Frequently Asked Questions
Determine Syphilis TP
1. How sensitive is Determine Syphilis
TP?
Whole Blood 92.31%
Plasma 100%
Serum 100%
2. How should Determine Syphilis TP be
stored?
2-30° C
3. What type of patient sample do I have
to use?
Human serum, plasma and whole blood
For whole blood and plasma specimens, EDTA collection tube must be
used.
For whole blood collection by Fingerstick, EDTA capillary tube must
be used.
For testing whole blood specimens, Chase Buffer is required.
4. How critical is the
timing?
The timing is critical and you cannot obtain the correct results
if you do not follow the instruction exactly.
5. How long are the results
stable?
The result can be read from 15miniutes to 24hours.
6. The Test Line was fainter than the
Control Line, what does this mean?
The test result is positive even if the Test Line appears
lighter or darker than the Control Line.
7. No line has appeared in the Control
Window, what does this mean?
The test is invalid. You will have to use a new device and run
the test again.
8. What is the shelf-life of Determine
Syphilis TP?
Up to a maximum of 12 months from the date of manufacture
9. If I add whole blood and forget to add
chase buffer will the test still run?
You cannot obtain the correct result. It should be
tested again.
10. Would a negative result conclude that
a patient does not have Syphilis?
No diagnostics test provides absolute assurance that a sample
does not contain either low levels of antibodies to Treponema
pallidum, such as those present at a very early stage of
infection, or antibodies with low reactivity to the Treponema
pallidum antigens. Therefore a negative result at any time
does not preclude the possibility of exposure to infection with
syphilis. If the overall clinical evaluation suggests that either
of the conditions described above is present, reading the test
results after at least 30 minutes up to overnight as allowed in the
instructions for use is recommended to maximize test
sensitivity.
11. What are the storage conditions for
Serum and Plasma samples?
Serum and plasma samples should be stored at 2-8°C if the test
is to be run within 7 days of collection. If testing is
delayed more than 7 days, the sample should be frozen (-20°C or
colder).
12. What are the storage conditions for
whole blood samples?
Whole blood collected by venipuncture should be stored at 2-8°C
if the test is to be run within 7 days of collection. Do not
freeze whole blood samples.
Whole blood collected by fingerstick should be tested
immediately.
13. What volume does the EDTA capillary
tube deliver?
50ul
Fill the tube with whole blood between the 2 marked lines and apply
the sample to the sample pad.
14. Can cloudy serum or plasma samples be
used with the Determine tests?
No. Specimens showing particulate matter or turbidity should be
centrifuged before testing in order to avoid providing erroneous
results.