# name
Analytical sensitivity of current best-in-class malaria rapid
                diagnostic tests

# metadata.dc.description.abstract[].value
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.

# metadata.dc.source[].value
Articles publicats en revistes (ISGlobal)

# metadata.dc.title[].value
Analytical sensitivity of current best-in-class malaria rapid
                diagnostic tests