Comparison between an immunochromatographic test with an amplified ELISA for detecting e antigen and anti-e antigen antibodies in chronic Hepatitis B

The disappearance of the e antigen and the appearance of anti-e antigen antibodies are two biomarkers that indicate favorable prognosis in Hepatitis B. In this study the Advanced Quality immunochromatographic test for detecting those biomarkers was compared to the Vidas semi-quantitative ELISA test. Our hypothesis was that it is possible to use these biomarkers measured in a rapid and simple Advanced Quality immunochromatographic test for evaluating the therapeutic response in clinical trials with chronic hepatitis B patients. The two methods were done following the manufacturer’s instructions. The sera were taken from 69 patients with chronic hepatitis B of the clinical trial of the CIGB 440 therapeutic candidate. The immunochromatographic test and ELISA for detecting e antigen and anti-e antigen antibodies presented from substantial to almost perfect agreement in the evaluation of the sera of chronic Hepatitis B patients in a clinical trial. The immunochromatographic test for detecting e antigen had a low positive average agreement and a high negative average agreement compared to the ELISA. Nevertheless, the immunochromatographic test for detecting anti-e antigen antibodies had a high negative and positive average agreement in comparison to the ELISA. The immunochromagraphic test for the e antigen had a lower positive average agreement compared to the ELISA and some patients infected with Hepatitis B virus could not be detected by the former assay. The immunochromatographic test for anti-e antigen antibodies showed a similar performance to that of ELISA and could therefore be used in clinical trials for chronic Hepatitis B in health institutions without the need of a highly qualified lab technician.