Evaluation of a urinary antigen-based latex agglutination test in the diagnosis of kala-azar in eastern Nepal
Article first published online: 8 JUN 2004
Tropical Medicine & International Health
Volume 9, Issue 6, pages 724–729, June 2004
How to Cite
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. and Koirala, S. (2004), Evaluation of a urinary antigen-based latex agglutination test in the diagnosis of kala-azar in eastern Nepal. Tropical Medicine & International Health, 9: 724–729. doi: 10.1111/j.1365-3156.2004.01251.x
- Issue published online: 8 JUN 2004
- Article first published online: 8 JUN 2004
- visceral leishmaniasis;
- sensitivity and specificity;
- diagnostic accuracy;
- urine antigen detection test;
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 < 0.001, n = 232).
Conclusion KAtex evaluation showed high specificity, low sensitivity and moderate reproducibility. A urine test for kala-azar could become a real breakthrough in kala-azar management if its reproducibility and sensitivity could be further improved.