Development and clinical detection of hepatitis B core-related antigen test kit

Abstract:

Objective To develop a quantitative test kit for determining hepatitis B core-related antigen（HBcrAg），and to evaluate its performance.Methods A chemiluminescent immunoassay for HBcrAg was established by studying the raw antibody，optimizing the preparation process，and adjusting the reaction system，and after the kit was assembled，recombinant HBcrAg and clinical serum were used to evaluate its detection performance. IBM SPSS Statistics 20 software was used for data processing.Results The standard curve of the kit was y=143.37x+344.91 （R²=0.999 8），with a detection sensitivity of 1.43 pg/mL and a reference interval of ≤25.595 pg/mL for healthy people. Serum samples were tested for 208 patients with chronic hepatitis B，and serum HBcrAg level was above this critical value for all 18 serum samples with an HBV DNA level of 10⁸-10⁴ IU/mL； for the 26 serum samples with an HBV DNA level of 10³-10² IU/mL，24（92.31%） tested positive for serum HBcrAg； for the 164 serum samples with HBV DNA below the limit of detection，73 （44.51%） tested positive for serum HBcrAg.Conclusion This kit can determine the serum level of HBcrAg in patients with chronic hepatitis B and thus has an important application value in monitoring the treatment outcome of patients with chronic hepatitis B and correctly judging the endpoint of treatment.