尿液分析系统自动审核规则建立与验证的多中心研究

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目的:建立全自动尿液分析系统自动审核规则并对其进行验证,在保证结果可靠性的前提下提高检验效率。方法:收集来自北京大学航天临床医学院航天中心医院、上海交通大学附属第六人民医院、广州医科大学附属第一医院、温州医科大学附属第一医院和山西省人民医院5家医院检验科2019年9月至2020年4月期间的尿液标本共5 359份,其中建立表观健康人群参考区间组355份,规则建立组3 449份和规则验证组1 555份。以显微镜检查结果作为金标准,应用贝克曼库尔特全自动尿液分析系统对尿液标本进行检测,建立尿液分析系统自动审核规则。各实验室均进行严格的室内质量控制,保证结果的准确性和稳定性。在规则建立阶段计算正常人群参考范围和自动审核规则结果(包括真阳性率、真阴性率、假阳性率、假阴性率、自动审核通过率),规则验证阶段计算自动审核规则的性能指标包括(有效拦截率、无效拦截率、有效审核率、无效审核率、自动审核通过率、自动审核通过正确率)。结果:以显微镜检查结果为金标准,初步建立贝克曼库尔特全自动尿液分析系统自动审核规则,其自动审核通过率为52.51%(1 811/3 449),显微镜检查率为2.58%(89/3 449),假阴性率、假阳性率、真阴性率和真阳性率分别为2.26%(78/3 449)、11.86%(409/3 449)、47.00%(1 621/3 449)和38.88%(1 341/3 449)。验证数据与规则建立数据一致并有一定提升,最终设定20条自动审核规则,其有效拦截率、无效拦截率、有效审核率、无效审核率、自动审核通过正确率分别为38.52%(599/1 555)、10.35%(161/1 555)、49.07%(763/1 555)、2.06%(32/1 555)和87.59%(1 362/1 555)。结论:应用全自动尿液分析系统自动审核规则能够提高尿液检验的效率,节省人力,同时保证检测结果可靠性。“,”Objective:To establish and validate auto verification criteria for Beckman Coulter iRECELL workstation, and improve the test efficiency under the promise of ensuring the reliability of the results.Method:A total of 5 359 urine specimens were collected from the clinical laboratory of five hospitals, namely, the Aerospace Center Hospital of Peking University, the Sixth People′s Hospital Affiliated to Shanghai Jiaotong University, the First Affiliated Hospital of Guangzhou Medical University, the First Affiliated Hospital of Wenzhou Medical University and the Shanxi Provincial People′s Hospital from September 2019 to April 2020. 355 specimens from healthy population were in the reference intervals group, 3 449 specimens were in the criteria establishment group, and 1 555 specimens were in the criteria verification group. Taking the microscopic examination results as the gold standard, the Beckman Coulter iRECELL workstation was used to detect the urine samples, and the auto verification criteria of the iRECELL workstation were established.. Each laboratory carried out strict indoor quality control to ensure the accuracy and stability of the results. The reference range of healthy population and the results of auto verification criteria (including true positive rate, true negative rate, false positive rate, false negative rate and auto verification pass rate) were calculated in the criteria establishment stage. The performance indicators of auto verification criteria were calculated, including effective interception rate, invalid interception rate, effective verification rate, invalid verification rate, automatic verification pass rate and auto verification pass accuracy rate in the criteria verification stage.Result:Taking the microscopic examination results as the gold standard, the auto verification criteria of Beckman Coulter iRECELL workstation were initially established. The auto verification pass rate was 52.51% (1 811/3 449); the microscopic examination rate was 2.58% (89/3 449); and the false negative rate, false positive rate, true negative rates and true positive rates were 2.26% (78/3 449), 11.86% (409/3 449), 47.00% (1 621/3 449) and 38.88% (1 341/3 449) respectively. The validation data were consistent with the criteria establishment data and improved to some extent. Finally, 20 auto verification criteria were set. The effective interception rate, invalid interception rate, effective verification rate, invalid verifacation rate and auto verification pass accuracy rate were 38.52% (599/1 555), 10.35% (161/1 555), 49.07% (763/1 555), 2.06% (32/1 555) and 87.59% (1 362/1 555) respectively.Conclusion:The auto verification criteria for Beckman Coulter iRECELL workstation can improve the efficiency of urine test, reduce manpower and ensure the reliability of the test results
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