Comparison of diagnostic performance of transcription-mediated amplification with chemiluminescent microparticle immunoassay in the detection of hepatitis C virus in dialysis patient group

Abstract: AIM: The aim of the study was to demonstrate that ID-NAT is more sensitive and specific in HCV detection in dialysis patients than serological tests such as chemiluminescence. Second, to establish that ID-NAT results are more in concordance to gold standard RT-PCR compared to chemiluminescence. MATERIALS AND METHOD: A prospective observational single center study conducted in the Department of Transfusion Medicine and Immunohematology and Department of Nephrology, Indraprastha Apollo Hospital, New Delhi from September 2020 to December 2022. The blood samples from patients within inclusion criteria were run with chemiluminescence, ID-NAT and RT-PCR. Results were analyzed to determine the association between categorical variables and Cohen kappa values, to show the concordance between the gold standard and the ID-NAT and RT-PCR. RESULTS: The total number of subjects who participated in the study was n = 145 and were all Indians from neighboring states near to the institution. As reflected in the study results, among the 130 non-reactive results in CMIA, PCR showed 127 negative and 3 positive results. In similar manner, among 15 reactive results in CMIA, 13 were positive and 2 were negative in PCR (p value 0.001). In the present study, it was revealed that among the 129 non-reactive results in ID-NAT, 129 were negative in PCR ( P value <0.001). Prevalence of HCV among patients with ID-NAT was 11.03% (CI = 6.44% to 17.30%). Similarly, the agreement of chemiluminescence with RT-PCR revealed kappa value = 0.819, whereas ID-NAT showed kappa value = 1, thus showing superior concordance to said gold standard. CONCLUSION: The study results confirm that ID-NAT is a more efficient and reliable test method compared to serological tests such as chemiluminescence in detecting HCV cases in immunosilent cases or cases in the immune period.