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Free Content Diagnostic accuracy of a new Leishmania PCR for clinical visceral leishmaniasis in Nepal and its role in diagnosis of disease

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Abstract:

Summary Objective  To develop a new PCR for 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. 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.

French
Objectif: 

Mettre au point une nouvelle PCR pour la détection de Leishmania et évaluer sa précision diagnostique dans une région endémique pour la leishmaniose viscérale (LV). Méthodes: 

Après avoir établi la preuve du concept, la précision diagnostique a étéévaluée sur le sang de 247 personnes contrôles non-endémiques et sur le sang et la moelle osseuse de 170 patients confirmés LV, 39 probables LV et 87 non-LV dans le sud-est du Népal. Résultats: 

La PCR a montré une spécificité de 99,64% (intervalle de confiance [IC] 95%: 98,93% - 100%) sur les contrôles non-endémiques et une sensibilité de 92,1% (IC95%: 87,6% - 96,6%) sur le sang et 92,9% (IC95%: 89% -96,8%) sur la moelle osseuse de patients LV confirmés. L’ADN de Leishmania a été détecté dans le sang et la moelle osseuse de 67,6% (IC95%: 50,8% - 80,9%) et 71,8% (IC95%: 56,2% - 83,5%) respectivement des patients probables LV et de 38,2% (IC95%: 28% - 49,4%) et 29,9% (IC95%: 21,3% - 40,2%) respectivement des patients non-LV. La PCR a montré 97% de concordance avec un statut positif DAT alors que pour un statut négatif DAT cette concordance n’était que de 41,3% (indice kappa-0,416, IC95%: 0,30 - 0,53). Conclusions: 

Nos résultats indiquent que la PCR seule procure plutôt un marqueur de l’infection qu’un marqueur de la maladie et son rôle dans le diagnostic de LV dans les régions endémiques est discuté.

Keywords: PCR; asymptomatic infection; diagnosis; diagnostic; diagnostic accuracy; diagnóstico; infección asintomática; infection asymptomatique; leishmaniasis visceral; leishmaniose viscérale; precisión diagnóstica; précision diagnostique; sensibilidad y especificidad; sensibilité et spécificité; sensitivity and specificity; visceral leishmaniasis

Document Type: Research Article

DOI: http://dx.doi.org/10.1111/j.1365-3156.2008.02154.x

Affiliations: 1:  Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium 2:  Department of Medicine, B.P. Koirala Institute of Health Sciences, Dharan, Nepal 3:  Department of Parasitology, Institute of Tropical Medicine, Antwerp, Belgium 4:  Laboratory of Medicinal Chemistry, Rega Institute for Medicinal Research, Leuven, Belgium

Publication date: November 1, 2008

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