Título:
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Analytical sensitivity of current best-in-class malaria rapid
diagnostic tests
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Autor/a:
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Jiménez, Alfons; Rees-Channer, Roxanne R.; Perera, Rushini; Gamboa, Dionicia; Chiodini, Peter L.; Gonzalez, Iveth J.; Mayor Aparicio, Alfredo Gabriel; Ding, Xavier C.
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Abstract:
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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. |
Materia(s):
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-Malària -Diagnòstic -Malaria -Diagnosis |
Derechos:
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cc by (c) Jiménez et al., 2017
http://creativecommons.org/licenses/by/3.0/es/ |
Tipo de documento:
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Artículo Artículo - Versión publicada |
Editor:
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BioMed Central
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Compartir:
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