Evaluation of Sensitivity and Specificity of Third and Fourth Generation ELISA in detecting Hepatitis B Virus among Blood Donors

Abstract

<p><strong>Aim</strong></p> <p>To compare the 4th generation ELISA with 3rd generation ELISA for early detection of HBV infection among voluntary blood donors and for specificity.</p> <p><strong>Material and methods</strong></p> <p>779 samples of voluntary blood donors were tested for HBsAg by 3<sup>rd</sup> generation ELISA and 4<sup>th</sup> generation ELISA.</p> <p>The results were compared and discrepant samples were further tested by NAT (RT-PCR) and HBe antigen and HBc antibody by CMIA.</p> <p><strong>Results</strong></p> <p>279 were found HBsAg reactive and 500 samples were found non-reactive by third generation ELISA.</p> <p><strong>Out of these 279 we found 3 samples to be non-reactive by fourth generation ELISA</strong>.</p> <p>Discrepant samples were then tested for NAT which also gave comparative results with fourth generation ELISA. Two samples were further tested for marker study. Marker study also showed that these two samples were negative for HBV infection.</p> <p><strong>Conclusions</strong></p> <ul> <li>The results of 4th generation ELISA, NAT and HBV markers were found comparable in our prospective study</li> <li>We had 3 false positives with III generation</li> <li>Thus 4<sup>th</sup> generation kit for HBsAg is more specific than 3<sup>rd</sup> generation ELISA and comparable with better method like NAT.</li> <li>In India where NAT testing is costly and not mandatory, 4<sup>th</sup> generation ELISA can be preferred as it is will decrease false positive and rejection of donors</li> </ul>