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One step High accuracy CE approved Malaria Pf/Pan Test kit

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Sensitivity

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%)*

Specificity

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.

INTENDED USE

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.

Company 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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