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

• Published in: Tropical medicine & international health Vol. 9; no. 6; pp. 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.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Science Ltd 01.06.2004; Blackwell Science
• Subjects: Adult; Antigens, Protozoan - urine; Biological and medical sciences; diagnostic accuracy; Human protozoal diseases; Humans; Infectious diseases; Latex Fixation Tests - methods; Leishmania donovani; Leishmaniasis, Visceral - diagnosis; Leishmaniasis, Visceral - epidemiology; Leishmaniasis, Visceral - urine; Leshmaniasis; Medical sciences; Nepal; Nepal - epidemiology; Parasitic diseases; Prospective Studies; Protozoal diseases; Reproducibility of Results; Sensitivity and Specificity; urine antigen detection test; visceral leishmaniasis; Asia; Nepal; Parasitological investigation; Human; Urine; Evaluation; Protozoal disease; Kala azar; Leishmaniasis; Parasitosis; Infection; Antigen; Latex agglutination test; Tropical medicine; Diagnosis
• ISSN: 1360-2276; 1365-3156
• DOI: 10.1111/j.1365-3156.2004.01251.x

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 < 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.