CAJ | 학술논문

目的：对罗氏Cobas c701全自动生化分析仪进行性能评价。方法按照美国临床和实验室标准化协会EP15‐A2文件的要求，通过电解质（钾、钠、氯）和涵盖各波长的9个项目（丙氨酸氨基转移酶、天门冬氨酸氨基转移酶、碱性磷酸酶、γ‐谷氨酰转移酶、肌酐、尿素氮、葡萄糖、总蛋白、三酰甘油）对仪器的精密度、准确度、线性范围等进行验证。结果所有检测项目的重复性标准差（Sr）≤厂家声明的标准差（σr）、精密度的标准差（St）≤σt ，均与厂家声明的精密度性能一致，可以接受。测定项目理论值与测定值相关性良好（回归系数为：0．9994～1．0000）；与参加卫生部临床检验中心室间质评的检测系统比对，结果偏移均在CLIA′88规定的范围内。结论罗氏Cobas c701检测项目的重复性、精密度、准确度均达到了厂家声明检测的性能。
목적：대라씨Cobas c701전자동생화분석의진행성능평개。방법안조미국림상화실험실표준화협회EP15‐A2문건적요구，통과전해질（갑、납、록）화함개각파장적9개항목（병안산안기전이매、천문동안산안기전이매、감성린산매、γ‐곡안선전이매、기항、뇨소담、포도당、총단백、삼선감유）대의기적정밀도、준학도、선성범위등진행험증。결과소유검측항목적중복성표준차（Sr）≤엄가성명적표준차（σr）、정밀도적표준차（St）≤σt ，균여엄가성명적정밀도성능일치，가이접수。측정항목이론치여측정치상관성량호（회귀계수위：0．9994～1．0000）；여삼가위생부림상검험중심실간질평적검측계통비대，결과편이균재CLIA′88규정적범위내。결론라씨Cobas c701검측항목적중복성、정밀도、준학도균체도료엄가성명검측적성능。
Objective To assess the performance of Roche Cobas c701 fully automatic biochemical analyzer. Methods According to EP15‐A2 from Clinical and Laboratory Standards Institute, the electrolyte (potassium, sodi‐um and chloride) and covers all the wavelengths of nine projects (alanine transaminase, aspartate transaminase, alka‐line phosphatase, gamma‐glutamine transaminase, creatinine and urea nitrogen, glucose, total protein, three acyl glyc‐erin) were measured by Roche Cobas c701 analyzer and original reagents. The precisions and accuracies of all parame‐ters were verified. Results In the 2 levels of tested parameters, the standard deviation of repeatability (Sr )was ≤the manufacture′s standard deviation of repeatability (σr ), and the standard deviation of prescision (St ) was≤the manu‐facture′s standard prescision (σt ), the prescision was acceptable and similar to what the manufacter declared. Correla‐tions between theoretic value and actual value were good (regression coefficient was :0. 999 4-1. 000 0). The bias of all parameters was acceptable (within the prescribed scope of CLIA′88)with Roche cobas c701analyzer, compared with the external quality assessment of the ministry of health clinical inspection center. Conclusion The repeatabili‐ty, precision and accuracy of the parameters by Roche Cobas c701 reach the performance that the manufacturer de‐clares.