湖北省临床化学室内质控数据实验室间比对情况分析

目的 通过开展临床化学室内质量控制数据实验室间比对工作,了解湖北省临床化学常规项目检测结果的可比性,促进实验室检测能力的提高,为检验结果的互认提供技术支持.方法 收集2007～2010年湖北省临床化学室内质控数据实验室间比对的数据,从参加实验室的构成比、回报率;比对项目的不合格率、实验室间的离散度进行分析.结果 2007～2010年共组织20次比对活动,参加实验室数分别为40,113,142和170个;平均回报率为78.9％,15个项目的全省数据平均变异系数在5％以内,93％的实验室SDI和CVI值满足要求.结论 室内质控数据实验室间比对评价活动,可以督促实验室规范开展室内质量控制工作,为室间质评提供有益的补充,有利于提高实验室的检测质量水平,能为实验室间结果的互认提供技术平台.     

福建省2004、2005年度肿瘤标志物室间质量评价情况分析

目的通过肿瘤标志物室问质量评价活动，提高全省医疗机构肿瘤标志物的检测质量和各临床实验室问检测结果的可比性。方法通过定期向全省参评实验室寄发质控样品，要求各参评实验室在规定的时问内分别检测甲胎蛋白（AFP）、癌胚抗原（CEA）、前列腺特异性抗原（PSA）、糖抗原（CA）153、CA125、CA199、β-人绒毛膜促性腺激素（β-HCG）、β2-微球蛋白（β2-MG）、铁蛋白9个项目，其中β-HCG、β2-MG、铁蛋白不作评价，按试剂分组统计结果作出评价。结果2年共计发放12支质控品。2004年有50家参评单位，优秀率为40．0％，总合格率为58．0％；2005年有99家参评单位，优秀率为51．5％，总合格率为63．7％。按试剂分组统计变异系数（CV）〉50％的共有30组。结论我省2年来的肿瘤标志物室间质量评价的结果显示，各实验室对质控品的测定结果离散度大，各实验室间的检测结果的可比性不理想。其原因是目前各厂家试剂的量值溯源、定标的标准不尽相同，因此选择可靠的方法，选用优质的试剂和规范的实验操作，才能提高肿瘤标志物的检测质量和各实验室间检测结果的可比性，为临床提供可靠的检测信息。     

全国同型半胱氨酸检测室间质量评价结果分析

目的依据《医疗机构临床实验室管理办法》（卫医发（2006]73号）,加强临床检测项目的质量管理。通过开展同型半胱氨酸室间质量评价工作,了解我国目前同型半胱氨酸实验室的检测能力。方法参照中华人民共和国国家标准GB／T20470—2006《临床实验室室间质量评价要求》,建立我国同型半胱氨酸检测的室间质量评价方案。通过每年1次,每次5个样本向参加质评的实验室邮寄质控物,实验室对其检测然后将其结果回报给室间质量评价组织者,组织者对所有回报的结果进行统计分析,做出实验室检测水平的评价。结果2008年按照实际回报数据的41家进行统计分析,循环酶法占51．22％,其实验室闻平均变异系数为17．47％;荧光偏振免疫检测（FPIA）法占29．27％,其实验室同平均变异系数为22．02％;酶联免疫法占4．88％,其实验室间平均变异系数为13．99％;其它方法组占14．63％,实验室阐平均变异系数为15．16％。2009年按照实际回报数据的70家进行统计分析,循环酶法占54．05％,其实验室间平均变异系数为19．78％;荧光偏振免疫检测（FPIA）法占22．97％,其实验室间平均变异系数为15．90％;酶联免疫法占2．70％,其实验室间平均变异系数为21．46％;其它方法组占20．28％,实验室间平均变异系数为24．50％。结论开展全国同型半胱氨酸检测室间质量评价,有助于发现同型半胱氨酸实验室检测中存在的问题,利于提高同型半胱氨酸检测质量水平。     

全国干化学胆红素检测室间质量调查结果分析

目的 了解目前我国干化学测定胆红素的检测现状,以改进和提高胆红素检测质量.方法 对2012年自愿参加干化学胆红素检测室间质量调查的148家实验室发放两个批号的冻干粉质控品（批号为A1565和B1567）,要求回报总胆红素（TBIL）、结合胆红素（CB）、未结合胆红素（UB）和Delta胆红素（DELB）,并对回报结果进行统计分析,以评价实验室检测水平.结果 调查回报率为81.8％（121/148）,分别有118,113,113和91家实验室回报了TBIL,CB,UB和DELB的检测结果,这四个检测项目在Vitros系列仪器上检测所得的稳健变异系数（RCV）差异较大.四个项目的实验室间CV的算术平均数分别为5.68％,19.41％,12.37％和53.98％;TBIL和CB的统计结果与2012年干化学第一次EQA比较,实验室间变异相差不大.根据目前干化学室间质量评价的评价标准,TBIL两个批号合格率较高,均为98.3％;CB为78.8％和92.9％;UB为85.8％和93.8％;Delta胆红素合格率较低,分别为46.2％和34.4％.结论 该次调查数据显示出目前我国干化学胆红素检测水平还需进一步提高,实验室应严格按照操作程序进行检测,并采取有效的室内质量控制,参加室间质量评价计划,以减小胆红素检测结果的误差并提高结果间的可比性.     

合肥地区基层医疗机构检验科血常规室间比对结果分析

目的了解合肥地区基层医疗机构检验科血常规的检测水平,分析影响室间比对结果的主要原因。方法随机抽取43家乡镇卫生院和社区卫生服务中心检验科,进行现场调查和血常规项目室间比对。结果室间比对合格率41.9%,平均72.37分,明显低于省临检中心合格率(94.1%)和平均分(95.97分),差异均有统计学意义(P0.05);血常规参数(白细胞、红细胞、血红蛋白、红细胞比容、血小板)平均合格率均低于安徽省临检中心,差异均有统计意义(P0.05);基层实验室人员学历偏低,非检验专业人员占18.80%;血常规分析仪以国产为主,且53.49%的仪器使用时间超过5年;实验室整体质量管理水平落后。结论合肥地区基层医疗机构实验室血常规检测水平远不及二级以上医疗机构。需做好日常实验室室内质控,逐步完善质量管理体系。     

上海市临床检验中心复合过敏原计划室间质量评价结果分析

目的 通过开展室间质量评价(简称室间质评),评价复合过敏原计划各项目检测结果的一致性。方法 收集2022年至2023年参加上海市临床检验中心复合过敏原计划(包括屋尘螨、粉尘螨、猫毛、艾蒿、梯牧草、牛奶、榛子、花生项目)的室间质评回报数据,对8个项目的回报结果进行统计分析。结果 复合过敏原计划共开展4次,参加实验室数分别为104、107、124和122家,总体合格率分别为99.04%、99.07%、99.19%和100%。屋尘螨、粉尘螨、艾蒿项目各组的指定值均相同,各试剂组结果一致性较高;猫毛及牛奶项目试剂组间出现指定值阴、阳性不一致情况;梯牧草、榛子及花生项目除复合靶点试剂无法检出外,其余各组试剂结果一致性较高。结论 复合过敏原计划参加实验室数量逐步增加,涵盖的8个项目的室间质评结果良好,总体合格率均较高,各试剂厂家一致性较好。     

2011年青岛市医疗机构输血实验室室间质量评价分析

目的 初步建立青岛市输血实验室室间质量评价方案,进一步规范输血相容性项目的检测,保证输血安全.方法 输血相容性检验选取ABO定型、Rh(D)血型、交叉配血、不规则抗体筛选四个项目对实验室检测质量进行评价.结果 参加输血相容性检测室间质评的实验室67家,ABO血型正定型正确率和交叉配血主侧结果符合率均为100％,ABO反定型结果正确率为97.88％,Rh(D)血型结果正确率为99.70％,不规则抗体筛选结果正确率为99.34％,交叉配血次侧符合率为96.42％.67家实验室每个项目质评成绩分别为:ABO合格率为100％,反定型合格率为95.5％,不规则抗体筛选合格率为96.7％,交叉配血次侧合格率为97.0％.结论 ABO反定型、Rh(D)血型、不规则抗体筛选及交叉配血次侧检测结果均存在与预期结果不符的情况,实验室检测水平存在一定的差距.开展全市医疗机构输血实验室的室间质量评价工作,对不断提高输血实验室的检测水平,保证输血安全非常必要.     

中孕期母血产前筛查的室内质控结果室间比对分析

目的分析母血产前筛查实验室的室内质量控制数据实验室间比对。方法在江苏省产前筛查质控数据平台上,收集2018年9月至2019年8月33家运用时间分辨荧光法检测的同批号、3个水平质控品的甲胎蛋白(AFP)和游离人绒毛膜促性腺激素(Freeβ-h CG)实验室质控数据9 632个,统计分析其精密度及一致性。结果纳入数据9 494个,其中33家实验室检测AFP和Freeβ-h CG的精密度合格率分别97.0%(32/33)和78.8%(26/33),33家实验室检测AFP和Freeβ-h CG结果的一致性合格率为100.0%。结论室内质量控制数据实验室间比对可发现同一检验平台中检测结果的不一致性,有利于提升检验结果的可比性和提高检验质量。     

2005～2012年贵州省凝血试验室间质量评价数据统计分析

目的 对2005～2012年贵州省凝血试验室间质量评价的数据进行统计分析,了解凝血试验开展的状况以及检测的质量,以提出整改措施,提高检测质量.方法 每年向参加室间质量评价的实验室发放质评物,每2次,每次5个批号,实验室在规定的时间内测定后回报数据,对回报数据进行分组统计分析.结果 全省凝血试验室间质量评价参加实验室数不断增加,各项目的变异系数(CV)值虽有逐年下降的趋势,但室间变异仍然较大;各项目水平2和水平3的CV值明显比水平1的大;平均合格率总体较低.结论 做好凝血试验检测仪器、试剂的评价和比对工作,加强凝血试验的溯源性和标准化管理,是提高凝血试验检测质量的有效途径.     

一致性比对工作在推进检验结果互认中的应用

目的分析中山市范围内常规化学项目、糖化血红蛋白一致性比对存在的问题并改进,为区域内检验结果互认提供依据。方法收集2020年中山市常规化学项目、糖化血红蛋白一致性比对数据,统计参加比对的医院、项目和结果情况,分析存在的问题。结果全市39家实验室参加了一致性比对,85%来自基层医院,民营医院占23%,公立医院占77%。同一项目使用的仪器仅品牌有7～13种、试剂12～20种、方法学2～6种。所有项目的比对合格率为96.15%,仅天门冬氨酸氨基转移酶、尿酸、血糖的室间加权变异系数(CV)达WS/T403-2012的室内CV标准;分析误差来源整改后比对合格率提至98.43%,新增8个项目的室间加权CV达标。结论一致性比对的合格率较满意,但不同实验室的检测系统差异很大,经误差检出并整改后一致性有所提高但仍未达检验结果互认的要求。     

Studies on the accuracy and precision of total serum cholesterol in regional interlaboratory trials (author's transl)]

The between-run precision of the Liebermann-Burchard reaction modified by Watson was, in our laboratory, 2-3%, the within-run coefficient of variation was 1-2%. The between-run precision of the enzymatic test was 3-4%, the within-run coefficient of variation was 3%. The regression analysis of 92 serum specimens from patients was y = -17.31 + 1.04 chi, the coefficient of regression was r = 0.996. Interlaboratory trials of serum cholesterol were studied in the normal and pathological range. Lyophilized samples of serum prepared commercially and from fresh specimens from patients were analysed by the method of Liebermann-Burchard as well as by the enzymatic procedure. Acceptable results estimated by Liebermann-Burchard were obtained in the different laboratories after using a common standard of cholesterol. The coefficient of variation of the enzymatic test in the interlaboratory trial was higher in comparison to the Liebermann-Burchard reaction. Methodological difficulties of the Liebermann-Burchard reaction are discussed and compared with the specific, enzymatic assay.     

不同实验室间血细胞分析仪比对试验的应用评价

目的：通过比对试验评价四家不同实验室血细胞分析结果的准确性和一致性,探讨血细胞分析仪室间比对试验的规范化。方法：以可溯源的XE-2100血细胞分析仪为参比仪器,连续6个月用新鲜抗凝全血在四家实验室的4台仪器上进行比对试验,收集WBC、RBC、HB、HCT、PLT五个项目数据,参照美国临床实验室修正法案（CLIA,88）文件规定的允许误差的1/2进行评估。结果：四家实验室血细胞分析仪6个月五个比对项目的平均值相对偏差均符合1/2CLIA,88的判断标准（WBC为1.52%、2.14%、3.25%;RBC为1.09%、0.65%、1.32%;HB为0.89%、2.08%、1.14%;HCT为0.25%、1.98%、2.36%;PLT为3.98%、6.54%、8.77%）,相关系数γ均〉0.96;部分仪器在3个月后有不同程度超出可接受范围,进行校准后系统误差得以消除。结论：定期使用新鲜全血在不同实验室间做比对分析,能及时发现仪器的系统误差,通过调整与校准可确保不同实验室间血细胞分析的准确性和一致性。     

Standardized susceptibility testing of fluconazole: an international collaborative study.

An international collaborative study of broth dilution (MIC) and disk diffusion susceptibility testing of fluconazole was conducted by using a chemically defined medium (High-Resolution Antifungal Assay Medium; Oxoid Ltd., Basingstoke, United Kingdom) and standard test methods performed in eight reference laboratories. Ten yeast isolates were tested by each test method in duplicate on each of 3 separate days. The intralaboratory reproducibility of the MIC test was excellent; 95.7% of the replicate tests (n = 220) were within 2 doubling dilutions of the other values in the set for the eight laboratories. The intralaboratory reproducibility of the disk test was also good, with 91% of the replicate tests (n = 234) agreeing with each other within an arbitrarily chosen value of 4 mm. Interlaboratory agreement of MIC test results was acceptable, with 84% of the MICs agreeing within 2 doubling dilutions. In contrast, the interlaboratory agreement of the disk test was not good, with only 59% of test results agreeing within 4 mm. Comparison of the rank order of MICs obtained in each laboratory with the reference rank order gave an agreement of 70 to 80% (median, 80%) with the MIC test and 70 to 90% (median, 80%) with the disk test. These preliminary results are encouraging for the development of standardized testing methods for testing fluconazole.     

Interlaboratory proficiency survey of high-density lipoprotein cholesterol measurement

Proficiency surveys of Seattle-area laboratories suggest only slight improvement in overall performance in high-density lipoprotein (HDL) measurement between 1978 and 1982, although the reported workload for HDL has increased by 15%. The mean interlaboratory SD was 64 mg/L (ranging from 34 for a pool averaging 299 mg/L to 136 for a pool averaging 886 mg of HDL cholesterol per liter) in 1982, compared with 79 mg/L (range 48-155) in 1978-79. Of the individual laboratory results in the current survey, 39% deviated by more than 50 mg/L from target values as compared with 37% in 1978-79. The discrepant values were primarily ascribable to method inaccuracy: only 30% of laboratories in 1982 reported results that averaged within 30 mg/L of target values (vs 50% in 1978). For within-run precision, 80% of laboratories in 1982 had SDs of less than 30 mg/L, vs 70% in 1978. The 1982 survey included a lyophilized serum prepared by spray freezing and bulk lyophilization (Hyland Omega), identical to the pools used in the College of American Pathologists Comprehensive Chemistry Survey, and five pools of frozen plasma. Interlaboratory variation and biases for the Omega pool were similar to those for the frozen pools.     

中国四家参考实验室间ALT和AST的测定结果比对分析

目的 调查我国4家参考实验室应用国际临床化学联合会(IFCC)推荐加和不加磷酸吡哆醛参考方法测定ALT和AST的室内和室间变异,为设定合适的室内和室间变异的范围提供依据.方法 建立加和不加磷酸毗哆醛的IFCC方法,用均一性良好的5个浓度冰冻混合人血清作为比对材料,观察各实验室测量比对样本的室内和室间变异,并与2006年和2007年参考实验室外部质量评价计划(RALE)的结果做比较.同时分析加与不加磷酸吡哆醛时AST、ALT测定值及AST/ALT比值的差异.结果 本次比对的室间变异大于室内变异,仅个别实验室在个别结果出现室内变异大于室间变异的情况.室内变异不大于RELA比对室内变异的变化,室间变异亦明显小于后者.加磷酸吡哆醛法的ALT和AST测量值均比未加法高,两种方法得到的AST/ALT比值具有显著性差异.结论 建议酶学参考实验室ALT、AST测定室内变异分别小于2.72%、2.58%;使用冰冻血清作比对材料时,二者的室间变异小于3.5%;冰冻干燥品作比对材料时,二者的室间变异小于4.5%,应观察不同个体样本加和不加磷酸吡哆醛转氨酶测定值及其比值的变化在疾病诊断与预后评估中的临床意义.     

A multisite physician's office laboratory evaluation of an immunological method for the measurement of HbA1c.

OBJECTIVE--To evaluate the clinical performance of a new immunological HbA1c method in physicians' office laboratories. RESEARCH DESIGN AND METHODS--Three physicians' offices participated in the evaluations. The clinicians routinely use HbA1c test results to monitor their patients' long-term blood glucose control. Precision and interlaboratory variability were assessed using three levels of lyophilized controls. Correlation of the method's results to currently available laboratory methods was made. Comparison of finger-stick (capillary) results to venous EDTA whole blood results was made on 134 patients. Physician and laboratory personnel input was evaluated with regard to the clinical utility of the system. RESULTS--The CVW and CVB were a maximum of 4.5 and 4.4% for the immunoassay system on three levels of control materials at the three sites. Interlaboratory variability among the control means was found to be 4.9-5.4, 8.0-8.3, and 11.7-12.0% HbA1c. Correlation coefficients (r) ranged from 0.95 to 0.99. There was a positive bias by the DCA 2000 compared with the in-house method at site 1. Minimal negative biases were seen by the DCA 2000 with comparative methods used at sites 2 and 3. Median percentage differences with the comparative methods were 12, -1.4, and -5.6%. Comparison of capillary to venous sample results, from the DCA 2000, showed no clinically significant differences. Operator and physician feedback were positive with respect to technical ease in performance of the test and accuracy of results. CONCLUSIONS--Precision was acceptable and interlaboratory variability was low. The immunological method correlated well with manual ion-exchange and automated HPLC methods. The small sample size and good comparison between capillary and venous sample results make fingerstick sampling acceptable. The method provided immediate test results (within 9 min) to the clinicians.     

Interlaboratory variation of leukocyte differential counts: results from the Finnish proficiency testing programme in haematological morphology, 1974-1977

The interlaboratory variation of leukocyte differential counts in the Finnish proficiency testing programme in haematological morphology is presented. During 1974-1977 altogether twenty-four different blood smears with neither leukocytosis nor abnormal leukocytes were examined by the participants. During this period 206 laboratories participated in the voluntary programme. The interlaboratory variation of leukocyte differential counts was analyzed for band neutrophils, segmented neutrophils, eosinophils, basophils, lymphocytes and monocytes. Except for band neutrophils and monocytes the observed variations were found to closely match the known random sampling variation which is inherent in the method for estimating the proportions of the various leukocytes of peripheral blood. It is suggested that the results point to variations in the definitions to differentiate band vs. segmented neutrophils and monocytes vs. lymphocytes. Interlaboratory proficiency testing is considered to offer an effective means to investigate the quality of morphologic analyses as practised on a day to day basis in the participating laboratories.     

T-lymphocyte immunophenotyping blind proficiency testing: a model system for CD4+ T-cells.

OBJECTIVE: To develop and evaluate methods and results for blind proficiency testing for CD4+ T-cells by T-lymphocyte immunophenotyping. DESIGN: A model system was developed to submit duplicate specimens for T-lymphocyte immunophenotyping as if they were routine patient specimens rather than proficiency specimens. Testing results were compared both interlaboratory and intralaboratory. The model system was designed to gather information on not just the analysis, but other segments of the total testing process. SETTING: Research facilities at the Graduate School of Public Health, San Diego State University, San Diego CA. PARTICIPANTS: 1) A healthy adult volunteer donating one pint of blood. 2) Laboratories offering T-lymphocyte immunophenotyping. MAIN OUTCOME MEASURES: 1) Feasibility of blind proficiency so that PT specimens are received, analyzed, and reported by laboratories without being identified as 'proficiency specimens.' 2) The ease and cost of such a system. 3) The comparability of results and report content among laboratories. RESULTS: A total of twenty-two laboratories received blind proficiency specimens. The model developed to submit specimens and receive results proved feasible. The interlaboratory coefficient of variation for CD4+ count for the four survey years ranged from 10% to 66% and for the CD4+ percent ranged from 4% to 15%. The per specimen cost in this blind proficiency testing was $437.65, approximately seven and a half times the cost for nonblinded proficiency testing or performance evaluations. CONCLUSIONS: Blind proficiency as a tool to compare laboratory test results for T-lymphocyte immunophenotyping is feasible but adds costs. The model system is useful to examine more of the laboratory total testing process than the analysis segment.     

Monitoring temporary immunodepression by flow cytometric measurement of monocytic HLA-DR expression: a multicenter standardized study

BACKGROUND: Single-center trials have shown that monocytic HLA-DR is a good marker for monitoring the severity of temporary immunodepression after trauma, major surgery, or sepsis. A new test for measuring monocytic HLA-DR is now available. METHODS: We evaluated a new test reagent set for monocytic HLA-DR expression (BD Quantibritetrade mark HLA-DR/Monocyte reagent; Becton Dickinson) in single-laboratory and interlaboratory experiments, assessing preanalytical handling, lyse-no-wash (LNW) vs lyse-wash (LW) values, reference values, and the effect of use of different flow cytometers and different instrument settings on test variance. RESULTS: For preanalytical handling, EDTA anticoagulation, storage on ice as soon as possible, and staining within 4 h after blood collection gave results comparable to values obtained for samples analyzed immediately after collection (mean increase of approximately 4% in monocytic HLA-DR). Comparison of LNW and LW revealed slightly higher results for LNW ( approximately 18% higher for LNW compared with LW; r = 0.982). Comparison of different flow cytometers and instrument settings gave CVs <4%, demonstrating the independence of the test from these variables and suggesting that this method qualifies as a standardized test. CV values from the interlaboratory comparison ranged from 15% (blood sample unprocessed before transport) to 25% (stained and fixed before transport). CONCLUSIONS: For the BD Quantibrite HLA-DR/Monocyte test, preanalytical handling is standardized. Single-laboratory results demonstrated the independence of this test from flow cytometer and instrument settings. Interlaboratory results showed greater variance than single-laboratory values. This interlaboratory variance was partly attributable to the influence of transport and can be reduced by optimization of transport conditions.     

External quality assessment of urine analysis in Europe. Results of a round table discussion during the symposium 'From uroscopy to molecular analysis', Seeon, Germany, September 18-20, 1999

Interlaboratory surveys on urine quantities have only recently been introduced in several European countries. Representatives of 10 European countries exchanged their experiences during an international urinalysis meeting held in September 1999. Although still not mandatory in most areas, more than 5000 laboratories participated in external quality assessment programs in the countries represented. Qualitative (test strips and microscopic morphology) as well as quantitative chemical and immunochemical quantities were included. The maximal allowable deviations are reported as well as methods used to determine target values. Consensus scales up to reference methods were applied. The participants agreed that quality criteria need to be defined separate from those already existing for plasma/serum analytes. Besides higher biological variables and different medical needs, less standardisation of methods to quantify urine constituents was observed as a major cause of higher interlaboratory differences.