Intended Use

The Malaria P.f/Pan Rapid Test Device (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of circulating antigens of Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, Plasmodium malariae in whole blood.

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MATERIALS

Materials Provided

·Test devices ·Disposable specimen droppers

·Buffer ·Package insert

Materials Required But Not Provided

·Pipette and disposable tips (optional) ·Specimen collection containers

·Lancets (for fingerstick whole blood only) ·Timer

DIRECTIONS FOR USE

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.

Place the test device on a clean and level surface. Transfer the specimen by a pipette or a dropper:

To use a Pipette: Transfer 10 L of whole blood to Well-1 (W1) of the test device, then add 3 full drops of buffer to Well-2 (W2), and start the timer. (See illustration ① below). Avoid trapping air bubbles in W1. At the end of 5 minutes, add 1 full drop of buffer to the W1 (See illustration ③ below).

To use a Disposable Specimen Dropper: Hold the dropper vertically; draw the specimen up to the Fill Line as shown in illustration ① below. Transfer the specimen to W1of the test device, then add 3 full drops of buffer to W2 and start the timer. Avoid trapping air bubbles in W1. At the end of 5 minutes, add 1 full drop of buffer to W1 (See illustration ③ below).

3.   Wait for the colored line(s) to appear. The result should be read at 15 minutes.  Do not

interpret the result after 20 minutes.

1Malaria pv