Browsing by Author "Dinesh Kumar Prajapati"

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A global comparative evaluation of commercial immunochromatographic rapid diagnostic tests for visceral leishmaniasis
(Oxford University Press, 2012) Jane Cunningham; Epco Hasker; Pradeep Das; Sayda El Safi; Hiro Goto; Dinesh Mondal; Margaret Mbuchi; Maowia Mukhtar; Ana Rabello; Suman Rijal; Shyam Sundar; Monique Wasunna; Emily Adams; Joris Menten; Rosanna Peeling; Marleen Boelaert; Murari Das; Edward Oliveira; Tália Machado de Assis; Khondaker Rifathassan Bhaskar; M. Mamun Huda; Mukidul Hassan; Asim Osman Abdoun; Aymen Awad; Mohamed Osman; Dinesh Kumar Prajapati; Kamlesh Gidwani; Puja Tiwary; Anamaria Mello Miranda Paniago; Maria Carmen Arroyo Sanchez; Beatriz Julieta Celeste; Diane Jacquet; Charles Magiri; A. Muia; J. Kesusu; Al Farazdag Ageed; Nuha Galal; Osman Salih Osman; A.K. Gupta; Afrad S. Bimal; V.N.R. Das
Background. Poor access to diagnosis stymies control of visceral leishmaniasis (VL). Antibody-detecting rapid diagnostic tests (RDTs) can be performed in peripheral health settings. However, there are many brands available and published reports of variable accuracy. Methods. Commercial VL RDTs containing bound rK39 or rKE16 antigen were evaluated using archived human sera from confirmed VL cases (n = 750) and endemic non-VL controls (n = 754) in the Indian subcontinent (ISC), Brazil, and East Africa to assess sensitivity and specificity with 95 confidence intervals. A subset of RDTs were also evaluated after 60 days' heat incubation (37°C, 45°C). Interlot and interobserver variability was assessed. Results. All test brands performed well against ISC panels (sensitivity range, 92.8-100; specificity range, 96-100); however, sensitivity was lower against Brazil and East African panels (61.5-91 and 36.8-87.2, respectively). Specificity was consistently > 95 in Brazil and ranged between 90.8 and 98 in East Africa. Performance of some products was adversely affected by high temperatures. Agreement between lots and readers was good to excellent ( > 0.73-0.99). Conclusions. Diagnostic accuracy of VL RDTs varies between the major endemic regions. Many tests performed well and showed good heat stability in the ISC; however, reduced sensitivity against Brazilian and East African panels suggests that in these regions, used alone, several RDTs are inadequate for excluding a VL diagnosis. More research is needed to assess ease of use and to compare performance using whole blood instead of serum and in patients coinfected with human immunodeficiency virus. © 2012 The Author.