Comparison of Real Time PCR, Chemilluminicensce, ELISA and Rapid Immunochromatographic Tests for Detection of Hepatitis B Virus Infection

Background: Hepatitis B virus (HBV) is one of the main causes of chronic hepatitis in developing countries. The current study was done to evaluate the efficacy of the chemiluminescence, ELISA and immune chromatographic (ICT) test to Real Time-PCR (RT_PCR) for establishing the diagnosis of hepatitis B virus (HBV) in indoor and outdoor patients of Department of Medicine, Rajendra Institute of Medical Sciences.

Methods and Material: This descriptive, cross-sectional study was carried out in 475 patients. The demographic data and patient’s serum samples of the subjects was collected. The samples were analysed by chemiluminescence, ELISA, ICT & real RT-PCR for HBV.

Result: In the present study, of total 70 by chemiluminescence, 64 by ELISA, 61 by ICT and 63 by RT PCR were found positive for HBV. By both RT PCR and chemiluminescence 63 samples were positive. Total 2 patients were positive for HBV by RT PCR and negative by chemiluminescence while 7 patients were negative for RT-PCR and positive by chemiluminescence. Total 8 patients were positive for HBV by RTPCR and negative by ELISA while 5 patients were negative for RT- PCR and positive for ELISA. Total 11 patients were positive for HBV by RT PCR and negative by ICT while 3 patients were negative for RT- PCR and positive for ICT. On the basis of above findings chemiluminescence, ELISA and ICT specificity was 98.32%,98.79%,99.27%, sensitivity was 97.01%,89.04%,52% , positive predictive value was 90.27%, 92.85 %,95.58% and negative predictive value was 99.51%,98.08%,97.38% .

Conclusion: The HBsAg negative patients should also be screened with HBc total antibody for suspecting the exposure which could be later confirmed by RT PCR .RT-PCR method is accredited as a specific and reliable method suitable for screening of HBV and should be recommended for establishing exact and final diagnosis of these patients.