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Precisión diagnóstica de una nueva PCR de Leishmania para leishmaniasis visceral clínica en Nepal y su papel en el diagnóstico de la enfermedad
Author(s) -
Deborggraeve Stijn,
Boelaert Marleen,
Rijal Suman,
De Doncker Simonne,
Dujardin JeanClaude,
Herdewijn Piet,
Büscher Philippe
Publication year - 2008
Publication title -
tropical medicine and international health
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.056
H-Index - 114
eISSN - 1365-3156
pISSN - 1360-2276
DOI - 10.1111/j.1365-3156.2008.02154.x
Subject(s) - visceral leishmaniasis , medicine , concordance , confidence interval , leishmaniasis , bone marrow , gastroenterology , leishmania , immunology , parasite hosting , world wide web , computer science
Summary 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): 98.93–100%) on non‐endemic controls and a sensitivity of 92.1% (95% CI: 87.6–96.6%) on blood and 92.9% (95% CI: 89–96.8%) on bone marrow from the confirmed VL patients. Leishmania DNA was detected in blood and bone marrow of 67.6% (95% CI: 50.8–80.9%) and 71.8% (95% CI: 56.2–83.5%) of the probable VL patients, respectively, and of 38.2% (95% CI: 28–49.4%) and 29.9% (95% CI: 21.3–40.2%) 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: 0.30–0.53). 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.