Abstract
BackgroundRapid 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.MethodsThirteen 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.ResultsThe 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.ConclusionThe 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.
Highlights
Rapid diagnostic tests (RDTs) are today the most widely used method for malaria diagnosis and are rec‐ ommended, alongside microscopy, for the confirmation of suspected cases before the administration of anti-malarial treatment
Rapid diagnostic tests selection The selection of the best-in-class RDTs was based on the results of the World Health Organization (WHO)–FIND product testing programme (Rounds 1–6), which has evaluated the performance of 171 unique RDT products on malaria samples at standardized parasitaemia (200 and 2000 parasites/μL) [8]
The reactivity of each RDT against P. falciparum or P. vivax isolates is reported as a panel detection score (PDS) which reflects the percentage of positive samples correctly detected when tested in duplicate by two distinct lots
Summary
Rapid diagnostic tests (RDTs) are today the most widely used method for malaria diagnosis and are rec‐ ommended, 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. The development of point-of-care lateral flow immunochromatographic assays in the mid 1990s for the detection of malaria parasites in minute amounts of capillary blood has radically changed the diagnosis of this parasitic disease in endemic areas. These tests, commonly referred to as rapid diagnostic tests (RDTs), have established themselves as an extremely valuable alternative to the examination of stained blood smears by light microscopy. It is more complex to implement and to maintain at a good quality level, requiring a microscope and a laboratory to stain and read blood smears, and is critically dependent on the training and performance level of the microscopist to generate accurate results
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