实验室内两台全自动凝血分析仪凝血酶原时间的校准与检验结果可比性研究

目的应用仪器配套定值血浆及试剂对实验室内相同厂家不同型号全自动凝血分析仪进行校准和比对后所得结果进行探讨。方法利用仪器配套标准定值血浆校准Sysmex CA7000和Sysmex CA1500,校准完成后,随机选取20例临床患者标本对凝血酶原时间（PT）两次平行测定后取平均值进行结果比对,所选标本尽量覆盖仪器检测线性范围。以通过卫生部临检中心室间质评测定的Sysmex CA7000检测值作为靶值,计算出偏差,对仪器间结果进行分析评价。结果校准完成后,两台凝血分析仪检测结果比对所得偏差均在可接受范围,在临床应用中可以相互替换使用。结论检测系统的定期校准和比对有利于减少仪器操作过程中由于试剂,仪器性能及人为操作所造成的差异,有效保证了室内检测结果的可靠性和可比性。

Study on calibration and comparability for automatic blood coagulation analyzers in detection of prothrombin time in laboratory

Objective To study calibration and comparability for blood coagulation analyzers in different types of the same company by using a complete set of standard plasma and regent.Methods Standard calibrator was used to calibrate Sysmex CA7000 and Sysmex CA1500.After calibration,20 patient samples were detected for prathrombin time two times and the mean of them were compared.Since detection results of Sysmex CA7000 conformed to the standard of National Center for Clinical Laboratory external quality assessment,the data was determined as targeted value.The detection results of Sysmex CA7000 and CA1500 were analyzed,the bias was calculated.Results After calibration,the compared data between the two blood coagulation analyzers showed that the bias of them were within the accepted limit.So they could be replaced by each other in clinical application.Conclusion It is of benefit to reduce the differences caused by regent,machine performance or artifical operation by regular calibration and comparability of different analyzers.The results detected in different analyzers can be guaranteed and stable by all of these operating processes.