中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2012年
9期
810-814
,共5页
马骏龙%陆玉静%李兴翠%王胜江%李洁%马晓婧%丛玉隆
馬駿龍%陸玉靜%李興翠%王勝江%李潔%馬曉婧%叢玉隆
마준룡%륙옥정%리흥취%왕성강%리길%마효청%총옥륭
尿分析%自动分析%质量控制%评价研究
尿分析%自動分析%質量控製%評價研究
뇨분석%자동분석%질량공제%평개연구
Urinalysis%Autoanalysis%Quality control%Evaluation studies
目的 制定针对朗迈全自动尿液分析工作站(LabUMat尿液干化学分析仪和UriSed有形成分分析仪)检测结果的尿液镜检复检规则.方法 采用人工镜检与UriSed仪器检测平行比对的方法,收集201 1年5月至10月解放军总医院门诊和住院随机尿液常规标本共2015份,用于建立复检规则；用朗迈全自动尿液分析工作站对2015份尿液标本进行尿液干化学和有形成分分析；检测完毕后采用双盲法进行显微镜检查,以此结果的平均值为判断标准.基于此标准,对2015份尿液标本的检测结果进行复检规则的设置,并计算复检规则的真阳性率、假阳性率、真阴性率、假阴性率(漏诊率)、复检率.根据自动化尿液分析工作站的检测方法,设计制定4种方案如下:(1)方案1:单纯干化学尿液分析仪检测的BLD、LEU、PRO、NIT任一参数出现阳性.(2)方案2:单纯尿有形成分仪器检测的RBC、WBC、CAST任一参数出现阳性.(3)方案3:联合干化学与有形成分分析仪检测的BLD、LEU与RBC、WBC结果不一致,或定量结果梯度相差2个或2个以上.(4)方案4:联合干化学与尿液有形成分分析仪BLD、LEU与RBC、WBC结果不一致,及CAST阳性或有报警提示出现,均进行复检.随机选取尿液常规标本300份,对该复检规则进行临床验证,通过漏诊率与复检率的结果来评判所制定的复检规则的合理性与可行性.结果 以显微镜检查结果为标准,用于建立复检规则的2015份尿液标本中,阳性标本占41.14％(829/2015),阴性标本占58.86％ (1186/2015).其中RBC阳性标本占50.30％(417/829),WBC阳性标本占53.32％(442/829),管型(CAST)阳性标本占3.74％(31/829).制定的4种方案的复检率分别为42.93％ (865/2015)、39.70％( 810/2015)、29.58％ (596/2015)、18.91％(381/2015),漏检率分别为6.36％(128/2015)、4.42％ (89/2015)、1.34％(27/2015)、1.04％(21/2015).选取方案4为理想的复检规则,对300份尿液常规标本进行复检规则的验证,验证结果符合率为91.67％ (275/300),真阳性率、假阳性率、真阴性率、假阴性率(漏诊率)分别为35.67％(107/300)、7.67％ (23/300)、56.00％ (168/300)、0.67％ (2/300),其复检率为19.67％(59/300),图片审核修正后的复检率为8.67％ (26/300).结论 针对朗迈全自动尿液分析工作站制定的复检规则能够有效地筛选异常标本,结合图片人工审核,显著减少了工作量.
目的 製定針對朗邁全自動尿液分析工作站(LabUMat尿液榦化學分析儀和UriSed有形成分分析儀)檢測結果的尿液鏡檢複檢規則.方法 採用人工鏡檢與UriSed儀器檢測平行比對的方法,收集201 1年5月至10月解放軍總醫院門診和住院隨機尿液常規標本共2015份,用于建立複檢規則；用朗邁全自動尿液分析工作站對2015份尿液標本進行尿液榦化學和有形成分分析；檢測完畢後採用雙盲法進行顯微鏡檢查,以此結果的平均值為判斷標準.基于此標準,對2015份尿液標本的檢測結果進行複檢規則的設置,併計算複檢規則的真暘性率、假暘性率、真陰性率、假陰性率(漏診率)、複檢率.根據自動化尿液分析工作站的檢測方法,設計製定4種方案如下:(1)方案1:單純榦化學尿液分析儀檢測的BLD、LEU、PRO、NIT任一參數齣現暘性.(2)方案2:單純尿有形成分儀器檢測的RBC、WBC、CAST任一參數齣現暘性.(3)方案3:聯閤榦化學與有形成分分析儀檢測的BLD、LEU與RBC、WBC結果不一緻,或定量結果梯度相差2箇或2箇以上.(4)方案4:聯閤榦化學與尿液有形成分分析儀BLD、LEU與RBC、WBC結果不一緻,及CAST暘性或有報警提示齣現,均進行複檢.隨機選取尿液常規標本300份,對該複檢規則進行臨床驗證,通過漏診率與複檢率的結果來評判所製定的複檢規則的閤理性與可行性.結果 以顯微鏡檢查結果為標準,用于建立複檢規則的2015份尿液標本中,暘性標本佔41.14％(829/2015),陰性標本佔58.86％ (1186/2015).其中RBC暘性標本佔50.30％(417/829),WBC暘性標本佔53.32％(442/829),管型(CAST)暘性標本佔3.74％(31/829).製定的4種方案的複檢率分彆為42.93％ (865/2015)、39.70％( 810/2015)、29.58％ (596/2015)、18.91％(381/2015),漏檢率分彆為6.36％(128/2015)、4.42％ (89/2015)、1.34％(27/2015)、1.04％(21/2015).選取方案4為理想的複檢規則,對300份尿液常規標本進行複檢規則的驗證,驗證結果符閤率為91.67％ (275/300),真暘性率、假暘性率、真陰性率、假陰性率(漏診率)分彆為35.67％(107/300)、7.67％ (23/300)、56.00％ (168/300)、0.67％ (2/300),其複檢率為19.67％(59/300),圖片審覈脩正後的複檢率為8.67％ (26/300).結論 針對朗邁全自動尿液分析工作站製定的複檢規則能夠有效地篩選異常標本,結閤圖片人工審覈,顯著減少瞭工作量.
목적 제정침대랑매전자동뇨액분석공작참(LabUMat뇨액간화학분석의화UriSed유형성분분석의)검측결과적뇨액경검복검규칙.방법 채용인공경검여UriSed의기검측평행비대적방법,수집201 1년5월지10월해방군총의원문진화주원수궤뇨액상규표본공2015빈,용우건립복검규칙；용랑매전자동뇨액분석공작참대2015빈뇨액표본진행뇨액간화학화유형성분분석；검측완필후채용쌍맹법진행현미경검사,이차결과적평균치위판단표준.기우차표준,대2015빈뇨액표본적검측결과진행복검규칙적설치,병계산복검규칙적진양성솔、가양성솔、진음성솔、가음성솔(루진솔)、복검솔.근거자동화뇨액분석공작참적검측방법,설계제정4충방안여하:(1)방안1:단순간화학뇨액분석의검측적BLD、LEU、PRO、NIT임일삼수출현양성.(2)방안2:단순뇨유형성분의기검측적RBC、WBC、CAST임일삼수출현양성.(3)방안3:연합간화학여유형성분분석의검측적BLD、LEU여RBC、WBC결과불일치,혹정량결과제도상차2개혹2개이상.(4)방안4:연합간화학여뇨액유형성분분석의BLD、LEU여RBC、WBC결과불일치,급CAST양성혹유보경제시출현,균진행복검.수궤선취뇨액상규표본300빈,대해복검규칙진행림상험증,통과루진솔여복검솔적결과래평판소제정적복검규칙적합이성여가행성.결과 이현미경검사결과위표준,용우건립복검규칙적2015빈뇨액표본중,양성표본점41.14％(829/2015),음성표본점58.86％ (1186/2015).기중RBC양성표본점50.30％(417/829),WBC양성표본점53.32％(442/829),관형(CAST)양성표본점3.74％(31/829).제정적4충방안적복검솔분별위42.93％ (865/2015)、39.70％( 810/2015)、29.58％ (596/2015)、18.91％(381/2015),루검솔분별위6.36％(128/2015)、4.42％ (89/2015)、1.34％(27/2015)、1.04％(21/2015).선취방안4위이상적복검규칙,대300빈뇨액상규표본진행복검규칙적험증,험증결과부합솔위91.67％ (275/300),진양성솔、가양성솔、진음성솔、가음성솔(루진솔)분별위35.67％(107/300)、7.67％ (23/300)、56.00％ (168/300)、0.67％ (2/300),기복검솔위19.67％(59/300),도편심핵수정후적복검솔위8.67％ (26/300).결론 침대랑매전자동뇨액분석공작참제정적복검규칙능구유효지사선이상표본,결합도편인공심핵,현저감소료공작량.
Objective To establish the proper review rules for the microscopic screening of urine samples tested by automatic urinalysis work station which is composed of LabUMat urine dry chemical analyzer and Urised urine sedimental analyzer.Methods The paired comparison was used to analyze the results tested by microscopy and Urised.A total of 2015 random urine samples were enrolled to establish and validate review rules.All the samples were collected from the inpatients and ontpatients of General Hospital of the People's Liberation Army from May to November 2011 and tested by urinalysis work station.2015 urine samples were firstly tested by urinalysis work station,including both urine dry chemical analyzer and urine sediments analyzer.Then each urine sample was examined microscopically by two technicians-in-charge using double-blind method.The average results from the two technicians were used as review results.Compared with review results,we set up the review rules and evaluated the Irue positive rate,false positive rate,true negative rate,false negative rate (omission diagnostic rate) and review rate.According to different test methods by automatic urinalysis work station,four microscopic review protocols were defined:( 1 ) Protocol 1:based on chemistry results only,microscopy review was performed when any of WBC,RBC,PRO and NIT was positive; (2) Protocol 2:based on urine sedimental analysis only,microscopy review was performed when any of WBC,RBC and CAST count was over upper limit of the reference range ; (3) Protocol 3:if any of BLD vs.RBC,LEU vs.WBC was different between two systems,or quantitative results had two or more than two gradient differences,microscopy review was performed; (4) Protocol 4:if any of BLD vs.RBC,LEU vs.WBC was different between two systems,or CAST was over upper limit of the reference range,or alam appeared,microscopic review was performed.300 randomly selected urine samples were tested to validate the review rules.Omission diagnostic rate and review rate were used to evaluate the rules.Results According to our review rules,the positive samples rate was 41.14％ (829/2015) and the negative rate was 58.86％ ( 1186/2015 ) ; Positive samples were composed of RBC (50.30％),WBC (53.32％) and CAST (3.74％).The review rates of four protocols were 42.93％ (865/2015),39.70％ (810/2015),29.58％(596/2015),18.91％ (381/2015 ),respectively.The false negative rates (omission diagnostic rates) were 6.36％ (128/2015),4.42％ (89/2015),1.34％ (27/2015)and 1.04％ (21/2015)respectively.Protocol 4 was selected as an ideal plan.Additional 300 urine samples were tested using protocol 4 in order to confirm the review rule.The review rate,consistency rate,true positive rate,false positive rate,true negative rate,omission diagnostic rate were 19.67％ (59/300),91.67％ (275/300),35.67％ (107/300),7.67％(23/300),56.00％ (168/300),0.67％ (2/300),respectively.After image review revised,the review rate was 8.67％ (26/300).Conclusion The review rules established by our research for Urinalysis Work Station can find the abnormal urine samples effectively and exactly and can reduce the workload significantly.(Chin J Lab Med,2012,35:810-814)
