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One step high accuracy Malaria P.f./P.v. Test kit

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Sensitivity

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.

Our advantage

1.Professional Manufacturer, a national-level technologically advanced “giant” enterprise.
2.Deliver goods as order request
3.ISO13485, CE, Prepare various shipping documents
4.Reply customers questions within 24 hours


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