Frequently Asked Questions
Determine® HIV-1/2
Ag/ Ab Combo
1. How sensitive is Determine® HIV-1/2 Ag/Ab
Combo?
A total of 1179 confirmed HIV Ab positive
specimens from patients at the chronic stage of the infection were
tested. The diagnostic sensitivity of Determine® HIV-1/2
Ag/Ab Combo on this population of specimens is calculated to be
100%.
Determine® HIV-1/2 Ag/Ab Combo
identifies infection on average 5 days earlier (range 2-20 days)
than 3rd generation antibody tests
Determine® HIV-1/2 Ag/Ab Combo
identified 92.31% of the 117 pre and per seroconversion samples
when compared to commercial CE marked 4th generation
EIA.
See performance data
section for more details.
2. How should
Determine® HIV-1/2 Ag/Ab Combo be
stored?
2-30°C
3. What type of patient sample do
I have to use?
Human serum, plasma and whole blood.
(fingerstick and venipuncture)
For whole blood (venipuncture) and plasma
specimens, EDTA collection tubes 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 instructions
exactly.
5. How long are results stable?
The result can be read from 20 minutes up to maximum of 30
minutes.
6. The Test line was fainter than
the Control Line, what does this mean?
The test result is positive even if the
patient bar(s) appear lighter or darker than the control bar.
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® HIV-1/2 Ag/Ab
Combo?
10 months
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
HIV?
No test provides absolute assurance that a
specimen does not contain low levels of HIV p24 antigen and/or
antibodies to HIV-1 and HIV-2 such as those present at a very early
stage of infection.
A negative result for both antibodies to HIV
and p24 antigen does not preclude the possibility of exposure to or
infection with HIV-1 or HIV-2 viruses.
11. What are the
storage conditions for Serum and Plasma samples?
Serum and plasma specimens 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 specimen should be
frozen (at -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?
50µl
Fill the tube with whole blood between the 2 marked lines and apply
the sample to the sample pad.