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

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dc.contributor.author Jimenez, Alfons
dc.contributor.author Rees-Channer, Roxanne R.
dc.contributor.author Perera, Rushini
dc.contributor.author Gamboa, Dionicia
dc.contributor.author Chiodini, Peter L.
dc.contributor.author Gonzalez, Iveth J.
dc.contributor.author Mayor, Alfredo
dc.contributor.author Ding, Xavier C.
dc.date.accessioned 2019-01-25T15:02:16Z
dc.date.available 2019-01-25T15:02:16Z
dc.date.issued 2017
dc.identifier.uri https://hdl.handle.net/20.500.12866/4598
dc.description.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. en_US
dc.language.iso eng
dc.publisher BioMed Central
dc.relation.ispartof urn:issn:1475-2875
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject Adult en_US
dc.subject Humans en_US
dc.subject Sensitivity and Specificity en_US
dc.subject Time Factors en_US
dc.subject Malaria, Falciparum en_US
dc.subject Malaria, Vivax en_US
dc.subject Analytical sensitivity en_US
dc.subject HRP2 en_US
dc.subject Malaria rapid diagnostic test en_US
dc.subject pLDH en_US
dc.subject Antigens, Protozoan/analysis en_US
dc.subject Diagnostic Tests, Routine/methods en_US
dc.subject Immunochromatography/methods en_US
dc.subject Malaria/diagnosis en_US
dc.subject Plasmodium falciparum/immunology/isolation & purification en_US
dc.subject Plasmodium vivax/immunology/isolation & purification en_US
dc.title Analytical sensitivity of current best-in-class malaria rapid diagnostic tests en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1186/s12936-017-1780-5
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.02.00 es_PE
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.03.07
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.03.08

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