Abstract
Malaria rapid diagnostic tests (RDTs) have had an enormous global impact which contributed to the World Health Organization paradigm shift from empiric treatment to obtaining a parasitological diagnosis prior to treatment. Microscopy, the classic standard, requires significant expertise, equipment, electricity, and reagents. Alternatively, RDT’s lower complexity allows utilization in austere environments while achieving similar sensitivities and specificities. Worldwide, there are over 200 different RDT brands that utilize three antigens: Plasmodium histidine-rich protein 2 (PfHRP-2), Plasmodium lactate dehydrogenase (pLDH), and Plasmodium aldolase (pALDO). pfHRP-2 is produced exclusively by Plasmodium falciparum and is very Pf sensitive, but an alternative antigen or antigen combination is required for regions like Asia with significant Plasmodium vivax prevalence. RDT sensitivity also decreases with low parasitemia (<100 parasites/uL), genetic variability, and prozone effect. Thus, proper RDT selection and understanding of test limitations are essential. The Center for Disease Control recommends confirming RDT results by microscopy, but this is challenging, due to the utilization of clinical laboratory standards, like the College of American Pathologists (CAP) and the Clinical Lab Improvement Act (CLIA), and limited recourses. Our focus is to provide quality assurance and quality control strategies for resource-constrained environments and provide education on RDT limitations.
Highlights
Rapid diagnostic tests (RDTs) have had an enormous impact on the global impact on malaria diagnostics since their emergence in the 1990s [1]
The World Health Organization has developed a Rapid Diagnostic evaluation program that utilizes a spreadsheet under the name Malaria FIND [18]
We reviewed 1076 “Malaria RDT” in a PUBMED Search to develop a table of sensitivity and specificity for the period of 2017–2021
Summary
Rapid diagnostic tests (RDTs) have had an enormous impact on the global impact on malaria diagnostics since their emergence in the 1990s [1]. The WHO and the Foundation for Innovative New Design (FIND) interactive guide provides a report of RDTs, including false positive and false negative rates, which can be accessed through a spreadsheet at https://www.who.int/malaria/areas/diagnosis/rapid_ diagnostic_tests/en/ (Accessed on 11 February 2021) [18,19]. This information assists with the regional selection of RDTs. expert microscopy is still considered the gold standard, information on the newer HRP-RDTs has often outperformed regional microscopy with sensitivities of 94.1% compared to local hospital microscopic diagnostic. Local laboratory microscopy was only 72–78% sensitive compared to the gold standard of expert microscopy at a reference laboratory [6,21]
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