中华临床实验室管理电子杂志
中華臨床實驗室管理電子雜誌
중화림상실험실관리전자잡지
2014年
1期
62-66
,共5页
李志荣%强翠欣%杨靖%刘晓雷%韩卫%常樱%赵建宏
李誌榮%彊翠訢%楊靖%劉曉雷%韓衛%常櫻%趙建宏
리지영%강취흔%양정%류효뢰%한위%상앵%조건굉
血细胞计数%检验结果互认%可比性
血細胞計數%檢驗結果互認%可比性
혈세포계수%검험결과호인%가비성
Blood cell count%Mutual recognition of test reports%Comparability
目的:分析探讨石家庄市区30家医院门诊实验室全血细胞计数检测(compete blood count,CBC)结果的可比性,为河北省实施临床检验结果互认提供可行方法。方法采用CBC单盲检测调查研究设计。2013年4月9日,由河北省临床检验中心(以下简称“中心”)采集1名健康人新鲜晨血62 ml,用乙二胺四乙酸抗凝,并分装为31管,每管2 ml。采血后3 h内,将其中1份标本送至卫生部临床检验中心,用血细胞分析校准系统将该新鲜血定值后,作为调查标本真值(可溯源至血细胞分析参考方法)。其他30份标本分别送至石家庄市区30家医院(三级医院11家、二级医院15家及未分级医院4家)门诊检验科,3 h内检测后带回检测结果。然后,选择白细胞计数(white cell count, WBC)、红细胞计数(red cell count, RBC)、血红蛋白(hemoglobin, Hb)、红细胞比容(hematocrit, HCT)、血小板计数(platelet, PLT)5项指标,计算30家医院实验室单盲检测CBC结果与真值的偏差,采用成组t检验评价分析三级医院与二级医院CBC检测结果间的可比性。同时,调查分析各实验室使用仪器和室间质量评价(external quality assessment,EQA)信息,探讨CBC检测不合格的原因。结果按美国临床实验室改进法案(clinical laboratory improvement amendments,CLIA)规定的可接受生物变异范围,分析30家医院5项CBC检测项目结果,不合格医院分别为RBC 2家[6.7%(2/30)]、Hb 3家[10.0%(3/30)]、HCT 8家[26.7%(8/30)]。11家三级医院5项CBC指标的参数范围为WBC(5.0~5.6)×109/L、RBC(5.3~5.6)×1012/L、Hb(156.7~169.1)g/L、HCT(46.1~52.1)%、PLT(238.0~286.0)×109/L,15家二级医院CBC检测结果的参数范围为WBC(4.5~5.6)×109/L、RBC(5.0~5.9)×1012/L、Hb (150.0~171.0) g/L、HCT 42.0%~52.0%、PLT(215.0~296.0)×109/L,两者间差异均无统计学意义(t值分别为1.44、0.01、0.91、1.93、0.20,P均>0.05)。各实验室检测CBC的仪器,使用Sysmex公司仪器进行检测的实验室最多[占57%(17/30)],其他分别为迈瑞公司血球仪23%(7/30)、法国ABX公司血球仪10%(3/30)、Beckman Coulter公司7%(2/30)和Thermo Fisher Scientific公司3%(1/30)。不合格实验室所用仪器种类无集中趋势,推测导致实验室不合格原因可能不是其检测系统的差别。调查30家医院CBC项目2012年EQA成绩仅2家不合格,与本调查结果不合格单位分布也不一致。结论石家庄市内二、三级医院间CBC检测结果具有很好的一致性。单盲调查有助于进一步发现临床实验室实际存在的一些问题,对了解本地区实行实验室间检验结果互认有积极作用。
目的:分析探討石傢莊市區30傢醫院門診實驗室全血細胞計數檢測(compete blood count,CBC)結果的可比性,為河北省實施臨床檢驗結果互認提供可行方法。方法採用CBC單盲檢測調查研究設計。2013年4月9日,由河北省臨床檢驗中心(以下簡稱“中心”)採集1名健康人新鮮晨血62 ml,用乙二胺四乙痠抗凝,併分裝為31管,每管2 ml。採血後3 h內,將其中1份標本送至衛生部臨床檢驗中心,用血細胞分析校準繫統將該新鮮血定值後,作為調查標本真值(可溯源至血細胞分析參攷方法)。其他30份標本分彆送至石傢莊市區30傢醫院(三級醫院11傢、二級醫院15傢及未分級醫院4傢)門診檢驗科,3 h內檢測後帶迴檢測結果。然後,選擇白細胞計數(white cell count, WBC)、紅細胞計數(red cell count, RBC)、血紅蛋白(hemoglobin, Hb)、紅細胞比容(hematocrit, HCT)、血小闆計數(platelet, PLT)5項指標,計算30傢醫院實驗室單盲檢測CBC結果與真值的偏差,採用成組t檢驗評價分析三級醫院與二級醫院CBC檢測結果間的可比性。同時,調查分析各實驗室使用儀器和室間質量評價(external quality assessment,EQA)信息,探討CBC檢測不閤格的原因。結果按美國臨床實驗室改進法案(clinical laboratory improvement amendments,CLIA)規定的可接受生物變異範圍,分析30傢醫院5項CBC檢測項目結果,不閤格醫院分彆為RBC 2傢[6.7%(2/30)]、Hb 3傢[10.0%(3/30)]、HCT 8傢[26.7%(8/30)]。11傢三級醫院5項CBC指標的參數範圍為WBC(5.0~5.6)×109/L、RBC(5.3~5.6)×1012/L、Hb(156.7~169.1)g/L、HCT(46.1~52.1)%、PLT(238.0~286.0)×109/L,15傢二級醫院CBC檢測結果的參數範圍為WBC(4.5~5.6)×109/L、RBC(5.0~5.9)×1012/L、Hb (150.0~171.0) g/L、HCT 42.0%~52.0%、PLT(215.0~296.0)×109/L,兩者間差異均無統計學意義(t值分彆為1.44、0.01、0.91、1.93、0.20,P均>0.05)。各實驗室檢測CBC的儀器,使用Sysmex公司儀器進行檢測的實驗室最多[佔57%(17/30)],其他分彆為邁瑞公司血毬儀23%(7/30)、法國ABX公司血毬儀10%(3/30)、Beckman Coulter公司7%(2/30)和Thermo Fisher Scientific公司3%(1/30)。不閤格實驗室所用儀器種類無集中趨勢,推測導緻實驗室不閤格原因可能不是其檢測繫統的差彆。調查30傢醫院CBC項目2012年EQA成績僅2傢不閤格,與本調查結果不閤格單位分佈也不一緻。結論石傢莊市內二、三級醫院間CBC檢測結果具有很好的一緻性。單盲調查有助于進一步髮現臨床實驗室實際存在的一些問題,對瞭解本地區實行實驗室間檢驗結果互認有積極作用。
목적:분석탐토석가장시구30가의원문진실험실전혈세포계수검측(compete blood count,CBC)결과적가비성,위하북성실시림상검험결과호인제공가행방법。방법채용CBC단맹검측조사연구설계。2013년4월9일,유하북성림상검험중심(이하간칭“중심”)채집1명건강인신선신혈62 ml,용을이알사을산항응,병분장위31관,매관2 ml。채혈후3 h내,장기중1빈표본송지위생부림상검험중심,용혈세포분석교준계통장해신선혈정치후,작위조사표본진치(가소원지혈세포분석삼고방법)。기타30빈표본분별송지석가장시구30가의원(삼급의원11가、이급의원15가급미분급의원4가)문진검험과,3 h내검측후대회검측결과。연후,선택백세포계수(white cell count, WBC)、홍세포계수(red cell count, RBC)、혈홍단백(hemoglobin, Hb)、홍세포비용(hematocrit, HCT)、혈소판계수(platelet, PLT)5항지표,계산30가의원실험실단맹검측CBC결과여진치적편차,채용성조t검험평개분석삼급의원여이급의원CBC검측결과간적가비성。동시,조사분석각실험실사용의기화실간질량평개(external quality assessment,EQA)신식,탐토CBC검측불합격적원인。결과안미국림상실험실개진법안(clinical laboratory improvement amendments,CLIA)규정적가접수생물변이범위,분석30가의원5항CBC검측항목결과,불합격의원분별위RBC 2가[6.7%(2/30)]、Hb 3가[10.0%(3/30)]、HCT 8가[26.7%(8/30)]。11가삼급의원5항CBC지표적삼수범위위WBC(5.0~5.6)×109/L、RBC(5.3~5.6)×1012/L、Hb(156.7~169.1)g/L、HCT(46.1~52.1)%、PLT(238.0~286.0)×109/L,15가이급의원CBC검측결과적삼수범위위WBC(4.5~5.6)×109/L、RBC(5.0~5.9)×1012/L、Hb (150.0~171.0) g/L、HCT 42.0%~52.0%、PLT(215.0~296.0)×109/L,량자간차이균무통계학의의(t치분별위1.44、0.01、0.91、1.93、0.20,P균>0.05)。각실험실검측CBC적의기,사용Sysmex공사의기진행검측적실험실최다[점57%(17/30)],기타분별위매서공사혈구의23%(7/30)、법국ABX공사혈구의10%(3/30)、Beckman Coulter공사7%(2/30)화Thermo Fisher Scientific공사3%(1/30)。불합격실험실소용의기충류무집중추세,추측도치실험실불합격원인가능불시기검측계통적차별。조사30가의원CBC항목2012년EQA성적부2가불합격,여본조사결과불합격단위분포야불일치。결론석가장시내이、삼급의원간CBC검측결과구유흔호적일치성。단맹조사유조우진일보발현림상실험실실제존재적일사문제,대료해본지구실행실험실간검험결과호인유적겁작용。
ObjectiveTo investigate the comparability of compete blood count (CBC) among 30 hospitals in Shijiazhuang in order to provide a reference for mutual recognition of test reports for outpatient laboratories from different hospitals.MethodsSingle-blind survey was designed for this research. Firstly, 62ml fresh morning blood sample using ethylene diamine tetraacetic acid as anticoagulant was collected from a healthy person and packed to 31 tubes. One of those was measured by the calibration laboratory of hematology analysis in Chinese National Center for Clinical Laboratories as real result which could be traceable to reference method. The outpatient laboratories in 30 hospitals (including 11 tertiary hospitals and 15 secondary hospitals and 4 other unranked hospitals) were investigated using the other 30 samples. Five parameters of CBC were taken to evaluate the results including white cell count (WBC), red cell count (RBC), hemoglobin (Hb), hematocrit (HCT) and platelet (PLT). Results of 11 tertiary hospitals and 15 secondary hospitals were evaluated by groupt test statistical analysis. Deviation between the real result and single-blinded results from 30 outpatient laboratories were analyzed to evaluate the comparability of CBC in different hospital. Information of test equipment and external quality assessment (EQA) was collected.ResultsThere were 2 [(6.7%(2/30)] hospitals unqualified in RBC, 3 [10%(3/30)] hospitals in Hb and 8 [26.7%(8/30)] hospitals in HCT according to the acceptable range of biological variation provided by Clinical Laboratory Improvement Amendments (CLIA’88). The results of CBC between tertiary hospitals [parameter range: WBC (5.0-5.6)×109/L, RBC (5.3-5.6)×1012/L, Hb (156.7-169.1) g/L, HCT (46.1-52.1)%, PLT (238.0-286.0)×109/L] and secondary hospital [parameter range: WBC (4.5-5.6)×109/L, RBC (5.0-5.9)×1012/L, Hb (150.0- 171.0)g/L, HCT 42.0%-52.0%, PLT (215.0-296.0)×109/L] were analyzed using Student′ st test with the 0.05 conifdence level accepted as signiifcant and proved to be not statistically significant (t=1.44, 0.01, 0.91, 1.93, 0.20, respectivily,P>0.05). According to the survey of test instruments, Sysmex blood analyser was most popular machine in these laboratories, accounting for 57% (17/30). Others were Mindray blood analyzer accounting for 23% (7/30), ABX blood cell counter 10% (3/30), Beckman Coulter Company 7% (2/30) and Thermo Fisher Scientiifc Company 3% (1/30). No central tendency of laboratory instruments was found in the survey, inferring that the reasons of unqualiifed laboratories were not the difference of detection systems. Investigation of CBC EQA in 2012 showed there were only 2 laboratories failed among these 30 hospitals. The survey results was not consistent with this investigation.ConclusionsThrough this investigation, good consistency of CBC test in different levels of hospitals in Shijiazhuang city is revealed. Single-blind test is conducive to discover the actual situation in the clinical laboratories, which could be helpful to perform mutual recognition among test results from different clinical laboratories in local district positively.