摘要
目的建立本实验室IQ200全自动尿液分析仪流水线的复检规则。方法随机选取1109份门诊患者尿液标本在IQ200进行干化学和有形成分检测,同时进行标准化显微镜镜检,以镜检结果为判断标准进行复检规则设置,并分析真阳性率、假阳性率、真阴性率、假阴性率、复检率。复检规则设置:1规则1,单纯干化学指标RBC、WBC和PRO任何一项参数出现阳性者;2规则2,单纯有形成分分析仪检测指标RBC、WBC和CAST任何一项参数出现阳性者;3规则3,干化学和尿液有形成分等两套分析系统的WBC检测结果不符合,而RBC、PRO或CAST中任何一个参数在任何一台仪器上结果为阳性者;4规则4,两套分析系统的RBC、WBC、PRO(CAST)结果不相符合者。选取200份尿液标本对选定规则进行验证,通过复检率和假阴性率来评价选定规则的合理性和可行性。结果以显微镜镜检为"金标准"与IQ200检测结果进行分析,1109份标本中阳性标本占57.26%。制定的4种规则复检率分别为79.98%、59.51%、61.95%、39.77%,假阴性率分别为1.71%、0.18%、0.09%、0。选择规则4为最佳复检规则,进行有效性验证真阳性率为51.5%,假阳性率21.0%,真阴性率27.5%,假阴性率为0,复检率为32.5%。结论选定规则4为本实验室尿液分析复检规则,实施规则后有效筛选异常尿液标本,减少工作量的同时提高工作效率。
Objective To establish the proper review criteria of urine sample tested by IQ200 automatic Urine Analyzer assembly line in our laboratory. Methods A total of 1109 urine samples of outpatients were selected randomly to be tested by IQ200,including both urine dry chemical analyzer and urine sediments analyzer. At the same time,each urine sample was examined microscopically for standardization. The results from microscopic examination were used as review standard. Compared with this review standard,we set up the review rules for 1109 urine samples,and analyzed the true positive rate,false positive rate,true negative rate,false negative rate（ omission diagnosis rate） and review rate. Review rules were set up according to the features of testing principle and specimen source of IQ200： 1rule 1： based on chemistry results only,microscopy review was performed when any of RBC,WBC and PRO was positive; 2rule 2： based on urine sedimental analysis only,microscopy review was performed when any of RBC,WBC and CAST was positive; 3rule 3： if WBC was different between two systems of dry chemical analyzer and sediments analyzer,and any of RBC,PRO and CAST was tested positive in any of the two analyzers,microscopy review was performed; 4rule 4： When urine samples were tested in the assembly line systems,if WBC,RBC or PRO（ CAST） were different between two systems,microscopy review was performed.200 randomly selected urine samples were tested to validate the review rules,review rate and false negative rate were used to evaluate the rationality and feasibility of the rules. Results Microscopic results were used as the gold standard,we compared the results from IQ200 with Microscopic examination. According to our review rules,the positive samples rate was 57. 26%（ 635 /1109） and the negative samples rate was 42. 74%（ 474 /1109）. The review rates of four rules were79. 98%（ 887 /1109）,59. 51%（ 660 /1109）,61. 95%（ 687 /1109） and 39. 77%（ 441 /1109）,respectively. The false negative rates were 1. 71%（ 19 /1109）,0. 18%（ 2 /1109）,0. 09%（ 1 /1109） and 0,respectively. Rule 4 was selected as the best review rule. Addtional 200 urine samples were tested using rule 4 in order to confirm clinic application effectivity. The true positive rate,false positive rate,true negative rate,false negative rate and review rate were 51. 5%（ 103 /200）,21. 0%（ 42 /200）,27. 5%（ 55 /200）,0 and 32. 5%（ 65 /200）,respectively. It was consistent with ideal screening condition of automatic urine routine analysis. Conclusion The review rule 4 was selected as the proper review criteria in our laboratory for low review rate and false negative rate. Using this criteria the abnormal urine samples can be found effectively,the workload was reduced and work efficiency was increased,omission diagnosis rate of graveness disease can be avoided and reduced.
出处
《中华全科医学》
2015年第2期268-270,共3页
Chinese Journal of General Practice
基金
浙江省卫生厅科研项目(2009B108)
浙江省温州市科技局科研项目(Y20090117)
