利用CLSI EP15-A指南验证精密度和准确度

Verification the Precision and the Accuracy with CLSI EP15A

目的利用CLSI EP15-A指南对本科新购置的SYSMEX公司生产的CA-7000血凝仪测定凝血酶原时间(PT)和活化部分凝血活酶时间(APTT)的精密度和准确度进行验证。方法精密度验证实验对3个不同水平的质控品每个每天测定4次,共测定5 d,分别计算其批内不精密度和天间不精密度,然后与厂家声称的不精密度进行比较,若小于厂家声称的不精密度则认为本仪器的精密度达到厂家声称的精密度;若本仪器的不精密度大于厂家声称的不精密度则进一步与验证值比较,若小于验证值则认为本仪器的不精密度达到厂家声称的不精密度,若仍大于验证值则认为本仪器的精密度未达到厂家声称的不精密度。准确度验证实验对3个不同水平的质控品每个测定2次,测定均值与靶值的偏差小于卫生部临床检验中心室间质评的允许误差表示准确度可以接受。结果 CA-7000测定PT、APTT的批内和天间不精密度均达到厂家声称的不精密度,而且均小于本科的不精密度质量目标。3个质控品的PT、APTT结果均落在厂家没定的范围内,与靶值的偏倚均小于卫生部临床检验中心室间质评的允许误差。结论 CA-7000测定PT和APTT的精密度和准确度达到厂家声称的性能。

Objective Use CLSI EP15-A to verify the precision and the accuracy of our new coagulation analyzer CA-7000. Methods For precision verifying experiment, three control materials with different concentrations were tested 4 times per day and last five days. Then calculale within-run precision and total precision respeelively,and compare the precision with that of claims. If the estimated precision is less than the manufacturerrs claimed precision,it indicates the analyzer＇s precision is consistent with the claimed. If the estimated precision is larger than the claimed precision, it should be comparee with the verification value. If the prior is less than the latter, the manufacturer＇s claim is verfied, too. Otherwise, the claim is not verified. For accuracy verifying experiment, three control materials were tested two times . If the deviation average of results for each level is less than allowable total error which issued by ministry of health,it means the accuracy is acceptable. Results The within run precision and total precision of PT, APTT examined by CA-7000 coagulation analyzer are consistent with the manufacturer＇s claim, and all are less than our labora tory＇s quality goal. And the bias of three quality control material for PT and APTT are less than the acceptable criteria of proficien cy testing,and the results are within the range listed in the packsheet. Conclusion The precision and accuracy of CA-7000 for PT and APTT met with the claim of the manufacturer.