Frequently Asked Questions
How Sensitive is
Clearview® Malaria P.f. and
Clearview® Malaria Combo?
Data was generated from previously frozen whole blood samples
and was determined by correlation to standard thick and thin smear
microscopic examination with discrepant samples evaluated via PCR.
The study results were:
Sensitivity: (P.f. Malaria) 96.0%
(262/273)
Sensitivity: (Non-P.f.
Malaria) 91.4% (32/35)
Specificity: 316/317 (99.7%)
How should
Clearview® Malaria
P.f. and Clearview®
Malaria Combo be stored?
Store at 4-40°C.
What
type of patient sample do I have to use?
Human Whole Blood (Venous or capillary samples)
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 test result can be read after 15 minutes.
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 need to use a new device and
run the test again.
What is the shelf- life of
Clearview® Malaria P.f. and
Clearview® Malaria Combo?
24 months.
Would
a negative result conclude that a patient does not have
Malaria?
Definitive clinical diagnosis should not be
made until the test has been evaluated in combination with other
clinical and laboratory findings.
What
are the storage conditions for Whole Blood Samples?
Whole Blood samples should be tested as soon
as possible after collection. If it is not possible to
perform the test immediately blood can be stored for up to 2
days at 2-8°C.
What volume does the (EDTA)
capillary tube deliver?
5µL.