Frequently Asked Questions
The seal on the Clearview
Exact Influenza A & B 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 Region, 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 has been applied.
How
should Clearview Exact Influenza A & B test 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 Clearview Exact Influenza A & B
test?
Influenza A - 81.7%
Influenza B - 88.6%
How
specific is the Clearview Exact Influenza A & B
test?
Influenza A - 98.5%
Influenza B - 97.4%