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A global comparative evaluation of commercial immunochromatographic rapid diagnostic tests for visceral leishmaniasis
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Cunningham, Jane, Hasker, Epco, Das, Pradeep, El Safi, Sayda, Goto, Hiro, Mondal, Dinesh, Mbuchi, Margaret, Mukhtar, Maowia, Rabello, Ana, Rijal, Suman, Sundar, Shyam, Wasunna, Monique, Adams, Emily R., Menten, Joris, Peeling, Rosanna and Boelaert, Marleen (2012) A global comparative evaluation of commercial immunochromatographic rapid diagnostic tests for visceral leishmaniasis. Clinical Infectious Diseases, 55 (10). pp. 1312-1319. doi:10.1093/cid/cis716 ISSN 1058-4838.
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Official URL: http://dx.doi.org/10.1093/cid/cis716
Abstract
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 (κ > 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.
| Item Type: | Journal Article | ||||
|---|---|---|---|---|---|
| Subjects: | R Medicine > RB Pathology | ||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Leishmaniasis, Diagnosis, Laboratory | ||||
| Journal or Publication Title: | Clinical Infectious Diseases | ||||
| Publisher: | University of Chicago Press | ||||
| ISSN: | 1058-4838 | ||||
| Official Date: | 15 November 2012 | ||||
| Dates: |
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| Volume: | 55 | ||||
| Number: | 10 | ||||
| Number of Pages: | 8 | ||||
| Page Range: | pp. 1312-1319 | ||||
| DOI: | 10.1093/cid/cis716 | ||||
| Status: | Peer Reviewed | ||||
| Publication Status: | Published | ||||
| Access rights to Published version: | Restricted or Subscription Access | ||||
| Funder: | UNICEF, United Nations Development Programme, World Bank, World Health Organization (WHO), Institute of Tropical Medicine, Antwerp |
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