INTENDED USE
PocTell® Malaria Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of circulating antigens of Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, Plasmodium malariae in whole blood.
Ordering Information
|
Test Item |
Format |
Specimen |
Reaction Time |
Shelf life |
Kit Size |
|
Malaria Pf/Pan Malaria Pf/Pv |
Cassette |
WB |
10 mins |
24 months |
25 T/Kit |
TEST PRINCIPLE
PocTell® Malaria Rapid Test Device (Whole Blood) is a qualitative, membrane based immunoassay for the detection of P.f, Pan (P.v, P.o and P.m) antigens in whole blood. The membrane is pre-coated with anti-HRP-II antibodies and anti-Lactate Dehydrogenase antibodies. During testing, the whole blood specimen reacts with the dye conjugate, which has been pre-coated on the test strip. The mixture then migrates upward on the membrane by capillary action, reacts with anti-Histidine-Rich Protein II (HRP-II) antibodies on the membrane on P.f Test Line region and with anti-Lactate Dehydrogenase antibodies on the membrane on Pan Line region. If the specimen contains HRP-II or Plasmodium-specific Lactate Dehydrogenase or both, a colored line will appear in P.f line region or Pan line region or two colored lines will appear in P.f line region and Pan line region. The absence of the colored lines in P.f line region or Pan line region indicates that the specimen does not contain HRP-II and/or Plasmodium-specific Lactate Dehydrogenase. To serve as a procedure control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

DIRECTIONS FOR USE
Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1.Remove the test device from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2.Place the test device on a clean and level surface. Transfer the specimen by a pipette or a dropper:
To use a Pipette: Transfer 5 L of whole blood to specimen well of the test device, and then add 3-4 drops of buffer (approximately 120ul-160ul) to the buffer well, and start the timer.
To use a Disposable Specimen Dropper: Hold the dropper vertically; draw the specimen up to the Fill Line (approximately 5ul). Transfer the specimen to the specimen well, then add 3-4 drops of buffer (approximately 120ul-160ul) to the buffer well and start the timer.
3. Wait for the colored line(s) to appear. The result should be read at 10 minutes. Do not
interpret the result after 20 minutes..
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