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.

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更新时间：2025-08-07
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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:

Site	Pos	Neg	Test Pos	Test Neg
India	66	86	64（97%）	86（100%）
Senegal	8	10	8（100%）	10（100%）
Varied Origin	48	53	46（95.8%）	53（100%）
South Africa	102	150	99（97%）	149（99.3%）
TOTAL	224	299	217（96.9%）	298（99.7%）