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
6
Used testing materials should be discarded according to
local regulations.
The tick must be crushed thoroughly, as
Borrelia
are located
in the tick's colon.
Keep the sample well of the test cassette clear of any tick
particles.
Only use the stick for the purpose described in the package
insert.
Immediately remove the stick from the reagent mixture
after crushing the tick.
8.
Specimen Collection and Preparation
Remove the tick carefully and ensure that the head is also
removed. The use of the tick removal device is
recommended. After removing the tick and before starting
the test, you can store the tick in the supplied specimen
collection tube. Testing of the tick directly after the removal
yields the best results. A thorough crushing of the tick is
crucial for optimal testing results, as
Borrelia
to be verified
are located in the tick's colon.
9.
Test Procedure
The optimal test procedure depends on the size of a tick. The
test is developed for the examination of small to medium-
sized ticks (≤8 mm) only.
1.
Place the tick into the tick tube
containing buffer.
2.
Crush the tick with the supplied
stick until the tick’s colon is
crushed and the liquid takes on
colour. Use the sharp and the dull
sides of the stick for this purpose.
Then remove the stick.
3.
When ready to perform the test,
open the foil pouch and remove
the test cassette. Place it on a
clean, flat surface.
4.
Fill the pipette with the tick-
buffer mixture. Ensure that you
do not take up any tick particles.
5.
Add the tick-buffer mixture to the
sample well of the test cassette.
Ensure that you do not add any
tick particles to the sample well,
as they may obstruct it.
The liquid will start to migrate
along the internal test strip.
6.
Read the test result after 10
minutes. Do not interpret the
result after more than 20
minutes.
10.
Result Interpretation
Positive:
Two coloured lines appear on the
membrane. One line appears in the control
line region (C) and the other line appears in
the test line region (T). The line in the test
line region (T) indicates that
Borrelia
antigens have been detected in the tick.
The less
Borrelia
antigens are present in the tick, the weaker
the test line is (T). Even a weak test line should be interpreted
as a positivie test result. The control line is not a reference line
and may have a different colour intensity as the test line.
Negative:
Only one coloured line appears in the
control line region (C). No apparent
coloured line appears in the test line region
(T). No
Borrelia
antigens have been
detected in the tick.
Invalid:
The control line fails to appear. Results from
any test which has not produced a control
line at the specified reading time must be
discarded.
Please review the procedure and repeat he
test with a new test cassette. If the problem
persists, discontinue using the test kit
immediately and contact your local
distributor.
Note:
Insufficient specimen volume, incorrect operating
procedure or expired tests are the most likely reasons for the
control line failure.
11.
Quality Control
A coloured line appearing in the control line region (C) is
considered an internal procedural control. It confirms
sufficient specimen volume, adequate membrane wicking and
correct procedural technique.
12.
Limitations
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.
13.
Performance Characteristics
A comparative study has investigated which
Borrelia
species in
spiked ticks can be detected with the help of the NADAL®
Borreliosis Ag Test in comparison with the polymerase chain
reaction (PCR). The following
Borrelia
species:
B. garinii
,
B. afzelii,
B. burgdorferi sensu stricto
and
B. spielmanii
were
detected with both test systems (comparison study
2012/2013).
The NADAL® Borreliosis Ag Test
Sensitivity: 92.86%
Specificity: 95.83%
Positive predictive value: 86.67%
Negative predictive value: 97.87%
Total Test Performance: 95.16%
14.
References
1.
J. Eckert, K.T. Friedhoff, H. Zahner, P. Deplazes: „Lehrbuch Der Parasitologie für die
Tiermedizin“, Enke Verlag, 2.vollst. überarb. Aufl. 2008 W.
2.
Luttmann, K. Bratke, M. Küpper, D. Myrtek: „Der Experimentator Immunologie“,
Spektrum Akademischer Verlag, S.110 f., 3. Auflage 2009.
Rev. 2, 2019-05-29 OM/UJ
