Inside Diagnostics Summer 2016 (EN)

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new art laboratories

Inside Diagnostics Summer 2016

CARDIAC MARKER TROPONIN

How sensitive is sensitive enough?

KNOCK OUT DROPS Urban legend or real danger?

HEALTHCAREAPPS

The doctor on the wrist

Rapid Test

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W P R I Z E D R Age 5 a

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Laboratory Diagnostics Laboratory Service Consulting & Service


Inside Diagnostics

Foreword

Dear readers,

In this issue of the Inside Diagnostics Magazine, again we will have interesting articles from the fields of medicine and drugs for you, where we emphasis as always on diagnostics. Among other subjects we will inform you about the positives and negatives of healthcare apps, give an insight into the problems of medical care for refugees and into the possibilities of early diagnosis of colon cancer. Furthermore there’s an article on the impact and dangers of knock out drops including ways to defend oneself against these insidious remedies. Of course our CSR campaign, which we already informed you in the last issue, is also featured in this issue! This time we’re giving you a review of our first campaign day

(the World Drug Day) which, this much can now be revealed was a huge success! Moreover, our article about the cardiac marker troponin already gives a preview of our next big project: World Heart Day on 29th of September 2016. The second part of our column “nvm around the world” gives you the possibility to join our trips to customers from all over the world. And, last but not least: In this issue’s prize draw you can win an activity tracker from Jawbone! Have fun reading! Your Inside Diagnostics editorial team

Subscribe to our customer magazine Write to: inside-diagnostics@nal-vonminden.com

Contact/Editor in chief Iris Schubert • Tel.: 0941 29010-46 inside-diagnostics@nal-vonminden.com

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Inside Diagnostics

Content Topics Corporate Social Responsibility ������������������������������������������������������ 4 Cardiac marker Troponin ���������������������������������������������������������������� 6 Knock out drops ����������������������������������������������������������������������������� 8 Healthcare Apps ��������������������������������������������������������������������������� 10 nvm Inside Prize Draw �������������������������������������������������������������������������������������� 5 nvm around the world part 2 ������������������������������������������������������� 11 Contact ����������������������������������������������������������������������������������������� 12

CARDIAC MARKER TROPONIN | page 6

In recent years, there is a trend towards ever more sensitive troponin tests to detect a myocardial infarction as early as possible. But is this trend not without risk? Read more on page 6

Flag Inside Diagnostics Customer magazine of nal von minden GmbH Responsible according to press law: Thomas Zander Editor in chief Iris Schubert Editorial Team: Iris Schubert, Torsten Winkler, Sonay Öktem, Andrea Kreuzer, Nicola Barabas, Helen Murr, Daniel Anstiss, Tina Sambs, Manuela Duschinger, Martina Kastenmaier inside-diagnostics@nal-vonminden.com Graphics: Martina Kastenmaier

Cover © istockphoto.com/STEEX

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nvm inside CSR

Corporate Social Responsibility Anytime, anywhere, we help you care! In our last issue of Inside Diagnostics, we introduced our Corporate Social Responsibility (CSR) strategy for this year: Anytime, anywhere, we help you care! In doing so, we explained what exactly CSR entails and our main focus for this year, 3 world awareness days; helping us spread our knowledge to a wider audience base and ultimately do our part to help improve health and wellbeing around the globe. Just to reiterate, these days are: 1. World Drug Day: 26.06.2016 – United Nations 2. World Heart Day: 29.09.2016 – World Heart Foundation 3. World Health Day (a focused topic will be released nearer the day): 07.04.2017 – World Health Organization As usual time has flown by and since then, we launched our CSR strategy with a bang, in the form creating awareness of the World Drug Day. As a company, we’ve been operating for almost 35 years and during this time, we’ve been at the forefront of all major developments and as such, have collated an array of knowledge on the topic of drug abuse. The question then on our minds: how do we spread this information to help empower our customers and the wider community? It all started with a group picture on a sunny day, perhaps a metaphor for our brainstorming and determination towards creating as much awareness as possible! From thereon, our graphics team quickly got to work to put together a dedicated booklet, drawing on ideas of informative and helpful context to include from the whole company. Not an easy feat! Highlights include background information on the World Drug Campaign such as how it all started and previous themes, a drug analysis timeline, helping you understand how long after consumption drugs can be detected in different samples, and a preview of handpicked Inside Diagnostics articles. All in a

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handy A5 format and an array of languages. This booklet is being sent out with orders (depending on availability), upon individual request and is also available in digital format at (insert link). Moreover, the full Inside Diagnostics articles can be found on our dedicated CSR webpage at wehelpyoucare.com. This website will be updated throughout the year to let you know of our plans for the following two days to come, along with a convenient calendar, information on our CSR strategy and the faces helping you care. For the 27th and 28th of June, we also sent out an offer to our customers across the globe, using our international corporate culture to translate into as many languages as possible. This offer guarantied end-user customers 10% off all drug tests for these two days. We hope you were able to make the most of this offer and we are sure to provide a similar offer for the World Heart Day, so keep your eyes peeled! We at nal von minden also supported your projects with free sample packs of Drug-Screen® 7B rapid tests – you simply stated what you needed them for, and we supplied! As our first companywide campaign, it was great to see how much of a success our World Drug Day awareness was and the impact it had on our wider audience. We’d also love to hear your feedback on the day, whether you have any suggestions for the promotion of the next awareness days, or whether you too got involved and would like to share your story. Let us know via info@nal-vonminden.com. Until then, don’t forget to keep up to date via wehelpyoucare.com, as just like our tests, you can access this anytime, anywhere. DA, IS


nvm inside Prize draw

Join in &

win!!! Dear readers,

Congratulations to Armin Parsch, the winner of the Amazon Kindle from last issue. We are happy to give you the opportunity to win a great prize again! For the summer issue we are giving away a Jawbone UP2 Fitnesstracker. Just answer the following question:

tion CSR What does the abbrevia at nal von minden? a) Cardio stress relief onisbilty b) Corporate Social Resp c) Creative Suite rights

Good luck!

Your Inside Diagnostics team

Participate now & win a Jawbone UP2! • With a battery life of one week • The Smart Coach creates activity plans and records steps , workouts and sleepduration and -quality • Can easily keep track of food, drinks, calories and nutrients and find the food score for the UP app • Scope of delivery: Jawbone 310007-004 UP2 activity-/sleeptracker-wristband oat spectrum, short instruction, USB-charging cable

Participate under the following link: www.nal-vonminden.com/gewinnspiel.html or send an Email to: gewinnspiel@ nal-vonminden.com; Closing date is 11th of November 2016 Conditions of Participation 1. The Promoter is nal von minden GmbH. 2. 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. You also can participate online: http://goo.gl/QruV82. 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 11th of November 2016. 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 an Amazon Kindle. 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. Data protection 1. Being a responsible entity as defined by the German Federal Data Protection Act, nal von minden GmbH collects, processes, and uses personal data (first name and last name, date of birth, street address, postal code, place, country, and email address) disclosed to nal von minden GmbH in connection with the Prize Draw only in compliance with the applicable laws and regulations referring to data protection. nal von minden GmbH will not disclose your personal data to any third party. Your personal data will be collected, processed and used exclusively for the purpose of carrying out the Prize Draw. The promoter is allowed to send future issues of the “Inside Diagnostics” by e-mail. Unsubscribe at any time by sending an informal e-mail to gewinnspiel@nal-vonminden.com 2. You are entitled by law to request free information about the personal data nal von minden has stored in relation to your person, and to request that nal von minden GmbH corrects, blocks or deletes these personal data. Please contact nal von minden GmbH if you want to claim any of these rights referred to above. 3. If you request that your personal data be deleted before the Prize Draw is completed, your entry into the Prize Draw is deemed to be terminated as well. In that case, you are no longer eligible for a prize.

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Cardiology Cardiac marker Troponin

Cardiac marker Troponin How sensitive is sensitive enough? Beneath ECG the cardial marker troponin is often used for diagnosis when there are indications of an acute myocardial infarction (AMI). In the last years there is a trend to increasingly sensitive troponin tests to detect a myocardial infarction as early as possible. But are there also risks in this trend? Diagnosis of a myocardial infarction Even if the number of deaths from a myocardial infarction decreased steadily in the last years, it is still the second highest cause of death in Germany, according to the Federal Statistical Office. An early and reliable diagnosis enables a fast therapeutic action and therefore increases the patient’s survival chances. A fast exclusion of an infarction additionally speeds up the patient’s discharge. Beneath general symptoms like acute chest pain, acute shortness of breath and vomiting, ECG and the measurement of cardiac troponin are used for the diagnosis of an infarction. Combination of different diagnostic methods In case of a suspected myocardial infarction usually an ECG is performed. A distinction is made between STEMI (AMI with infarction typical admission ECG; ST elevation) and NSTEMI (non-ST elevation). In the case of a STEMI the determination of biochemical myocardial infarction markers plays a minor role, as the diagnosis is made through clinical symptoms and ECG. In the case of a NSTEMI the determination of troponin can be decisive. A negative result with a high-sensitive troponin tests can help to rule out a NSTEMI within 3 hours, with almost 100% sensitivity. Values higher than the 99th percentile of a healthy population or increasing or decreasing kinetics of the marker over time give clear indications of a myocardial infarction. Cardial troponins – troponin I vs. troponin T Troponin I (TnI) and troponin T (TnT) are part of the troponin complex, which play a crucial role in muscle contraction. If muscle tissue is irreversibly damaged these proteins are released into the blood stream. The cardial variations (cTnI and cTnT) show high sensitivity and specificity in the diagnosis of an acute myocardial infarction. The concentration increases directly after the infarction and after 3h values are reached, that can be detected by high-sensitive tests. After 12 hours the troponin concentration is at its maximum and stays elevated for several days.

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Also if troponin I and troponin T undertake different tasks in muscle contraction, they are both suitable for the detection of a myocardial infarction. Both markers increase with the same speed and therefore provide first positive results at the same time. The main difference consists in the detection time. While cTnI is elevated for 4-7 days, cTnT is detectable for 1014 days in blood. There are a lot of different cTnI tests in the market, but due to patent law just one company offers a cTnT test. High sensitive troponin tests In the last few years it has been noticed that high sensitive troponin tests are increasingly becoming used. These tests show a 10 to 100 fold lower detection limit compared to conventional ones. In this context, the time and point of sample collection for the determination of the respective parameter changes significantly. The first blood sample is always taken with hospital admission. Using high sensitive tests the next sample can be measured just after 3 hours, while conventional tests can only provide further information to the patient’s condition from 6-9 hours. If there are still further negative results, with a clear indication of an ischemic event, then the blood test should be repeated after 12 to 24 hours. According to the ESC/ACCF/AHA/WHF Task Force recommendations a troponin increase is given if the concentration exceeds the 99th percentile of the reference control group. Due to the lower decision limit of more sensitive tests, serial measurements for the detection of an increase in troponin concentration are inevitable for the diagnosis of a myocardial infarction. Advantages and disadvantages Due to the relatively low analytical sensitivity conventional troponin tests are often not able to give a statement to an AMI at the hospital admission of a patient with acute chest pain. Sensitive tests in contrast can improve the early diagnosis and especially the exclusion of an acute myocardial infarction in the first 3 hours. Different studies were able to show that particularly a higher amount of NSTEMI patients were identified. On the other hand, the higher sensitivity (>99% after 3-6 hours) of the high sensitive tests is let down by a lower specificity (80-85%). In comparison conventional tests have a specificity of about 97% with just a slightly lower sensitivity

© www.istockphoto.com/Pixel_away


Cardiology Cardiac marker Troponin

of 97-99%. That means: On the one hand, the exclusion of an AMI with a high sensitive test is very reliable, but on the other hand, the rate of potential wrong positive troponin results is relatively high. Although cardiac troponins are specific for myocardial damage, they are not specific for a myocardial infarction. Thus also myocardial damage through traumas, sepsis or renal failure leads to increased troponin levels, as well as hypothyroidism or extreme endurance sports. 28% of marathon runners for example will be tested positive with a high sensitive test before a run and even 100% after a run. Additionally it has to be considered that elder patients can show increased troponin levels due to other reasons and therefore different thresholds have to be defined.

Thus troponin tests are not suitable to be used as a sole method to diagnose a myocardial infarction, but should be seen in overall context. Furthermore, single measurements do not provide sufficient significance. Especially for high sensitive tests only the difference in concentration over time allows a statement. Additionally the loss of specificity in favor of the sensitivity requires special attention and responsibility of the physician to consider troponin levels in the clinical context. Due to the better specificity also conventional tests still have their justification. Different studies showed that the usage of high sensitive tests had no significant influence on the clinical outcome. NB

Source: Labor und Diagnose – Indikationen und Bewertung von Laborbefunden fßr die medizinische Diagnostik. 8. Auflage, Lothar Thomas, TH Books, 2012 High-sensitivity troponin – six lessons and a reading. J H P Gamble et al., Br J Cardiol. 2013;20(4) Prognostic significance of an elevated conventional or high-sensitive cardiac troponin in patients with chest pain with and without a diagnosis of myocardial infarction. M Lipinski et al., J Am Coll Cardiol. 2015;65(10_S)

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Rapid Tests Knock out drops

Knock out drops

Urban legend or real danger? They are colour- and odourless, recognisable only by their bitter taste. Knock out drops are cheap and very hard to detect in most cases. They can immobilise consumers for several hours and lead to a loss of memory. But how do these substances operate, what exactly makes the detection that complicated and how did they come to the name “Date Rape Drugs”? What’s behind the label knock out drops? The most known and used among these substances is 4-hydroxybutanoic acid or its lactone gamma butyrolactone, which is converted to GHB in the body within seconds by serum lactonase. Originally used as anesthetic, GHB is now mainly known under the name “liquid ecstasy” in the party scene GBH is a misnomer, due to it neither being a chemical or the fact it isn’t comparable to ecstasy or other amphetamines. While GHB is governed by the narcotics act, GBL is easily available. The only restriction the classification of GBL as a dubious pharmaceutical. According to § 95 sentences 1 number 1 of the Medicinal Products Act, it is indictable to put a pharmaceutical into circulation if there’s a justified suspicion of a harmful impact. However attention should be paid to the fact, that only people who are positive for GBL consumption are guilty of an offence. GBL itself is legal , for example it is a component of nail polish removers and wheel rim cleaners. Due to the risk of misuse of GBL the chemical industry inaugurated a Monitoring system.. Compounds developed from drugs originally used in medicine such as ketamine (anaesthetics in human and veterinary medicine, painkillers in emergency medicine) and psychotropic drugs from the group of benzodiazepines (tranquiliser and soporifics available only on prescription).

O HO structural formula GHB

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OH

These substances are used to stun unsuspecting victims. In most cases the use would be for an offence such as commit a robbery or rape. On the other hand there are also people who consume GHB knowingly and willingly; most commonly via a syringe, so that they can measure out the substance as good as possible and thus avoid unwanted side effects. The impact sets in after 10-20 minutes From the details mentioned above, it shows that a common factor that the substances have, is the constraint to act and move. A respectively high dosage can lead to blackouts, becoming unconscious and in extreme cases death. Effects of GHB in a dose-dependent Dose

Effect

Low: ≤ 1 g

Like light alcohol intoxication, light euphoria, stimulation

Medium: 1-2,5 g Euphoria, increase of urge and libido, amnesia High: 2,5-4 g

Somnolence, nausea, dizziness, vision disorder, unconsciousness

Very high: ≥ 4 g

Respiratory depression, coma

The impact of GHB/GBL sets in 10-20 minutes after the substance has entered the body (dependent on the dosage and the General health of the person affected). The effect gets extremely dangerous if it is used with multiple drugs. Alcohol for example reinforces the impact of knock out drops many times over. First symptoms of GHB/GBL intoxication are, in most cases a sudden feeling of nausea and circulation problems. Furthermore the substances can have a disinheriting effect for a moment. The consumer can talk and move normally for some while – which leads to the fact that there’s no reason to worry for the general public. As opposed to drunkenness the victims are not able to remember this alert state later on. For all those reasons it’s very easy for offenders to use these substances in public: After the victim has consumed the drops there’s enough time for the offender to establish contact, offer help and separate the victim from others present. After some time a strong feeling of tiredness sets in which leads to a deep sleep or even unconsciousness. The person affected usually comes around after hours and has no memory of what happened.

© www.istockphoto.com/Ljupco


Rapid Tests Knock out drops

The problem of verifiability While a single dose of ketamin or benzodiazepine is usually traceable in urine for several days, GHB can only be detected within 6 to 10 hours after consumption. This means: Only those who undergo a test within that short time have a chance to prove that they’ve been drugged. Furthermore the detection limit cannot be lowered randomly as GHB is also egested in a certain amount by the body. There are enzymatic rapid tests which can be used for a quick validation – but these of course also underlie the limitation of the parameter. Here it becomes particularly clear what the term “Date Rape Drug” means and

why GHB is the choice for offenders. The short time of detection together with the loss of memory lead to the fact that there are very few documented cases in which GHB is related to rape or robbery. The only way to defend oneself are to keep an eye on your drinks, don’t accept drinks from strangers or doing a rapid test for drinks in order to check if it contains substances like GHB, ketamine or other knock out drops. IS

Knock out drops

can incapacitate the consumer for

several hours ...

... and lead to a

memory loss. Source: https://www.aerztekammer-bw.de/10aerzte/05kammern/10laekbw/20ehrenamt/ 30ausschuesse/suchtmedizin/suchtmedizin/gbl-ghb.pdf - Stand 30.05.2016

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Lifestyle Healthcare Apps

Healthcare-Apps

Allow me, my name is Doctor App. The technical progress in the field of smartphones and tablets has increased extortionately over the past few years. The times in which the only use of a mobile phone was making calls and writing messages are done and dusted. The market of software applications for mobile operating systems, so called apps, is huge. In the course of this, applications from the field of healthcare are gaining more and more importance. This ranges from applications for fitness and wellbeing (such as pedometers, calorie counters or heart rate monitoring) to apps with more complex benefits like the so called Disease-Management-Programs which can be used for example, by diabetics. For this purpose, apps are combined with “wearables”. This portable technology is able to measure somatic functions. Most common are bracelets but there are also other devices which are worn on the body and transfer the information to the mobile device. Apps as medical devices Applications serving a medical purpose serve as not only a source of information for the patient but are also used for diagnosis and treatment of diseases and thus underlie the purview of the Medical Devices Act. An app which is defined

as a medical product therefore underlies the same bye-laws and directives as all analogous products from this field. This applies to so called standalone software which does not act as control software for another medical device. The doctor on the wrist The medical advantage of these apps can be enormous. An application can for example alarm, analyse, calculate, detect, diagnose, interpret, convert, measure, steer or monitor. Doctor and patient can stay in contact via an application, thus improving communication flow in comparison to more conven-

tional methods. So called mobile health also plays a large role for chronically ill patients where the dosage of medicines can be calculated and archived on the basis of measured data like blood pressure or cardiac rhythm. The transparent patient A big issue for all applications which measure and save the functions of our body is data protection. Information about our personal health is sensitive and should not fall into the wrong hands. Especially with free apps it’s hard to see how well personal data is saved or if the application funds itself through passing on data. A look on the wrist instead of going with the gut But the user can lose more than “just” personal data: Trusting the gut instinct. The possibility to always monitor and evaluate yourself accommodates the current trend of self-optimisation. But what if the technical assistance leads to self diagnostics instead of seeing a doctor? The wrong application of app and wearable could be fatal, especially if the wrong medication dosage is recommended. Precise user guidance and transparent agreement with the practicing doctor are crucial here.

Clear weigh in of advantages and disadvantages The benefit of apps in the field of mobile health is obvious, but like in every other case, common sense should also prevail when choosing and right application. Instead of trusting technology implicitly, it would be better to trust physical feelings – and in the advice of a doctor.

KS/MD

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*Source: http://de.statista.com/themen/882/apps-app-stores

www.istockphoto.com © Elena Belyakova


nvm inside nvm Around the World

Cameroon

nal von minden

Around the World – Part 2 of our series Did you know that we provide tests to more than 100 countries all over the world? From Finland to Cameroon, Ireland to Germany and Togo to Taiwan our tests are used by professionals all over the earth. We invite you to join us once again on the discovery tour. Read the second part of our section “nal von minden Around the World”!

Customers of Steven Landgren (Team FR), posing for a photo in Cameroon, after trying out one of our typhoid tests. Steven has sold over a million tests to over 10 African countries, supplying them with everything from ovulation tests to tests for salmonella and malaria.

Finland Jutta Rautio (Team Finland) meeting with Kimmo Kurki from Konstan koti ja koulu – a Finnish facility for young people.

Ireland Freddie Swaine and Helen Murr (Team UK/Ireland) whilst visiting customers in Ireland. The trade fair delegation of nal von minden smiling into the camera at our booth stand on MEDICA 2015. The annual exhibition is the largest of its kind and takes place in Düsseldorf, Germany. Medical companies from all over the world are brought together during the event.

Germany

HM

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Contact

Carl-Zeiss-Strasse 12 47445 Moers Germany Friedenstrasse 32 93053 Regensburg Germany

Chief executive officers: Sandra von Minden Roland MeiĂ&#x;ner Thomas Zander

Tel.: +49 941 29010-0 Fax: +49 941 29010-50 info@nal-vonminden.com www.nal-vonminden.com

Commerical Reg: HRB 5679 Steuer-Nr. 244/133/00130 UST-ID-Nr. DE 189 016 086

Discover our comprehensive product range! For all products and innovations please visit: www.nal-vonminden.com

Rapid Tests Laboratory Diagnostics Laboratory Service Consulting & Service

www.nal-vonminden.com/inside-diagnostics

Rev 01 / INSIDE-EN / 10-16

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