Performance comparison of new generation HCV core antigen test versus HCV RNA test in management of hepatitis C virus infection

• Published in: Transfusion and apheresis science Vol. 56; no. 3; pp. 362 - 366
• Main Authors: Çetiner, Salih, duran, Alev Çetin, Kibar, Filiz, Yaman, Akgün
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.06.2017
• Subjects: Chemiluminescent enzyme immunoassay; Comparison; HCV; HCV core antigen test; HCV RNA real time PCR; Health technology assessment; Hematology, Oncology and Palliative Medicine; Hepacivirus - genetics; Hepatitis C - therapy; Hepatitis C Antibodies - metabolism; Humans; Real-Time Polymerase Chain Reaction - methods; RNA, Viral - metabolism; HCV core antigen test; HCV; comparison; chemiluminescent enzyme immunoassay; HCV RNA real time PCR; Chemiluminescent enzyme immunoassay; Comparison
• ISSN: 1473-0502; 1878-1683
• DOI: 10.1016/j.transci.2017.02.005

Abstract The study has evaluated the performance of HCV core antigen (Cag) test by comparing HCV RNA PCR assay which is considered the gold standard for management of HCV infection. Totally, 132 samples sent for HCV RNA (real-time PCR) test were included in the study. Anti HCV antibody test and HCV Cag test were performed by chemiluminescent enzyme immunoassay (CMEI). Anti HCV test was positive in all samples. HCV RNA was detected in 112/132 (84.8%) samples, and HCV Cag in 105/132 (79.5%). The most common HCV genotype was genotype 1 (86%). Considering the HCV RNA test as gold standard; the sensitivity, specificity, positive predictive value, negative predictive value and accuracy of Cag test were found to be 93.75%, 100%, 100%, 74.07% and 94.69%, respectively, and paired test results were detected as highly concordant. A high level of correlation was seen between HCV RNA and Cag tests, however, the concordance between the two tests appeared to be disrupted at viral loads lower than 103 IU/mL. On the contrary, the correlation reached significance for the values higher than 103 IU/mL. Viral loads were in the 17 - 2500 IU/mL range for the negative results for Cag test. Pearson's correlation coefficient revealed a considerably high correlation. The concordance between HCV RNA and Cag tests was disrupted under a viral load lower than 103 IU/mL. Therefore, it would be appropriate to consider cost effectiveness, advantages and limitations of the HCV RNA and Cag tests during the decision on which method to use for patient management.