CAJ | 학술논문

目的：评价快速化学发光超敏C反应蛋白（hs-CRP）定量检测试剂盒的性能。方法按照美国临床实验室标准化委员会（NCCLS ）EP10-A2文件，采用快速化学发光hs-CRP定量检测试剂盒对CRP低、中、高值质控血清进行检测，计算其偏倚、总不精密度及其斜率、截距、非线性、携带污染率和漂移性，并判断其临床可接受性。结果快速化学发光hs-CRP定量检测试剂盒的偏倚和总不精密度均在允许范围内，其斜率、截距、携带污染率、非线性、漂移性平均值分别为1．0057、0．5378、0．7896％、0．0192、0．0360，差异无统计学意义（P＞0．05）。结论快速化学发光hs-CRP试剂盒准确度和精密度良好，性能稳定，符合临床检测要求。
목적：평개쾌속화학발광초민C반응단백（hs-CRP）정량검측시제합적성능。방법안조미국림상실험실표준화위원회（NCCLS ）EP10-A2문건，채용쾌속화학발광hs-CRP정량검측시제합대CRP저、중、고치질공혈청진행검측，계산기편의、총불정밀도급기사솔、절거、비선성、휴대오염솔화표이성，병판단기림상가접수성。결과쾌속화학발광hs-CRP정량검측시제합적편의화총불정밀도균재윤허범위내，기사솔、절거、휴대오염솔、비선성、표이성평균치분별위1．0057、0．5378、0．7896％、0．0192、0．0360，차이무통계학의의（P＞0．05）。결론쾌속화학발광hs-CRP시제합준학도화정밀도량호，성능은정，부합림상검측요구。
Objective To evaluate the performance of the hypersensitive C-reactive protein(hs-CRP) rapid quantitative chemilu-minescent detection kit .Methods According to National Committee for Clinical Laboratory Standards (NCCLS) EP10-A2 docu-ment ,hs-CRP rapid quantitative chemiluminescent detection kit was employed to measure the CRP at low ,medium and high con-centration levels of quality control serum .Bias ,total imprecision and their slope rates ,intercepts ,carryover ,non-linearity and drift were calculated ,and its clinical acceptability was evaluated .Results Bias and total imprecision of hs-CRP rapid quantitative chemi-luminescent detection kit were within the allowable ranges ,the average values of slope rates ,intercepts ,carryover ,non-linearity and drift were 1 .005 7 ,0 .537 8 ,0 .789 6% ,0 .019 2 ,0 .036 0 ,respectively ,the differences showed no statistically significance ( P>0 .05) .Conclusion hs-CRP rapid quantitative chemiluminescent detection kit has good accuracy and precision ,stable perform-ance ,and consistent with the clinical testing requirements .