HBeAg化学发光法临界值验证和灰区设定的方法探讨及意义  

The signification and method of HBeAg gray zone setting and its cut-off verification in chemiluminescent assay

作　　者：安成[1] 程实[1] 李杰[1] 刘贵建[1] 

机构地区：[1]中国中医科学院广安门医院检验科,北京100053

出　　处：《中华检验医学杂志》2012年第11期1045-1047,共3页Chinese Journal of Laboratory Medicine

摘　　要：目的探讨化学发光法临界值验证和灰区设定的方法及意义。方法NCCLSEP一12A2文件定义C50是免疫学定性实验临界值的浓度，C5～C95是免疫学定性实验阳性率为5％一95％的浓度区间。根据ARCHITECTi2000HBeAg试剂临界值确定其C50浓度和C5～C95区间，验证其是否达到厂家声明的性能参数，并确定试验灰区，建立化学发光法临界值验证和灰区设定的程序；用两批号试剂（06087L100、96378HN00）测定同一批号的质控品各20次，计算S／CO，采用t检验比较两批号试剂之间S／CO的检测结果。结果试剂批号为06087L100的C50为0．171PEIU／ml，C5～C95区间为〉0．154～0．188PEIU／ml，测定阴性质控品S／CO为0．550±0．038，阳性质控品为2．422±0．084；试剂批号为96378HN00的C50为0．125PEIU／ml，C5～C95区间为0．119～〈O．150PEIU／ml，测定阴性质控品S／CO为0．334±0．063，阳性质控品S／CO为3．587±0．321。两批号试剂均能达到厂家声明的性能参数（在临界值处测定的灵敏度〈0．5PEIU／m1），其测定的阴性、阳性质控品S／CO结果问差异均有统计学意义（t=9．944、15．499，P均〈0．01）。结论应用C50和C5～C95区间可以验证化学发光法临界值并设定试验灰区；试剂批号不同，其C50和C5～C95区间可能不同，必须进行验证.Objective To explore the signification and method of Cut-off verification and gray zone setting in chemilumineseent assay. Methods NCCLS EP-12 A2 document defines that C50 is the analyte concentration of cut off value for immunology qualitative test and C5-C95 interval is the range of analyte concentration that yields 5% positive results to 95% positive results for immunology qualitative test. The C50 and C5-C95 interval of HBeAg in ARCHITECT i2000 were worked out according to the cut off value provided by HBeAg reagent calibrated in ARCHITECT i2000, which were verified to approve the character declaimed by manufactory or not. Gray zone was set and the procedure of cut off verification and gray zone set in ehemiluminescent were built; A set of quality control was detected 20 times with two different lot HBeAg reagent kits, S/CO was eaeulated and compared with t test. Results C50 and C5-C95 interval of reagent （lot 06087L100, 96378HN00） were 0. 171 PEI U/ml, 0. 125 PEI U/ml; 〉0. 154 PEI U/ml to 0. 188 PEI U/ml, 0. 119 PEI U/ml to 〈0. 150 PEI U/ml ,respectively. S/CO of negative quality control and positive quality control were （0.550 -＋0.038）, （2.422 _＋0.084） and（0.334 -＋0.063）, （3.587 -＋0.321）, respectively. They all approved the character （ the sensitivity at cut off was less than 0. 5 PEI U/ml ） declaimed by manufactory, and the results of S/CO between two lot kits were obvious difference （ t = 9. 944, 15.499 ,P 〈0. 01 ）. Conclusion C50 and C5-95 interval ean be used to verify cut off value and set gray zone in ehemilumineseent assay;They may vary in different lot reagents and they must be verified to approve the character declaimed by manufactory.

关 键 词：化学发光测定法 肝炎e抗原 乙型 指示剂和试剂 参考值 

分 类 号：R446.6[医药卫生—诊断学]