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. 2021 Oct 7;8(1):52.
doi: 10.1186/s40779-021-00345-0.

Secondary analysis of malaria rapid diagnostic tests from rounds 5-8 of WHO product testing with a focus on false-negative results

Biao Xu  1 , Bo Tu  1 , Fang Chu  1 , Mohamed Jalloh  2 , Jin-Song Mu  1 , Jun-Jie Zheng  1 , Wei-Wei Chen  3
Affiliations

Secondary analysis of malaria rapid diagnostic tests from rounds 5-8 of WHO product testing with a focus on false-negative results

Biao Xu et al. Mil Med Res. .

Abstract

Despite the widespread use of malaria rapid diagnostic test (RDT) in clinical practice, there are a lot of challenges. We conducted a secondary analysis of 129 malaria RDT data from rounds 5-8 of the World Health Organization (WHO) product testing summary and discuss the causes of false-negative (FN) results with a focus on low parasite density, improper RDT storage, operation and interpretation, and plasmodium falciparum with a pfhrp2/3 gene deletion. The results demonstrated that the malaria RDTs currently commercially available might cause FN results in practice.

Keywords: False-negative results; Malaria; Rapid diagnostic tests; WHO product testing.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Assessment of malaria RDT performance in rounds 5–8 against wild type (clinical) samples containing Pf (a) and Pv (b) at 200 parasites/µl (%). Pf Plasmodium falciparum, Pv Plasmodium vivax, Pan all Plasmodium species, Pvom Plasmodium vivax, ovale and malariae
See this image and copyright information in PMC

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