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Last Updated: 10/10/2023
Lab evaluation of Abbott and commercially available comparator malaria rapid Dx tests using hrp2/hrp3 deletion panel
Objectives
The main objective of this study is to test the relative performance of malaria rapid diagnostic tests
(RDTs): the Abbott NxTek Malaria Pf Plus and Abbott NxTek Pf/Pv Plus rapid diagnostic tests (“Pf Plus RDT” and “Pf/Pv Plus RDT”, P/Ns 05FK150 and 05FK160), Abbott SD Bioline rapid diagnostic tests (P/Ns 05FK90, and 05FK120) and commercially-available comparator rapid tests from Rapigen. Performance will be established using a panel of malaria-positive specimens with hrp2/3-deletions mutations of Plasmodium falciparum (Pf).
Abbott has recreated a panel of hrp2 negative samples to mimic as closely as possible a CDC panel. PATH will begin testing the samples against the selected Abbott malaria RDTs and comparator RDTs. The testing will provide evidence of
relative analytical performance of the RDTs evaluated in detecting a range of PfLDH antigen concentrations and parasite densities. High sensitivity multiplex ELISA (Quansys QPlex) will be used to quantify malaria antigen concentrations of the panel members.
Jun 2023 — Sep 2023
$25,472
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