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The persistence of parasite histidine-rich protein 2 (HRP2) in the circulation after parasite clearance has been considered a drawback for rapid diagnostic tests (RDTs) targeting HRP2 and a major cause of false-positive results. This paper reports results of a study into whether a proportion of RDT HRP2 false-positive cases carried parasites using polymerase chain reaction analysis as the gold standard rather than microscopy. The high rate of RDT false-positive parasitemia results in comparison with microscopy was shown to predominantly represent cases that had a parasite density below the threshold for detection by microscopy. Despite the generally low disease-endemic prevalence of malaria in the area, there was a high prevalence of chronic infections with low, fluctuating, parasite densities that were better detected by RDT. Our results suggest that in areas known to have low-density parasitemias, RDTs targeting HRP2 may increase diagnostic sensitivity in comparison with microscopy. While microscopy remains the standard for comparison of malaria diagnostic accuracy, the limitations of microscopy, and the possibility that RDTs may have superior accuracy in some circumstances, should be taken into account when interpreting results of diagnostic trials.
Received October 18, 2004. Accepted for publication January 4, 2005.
Acknowledgments: We acknowledge the assistance of the Barangay health workers and officials in Agusan del Sur, and the staff of the Agusan del Sur-Malaria Control and Prevention Program project. We also thank Rouel Go, Lillibeth Cacal, and John Walker for initial field work, and Qin Cheng and the staff at the Army Malaria Institute (Enoggera, Queensland, Australia) and Allan Saul (National Institutes of Health, Bethesda, MD) for assistance with the text and figures.
Financial support: The work was supported by the National Health and Medical Research Council, Australia, and assisted by AusAID through the Research Institute for Tropical Medicine, The Philippines.
* Address correspondence to David R. Bell, Malaria Diagnostics, Malaria, Vector-Borne, and Other Parasitic Diseases, Western Pacific Regional Office, World Health Organization, PO Box 2932, Manila, The Philippines. E-mail: belld{at}wpro.who.int
Authors’ addresses: David R. Bell, Malaria Diagnostics, Malaria, Vector-Borne, and Other Parasitic Diseases, Western Pacific Regional Office, World Health Organization, PO Box 2932, Manila, The Philippines, Telephone: 63-2-528-801, Fax: 63-2-521-1036, E-mail: belld{at}wpro.who.int. Danny W. Wilson, Walter and Eliza Hall Institute, Melbourne, Victoria 3050, Australia. Laura B. Martin, Malaria Vaccine Development Branch, National Institutes of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD 20852.
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