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

目前有四种获得许可的检测试剂盒用于检测抗体。 乙肝表面抗原(抗-HBs)。这项研究旨在 评价试剂盒对试剂盒和方法对方法分析灵敏度(检测) 变种。在此上下文中，分析灵敏度被定义为较低 检出限(即截止点的稀释度)。插补 稀释终点因HBs Ag亚型和检测试剂盒不同而异。CBER参考文献 小组#3抗-HBs(Ad)终点从最小176个到最大176个不等 所有检测试剂盒方法得出的变异为7倍。CBER 参考面板#3抗-HBs(Ay)终点的范围从最少1242个到 所有检测试剂盒方法的最大偏差为1 1223，差异为W5倍。 这项研究表明，最小检测的很大变化 目前获得许可的抗-HBs检测试剂盒存在限制。这个变种 会对测试结果的解释产生重大影响 取决于预期用途(诊断、预后、疫苗监测 或来源血浆中的抗-HBs含量监测)。

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).