There is an urgent need for accurate and simple dengue virus
infection diagnostic assays in limited-resource settings of
dengue endemicity, to assist patient management. Using a panel of reference samples (S. D. Blacksell, P. N. Newton, D. Bell, J. Kelley, M. P. Mammen, D. W. Vaughn, V. Wuthiekanun, A. Sungkakum, A. Nisalak, and N. P. Day, Clin. Infect. Dis. 42:1127-1134, 2006), we recently evaluated eihgt commercially available immunochromatographic rapid diagnostic tests (RDTs) designed to detect dengue virus-specific
immunoglobulin M (
IgM) and/or
IgG. We found that 6/8 RDTs had sensitivities of less than 50% (range, 6 to 65%), but specificities were generally high. Here, in conjuction with dengue virus serotyping by
reverse transcriptase PCR and in the limited-resource setting of Laos, where dengue virus is endemic, we evaluated the same eight RDTs against a previously validated
dengue IgM/
IgG enzyme-linked
immunosorbent assay for diagnosis of acute dengue virus
infection. Paired serum samples were collected from 87 patients, of whom 38 had confirmed dengue virus
infections (4 had primary
infections, 33 had
secondary infections, and 1 had an
infection of indeterminate status). RDT sensitivity was low, with 7/8 RDTs having admission sample sensitivities of less than 20% (range, 4 to 26%). The majority (6/8) of the RDTs, demonstrated high specificity (>95%). Kappa statistic values ranged from 6 to 54% for the RDTs, demonstrating poor to moderate variation between three operators. No RDT adequately differentiated between primary and secondary dengue virus
infections. The findings of this study suggest that currently available RDTs based on the detection of
IgM antibodies for the diagnosis of acute dengue virus
infections are unlikely to be useful for patient management.