ENGLISH
NADAL® Borreliosis Ag Test
(Ref. 870004N-01/870004N-05)
nal von minden GmbH • Carl-Zeiss-Strasse 12 • 47445 Moers • Germany • [email protected] • www.nal-vonminden.com
5
1.
Intended Use
The NADAL® Borreliosis Ag Test is a membrane-based
immunoassay for the rapid, direct detection of
Borrelia
antigens
(B. garinii
,
B. afzelii
and
B. burgdorferi sensu stricto
and
B. spielmanii)
in ticks. The test is developed for the
examination of small to medium-sized ticks (≤8 mm) only. A
positive result with this test indicates the presence of
Borrelia
in the tick.
2.
Introduction and Clinical Significance
Over 800 species of ticks are known worldwide, which can be
divided into two main families: the hard ticks and soft ticks.
Soft ticks are usually to be found in the tropics and subtropics.
Hard ticks, however, including the castor bean tick, are spread
around the world and are carriers of Lyme borreliosis disease
and tick-borne encephalitis (TBE). While TBE viruses are in the
salivary glands of ticks and can be transmitted directly to the
the victim through the tick bite,
Borrelia
are initially located in
the midgut of the tick.
Borrelia
reach the salivary glands while
the tick is sucking blood and are transmitted to the victim only
after a few hours. Thus, there is no great risk of a
Borrelia
infection within the first few hours after being bitten by the
tick. The excretion of pathogens begins as early as two hours
after being bitten by the tick and reaches its peak only after 72
hours.
Symptoms of Lyme borreliosis disease in humans can be
divided into three stages.
Several days to weeks after infection:
characteristic skin
redness, so-called erythema chronicum migrans, appears
around the tick bite and spreads into a ring shape. It occurs
in about 70 percent of cases and is followed by general flu-
like sysmptoms, such as profuse sweating, fever,
headaches, and muscular and joint pain.
A few weeks to months later:
Inflammation of the nerves and meninges are possible. A
strong, burning pain around the original site of the tick bite
and redness, which can spread over the whole body,
frequently occur. Swelling of joints, as well as impairments
of the locomotor system, the psyche and the cognitive
abilities may appear. In some cases, paralysis of, for
instance, facial muscles and less often inflammation of the
heart and heart rhythm disorder occur.
Months to years after the infection:
Cases of chronic or recurring inflammation of joints, mostly
in the knees and ankles (lyme arthritis) or skin changes,
known as acrodermatitis chronica atrophicans herxheimer
occur.
3.
Test Principle
The NADAL® Borreliosis Ag Test is a membrane-based
immunoassay for the rapid, direct detection of
Borrelia
antigens in ticks.
The test principle involves polyclonal antibodies, which are
used as capture antibodies, along with conjugated
Borrelia
antibodies on the internal test strip to detect
Borrelia
antigens
in the sample.
First, the extracted tick material is added to the sample well of
the test cassette. The sample migrates along the internal test
strip by capillary action. If
Borrelia
antigens are present in the
sample, an antibody-antigen-antibody complex is formed in
the test line region and as a result, a coloured line appears.
The appearance of a test line indicates a positive result. If the
sample does not contain
Borrelia
antigens, no antibody-
antigen-antibody complex is produced and no coloured line
develops in the test line region. The test result should be
considered negative.
The appearance of a coloured line in the control line region
serves as a procedural control, indicating that the proper
volume of specimen has been added and membrane wicking
has occurred.
4.
Reagents and Materials Supplied
1/5 NADAL® Borreliosis Ag test cassette(s) (incl. pipette(s)
and desiccant)
1/5 tick tube(s) containing buffer (0.2 ml)
1/5 stick(s)
1 tick removal device
1 package insert
5.
Additional Materials Required
Timer
6.
Storage & Stability
The test kit should be stored at 2-30°C until the expiry date
printed on the packaging. The test cassette should remain in
the sealed foil pouch until use. Do not freeze the test kit.
7.
Warnings and Precautions
Carefully read through the test procedure prior to testing.
Failure to follow the instructions will lead to inaccurate test
results.
Do not use the test beyond the expiration date indicated on
the package.
Do not use the test if the foil pouch is damaged.
Do not reuse tests.
Do not add samples to the reaction area (result area).
In order to avoid contamination, do not touch the reaction
area (result area).
Avoid cross-contamination of specimens by using a new tick
tube for each specimen obtained.
Do not substitute or mix components from different test
kits.
Do not eat, drink or smoke in the area where specimens
and test kits are handled.
Wear protective clothing such as laboratory coats,
disposable gloves and eye protection when specimens are
being assayed.
Handle all specimens as if they contain infectious agents.
Observe established precautions for microbiological risks
throughout all procedures and standard guidelines for the
appropriate disposal of specimens.
The test kit contains products of animal origin. Certified
knowledge of the origin and/or sanitary state of the animals
does not completely guarantee the absence of transmissible
pathogenic agents. It is therefore recommended that these
products be treated as potentially infectious, and handled
in accordance with usual safety precautions (e.g., do not
ingest or inhale).
Humidity and temperature can adversely affect test results.
