Author | Cunningham, Jane | |
Author | Hasker, Epco | |
Author | Das, Pradeep | |
Author | Safi, Sayda El | |
Author | Goto, Hiro | |
Author | Mondal, Dinesh | |
Author | Mbuchi, Margaret | |
Author | Mukhtar, Maowia | |
Author | Rabello, Ana Lúcia Teles | |
Author | Rijal, Suman | |
Author | Sundar, Shyam | |
Author | Wasunna, Monique | |
Author | Adams, Emily | |
Author | Menten, Joris | |
Author | Peeling, Rosanna | |
Author | Boelaert, Marleen | |
Access date | 2014-03-19T17:26:12Z | |
Available date | 2014-03-19T17:26:12Z | |
Document date | 2012 | |
Citation | CUNNINGHAM, Jane et al. A Global comparative evaluation of commercial immunochromatographic rapid diagnostic tests for visceral leishmaniasis. Clinical Infectious Diseases. 2012, vol.55, n.10, pp. 1312-1319. | pt_BR |
ISSN | 1058-4838 | |
URI | https://www.arca.fiocruz.br/handle/icict/7426 | |
Sponsorship | UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases; and Institute of Tropical Medicine Antwerp through the Third Framework Agreement with the Belgian Directorate-General for Development Cooperation. | pt_BR |
Language | eng | pt_BR |
Publisher | Infectious Diseases Society of America | pt_BR |
Rights | open access | pt_BR |
Title | A Global comparative evaluation of commercial immunochromatographic rapid diagnostic tests for visceral leishmaniasis | pt_BR |
Type | Article | pt_BR |
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 | pt_BR |
Affilliation | World Health Organization Special Programme for Research and Training in Tropical Diseases. Geneva, Switzerland | pt_BR |
Affilliation | Institute of Tropical Medicine. Antwerp, Belgium | pt_BR |
Affilliation | Rajendra Memorial Research Institute of Medical Science. Patna, India | pt_BR |
Affilliation | University of Khartoum. Department of Medical Microbiology and Parasitology. Sudan | pt_BR |
Affilliation | Instituto de Medicina Tropical de São Paulo Laboratório de Soroepidemiologia e Imunobiologia. São Paulo, SP, Brazil | pt_BR |
Affilliation | International Centre for Diarrhoeal Disease Research. Dhaka, Bangladesh | pt_BR |
Affilliation | Kenya Medical Research Institute. Nairobi | pt_BR |
Affilliation | University of Khartoum. Institute Endemic Diseases. Sudan | pt_BR |
Affilliation | fundação Oswaldo Cruz. Centro de Pesquisas René Rachou. Belo Horizonte, MG, Brazil | pt_BR |
Affilliation | B. P. Koirala Institute of Health Sciences. Dharan, Nepal | pt_BR |
Affilliation | Banaras Hindu University. Varanasi, India | pt_BR |
Affilliation | Kenya Medical Research Institute. Nairobi | pt_BR |
Affilliation | Royal Tropical Institute/Koninklijk Instituut voor de Tropen. Amsterdam, Netherlands | pt_BR |
Affilliation | Institute of Tropical Medicine. Antwerp, Belgium | pt_BR |
Affilliation | London School of Hygiene and Tropical Medicine. London, United Kingdom | pt_BR |
Affilliation | Institute of Tropical Medicine. Antwerp, Belgium | pt_BR |
Subject | visceral leishmaniasis | pt_BR |