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DETECTION OF LEISHMANIAL ANTIGEN IN THE URINE OF PATIENTS WITH VISCERAL LEISHMANIASIS BY A LATEX AGGLUTINATION TEST

Diagnosis of visceral leishmaniasis (VL) is usually done by demonstration of parasites in tissue smears. However, obtaining these smears may be risky, painful, and difficult. Antibody-based diagnostics are limited by their inability to predict active disease. In this study, a new latex agglutination test (KAtex), which detects parasite antigen in freshly voided and boiled urine, was evaluated in patients with VL before the start (n = 382) and at the end of treatment (n = 273); 185 healthy controls from leishmaniasis-endemic region were also studied. The KAtex result was positive in 87% (95% confidence interval [CI] = 83.3–90.3). However, at the end of treatment only 3% (95% CI = 1.6–6.2) patients were positive. The specificity of the test was 99% and 2 of 185 healthy controls tested positive. Positive and negative predictive values were 0.994 and 0.788, respectively. KAtex is a promising test, and in a simplified and improved format it could be applied meaningfully in the diagnosis of VL.

Received June 28, 2004. Accepted for publication February 18, 2005.

Acknowledgment: We are grateful to the nursing and technical staff of the Kala-Azar Medical Research Center (Muzaffarpur, India) for their participation and help in conducting the study.

Financial support: This work was supported by World Health Organization//World Bank/United Nations Development Program Special Programme for Research and Training in Tropical Diseases (ID 99106).

Disclosure: None of the authors have any conflicts of interest.

^* Address correspondence to Shyam Sundar, Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi 221 005, India. E-mail: shyam_vns{at}satyam.net.in

Authors’ addresses: Shyam Sundar, Shrinkhla Agrawal, and Kalpana Pai, Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi 221 005, India, Telephone: 91-542-236-7795, 91-94152-28390, and 91-542-231-2138, Fax: 91-542-236-7568, E-mails: shyam_vns{at}satyam.net.in, nehshri{at}yahoo.com, and kalpnapai{at}yahoo.com Michael Chance and Marcel Hommel, Liver-pool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, United Kingdom, Telephone: 44-151-705-3232 and 44-151-705-3169, Fax: 44-151-705-3371, E-mails: mchance{at}liv.ac.uk and mhommel{at}liverpool.ac.uk.

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