Diagnostic accuracy of rapid immunochromatographic test in the diagnosis of visceral leishmaniasis, taking bone marrow as gold standard

Objective: To determine the sensitivity, specificity, positive predictive value and negative predictive value of Immuno-chromatographic test (ICT) in patients with visceral Leishmanias is simultaneously diagnosed by examination of bone marrow aspirate, a gold standard test. Methodology: This descriptive cross sectional study was conducted at a tertiary care hospital from February 2016 to February 2020 on 55 consecutive patients from endemic areas with clinical suspicion of visceral Leishmaniasis, coming for bone marrow examination. A nonrandom convenience sampling technique after informed written consent. Bone marrow was aspirated from each patient under local anesthesia, followed by 3 ml venous blood sample. The ICT was done by trained personal that was kept blind of the prior diagnosis of visceral Leishmaniasis. The data obtained were analyzed by SPSS-24. Results: Age group <5 years was commonest among affected with male redominance, followed by 5-10 years & >10 years. The ICT was positive in 49/55 (87.27%) and negative in 6/55 (12.73%). Bone marrow examination revealed LD bodies in 50/55 (90.91%) and no LD bodies in 05(9.09%) patients. Conclusion: ICT had high sensitivity and positive predictive value, but comparatively low specificity and negative predictive value for visceral Leishmaniasis. It should not be used as a single confirmatory test for visceral leishmaniasis. (author)