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Evaluation of a urinary antigen‐based latex agglutination test in the diagnosis of kala‐azar in eastern Nepal

Summary Background  We evaluated the diagnostic accuracy as well as the reproducibility of the urine latex agglutination test ‘KAtex’ in the diagnosis of kala‐azar in patients recruited at a tertiary care centre in Dharan, Nepal, between November 2000 and January 2002. Methods  All patients presenti...

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Published in:Tropical medicine & international health 2004-06, Vol.9 (6), p.724-729
Main Authors: Rijal, S., Boelaert, M., Regmi, S., Karki, B. M. S., Jacquet, D., Singh, R., Chance, M. L., Chappuis, F., Hommel, M., Desjeux, P., Van der Stuyft, P., Le Ray, D., Koirala, S.
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Language:English
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Summary:Summary Background  We evaluated the diagnostic accuracy as well as the reproducibility of the urine latex agglutination test ‘KAtex’ in the diagnosis of kala‐azar in patients recruited at a tertiary care centre in Dharan, Nepal, between November 2000 and January 2002. Methods  All patients presenting with fever of 2 weeks or more and splenomegaly were consecutively enrolled. Bone marrow and – if negative – spleen aspirates were examined for Leishmania donovani. Serum and urine samples were taken in duplicate for the Direct Agglutination Test (DAT) and KAtex. The reference laboratory determined sensitivity and specificity of KAtex. Reproducibility between both laboratories was assessed. Results  KAtex was performed on urine from 155 parasitologically confirmed kala‐azar and 77 non‐kala‐azar cases (parasitology and DAT‐negative). KAtex showed a sensitivity of 47.7% (74/155, 95% CI: 39.7–55.9) and a specificity of 98.7% (76/77, 95% CI: 93.0–100.0). Reproducibility of KAtex showed a kappa of 0.684 (P 
ISSN:1360-2276
1365-3156
DOI:10.1111/j.1365-3156.2004.01251.x