A rapid test for the qualitative detection of circulating antigens of Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, Plasmodium malariae in whole blood.

For professional in vitro diagnostic use only.

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, laborintensive,

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/Pan Rapid Test Device (Whole Blood) is a rapid test to qualitatively detect the presence of the P. falciparum - specific HRP-II antigens and/or Pan-malarial Aldolase antigens found in P. falciparum (P.f), P. vivax (P.v), P. ovale (P.o) and P. malariae (P.m).

The test utilizes colloid gold conjugate to selectively detect P.f-specific and Pan-malarial antigens (P.f, P.v, P.o and P.m) in whole blood.