Frequently Asked Questions
How
sensitive is Clearview COMPLETE HIV 1/2?
How
should Clearview COMPLETE HIV 1/2 be stored?
What type
of patient sample do I have to use?
How critical is the
timing?
How long are the
results stable?
The Test Line was
fainter than the Control Line, what does this mean?
No line
has appeared in the Control Window, what does this mean?
What
is the shelf-life of Clearview COMPLETE HIV 1/2?
If I add whole blood and
forget to add running buffer will the test still run?
Would a negative
result conclude that a patient does not have HIV?
What are the
storage conditions for Serum and Plasma samples?
What
are the storage conditions for whole blood samples?
How sensitive is
Clearview COMPLETE HIV 1/2?
99.7% sensitive and 99.9%
specific for all sample types
How should
Clearview COMPLETE HIV 1/2 be stored?
Store 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), and in a tube 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 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.
What is the
shelf-life of Clearview COMPLETE HIV 1/2?
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.