Infectious Disease Malaria rapid test kits

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INTENDED USE Rapid Malaria P.f/P.v test is is a two site sandwich immunoassay utilizing whole blood for the detection of P. falciparum specific histidine rich protein-2 (Pf. HRP-2) and P. vivax specific pLDH. The test can also be used for specific detection and differentiation of P. falciparum and P. vivax malaria. 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: Site Pos NegTest PosTest Neg India 66 86 64(97%) 86(100%) Senegal 8 10 8(100%) 10(100%) Varied Origin 48 53 46(95.8%) 53(100%) South Africa 102 150 99(97%)149(99.3%) TOTAL 224 299 217(96.9%) 298(99.7%) The Malaria Test did not cross-react with any of the following species of malaria: P.malariae, P.ovale.

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AccuBioTech Co.,Ltd

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