Quality Control - nal von minden tamaVet Instructions D'utilisation

tamaVet®
Canine Lyme Borreliosis Test
8. Specimen Collection and Preparation
The tamaVet® Canine Lyme Borreliosis Test was developed for
the examination of whole blood, serum or plasma of dogs.
General comments:
 Perform testing immediately after specimen collection. If
tests are not to be performed immediately after sample
collection, serum and plasma specimens may be stored for
up to 3 days and whole blood samples for up to 2 days in a
closed container at 2-8°C. For long-term storage, serum and
plasma samples must be kept below -20°C. The samples
should not be frozen and thawed repeatedly. Do not freeze
whole blood specimens.
 Use only clear, non-hemolyzed serum or plasma specimens.
Heparin or EDTA blood is also suitable.
 Samples must be brought to room temperature. However,
do leave the samples at room temperature for prolonged
periods.
 The testing of whole blood may decrease the sensitivity of
the test. If the test result is negative despite an existing
suspicion of an infection, the test must be repeated with
serum or plasma samples.
 Shake whole blood samples well before testing.
 If specimens are to be shipped, they should be packed in
compliance with local
transportation of etiologic agents.
 The transportation of whole blood samples should only be
performed in exceptional occasions. The shipping of serum
and plasma is preferable.
9. Test Procedure
1. Specimen and kit components should be brought to room
temperature before performing the test.
2. Open the pouch and place the cassette on an even surface.
Remove the pipette from the pouch and take up the sample
material with the pipette.
3. Holding the pipette
dispense 1 drop (30µL) of sample
(serum, plasma or whole blood) into
the sample well. Avoid the formation
of air bubbles. Wait a couple of
seconds until the sample fluid has
been completely absorbed.
4. Open the buffer bottle and, holding
it vertically, dispense 2 drops of the
buffer solution into the sample well.
Avoid the formation of air bubbles.
Start the timer.
If the liquid is not migrating
sufficiently along the strip after
60 seconds for serum and plasma, or
90 seconds for whole blood, add an
additional drop of buffer solution
into the sample well.
tamaVet® Ref. 1172046N-05
regulations covering
vertically,
or
5. Read the results 10 minutes after starting
the timer. Do not interpret the result after
more than 10 minutes. The test and the
result are considered as invalid after this
period.
10. Result Interpretation
Positive result
The test is positive when the control line (C)
and the test line (T) are visible in the reaction
area. Anti-Borrelia burgdorferi antibodies have
been detected in the sample material. If a
weakly defined test line appears, the test
result is nevertheless positive.
Negative result
The test is negative when only the control line
(C) is visible in the reaction area. No anti-
Borrelia burgdorferi antibodies have been
detected in the sample material.
Invalid result
If no control line is visible after the test was
performed, the test is invalid. All results, that
show no control line after the defined reading
the
time, must be disregarded. Review the test
procedure and repeat the test with a new test
cassette.
If problems continue, discontinue using the
test kit and contact your distributor.

11. Quality Control

An internal procedural control is included in the test cassette:
A red 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
 Test results must always be interpreted in the light of all
medical findings and never individually. All test results,
which do not correlate with the clinical picture, must be
repeated. Positive results detected with the tamaVet®
veterinary rapid tests must be approved with another
analytical method.
 There is a possibility that the test result can be distorted by
technical errors, errors in the experiment or by substances
or factors that influence the test and have not been
mentioned here.
13. Performance Characteristics
Sensitivity: 95.8%
Specificity: 94.1%
Overall agreement: 95.1%
Comparison methods: IgG ELISA, IgM ELISA, ImmunoBlot
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