摘要目的:建立和验证全自动凝血分析仪检测人抗凝血酶Ⅲ(human antithrombin Ⅲ，AT-Ⅲ)活性的方法。方法:参照全自动凝血分析仪操作说明书进行AT-Ⅲ活性的检测，并对方法的线性、检测范围、精密度和准确度进行方法学验证。结果:全自动凝血分析仪检测AT-Ⅲ活性的方法稳定，仪器自动运行标准曲线的决定系数均>0.980，定标血浆标准曲线线性范围为0.12~1.23 IU/ml，定标血浆高、中、低值和定量下限稀释样品的效价回收率均在80%~120%范围内，且高、中、低值效价回收率的相对标准偏差(relative standard deviation，RSD)均<15%，定量下限稀释样品的效价回收率的RSD<20%，供试品的批内精密度RSD均<5%，批间精密度RSD均<10%，对3批AT-Ⅲ制品及其中间品进行活性检测，每批样品分别测定3次的平均RSD均<5%。结论:全自动凝血分析仪检测AT-Ⅲ活性的方法具有较好的线性、检测范围、准确度和精密度，可用于AT-Ⅲ生产工艺中活性的检测。

abstractsObjective:To establish and verify the method for detecting human antithrombin Ⅲ (AT-Ⅲ) activity by automatic coagulation analyzer.Methods:According to the operation manual of automatic coagulation analyzer, the AT-Ⅲ activity was detected, and the linearity and detection range, precision and accuracy of the method were verified.Results:Automatic coagulation analyzer detectd AT-Ⅲ activity stably and automatically ran the standard curves with coefficients of determination all >0.980. The standard curve of the calibrator was 0.12-1.23 IU/ml, the titer recovery rate range of the high, middle, low value calibrator and quantitative lower limit dilution samples were 80%-120%, and the relative standard deviations (RSDs) of the high, middle and low value titer recovery rates were <15%. The RSD of quantitative lower limit dilution sample titer recovery rate was <20%. Inter-batch RSDs for the test products were <5%, and intra-batch RSDs were <10%. The average RSDs of 3 batches of AT-Ⅲ products and intermediates tested 3 times were all <5%.Conclusion:The method of automatic coagulation analyzer for detecting AT-Ⅲ activity has good linearity, test range, accuracy and precision, which can be used for the detection of AT-Ⅲ activity in the production process.