INTENDED USE

Rapid Malaria（p.f.）Test is A Colloidal Gold Enhanced, Rapid Immunochromatographic Assay for testing, in vitro , the presence of Plasmodium falciparum malaria in blood. The test is an antigen-capture assay detecting presence of a specific soluble protein, histidine-rich protein II （PfHRP-II）, which is present in, and released from, infected red blood cells. The assay is intended for use with whole blood and does not require additional instruments.

PERFORMANCE CHARACTERISTICS

The following data was generated by from previously frozen whole blood samples, and was determined by correlation to standard thick and thin smear microscopic examination with discrepants evaluated via PCR. Retrospective study results are summarized below:

The Malaria Test did not cross-react with any of the following species of malaria: P.malariae, P.ovale, and P.vivax