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Field validity, reproducibility and feasibility of diagnostic tests for visceral leishmaniasis in rural Nepal

Summary Objectives  To assess the field accuracy, reproducibility and feasibility of the formol gel test (FGT), the urine latex agglutination test (KAtex) and a rK39 antigen‐based dipstick for the diagnosis of visceral leishmaniasis (VL) in rural Nepal. Method  Patients with clinical suspicion of VL...

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Published in:Tropical medicine & international health 2006-01, Vol.11 (1), p.31-40
Main Authors: Chappuis, François, Rijal, Suman, Jha, Uma Kant, Desjeux, Philippe, Karki, Bal Man Singh, Koirala, Shekhar, Loutan, Louis, Boelaert, Marleen
Format: Article
Language:English
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Summary:Summary Objectives  To assess the field accuracy, reproducibility and feasibility of the formol gel test (FGT), the urine latex agglutination test (KAtex) and a rK39 antigen‐based dipstick for the diagnosis of visceral leishmaniasis (VL) in rural Nepal. Method  Patients with clinical suspicion of VL were recruited at Rangeli District Hospital (DH), a 15‐bed government hospital located in south‐eastern Nepal. FGT, KAtex and rK39 dipstick tests were performed on site and later repeated at a reference kala‐azar diagnostic laboratory to assess reproducibility. Diagnosis of VL was confirmed by either a positive bone marrow aspirate examination or a positive direct agglutination test (DAT titre ≥1:3200) in patients who later responded to anti‐leishmanial therapy. Results  Of 155 patients initially recruited, 142 (85 with VL and 57 with another diagnosis) were included in the study. The sensitivity of the rK39 dipstick [89%; 95% confidence interval (CI): 81–94] was significantly higher than that of the KAtex (57%; 95% CI: 46–67) and the FGT (52%; 95% CI: 41–62). All three tests had a specificity of at least 90%. Agreement was higher for the rK39 dipstick (κ = 0.87) than for the FGT (0.68) and the KAtex (0.43). All tests required ≤20 min of actual work and ≤40 min to obtain the results. Conclusion  The rK39 dipstick was easy to do, more accurate and reproducible than other rapid diagnostic tests for VL in a DH of rural Nepal. It should be integrated into the field diagnostic algorithm of VL in this region and mechanisms to secure its availability should be found. Objectifs  Evaluer sur le terrain la précision, la reproductibilité et la faisabilité du test au Gel de Formol (FGT), du test de l'agglutination urine‐latex (KAtex) et du test sur bandelette à l'antigène rK39, pour le diagnostic de la leishmaniose viscérale (LV) en milieu rural du Népal. Méthode  Les patients avec une suspicion clinique de la LV ont été recrutés à l'hôpital du district de Rangeli, un hôpital gouvernemental de 15 lits, situé dans le sud‐est du Népal. Les tests FGT, KAtex et au rK39 ont été appliqués sur place et répétés ultérieurement dans le laboratoire de diagnostic de référence du Kala‐azar pour évaluer leur reproductibilité. Le diagnostic de la LV a été confirmé soit par examen positif d'aspiration de moelle osseuse ou par un résultat positif du test d'agglutination direct (titre DAT ≥1:3200), chez les patients qui, plus tard ont répondu au traitement anti‐leishmaniose. Résultats  Sur
ISSN:1360-2276
1365-3156
DOI:10.1111/j.1365-3156.2005.01533.x