Evaluation of Fully Automated Electrochemiluminescence Immunoassay for Rapid Detection of Hepatitis B surface antigen and antibodies to Hepatitis C Virus

Abstract

Background: Hepatitis B virus (HBV) and hepatitis C virus (HCV) infections are important global public health problems. The earliest antibody to hepatitis C virus (anti-HCV) and hepatitis B surface antigen (HBsAg) assays had important limitations, notably, a high rate of false positive and false-negative results. Newer enzyme immunoassay (EIA) generations have improved the specificity and sensitivity of these assays. Recently, various assay formats of anti-HCV and HBsAg chemiluminescent techniques have been developed. Objective and Methods: This study aimed at evaluating the performance of a new, fully automated rapid electrochemiluminescence immunoassay (ECLIA) for qualitative detection of HBsAg and antibodies to HCV in terms of specificity, sensitivity, and suitability for use in the diagnosis of viral hepatitis compared to commercially available and commonly used screening Abbot EIA, based on confirmatory test results. Results: The present study included 549 cases, in which the age varied from 18 to 56 years old, attending the Premarital Screening clinic, from which 40 (7.3%) and 23 (4.2%) were anti-HCV and HBsAg confirmed positive cases, respectively. Regarding anti-HCV the results were concordant in 538 (98%) samples (500 and 38 cases were negative and positive by both Elecsys/ECLIA and EIA, respectively.), and discordant in 11 (2%) samples. Whereas, for HBsAg, the results were concordant in 545(99.3%) samples (522 and 23 were negative and positive by both Elecsys/ECLIA and EIA, respectively.), and discordant in 4 (0.7%) samples. The specificities of the new assays for anti-HCV and HBsAg were 98.2% and 99.2%, respectively. The sensitivities of the new assays were 100% in the detection of both anti-HCV and HBsAg. Conclusion: the Elecsys/ECLIA assay for the detection of Anti-HCV and HBsAg is a highly specific and sensitive assay. The rapid turnaround time, random access, full automation makes it an effective assay system for clinical laboratory diagnosis of HCV and HBV infections, especially if the results can be correlated with the patients’ clinical profiles. Further studies are needed, especially among high-risk individuals and not just screening setting: in which the clinical picture may support the Elecsys/ ECLIA results.