Browsing by Author "James Kelley"

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    The comparative accuracy of 8 commercial rapid immunochromatographic assays for the diagnosis of acute dengue virus infection
    (2006-04-15) Stuart D. Blacksell; Paul N. Newton; David Bell; James Kelley; Mammen P. Mammen; David W. Vaughn; Vanaporn Wuthiekanun; Amornwadee Sungkakum; Ananda Nisalak; Nicholas P.J. Day; Nuffield Department of Clinical Medicine; Mahidol University; Armed Forces Research Institute of Medical Sciences, Thailand; Mahosot Hospital; Organisation Mondiale de la Sante; U.S. Army Medical Research and Materiel Command
    Background. The serological diagnosis of acute dengue virus infection relies on the detection of dengue-specific immunoglobulin M (IgM) antibodies. Immunochromatographic tests are rapid diagnostic tests (RDTs) that can be performed at the bedside, but they have not been fully validated for diagnosis of dengue infection. Methods. More than 20 RDTs for diagnosis of acute dengue infection are commercially available. Of these, 8 were selected for evaluation of performance by use of characterized dengue and nondengue serum specimens, and results were compared with those of a previously published dengue IgM/IgG enzyme-linked immunosorbent assay in conjunction with dengue virus serotyping by reverse-transcriptase polymerase chain reaction. Results. Assay sensitivities were low, ranging from 6.4% (95% confidence interval [CI], 4.0%-9.7%) to 65.3% (95% CI, 59.9%-70.5%), and specificities ranged from 69.1% (95% CI, 61.4%-76.0%) to 100% (95% CI, 97.8%-100%). Of the 8 tests, only 2 had sensitivities of >50%, the level considered to be clinically useful, and, of these, 1 had relatively low specificity (69.1%). Samples collected early in the infection were less likely to test positive than those collected later. A thermal stability study demonstrated a loss in performance of some RDTs when they were stored at a high ambient temperature for 3 months. Conclusions. Users of RDTs for dengue should be aware that many of these tests have a diagnostic accuracy that falls well below the manufacturers' claims. If an acute specimen yields a negative result, a convalescent serum sample should be tested to confirm the result. No RDT adequately differentiated primary and secondary dengue infections, and the tests should not be used for this purpose. © 2006 by the Infectious Diseases Society of America. All rights reserved.
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    Prospective study to determine accuracy of rapid serological assays for diagnosis of acute dengue virus infection in Laos
    (2007-11-01) Stuart D. Blacksell; David Bell; James Kelley; Mammen P. Mammen; Robert V. Gibbons; Richard G. Jarman; David W. Vaughn; Kemajittra Jenjaroen; Ananda Nisalak; Soulignasack Thongpaseuth; Manivanh Vongsouvath; Viengmone Davong; Phonelavanh Phouminh; Rattanaphone Phetsouvanh; Nicholas P.J. Day; Paul N. Newton; Mahosot Hospital; Nuffield Department of Clinical Medicine; Mahidol University; Organisation Mondiale de la Sante; Armed Forces Research Institute of Medical Sciences, Thailand; U.S. Army Medical Research and Materiel Command
    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. Blackseil, 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. Copyright © 2007, American Society for Microbiology. All Rights Reserved.