Publication Type

Journal Article

Journal Name

Journal of Molecular Diagnostics

Publication Date

1-1-2018

Abstract

Decreasing malaria transmission warrants the search for highly sensitive point-of-care diagnostics, especially in resource-limited settings. The direct-on-blood PCR nucleic acid lateral flow immunoassay (db-PCR-NALFIA) is a simplified PCR-based technique with a lateral flow readout that does not require sample preparation. Two duplex db-PCR-NALFIAs were developed: a pan-Plasmodium/Plasmodium falciparum (pan/P. falciparum) and a pan-Plasmodium/Plasmodium vivax (pan/P. vivax) assay. Confirmed positive samples (n = 61) and negative controls (n = 40) were used for laboratory validations. A prospective field evaluation of the pan/P. falciparum assay was performed in Kenya (n = 300). In the laboratory validation, sensitivity and specificity of the pan/P. falciparum assay were 100% (95% CI, 94.1%–100%) and 100% (95% CI, 91.2%–100%), respectively. Sensitivity and specificity of the pan/P. vivax assay were 100% (95% CI, 94.1%–100%) and 97.5% (95% CI, 86.8%–99.9%), respectively. In Kenya, sensitivity of the pan/P. falciparum db-PCR-NALFIA was 97.2% (95% CI, 93.0%–99.2%) and specificity was 74.2% (95% CI, 67.0%–81.0%) compared with reference standard microscopy. When using real-time quantitative PCR as a reference standard, sensitivity was 84.5% (95% CI, 78.7%–89.3%) and specificity was 85.4% (95% CI, 77.1%–91.6%). Db-PCR-NALFIA is a sensitive, specific, and easy method for the detection and species differentiation of Plasmodium. This test is especially of interest for malaria control or elimination programs in low-transmission settings that require accurate detection of low parasite densities.

PubMed ID

29056574

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