Malaria Pf and Pv Rapid Test

Intended Use

Malaria P.f/P.v Rapid Test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of circulating antigens of Plasmodium falciparum, Plasmodium vivax malaria in whole blood. Malaria P.f/P.v Rapid Test (Whole Blood) contains monoclonal anti-HRP-II antibodies and anti- P.vivax LDH antibodies coated on the membrane.

About Malaria

Malaria is caused by a protozoan which invades human red blood cells.1 World Health Organization estimates that 3.3 billion were at risks of acquiring malaria in 2006, with 247 million of these developing clinical malaria (86% in Africa), and nearly 1 million (mostly African children) dying from the disease. 2 Microscopic analysis of appropriately stained thick and thin blood smears has been the standard diagnostic technique for identifying malaria infections for more than a century.3 The technique is capable of accurate and reliable diagnosis when performed by skilled microscopists using defined protocols. The skill of the microscopist and use of proven and defined procedures, frequently present the greatest obstacles to fully achieving the potential accuracy of microscopic diagnosis. Although there is a logistical burden associated with performing a time-intensive, labor-intensive, and equipment-intensive procedure such as diagnostic microscopy, it is the training required to establish and sustain competent performance of microscopy that poses the greatest difficulty in employing this diagnostic technology. The Malaria P.f/P.v Rapid Test Device (Whole Blood) is a rapid test to qualitatively detect the presence of the P.falciparum-specific HRP-II antigens and/or P.vivax LDH antigens found in P.vivax(P.v), The test utilizes colloid gold conjugate to selectively detect P.f-specific HRP-II antigens and P.v-LDH antigens in whole blood.

Materials

● Individually packed test

● Package insert

● Disposable specimen pipettes

● Specimen tubes

● Buffer

Procedure

Allow the test Strips, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1. Remove the test strip 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. Transfer the specimen to the specimen tube by a pipette or a dropper:

● To use a Pipette: Transfer 10 uL of whole blood to the specimen tube, then add 3 full drops of buffer (approximately 120 uL).

● To use a Disposable Specimen Dropper: Hold the dropper vertically, draw the specimen up to the Fill Line as shown in illustration below (approximately 10 uL). Transfer the specimen to the specimen tube, then add 3 full drops of buffer (approximately 120 uL).

3. With arrows pointing toward the specimen, immerse the test strip vertically in the specimen and start the timer. Do not pass the maximum line (MAX) on the test strip when immersing the strip.

4. 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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