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Title: Analytical sensitivity of current best-in-class malaria rapid diagnostic tests
Author: Jiménez, Alfons
Rees-Channer, Roxanne R.
Perera, Rushini
Gamboa, Dionicia
Chiodini, Peter L.
Gonzalez, Iveth J.
Mayor Aparicio, Alfredo Gabriel
Ding, Xavier C.
Keywords: Malària
Issue Date: 24-Mar-2017
Publisher: BioMed Central
Abstract: BACKGROUND: Rapid diagnostic tests (RDTs) are today the most widely used method for malaria diagnosis and are recommended, alongside microscopy, for the confirmation of suspected cases before the administration of anti-malarial treatment. The diagnostic performance of RDTs, as compared to microscopy or PCR is well described but the actual analytical sensitivity of current best-in-class tests is poorly documented. This value is however a key performance indicator and a benchmark value needed to developed new RDTs of improved sensitivity. METHODS: Thirteen RDTs detecting either the Plasmodium falciparum histidine rich protein 2 (HRP2) or the plasmodial lactate dehydrogenase (pLDH) antigens were selected from the best performing RDTs according to the WHO-FIND product testing programme. The analytical sensitivity of these products was evaluated using a range of reference materials including P. falciparum and Plasmodium vivax whole parasite samples as well as recombinant proteins. RESULTS: The best performing HRP2-based RDTs could detect all P. falciparum cultured samples at concentrations as low as 0.8 ng/mL of HRP2. The limit of detection of the best performing pLDH-based RDT specifically detecting P. vivax was 25 ng/mL of pLDH. CONCLUSION: The analytical sensitivity of P. vivax and Pan pLDH-based RDTs appears to vary considerably from product to product, and improvement of the limit-of-detection for P. vivax detecting RDTs is needed to match the performance of HRP2 and Pf pLDH-based RDTs for P. falciparum. Different assays using different reference materials produce different values for antigen concentration in a given specimen, highlighting the need to establish universal reference assays.
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It is part of: Malaria Journal, 2017, vol. 16, num. 128
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ISSN: 1475-2875
Appears in Collections:Articles publicats en revistes (ISGlobal)

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