Sysmex全自动尿液分析仪流水线复检规则制定

The Development of Re-Inspection Rules for Sysmex Automatic Urine Analyzer Pipeline

目的制定Sysmex全自动尿液分析仪流水线UC-3500及UF-4000复检规则。方法收集497份尿液标本,采用Sysmex全自动尿液分析仪流水线UC-3500及UF-4000检测尿液标本,根据双盲法验证的结果,制定出尿有形成分数量级范围与干化学定性结果一致的复检规则。通过再次检测125份尿液标本计算漏检率,验证复检规则的有效性。结果制定复检规则前,红细胞干化学、流式的正确率分别为80.68%、91.75%;白细胞干化学、流式的正确率分别为82.29%、75.45%。尿红细胞、白细胞漏诊率分别为9.84%、5.88%。通过对497份样本分析,制定出以干化学与尿流式分级对等为原则的复检规则,经验证复检率22.3%,正确率92.6%,漏检率2.4%。结论通过制定尿有形成分与干化学定性结果的一致性复检规则,既可满足临床及患者对结果的及时性、准确性的要求,同时降低复检率,减少漏检率,并提高检验工作的效率。

Objective To establish the re-inspection rules of SYSMEX automatic urine analyzer line UC-3500 and UF-4000.Methods Urine samples from 497 cases were collected for the study,and these samples were detected by UC-3500 and UF-4000 of SYSMEX automatic urine analyzer.According to the results of double-blind verification,the re-examination rules of the order of magnitude of urine physical composition were established,which were consistent with the qualitative results of dry chemistry.125 urine samples were then tested again to calculate the missed rate and verify the validity of the retest rule.Results The correct rate of erythrocyte dry chemistry and flow cytometry were 80.68%and 91.75%,respectively,before the re-examination rule was established.The correct rates of dry chemistry and flow cytometry were 82.29%and 75.45%,respectively.The rate of missed diagnosis were 9.84%and 5.88%,respectively.Based on the analysis of 497 samples,the re-examination rule was established based on the principle of equivalence of dry chemistry and urine flow classification.The re-examination rate was 22.3%,while the correct rate was 92.6%,and the missed rate was 2.4%.Conclusion The developed re-examination rules of consistency between urine physical composition and dry chemical qualitative results can not only meet the requirements of clinical and patients for timeliness and accuracy of results,but also reduce the re-examination rate and miss rate,and improve the efficiency of the examination procedure.