CAJ | 학술논문

目的：评价用 Roche e601检测乙型肝炎病毒表面抗原的可行性。方法用 Roche e601测定新鲜标本和 HBsAg 质控品，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 HBsAg 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；在60个室间质评样品检测结果中，HBsAg 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0．01 IU/mL；40份 HBsAg 浓度在0．8＜COI＜1．0（接近临界值）且 HBV-DNA 检测结果均小于5．0×102的患者样本，用该检测系统检测结果均为阴性，阴性标本可靠性为100％。结论该检测系统检测乙型肝炎病毒表面抗原的性能能够满足临床要求。
목적：평개용 Roche e601검측을형간염병독표면항원적가행성。방법용 Roche e601측정신선표본화 HBsAg 질공품，통과분석정밀도、준학도、음성화양성부합솔、검측저한、음성표본가고성등성능지표평개해검측계통측정 HBsAg 결과적가고성。결과저、고치표본비내、비간정밀도적변이계수（CV）균비엄가요구소；재60개실간질평양품검측결과중，HBsAg 음성부합솔위100％（40/40）、양성부합솔100％（20/20）；해계통적검측림계치위0．01 IU/mL；40빈 HBsAg 농도재0．8＜COI＜1．0（접근림계치）차 HBV-DNA 검측결과균소우5．0×102적환자양본，용해검측계통검측결과균위음성，음성표본가고성위100％。결론해검측계통검측을형간염병독표면항원적성능능구만족림상요구。
Objective To evaluate the of feasibility of Roche e601 for detecting hepatitis B virus surface antigen(HBsAg).Meth-ods To evaluate the feasibility of Roche e601 for detecting hepatitis B virus surface antigen(HBsAg).Results The coefficient of variation(CV)of inter-run and between-run from low and high value specimens was lower than the requirements of manufacturers;the negative and positive coincidence rates in detecting 60 external quality assessment controls were 100%(40/40)and 100%(20 /20),respectively;the detection threshold values of the system was 0.01 IU/mL;the results detected by this detecting system in 40 samples,in which the concentration of HBsAg was 0.8<COI<1(close to the critical value)and the detection results of HBV-DNA were less than 5.0×102 ,were negative with the negative sample reliability of 100%.Conclusion The performance of this detection system for detecting HBsAg can meet the clinical requirements.