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Rapid Diagnostic Cards Malaria Pf/Pan Kits

1.Intended Use

(1)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.

2.Performance Characteristics

(1)The Malaria P.f/ Pan Rapid Test Device (Whole Blood) has been tested with thin or thick microscopy on clinical samples. The results show that the sensitivity of the Malaria P.f/ Pan Rapid Test Device (Whole Blood) is >99.9% relative to microscopy.

(2)For Pan:Relative Sensitivity: >99.9% (158/158) (97.6%~100.0%)*            

(3)For P.f:Relative Sensitivity: >99.9% (53/53) (93%~100.0%)*                

(4)Specificity:The Malaria P.f/ Pan Rapid Test Device (Whole Blood) uses highly specific antibodies for Malaria P.f/ Pan antigens in whole blood. The results show that the specificity of the Malaria P.f/ Pan. Rapid Test Device (Whole Blood) is over 99.0% relative to microscopy.

(5)Relative Specificity: >99.0% (324/327)(97.3%~99.8%)*

(6)Accuracy: >99.4%(535/538)(98.3%~99.8%)*