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Using Reference Quantitative Polymerase Chain Reaction to Assess the Clinical Performance of the Paracheck-Pf® Rapid Diagnostic Test in a Field Setting in Uganda
Malaria rapid diagnostic tests (RDTs) are widely used in clinical and surveillance settings. However, the performance of most RDTs has not been characterized at parasite densities below detection by microscopy. We present findings from Uganda, where RDT results from 491 participants with suspected malaria were correlated with quantitative polymerase chain reaction (qPCR)-defined parasitemia. Compared with qPCR, the sensitivity and specificity of the RDT for Plasmodium falciparum mono-infections were 76% (95% confidence interval [CI]: 68–83%) and 95% (95% CI: 92–97%), respectively. The sensitivity of the RDT at parasite densities between 0.2 and 200 parasites/μL was surprisingly high (87%, 95% CI: 74–94%). The high sensitivity of the RDT is likely because of histidine-rich protein 2 from submicroscopic infections, gametocytes, or sequestered parasites. These findings underscore the importance of evaluating different RDTs in field studies against qPCR reference testing to better define the sensitivity and specificity, particularly at low parasite densities.
Author Notes
Financial support: S. K. Y. reports grants from Canadian Institutes of Health Research and Alberta Economic Development and Trade.
Authors’ addresses: Catherine J. Mitran, School of Public Health, University of Alberta, Edmonton, Alberta, Canada, E-mail: mitran@ualberta.ca. Anthony K. Mbonye, School of Public Health, Makerere University College of Health Sciences, Kampala, Uganda, E-mail: akmbonye@yahoo.com. Michael Hawkes, Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada, E-mail: mthawkes@ualberta.ca. Stephanie K. Yanow, School of Public Health, University of Alberta, Edmonton, Alberta, Canada, and Department of Medical Microbiology and Immunology, University of Alberta, Edmonton, Alberta, Canada, E-mail: yanow@ualberta.ca.