Title
Diagnostic accuracy of a new **Leishmania** PCR for clinical visceral leishmaniasis in Nepal and its role in diagnosis of diseaseDiagnostic accuracy of a new **Leishmania** PCR for clinical visceral leishmaniasis in Nepal and its role in diagnosis of disease
Author
Faculty/Department
Institute of Development Policy and Management
Faculty of Pharmaceutical, Biomedical and Veterinary Sciences . Biomedical Sciences
Research group
Department of Biomedical Sciences - other
Institute of Development Policy and Management - other
Publication type
article
Publication
Oxford,
Subject
Human medicine
Source (journal)
Tropical medicine and international health. - Oxford
Volume/pages
13(2008):11, p. 1378-1383
ISSN
1360-2276
ISI
000261085800008
Carrier
E
Target language
English (eng)
Full text (Publishers DOI)
Abstract
Objective To develop a new PCR for Leishmania detection and to estimate its diagnostic accuracy in a visceral leishmaniasis (VL) endemic area. Methods After providing the proof-of-concept, the diagnostic accuracy was estimated on blood from 247 non-endemic control persons and on blood and bone marrow from 173 confirmed VL, 39 probable VL and 87 non-VL patients from south-eastern Nepal. Results The PCR showed a specificity of 99.64% [95% confidence interval (CI): 98.93100%) on non-endemic controls and a sensitivity of 92.1% (95% CI: 87.696.6%) on blood and 92.9% (95% CI: 8996.8%) on bone marrow from the confirmed VL patients. Leishmania DNA was detected in blood and bone marrow of 67.6% (95% CI: 50.880.9%) and 71.8% (95% CI: 56.283.5%) of the probable VL patients, respectively, and of 38.2% (95% CI: 2849.4%) and 29.9% (95% CI: 21.340.2%) of the non-VL patients, respectively. The PCR showed 97% concordance with a positive DAT status while for a negative DAT status this was only 41.3% (kappa-index 0.416, 95% CI: 0.300.53). Conclusions Our findings indicate that PCR alone rather provides a marker for infection than a marker for disease and its role in VL diagnosis in endemic regions is discussed.
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