Rapid Malaria (pf pv) Test Kits (CE)

Rapid Malaria (pf pv) Test kits CE certificate Accurate: Sensitivity>96.9%;Specificity>99.7%

MALARIA POCT TEST Kits

Intended Use:

The Advanced Quality™ One Step Malaria(p.f.)Test is A Colloidal Gold Enhanced, Rapid Immunochromatographic Assay for testing, in vitro , the presence of Plasmodium falciparum malaria in blood. The test is an antigen-capture assay detecting presence of a specific soluble protein, histidine-rich protein II (PfHRP-II), which is present in, and released from, infected red blood cells. The assay is intended for use with whole blood and does not require additional instruments.

Features:

Format	Cassette
Specimen	Whole Blood
Specificity	96.9%
Sensitivity	99.7%
Shelf life	2 years
Storage	2-30°C
Reading Time	15 -20 minutes
Certification	CE Certificate
Quality Guaranty	GMP & ISO 13485

 Sample Collection and storage:

1. Collect whole blood specimens following regular clinical laboratory procedures.

2. Storage: A specimen should be refrigerated if not used the same day of collection. 0.1% of sodium azide can be added to specimen as preservative without affecting the results of the assay.

Performance Characteristics:

The following data was generated by from previously frozen whole blood samples, and was determined by correlation to standard thick and thin smear microscopic examination with discrepants evaluated via PCR. Retrospective study results are summarized below:

The Malaria Test did not cross-react with any of the following species of malaria: P.malariae, P.ovale.

Rapid Malaria (pf pv) Test Kits (CE)