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The Malaria P.f./ P.v. Rapid Test Device (Whole Blood) has been tested with microscopy on clinical samples. The results show that the sensitivity of the Malaria P.f./ P.v. Rapid Test Device (Whole Blood) is >98% when compared to results obtained with microscopy.
Specificity
The Malaria P.f./ P.v. Rapid Test Device (Whole Blood) uses antibodies that are highly specific to Malaria P.f.-specific and P.vivax LDH antigens in whole blood. The results show that the specificity of the Malaria P.f./ P.v. Rapid Test Device (Whole Blood) is over 99.9%, when compared to results obtained with microscopy.
Method
Microscopy
Total Results
Malaria P.f./ P.v. Rapid Test Device
Results
Positive
Negative
P. v.
P. f.
Positive
49
80
0
129
Negative
1
0
451
452
Total Results
50
80
451
581
Comment: Blood Samples infected by Plasmodium falciparum (n=80). Plasmodium vivax (n=50) were included, as well as 451 malaria negative samples to be confirmed with microscopy. Relative Sensitivity for P.f.-specific antigens: 80/80> 99.9% (96.4%～100.0%)* Relative Sensitivity for P.v. antigens: 49/50=98.0% (89.6%～100.0%)* Relative Specificity: 451/451>99.9% (99.3%～100.0%)* Accuracy: (49+80+451)/(50+80+451)=580/581=99.8% (99.0%～100.0%)* * 95% Confidence Interval
INTENDED USE
The Malaria P.f./P.v. Rapid Test Device (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of two kinds of circulating Plasmodium falciparum (P.f.) and Plasmodium vivax(P.v.) in whole blood.
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