Assessment of Two Immunoassays Detecting Hepatitis B Virus Surface Antigen in Blood Donor Population

As hepatitis is the most alarming disease all over the world, it can cause acute as well as chronic infections. Different serological test and molecular assays used for the detection of HBV infection. CLIA and ELISA are the most common techniques and widely used for the quantification of the anti-HBs antibody. To compare the detection efficacy of HBsAg in blood donors via two immunoassays i.e ELISA and CLIA and to determine the environmental risk factors associated with HBV in blood donor population. The qualitative and quantitative study was done to compare the detection efficacy of HBsAg performed by the help of by two immunoassays CLIA (ROCHE COBAS E411) and ELISA technique (ELISA Reader Plates) for a period of one year. Moreover, this study was carried out to investigate the environmental risk factors involved in the development of HBV infection conducted in the department of Biotechnology, SBK Women's University and RBC; Quetta, Balochistan. Overall, 89 blood samples were randomly collected from the blood donors. Cut of valve which is 0.00-0.99 was considered as standard for interpretation of data by CLIA and cut of value of ELISA was 0.15. The values which were below from the cut of value were interpreted as non-reactive and above values were interpreted as reactive. Data was statistically analyzed by using SPSS (IBM SPSS statistics version 20) and graphs were designed using Microsoft Excel. The sensitivity of CLIA (1) and ELISA (0.92) was also observed in the present study. Overall 89 samples were randomly collected from the blood donors. 37.70% and 40.44% positive results were obtained via ELISA and CLIA respectively. Some of the risk factors of HBV were blood transfusion (13%), sexual transmission (11%), causality cases (19%), unawareness about HBV (13%), saloon practices or tattooing (16%) and use of contaminated needles/surgical and dental equipment's (25%). Using SPSS software and applying one sample statistics T test the mean values and the standard deviation for both CLIA and ELISA assays were calculated as 2048.56+ 2592.80 and 3.12+1.17, standard error mean 432.13 and 0.20, the coefficient of variance were 126.56% and 37.65% respectively (table 4.6 and 4.7). In this study, highly significant difference was observed between both immunoassays (0.000***) with respect to reactivity of samples. Both CLIA and ELISA were correspondingly experienced in categorizing reactive and non-reactive antibody titer against HB antigen. However, there are some differences in quantitative measurement. The two testsdisagreed on three samples; these three samples are reported as non-reactive by ELISA were observed as reactive by CLIA. This might be due the variation in the standard calibrators used in each assay. Both assays can be used as substitute to each other.