Frequently Asked Questions
How sensitive is
the Clearview COMPLETE HIV 1/2 test?
Clearview COMPLETE
HIV 1/2 is 99.7% sensitive and 99.9% specific for all
sample types.
How
should the Clearview COMPLETE HIV 1/2 test be stored?
Clearview COMPLETE
HIV 1/2 should be stored at 8° to 30°C (46° to 86°F).
What type of patient sample
do I have to use?
Human serum, plasma and
whole blood from venipuncture or fingerstick. For Serum or Plasma,
collect specimen in a tube not containing any anticoagulant
(serum), but containing citrate, heparin, or EDTA (plasma).
How critical is the
timing?
The timing is critical and
you cannot obtain the correct results if you do not follow the
instructions exactly.
How long are the results
stable?
The result can be read from
15 to 20 minutes.
The Test Line
was fainter than the Control Line, what does this
mean?
The test result is reactive
even if the Test Line appears lighter or darker than the Control
Line.
No Control line has
appeared, what does this mean?
The test is invalid. You
will have to use a new device and run the test again.
What is the shelf-life of the
Clearview COMPLETE HIV 1/2 test?
Up to a maximum of 24 months
from the date of manufacture
If I add
whole blood and forget to add running buffer will the test still
run?
You cannot obtain the
correct result. It should be tested again.
Would a negative result conclude
that a patient does not have HIV?
A non-reactive result with
Clearview COMPLETE HIV 1/2 does not exclude the
possibility of infection with HIV. A false negative result can
occur in the following circumstances;
- low levels of antibody
(e.g., early seroconversion specimens) are below the detection
limit of the test
- infection with a variant of
the virus that is less detectable by the Clearview assay
configuration
- HIV antibodies in the
patient that do not react with specific antigens utilized in the
assay configuration - in exceptional cases this may lead to
observation of false negative results
- specimens handling
conditions which result in loss of HIV antibody
multivalency.
What are the storage
conditions for Serum and Plasma samples?
Serum and plasma samples can
be run immediately or refrigerate them at 2 to 8°C (36 to 46°F)
following collection. These specimens should be tested within 3
days of collection. If specimens are not tested within 3 days of
collection, serum or plasma specimens should be frozen at -20°C
(-4°F) or colder.
What
are the storage conditions for whole blood samples?
Venous whole blood can be
run immediately or refrigerated at 2 to 8°C (36 to 46°F) following
collection. Venous whole blood may be stored for up to 3 days
between 2 and 8°C (36 to 46°F) before testing. Do not freeze whole
blood.
Whole blood collected by
fingerstick should be tested immediately.