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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 falsenegative 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. 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. 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 antiHCV 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. In 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. INTRODUCTION Viral hepatitis is a major global public health problem. Hepatitis C virus (HCV), First identified in 1989, is an enveloped positive-strand RNA virus of the family Flaviviridae, has been demonstrated to be the etiologic agent of 150 Bull High Inst Public Health Vol.39 No.1 [2009] 90% of chronic non-A, non-B hepatitis. HCV is a major cause of acute hepatitis and chronic liver disease, including cirrhosis and liver cancer. Globally, an estimated 170 million persons are chronically infected with HCV and 3 to 4 million persons are newly infected each year. Since their introduction in 1990, enzyme immunoassays (EIAs) for antibodies to HCV have been the principle tests for the detection of exposure to HCV. Three generations of serodiagnostic anti-HCV antigen tests have been developed, with each new generation providing incremental improvements in the sensitivity to antiHCV. EIAs have many advantages in the diagnostic setting, including ease of automation and use, relative cost effectiveness, low variability and high sensitivity in screening. Some of the major disadvantages include suboptimal sensitivity and specificity, and abundance of false positives in low risk populations. ) To minimize the likelihood of false-positive anti-HCV results, the Centers for Disease Control and Prevention (CDC) has recommended confirmation of all antiHCV results by either the recombinant immunoblot assay or a nucleic acid test. HBV is the smallest human DNA virus, with a genome of 3200 base pairs, which belongs to the family Hepadnaviridae. Viral hepatitis due to HBV is a major public health problem, with an estimated 350 million persistent carriers of HBV worldwide. HBV infection may present with a broad clinical spectrum ranging from mild hepatitis to aggressive disease that ultimately leads

journal of high institute of public health

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