ANALYTICAL SENSITIVITY OF TEST KITS TO DETECT ANTIBODIES TO HEPATITIS B ANTIGENS

乙型肝炎抗原抗体检测试剂盒的分析灵敏度

• 批准号: 3804835
• 负责人: L WILSON
• 金额: --
• 依托单位: CENTER BIOLOGICS EVALUATION RESEARCH TRANSFUSION
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3804835
• 关键词: antigen antibody reaction; antiviral antibody; diagnosis quality /standard; diagnostic tests; hepatitis B; hepatitis B antigens; hepatitis B virus group; human tissue

There are currently four licensed test kits used to detect antibody to hepatitis B surface antigen (anti-HBs). This study was designed to evaluate kit to kit and method to method analytical sensitivity (detection) variation. Analytical sensitivity in this context is defined as the lower limit of detection (i.e., the dilution at the cutoff). Interpolated dilution endpoints varied with HBsAg subtype and test kit. CBER Reference Panel #3 Anti-HBs(ad) endpoints ranged from a minimum of 1 76 to a maximum of 1 539 with all test kit methods giving a variation w7-fold. CBER Reference Panel #3 Anti-HBs(ay) endpoints ranged from a minimum of 1 242 to a maximum of 1 1223 with all test kit methods giving a variation W5-fold. This study demonstrates that a large variation of the minimum detection limit exists with currently licensed anti-HBs test kits. This variation can have a significant effect on the interpretation of test results depending on the intended use (diagnostic, prognostic, vaccine monitoring or anti-HBs content monitoring in Source Plasma).

目前有四种获得许可的检测试剂盒用于检测抗体