ISO15189认可实验室中Sysmex XN-9000血细胞分析仪复检规则的制订及评价

目的建立适合该实验室中Sysmex XN-9000血细胞分析流水线的复检规则,保证检测结果的准确性。方法选取2017年1-2月住院、门诊及体检患者的全血标本2 250例,采用Sysmex XN-9000血细胞分析仪进行检测,以人工镜检为金标准,对自定义的26条复检规则进行验证评价,统计阳性预测值、阴性预测值、假阳性率、假阴性率和复检率等。结果将仪器报警信息与镜检结果进行比较,阳性预测值为91.59%,阴性预测值为98.64%,假阳性率为2.09%,假阴性率为1.02%,复检率为24.84%。结论制订的Sysmex XN-9000血细胞分析仪复检规则符合该实验室特点,提高了检测效率,防止了漏检和误检,具有临床指导意义。

Formulation and evaluation on Sysmex XN9000 blood cell analyzer re-examination criteria in ISO15189 accredited laboratory

Objective To establish the re-examination criteria of the Sysmex XN-9000 automatic blood cell analyzer pipeline suitable for this laboratory for ensuring the accuracy of detection results .Methods A total of 2250 whole blood samples were se-lected from inpatients ,outpatients and subjects undergoing physical examination .The Sysmex XN-9000 blood cell analyzer was a-dopted to conduct the detection .With the manual microscopic examination as the golden standard ,26 items of re-examination criteria were performed the verification and evaluation .The positive predicting value ,negative predicting value ,false positive rate ,false neg-ative rate and re-examination rate were performed by the statistics .Results In compariing the instrument alarm information with the microscopic examination results ,the positive predicting value was 91 .59% ,the negative predicting value was 98 .64% ,the false positive rate was 2 .09% ,the false negative rate was 1 .02% and the re-examination rate was 24 .84% .Conclusion The formulated re-examination criteria of the Sysmex XN-9000 blood cell analyzer is in accord with the characteristics of our laboratory ,which in-creases the detection efficiency ,prevents the missing detection and false detection and has clinical guidance significance .