Development of an amplified luminescent proximity homogeneous immunoassay kit for detecting human hepatitis B virus e antibody / 南方医科大学学报

<p><b>OBJECTIVE</b>To develop an amplified luminescent proximity homogeneous immunoassay (AlphaLISA) kit for the detection of human hepatitis B virus e antibody (HBeAb).</p><p><b>METHODS</b>The neutralizing and competitive inhibition method was used to develop the AlphaLISA kit for detection of serum HBeAb.</p><p><b>RESULTS</b>The working range of the kit was 0.003-16 NCU/ml with a sensitivity up to 0.003 NCU/ml. The intra- and inter-assay coefficient of variation was 5.3% and 6.8%, respectively. The kit showed no cross-reaction with HBcAb, and comparison of the detection results with those of a commercially available Elecsys HBeAb kit (Roche) for 136 samples showed a correlation coefficient of 0.961.</p><p><b>CONCLUSION</b>The AlphaLISA kit for HBeAb detection meets the clinical requirements for detection HBeAb in human serum.</p>

Development of time-resolved fluoroimmunoassay kit for detection of IgM antibodies against hepatitis B core antigen / 南方医科大学学报

<p><b>OBJECTIVE</b>To prepare a time-resolved fluoroimmunoassay (TRFIA) kit for clinical detection of IgM antibodies to hepatitis B core antigen (HBc).</p><p><b>METHODS</b>Immunocapture method was used to develop the TRFIA kit for detection of the anti-HBc IgM antibodies, and the precision, cross-reactivity and sensitivity of the kit were tested with the clinical serum samples.</p><p><b>RESULTS</b>The intra- and inter-assay coefficients of variation of the TRFIA kit were 4.8%-7.2% and 7.5%-8.6%, respectively, and no cross-reactivity with anti-HBs, anti-HBc-IgG or anti-HBe was found. Comparison of the results of the TRFIA kit and enzyme-linked immunosorbent assay (ELISA) demonstrated greater sensitivity of the kit than ELISA in detecting the anti-HBc IgM antibodies in 584 serum samples. According to the detection results in 300 serum samples from healthy donors, the cutoff value of the TRFIA kit was 4.5 times of the fluorescence value of the negative control.</p><p><b>CONCLUSION</b>This TRFIA kit for detecting anti-HBc IgM antibodies meets the demand for clinical application and can replace the ELISA kits.</p>