Grubbs 法在酶联免疫吸附试验乙型肝炎两对半室内质控的应用探讨

摘要

目的：探讨 Grubbs 法结合±3 s、±2 s 和7 T 规则在乙型肝炎两对半酶联免疫吸附试验(ELISA)定量检测中的临时室内质控的可行性。方法查阅同一质控批号的 ELISA 乙型肝炎两对半定量检测的连续20批室内质控数据，并对 Grubbs 法结合±3 s、±2 s 和7 T 规则应用进行统计分析。结果ELISA 乙型肝炎表面抗原(HB-sAg)、乙型肝炎表面抗体(HbsAb)、乙型肝炎 E 抗原(HbeAg)定量测定中20次测定值均处于在控状态；乙型肝炎E 抗体(HbeAb)定量测定中 Grubbs 法显示20次测定值均处于在控状态，但第13次测定结果违反了±2 s 规则，判定为警告状态，保留数据，且予以注意，积极分析原因，避免后续的检测继续警告甚至失控；乙型肝炎核心抗体(Hb-cAb)测定20次测定值均处于在控状态。结论Grubbs 法结合±3 s、±2 s 和7 T 规则能作为 ELISA 乙型肝炎两对半定量检测的临时室内质控方法。%Objective To investigate the feasibility of the Grubbs method combined with the ±3 s,±2 s and 7 T rule applied to the temporary internal quality control method for hepatitis B determination by ELISA.Methods The continuous 20 batches of internal quality control data in the hepatitis B quantitative determination by ELISA at the same quality control batch number were consulted and the application of Grubbs method combined with the ±3 s,±2 s and 7 T rule was statistically analyzed.Results The 20 times detection values in the HBsAg,HbsAb and HbeAg quantitative determination by ELISA were in the controlled state;the 20 times detection values displayed by the Grubbs method in the HbeAb quantitative determination were in the controlled state,but the thirteenth detection results violated the ±2 s rule,which was judged as a warning condition,its data were retained and paid attention,the reasons were actively analyzed to avoid the subsequent determination being warning or out of control again;the 20 times detection values in the HbcAb quantitative determination by ELISA were in the controlled state.Conclusion The Grubbs method combined with the ±3 s,±2 s and 7 T rule can be used as the temporary internal quality control method for hepatitis B determination by ELISA.