电化学发光法检测HCV抗体可靠性分析

Reliability analysis of electro-chemiluminescence assay to detect hepatitis C virus antibody

目的评价电化学发光法检测丙型肝炎病毒IgG型抗体的可靠性。方法用Roche E601测定新鲜患者标本和质控品的HCV-Ab,通过分析精密度、准确度、阴性和阳性符合率、检测低限、阴性标本可靠性等性能指标评价该检测系统测定HCV-Ab结果的可靠性。结果低、高值标本批内、批间精密度的变异系数(CV)均比厂家要求小;60个室间质评样品检测结果中,HCV抗体阴性符合率为100%(40/40)、阳性符合率100%(20/20);该系统的检测临界值为0.004NCU/ml;40份HCV抗体浓度在0.8<COI<1.0(接近临界值)且HCV RNA检测结果均小于5.0×102的患者样本,用该检测系统检测均为阴性,阴性标本可靠性为100%。结论该检测系统检测丙型肝炎病毒抗体的性能能够满足临床要求。

Objective To evaluate the reliability of electro-chemiluminescence assay to detect IgG antibody of hepati- tis C virus （HCV-Ab）. Methods The performance indexes of the precision,accuracy,coincidence rate of negative and positive resluts,lower limit of detection, reliability of negative specimens of Roche E601 electrogenerated chemiluminescence machine were analyzed by determining HCV-Ab in fresh specimens and control substances. Results Coefficient of variation （ CV ） of inter-run and between-run from low and high value specimens was lower than the requirements of manufacturers;Negative and positive coincidence rate in detecting 60 external quality assessment controls was 100% （40/40） and 100% （20/20） ,respectively;Detection threshold values of the system was 0. 004 NCU/ml ;Detection results from 40 sampies,which the concentration of HCV-Ab was 0. 8 〈 COI 〈 1 （close to the critical value ） as well as detection results of HCV-RNA were less than 5 × 10^2 ,were negative （ 100% negative concidence）. Conclusion The detection system for detecting HCV-Ab is able to meet clinical needs.