肝素抗凝治疗监测相关项目的性能验证

Verification of Assays for Heparin Therapy Monitoring

目的对低分子量肝素(low molecular weight heparin,LMWH)抗-Ⅹa活性、抗凝血酶(antithrombin,AT)活性和活化部分凝血活酶时间(activated partial thromboplastin time,APTT)检测系统的性能进行验证。方法参考美国临床和实验室标准协会(CLSI)发布的多项指南、多项卫生行业标准和试剂厂家的要求,对LMWH抗-Ⅹa活性检测的批内精密度、日间精密度、线性、准确度和检出限,AT活性检测的批内精密度、日间精密度、线性和准确度,以及APTT检测的批内精密度、日间精密度和可比性进行验证。结果 LMWH抗-Ⅹa活性检测的批内精密度分别为0.03抗-Ⅹa IU/ml和0.05抗-Ⅹa IU/ml,日间精密度分别为0.04抗-Ⅹa IU/ml和0.05抗-Ⅹa IU/ml,线性范围为0~1.83抗-Ⅹa IU/ml,准确度百分偏差分别为4.3%和2.2%,检出限验证结果为0.05抗-Ⅹa IU/ml,均符合厂家要求。AT活性检测的批内精密度分别为2.0%和3.5%,日间精密度分别为2.7%和5.3%,线性范围为0~139%,准确度百分偏差分别为0.9%、–1.4%和–2.7%,均符合厂家要求。APTT活性检测的批内精密度分别为0.5%和0.4%,日间精密度分别为3.4%和4.4%,可比性验证结果符合行业标准的要求。结论 3个项目的性能能够满足厂家和行业标准的要求,性能验证方法和指标的研究有助于临床实验室实施质量改进。

Objective To verify the measurement performance of low molecular weight heparin （LMWH） anti-Xa activity assay, antithrombin （AT） activity assay and activated partial thromboplastin time （APTT） test. Methods According to the Clinical and Laboratory Standards Institute （CLSI） guidelines, the professional standards and manufacturer＇s instructions, the performance characteristics ofLMWH anti-Xa activity assay, AT activity assay and APTT test were verified as follows： within-run precision, between-day precision, linearity, accuracy or comparability and the limit of detection （LoD, only for LMWH anti-Xa activity assay） . Results The within-run precision, between- day precision, linear range, bias for accuracy and LoD of LMWH anti-Xa activity assay were 0.03 anti-Xa IU/ml and 0.05 anti-Xa IU/ml, 0.04 anti-Xa IU/ml and 0.05 anti-Xa IU/ml, 0-1.83 anti-X a IU/ml, 4.3% and 2.2%, 0.05 anti- Xa IU/ml, respectively, all of which were acceptable following manufacturer＇ s instructions. The within-run precision, between-day precision, linear range and bias for accuracy of AT activity assay were 2.0% and 3.5%, 2.7% and 5.3%, 0%- 139%, 0.9%, -1.4% and -2.7%, respectively, all of which were acceptable following manufacturer＇s instructions. The within-run precision, between-day precision and bias for comparability of APTT test were 0.5% and 0.4%, 3.4% and 4.4%, within ＋15.0%, respectively, all of which were acceptable according to professional standards and manufacturer＇s instructions. Conclusion The verified data of the LMWH anti-Xa activity, AT activity and APTT detection systems were acceptable according to the professional standards and manufacturer＇s instructions. It is very important to set up the methods and specifications of verification for clinical laboratories to implement quality improvement.