摘要
目的按照ISO15189要求对两台强生VITROS3600化学发光分析仪上的相同项目进行比对试验，以评估检测结果的一致性。方法分别使用两台仪器对anti—HCV的精密度，准确度进行验证试验，并对临床收集的Anti-HCV阴性10份、阳性10份和弱阳性20份血清样本共40份进行比对试验，检测结果行统计学分析。结果两台仪器阴性和阳性质控品批内精密度变异系数分别为5％、4％、7．14％和7．23％，批间精密度分别为9．47％、7．7％和8．04％、7．6％，均小于IS015189要求的CV（15％），两仪器准确度为100％，质控品检测结果差异无统计学意义（P〈0．05）。临床样本检测结果相关性分析R^2=0．9984，具有良好的一致性。结论两台强生VITROS3600化学发光分析仪检测结果，一致性良好，具有可比性。
Objective To estimate the consistency of two VITROS 3600 chemiluminescent analyzers according to the requirement of IS015189. Methods Verification tests were made for precision and accuracy of anti-HCV in two instruments. While 40 serum samples including Anti-HCV negative （10 cases）, positive （10 cases）, and weakly positive （20 cases）, and the test results were statistical analised. Results Two instruments negative and positive control samples intra-bateh precision and coefficients of variation were 5% , 4% and 7. 14% , 7.23% , inter-batch precision and coefficients of variation were 9.47% , 7.7% and 8.04% , 7.6% , are less than requirement CV （15%） by ISO15189. The accuracy of two instrument were 100% , The test results of the control samples showed no significant difference （P 〈 0.05）. The correlation analysis of the test results of clinical samples R^2 = 0. 9984, with good consistency. Conclusion Test results of two Vitros 3600 has good consistency and comparability.
出处
《中华实验和临床病毒学杂志》
CAS
CSCD
2013年第1期64-66,共3页
Chinese Journal of Experimental and Clinical Virology
关键词
肝炎病毒
化学发光
临床实验室技术
Hepacivirus
Chemiluminescence
Clinical laboratory techniques
