CAJ | 학술논문

目的：对罗氏Cobas E601全自动电化学发光免疫分析仪检测癌胚抗原（CEA）的分析性能进行验证。方法对CEA的精密度、准确度、测量线性范围、参考区间和交叉污染率进行验证实验。结果批内精密度高低两种浓度的（CV）分别为4.96%和4.38%，日间精密度高低两种浓度的CV分别为4.99%和4.81%；5份室间质控品的检测结果与靶值的偏倚在1.49%~3.57%；测量线性范围与厂家提供的范围相近；CEA的测量数值有96.3%在提供的参考区间内；交叉污染率为0.12%。结论罗氏Cobas E601检测CEA的方法学性能良好，检验结果准确可靠，能够满足临床检测的要求。
목적：대라씨Cobas E601전자동전화학발광면역분석의검측암배항원（CEA）적분석성능진행험증。방법대CEA적정밀도、준학도、측량선성범위、삼고구간화교차오염솔진행험증실험。결과비내정밀도고저량충농도적（CV）분별위4.96%화4.38%，일간정밀도고저량충농도적CV분별위4.99%화4.81%；5빈실간질공품적검측결과여파치적편의재1.49%~3.57%；측량선성범위여엄가제공적범위상근；CEA적측량수치유96.3%재제공적삼고구간내；교차오염솔위0.12%。결론라씨Cobas E601검측CEA적방법학성능량호，검험결과준학가고，능구만족림상검측적요구。
Objective To evaluate the effects of Roche Cobas E601 automatic electrochemiluminescence immunoassay analyzer for determining CEA. Methods To analyze E601’s measurement precision, accuracy, measurement range, reference interval and carryover rate of CEA, verification experiments were taken to measure. Results The high and low values of CV of inter-assay were 4.96%and 4.38%, and between-day CV were 4.99% and 4.81%; 5 quality-control serum’s relative bias were between 1.49%-3.57%; there was good linear relationship between measured values and expected values;there was 96.3%of the measurement data in the recommended reference interval;carryover rate range was 0.12%. Conclusion Roche Cobas E601 analyzer is stable, precise and accurate.