Frequently asked Questions
Questions about the device
The
seal on the pouch is broken, can I still use the device?
Can the
devices be used after storage in the fridge?
Specimen collection
How long can I
store swab specimens before use?
Interpretation of results
How
critical is the timing?
How long are
the results stable for?
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?
Would a negative result
conclude that a patient does not have Influenza?
Further questions
No lines
appeared, what does this mean?
How should
Clearview Exact Influenza A & B be stored?
How sensitive is the
test?
How specific is the
test?
The seal on the pouch is
broken, can I still use the device?
No. The
device may take up moisture from the atmosphere and no longer
function correctly.
Can the
devices be used after storage in the fridge?
Yes. However, devices must be allowed to come to room
temperature before opening to avoid moisture condensation on the
membrane.
How long can I
store swab specimens before use?
It is recommended that swab specimens be processed as soon as
possible after collection. If swabs are not processed
immediately they should be placed into a dry sterile and tightly
sealed plastic tube for storage. Swabs can be stored
dry at room temperature for up to 48 hours.
How critical is the
timing?
The timing is critical and you cannot obtain
the correct results if you do not follow the instruction
exactly.
How long are the
results stable for?
Results should remain stable for
up to 20 minutes. Results should not be read after this
time.
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.
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.
Would a negative result conclude
that a patient does not have Influenza?
A negative
result with Clearview Exact Influenza A & B does not exclude
the possibility of infection with Influenza virus.
A false negative result can occur in the following
circumstances;
- low levels of antigen are below the detection limit of the
test
- infection with a variant of the virus that is less detectable
by the Clearview Exact Influenza A & B assay configuration
- Influenza viral antigens in the patient that do not react
with specific antibodies utilized in the assay configuration - in
exceptional cases this may lead to observation of false negative
results
- specimen handling conditions which result in loss of Influenza
antigen multivalency.
No lines appeared, what does this
mean?
The test has not run correctly. This may
be encountered if the pouch has been opened and the absorbent wick
has absorbed moisture from the atmosphere. It could also
occur if an insufficient amount of sample.
How should
Clearview Exact Influenza A & B be
stored?
Clearview Exact Influenza A & B should be
stored at room temperature ranging from 2°C to 30°C (36°F to
86°F). Room temperature is recommended.
How sensitive is the
test?
Influenza A - 81.7%
Influenza B - 88.6%
How specific is the
test?
Influenza A - 98.5%
Influenza B - 97.4%