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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
A global comparative evaluation of commercial immunochromatographic rapid diagnostic tests for visceral leishmaniasis
Clinical Infectious Diseases, Volume 55, No. 10, Year 2012
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Description
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.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC3478143/bin/supp_55_10_1312__index.html
https://efashare.b-cdn.net/share/pmc/articles/PMC3478143/bin/supp_cis716_cis716supp.doc
Authors & Co-Authors
Cunningham, Jane A.
Unknown Affiliation
Hasker, Epco C.
Unknown Affiliation
Das, Pradeep Kumar
Unknown Affiliation
El-Safi, Sayda Hassan
Unknown Affiliation
Goto, Hiro
Unknown Affiliation
Mondal, Dinesh K.
Unknown Affiliation
Mbuchi, Margaret W.
Unknown Affiliation
Mukhtar, Maowia Mohamed
Unknown Affiliation
Rabello, Ana
Unknown Affiliation
Rijal, Suman
Unknown Affiliation
Sundar, Santhanam
Unknown Affiliation
Wasunna, Monique K.
Unknown Affiliation
Adams, E. R.
Unknown Affiliation
Menten, Joris
Unknown Affiliation
Peeling, Rosanna Wai Wan
Unknown Affiliation
Boelaert, Marleen C.
Unknown Affiliation
Das, M. L.
Unknown Affiliation
Oliveira, Edward
Unknown Affiliation
de Assis, Tália Machado
Unknown Affiliation
Bhaskar, Khondaker R.H.
Unknown Affiliation
Huda, M. Mamun
Unknown Affiliation
Hassan, Mukidul
Unknown Affiliation
Abdoun, Asim Osman
Unknown Affiliation
Awad, Aymen
Unknown Affiliation
Osman, Mohamed
Unknown Affiliation
Prajapati, Dinesh Kumar
Unknown Affiliation
Gidwani, Kamlesh
Unknown Affiliation
Tiwary, Puja
Unknown Affiliation
Paniago, Anamaria Mello Miranda
Unknown Affiliation
Sanchez, Maria Carmen A.
Unknown Affiliation
Celeste, Beatriz Julieta
Unknown Affiliation
Jacquet, D.
Unknown Affiliation
Magiri, Charles G.
Unknown Affiliation
Muia, Alfred
Unknown Affiliation
Kesusu, J.
Unknown Affiliation
Ageed, Al Farazdag
Unknown Affiliation
Galal, Nuha
Unknown Affiliation
Osman, Osman S.
Unknown Affiliation
Gupta, A. K.
Unknown Affiliation
Bimal, Afrad S.
Unknown Affiliation
Das, Vidyananda Nand Rabi
Unknown Affiliation
Statistics
Citations: 140
Authors: 41
Affiliations: 16
Identifiers
Doi:
10.1093/cid/cis716
ISSN:
10584838
e-ISSN:
15376591
Research Areas
Health System And Policy
Study Locations
Multi-countries