will take swab sample and evaluate it either with a rapid test or through a laboratory. If the result is positive, usually antibiotics and vaginal suppositories are prescribed. It is important to inform ones partner about the diagnosis, because an infection of the partner cannot be excluded. Unprotected intercourse should only be performed again after a full healing process is confirmed; otherwise re-infection of either partner is possible. If such an infection is not recognised for a longer period of time, it can lead to infertility in women. This is because the pathogens can severely affect the abdomen, causing purulent salpingitis (inflammation of the fallopian tubes.) Chronic inflammation can then lead to scarring or adhesions on the fallopian tubes, whereby a woman´s eggs are no longer able to get to the womb and pregnancy is no longer possible. Ac-

ross industrialised countries infection with Chlamydia is the leading cause of infertility; where one fifth of all cases of infertility can be traced back to protracted Chlamydiosis. The World Health Organization (WHO) estimates the number of Chlamydia infections worldwide to be higher than 140 million. „Over 6 million cases of blindness are caused by Chlamydia infections especially in countries in Africa, Latin America, the Middle East, and Central and Southeast Asia” (Roche Diagnostics online.)

Chlamydia

is one of Europe‘s most common sexually

transmitted diseases. Page 17

Bacteriology Borreliosis

The Spread within Europe

212004 – WiduMed Chlamydia:

Worldwide, around 10 percent of the population is affected by Chlamydia and in Germany, it is estimated that 300,000 woman become infected with Chlamydia each year. In Europe, Chlamydia is the most frequently reported sexually transmitted disease , whereby young women are the most commonly affected. Across Europe, in 2007 more than 250,000 infections were reported, equating to 123 infected people per every 100,000. More serious is the situation for younger people aged between 15 and 20 years. In this age group there are 368 infected adolescents per 100,000. Despite these statistics, it is estimated that the number of unreported cases of Chlamydia is much higher. An infection with the bacteria often causes no symptoms, making diagnosis more difficult.

Product Details:

In Germany, a check for Chlamydia is usually covered by one´s health insurance, if there is reasonable suspicion that an infection is present. Below 25 years old, health insurance companies will also cover the cost of annual Chlamydia testing. However should a patient want an examination just as a precaution and is over 25 years old, they must pay for the test. In the case of frequently varying sexual partners this will be recommended by any doctor. Yet what happens when a patient asks a doctor for a Chlamydia test, and the doctor can only offer a laboratory test for a price of between 100 and 200€? Since there is no suspicion and the patient just wants to be cautious, they would have to pay for the test themselves. In such a case it is most likely that the patient will decide not to take the test and they will go home with the feeling that their most urgent question has not been answered. In an alterative scenario, the patient could search for a doctor, who can offer a Chlamydia test much cheaper. The alternative to laboratory testing is the use of simple rapid tests. The patient is not forced to spend a fortune and can, if they want, get the results right away and thus leave the doctor’s office with a good feeling. The following rapid test from nal von minden´s portfolio detects a Chlamydia infection effectively:

Principle of the Test The WiduMed Chlamydia Rapid Test is an immunochromatographic rapid test. To perform the test a clinical sample is taken and placed into the extraction tube with extraction solution A. After 2 minutes, extraction solution B is added to the tube. After extraction, 3 drops (approximately 120 µl) of the extracted sample is added to the sample well of the test cassette. The membranes in the test cartridge are coated with antigen-specific monoclonal antibodies on the test line and with anti-rabbit antibodies (goat) on the control line. During the performance of the test, antigens present may react with the gold-labeled monoclonal antibodies in the test and then move laterally by capillary forces along the membrane. If the sample contains Chlamydia antigens, a coloured line will appear in the test region, which is formed from a Chlamydia antibody and gold particle complex. If no Chlamydia antigen is present, no test line will appear and a coloured line will only appear in the control region. This control line will always appear regardless of the presence of Chlamydia antigen in the sample. RS

1 http://www.gib-aids-keine-chance.de/wissen/sti/chlamydien.php http://www.apotheken-umschau.de/Krankheiten/Chlamydien-Unerkannte-Gefahr-106659.html 3 http://www.eltern.de/kinderwunsch/fruchtbarkeit/chlamydien.html 4 http://www.roche-diagnostics.de/diagnostics/indikationsgebiete/chlamydien/Seiten/ueberblick_chlamydien.aspx 5 www.ecdc.europa.eu 2

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A visual test, which is fast and easy to handle, for the qualitative detection of Chlamydia in endocervical swabs from women and urethral swabs and urine samples from men.

Rapid Tests Gerinnungsmessung

nal von minden

Short News

CHEAP HOLIDAYS MAY COST YOU YOUR LIFE. Research has found that more affordable holidays to sunny destinations have greatly contributed to the fivefold increase in rates of skin cancer. Since the 1970s traveling overseas to hotter destinations has become a more affordable holiday option for the average family. As a result, more and more people are experiencing damage to the skin from over exposure to the sun. Now, experts are finding that many who are being diagnosed with skin cancer today, actually suffered from sunburn decades ago when the trend of cheap, package holidays began. According to Cancer Research, one of the UKs leading cancer charities, more than 13,000 people are now developing the disease each year compared to about 1,800 in 1975. The number of cases of malignant melanoma, the most deadly form of skin cancer, has increased by 78% among men, and 48% among women since 2003. Malignant melanoma is the fifth

most common cancer in the UK and more than 2,000 people die from the disease each year. However the good news for those who are diagnosed is that survival rate for the disease is amongst the highest for any cancer. More than eight in 10 people will now survive it. It is commonly known that the main cause of most skin cancers is over exposure to UV rays which come from the sun. Therefore to greatly reduce the risk of developing the disease it is advised to take precautions when you are outside enjoying the sun. These include wearing a sun screen with a factor of 15 or more, covering up skin with clothing and spending time in the shade too. Sources: http://www.telegraph.co.uk/health/healthnews/10912863/ Cancer-legacy-caused-by-package-holiday-boom.html http://news.sky.com/story/1246233/skin-cancer-rise-linkedto-package-holidays JB

The adventures of Medical Man mEDICAL mAN is doing his regular training, As there is suddenly a cry for help...

Grrrr, wHy is this %&@!§? Thing not working? How on earth shall i quantify my sample now?

HEEEEEEEEEELP!!!!!!!

Just a second!!!!!

But the mistake is hard to find, as...

yippiiiieh!! YIPPIIIEH! It‘s working!!!

What the... !!!!!!!!!

He immediately starts to get ready for the operation...

Hm?!!

Grmbl HMPF GRRRR...

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