Evaluation of Signal/Cut-off Ratio by Anti-hepatitis Delta Virus Enzyme Immunoassay Method in the Diagnosis of Hepatitis Delta Virus Infection
Journal Title: Viral Hepatitis Journal - Year 2019, Vol 25, Issue 3
Abstract
Objectives: The hepatitis delta virus (HDV) is an enveloped, negative-sense, single-stranded RNA virus in the genus Deltavirus. In this study, it was aimed to evaluate the ratio of anti-HDV signal/ cut-off (S/CO) in the diagnosis of HDV infection in patients who were positive for anti-HDV. Materials and Methods: Between August 2014 and December 2018, 156 patients, who were detected hepatitis B surface antigen (HBsAg) and anti-HDV positivity and were analyzed HDV-RNA, were included in the study. Anti-HDV antibody and HBsAg tests were analyzed by micro-ELISA method in serum samples and HDV-RNA was studied by real-time polymerase chain reaction method in plasma samples. Results: HDV-RNA was detected in 42.9% (67/156) of the anti-HDV positive patients. The mean S/CO value of anti-HDV in HDV-RNA positive group (8.99±3.53) was significantly higher than HDV-RNA negative group (5.99±3.73) (p<0.001). When the S/CO value was determined as 6.13 by receiver operating characteristic (ROC) analysis; sensitivity, specificity, positive, and negative predictive values were 79.8%, 59.7%, 72.4%, and 68.9%, respectively. Conclusion: In this study, the optimal cut-off value which provides the maximum sum of sensitivity and specificity for the test was found 6.13 by ROC analysis. The reporting with the S/CO ratio of anti-HDV ELISA results and determining each laboratory’s optimal cut-off value may be helpful for the diagnosis of HDV infection.
Authors and Affiliations
Ayfer Bakır, Nuran Karabulut, Sema Alaçam, Murat Yaman, Mustafa Önel, Ali Ağaçfidan
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