摘要
目的按美国病理家协会(CAP)实验室认可的要求,对Lumipulse G1200化学发光系统检测涎液化糖链抗原(KL-6)进行方法学评价和本实验室参考区间验证。方法取高、中、低浓度混合血清,分别进行批内20次和连续20d检测,分析批内不精密度和批间不精密度;将高浓度和低浓度血清按一定比例混合进行检测,验证分析测量范围(AMR);取接近厂商提供最低检测限值的样本连续检测12d,进行可报告低限值(LoQ)验证;将高浓度血清按一定比例稀释,分析样本稀释后理论值和检测值的符合程度,得出临床可报告范围(CRR);取206名健康人群血清检测KL-6,进行参考区间验证。结果高、中、低浓度样本批内不精密度评价变异系数的CV分别为2.63%、2.52%和2.74%;批间不精密度评价的CV分别为3.48%、2.72%和3.86%;AMR为52~10000U/mL;LoQ为54.6U/mL;CRR为5.2~100 000U/mL;本实验室206名健康人群KL-6的检测结果为82~465U/mL,平均(183±71)U/mL。结论该系统检测性能符合CAP要求。
Objective To evaluate the method for KL-6 measurement with LUMIPULSE G1200 chemiluminescence（ECL）system and to verify the reference range in our laboratory.Methods The within-run and between-day imprecision was performed with high,middle and low value mixed serums.The analytic measure range（AMR）was evaluated with serially diluted serums.Limit of quantity（LoQ）was evaluated with continuous detection of low value serum,of which value was close to the minimum detection limit of manufacturer specifications.The clinical reportable range（CRR）was established according to the coincidence degree of high value serum before and after serial dilution.The reference range of KL-6 was verified with samples of 206 healthy people.Results The imprecision for high,middle and low value sample was 2.63%, 2.52% and 2.74%, respectively for within-run imprecision and were 3.48%, 2.72% and 3.86%, respectively for between-day imprecision.The AMR was 52-10 000 U/mL,the LoQ was 54.6 U/mL and the CRR was 5.2-100 000 U/mL.The KL-6 value of 206 healthy people in our laboratory was （183±71）U/mL, and the range was 82-465 U/mL.Conclusion The chemiluminescence system for the KL-6 measurement meets the requirement of CAP.
出处
《山西医药杂志》
CAS
2017年第9期1013-1015,共3页
Shanxi Medical Journal
基金
上海市长宁区科委基金(CNKW2015Y10)
