The Malaria Pf/ 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.
For Pan:
Relative Sensitivity: >99.9% (103/103) (96.5%~100.0%)*
For P.f:
Relative Sensitivity: >99.9% (53/53) (93.3%~100.0%)*
The Malaria Pf/ Pan Rapid Test Device (Whole Blood) uses highly specific antibodies for Malaria Pf/ Pan antigens in whole blood. The results show that the specificity of the Malaria Pf/ Pan Rapid Test Device (Whole Blood) is over 99.0% relative to microscopy.
Relative Specificity: 99.1% (213/215)(96.7%~99.9%)*
Accuracy: 99.4% (359/361)(98.0%~99.9%)*
* 95% Confidence Interval
Method |
Microscopy |
Total Results |
||||
Malaria P.f/ Pan.
Rapid Test Device |
Results |
Positive |
Negative | |||
Pan |
P. f |
|||||
Positive | Pan |
103 |
0 |
0 |
103 |
|
P.f |
0 |
43 |
2 |
45 |
||
Negative |
0 |
0 |
213 |
213 |
||
Total Results |
146 |
215 |
361 |
Note: The comparison for Pan line has been only done with blood specimens positive with Plasmodium vivax specimen. The claims for Pan lines are based on scientific findings that Pan-malarial Lactate Dehydrogenase is found in other malarial parasites including Plasmodium ovale and Plasmodium malariae.
The Malaria Pf/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.
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