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

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Abstract:

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 ( = 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.

Keywords: Nepal; antigen detection; diagnosis; kala-azar; serology; visceral leishmaniasis

Document Type: Research Article

DOI: http://dx.doi.org/10.1111/j.1365-3156.2005.01533.x

Affiliations: 1: Travel and Migration Medicine Unit, Geneva University Hospital, Geneva, Switzerland 2: Department of Medicine, B. P. Koirala Institute of Health Sciences, Dharan, Nepal 3: Rangeli District Hospital, Rangeli, Nepal 4: Disease Control, Prevention and Eradication, World Health Organization, Geneva, Switzerland 5: Department of Microbiology, B. P. Koirala Institute of Health Sciences, Dharan, Nepal 6: Institute of Tropical Medicine, Antwerp, Belgium

Publication date: January 1, 2006

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