Inside Diagnostics magazine

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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
n
Read more o
p
Rapid Tests
Laboratory Diagnostics
Laboratory Service
Consulting & Service
Inside Diagnostics Vorwort
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Page 2
Inside Diagnostics
Forword
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 ‘Medical Man’!
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
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Executive editor:
Inside Diagnostics
Nicolas Kennof
Tel.: 0941 29010-36
[email protected]
Page 3
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.
Page 4
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
[email protected]
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
Page 5
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
Page 6
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 „laboratory method“.
However through the qualification of a test, other regulations
are often applied (e.g. in Germany RiliBÄK). 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
Page 7
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.
Page 8
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
Page 9
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.
Page 10
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
Page 11
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 [email protected]. The
winner will be drawn from all of the correct entries received. Closing date is 15.08.2014.
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Rapid
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insideSubstitution
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Please mark the right answer,
simply fill the form & win!
a)
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Conditions of Participation
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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 [email protected]. 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
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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
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Page 13
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
Page 14
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 – 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 patient´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.
Page 15
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
patient´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.
Page 16
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 NADAL® Lyme Borreliose
Rapid Tests? Contact us on:
0941/29010-0 o or by Email:
[email protected]
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
www.istockphoto.com © Michele Princigalli
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
Page 18
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... !!!!!!!!!
© Martina Kastenmaier
He immediately starts to get
ready for the operation...
Hm?!!
Grmbl HMPF GRRRR...
Page 19
Contact Details
nal von minden GmbH
Carl-Zeiss-Straße 12
47445 Moers
Germany
Friedenstraße 32
93053 Regensburg
Germany
CEOs:
Sandra von Minden
Roland Meißner
Thomas Zander
Tel.: +49 941 29010-0
Fax: +49 941 29010-50
Commerical Reg: HRB 5679
Steuer-Nr. 244/133/00130
UST-ID-Nr. DE 189 016 086
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Rapid Tests
Laboratory Diagnostic
Laboratoy Service
Consulting & Service
http://www.nal-vonminden.com/en/about-us/inside-diagnostics-magazine.html
Rev 01 / IMAGE-DE / 01-13
[email protected]
www.nal-vonminden.com