常规生化检验项目参考区间适用性验证

目的验证新发布的卫生行业标准《临床常用生化检验项目参考区间》,判定其是否适用于长春地区。方法筛选20～80岁汉族健康体检者,男女每10岁均入组30例以上。使用日立7600-210全自动生化分析仪进行生化项目检测。分析行业标准中8个生化检验项目性别及年龄的差异,判断其是否通过参考区间验证。结果男性血清清蛋白(ALB)水平随着年龄增长呈缓慢下降趋势,男性天门冬氨酸氨基转移酶(AST)、女性碱性磷酸酶(ALP)水平随着年龄增长逐渐上升。女性丙氨酸氨基转移酶(ALT),男性ALT及γ-谷氨酰基转移酶(GGT)水平在20～60岁随年龄增长呈上升趋势,反之,在60～80岁则随年龄增长逐渐下降,所有年龄段检测值均在推荐的参考区间内。常规生化检验项目男女12个亚组测定值94%以上均在参考区间内,均通过了参考区间验证。结论卫生行业标准《临床常用生化检验项目参考区间》适用于吉林地区汉族人群。     

多项生化项目参考区间验证分析

目的对DXC800全自动生化分析仪丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、γ谷氨酰基转肽酶(GGT)、碱性磷酸酶(ALP)、总蛋白(TP)、清蛋白(GLB)、清蛋白/球蛋白比值(A/G)参考区间进行验证分析。方法根据《WS/T402-2012临床实验室检验项目参考区间的制定》的要求,每个被验证项目纳入至少20例健康参考个体,在DXC800全自动生化分析仪性能可靠、室内质控在控的前提下,按实验室标准化操作程序进行检测,采用DIXON方法剔除离群值。结果健康参考个体所有被验证项目测定结果100%落在《WS/T402-2012临床实验室检验项目参考区间的制定》规定的参考区间之内。结论《WS/T402-2012临床实验室检验项目参考区间的制定》所规定的8个生化常规项目参考区间适用于本实验室。     

13项生化项目生物参考区间适用性的验证

生物参考区间是解释、分析检验结果的依据和尺度。临床检验对象由于民族、性别、年龄、生活习惯、居住地区等不同，其生物参考区间存在差异。建立适合本实验室的生物参考区间，为临床提供准确的诊断依据．对每个实验室来说尤为必要。（NCCLS）C28-A2说明：建立参考区间．测定参考个体，统计结果是最可靠的，但又说明：每个实验室、每个检测系统、每个项目都自建生物参考区间工程庞大、昂贵．存在客观难度，本研究采用（NCCLS）C28-A2推荐的方法。对本实验室目前所用的13个常规生化项目的生物参考区间进行验证．探讨其生物参考区间是否适用于本实验。     

13项生化项目生物参考区间适用性的验证

生物参考区间是解释、分析检验结果的依据和尺度。临床检验对象由于民族、性别、年龄、生活习惯、居住地区等不同，其生物参考区间存在差异。建立适合本实验室的生物参考区间，为临床提供准确的诊断依据．对每个实验室来说尤为必要。（NCCLS）C28-A2说明：建立参考区间．测定参考个体，统计结果是最可靠的，但又说明：每个实验室、每个检测系统、每个项目都自建生物参考区间工程庞大、昂贵．存在客观难度，本研究采用（NCCLS）C28-A2推荐的方法。对本实验室目前所用的13个常规生化项目的生物参考区间进行验证．探讨其生物参考区间是否适用于本实验。     

25个常规生化检验项目的参考区间验证

目的评价该实验室目前的25个常规生化检验项目参考区间是否适用于所服务的人群,验证参考区间的适用性。方法依据《WS/T 402-2012临床实验室检验项目参考区间的制定》的规定,每个项目至少选择20例健康参考个体,在该实验室3个分析系统(Beckman公司DxC800、AU5421型以及雅培公司c16000型)上,进行了25个常规生化检验项目的参考区间验证。结果该实验室所开展的25个常规生化检验项目的参考区间均通过验证。结论该实验室现在使用的25个常规生化检验项目参考区间适用于所服务的人群。     

日立7600-110全自动生化分析仪D模块试剂交叉污染及对策

目的分析日立7600-110全自动生化分析仪D模块试剂交叉污染现象,探讨解决方案。方法将D模块4组通道均配置项目后,按单组或4组同时测定各项目(重复3～5次),统计分析各项目结果,验证是否存在交叉污染,若不存在则可按该配置进行临床标本的检验工作;若存在应进一步将4组项目按不同组合再检测,确定具体是哪两个项目存在交叉污染,以便对通道进行调整。结果由天门冬氨酸氨基转移酶(AST)和清蛋白(Alb)分别与尿酸(UA)组合检测结果可以确定UA受Alb污染会导致结果偏高。结论运用该验证方法能有效避免D模块各项目间的交叉污染,提高了检测结果的准确度和精密度。     

日立7600-020型全自动生化仪性能验证

目的对日立7600-020型全自动生化仪装机性能进行验证测试。方法根据美国国家临床实验室标准化委员会(NCCLS)制定的评价标准,用日立7600-020型自动生化仪配套生化试剂对该仪器的精密度、准确性、线性范围、回收率和交叉污染率等进行验证性试验。结果通过对钾(K)、葡萄糖(GLU)、丙氨酸氨基转移酶(ALT)、总蛋白(TP)、三酰甘油(TG)的检测,精密度实验总CV值均小于5%;线性实验相关系数r分别是:0.995 00、.984 90、.989 9、0.995 0、0.984 9;回收率分别为:101.2%、100.7%、98.3%、99.5%、98.9%;交叉污染率为0.63%、0.87%、0.77%、0.82%、0.56%。结论日立7600-020型全自动生化仪交叉携带污染率低,精密度和线性好,各项指标参数均符合仪器设定的要求,达到国家规定的标准。     

VITROS950全自动干化学分析仪生物参考区间适用性验证探讨

目的对950型全自动生化分析仪检验项目的现用生物参考区间进行验证,确保其适用于该实验室,为临床提供准确的诊断依据。方法按照美国临床实验室标准化委员会（NCCLS）C28一A2推荐方法,采集符合要求健康参考个体标本20名．按实验室标准化操作程序（SOP）文件要求规范用VITROS950全自动干化学分析仪检测标本．分析实验结果。结果共计测定19项。其中总蛋白（TP）、白蛋白（ALB）和肌酐（CREA）5％以上在现用的生物参考区问以外,TP、ALB超出上限,CREA超出下限;尿素（UREA）、氯（CI）、总胆红素（TBIL）和乳酸脱氢酶（LDH）95％结果在现用的生物参考区间内;其余项目100％在现用的生物参考区间内。结论该次验证的项目除TP、ALB和CREA外,现用的生物参考区间适用于该实验室,可以继续使用;实验的验证具有科学的说服力,容易发现生物参考区间的偏离,建立完善的验证制度、程序,值得推广应用。     

“实验室管理”讲座之一：临床检验项目的参考值和参考区间

“实验室管理”讲座之一临床检验项目的参考值和参考区间上海市临床检验中心冯仁丰建立一个检验项目，或者临床对病人的某检验项目的结果作出判断时，都须有参考区间。究竟应该怎样来称呼这个专业内容？是正常值，还是参考值；是正常范围还是参考范围，还是参考区间？实验...     

Dimension RxL全自动生化分析仪部分项目参考范围的建立

在临床生化项目测定中,由于各个医院检验科使用的仪器、分析试剂(包括测定方法、试剂组分等)不同,仪器设定的参数也各不相同,故同一份标本不同医院的测定结果和参考范围也会有所不同.但许多测试项目的参考范围的设定仍多以临床教科书、试剂说明书或手工操作为标准,故给病人和临床医生造成许多困惑及不便.因此,我科对常规的几种生化项目:丙氨酸氨基转移酶(ALT)、总蛋白(TP)、白蛋白(Alb)、尿素(Urea)、肌酐(Cr)、尿酸(UA)、血清葡萄糖(Glu)根据NCCLS对有关检验项目的参考值和参考区间设定的导则要求[1],用Dimension RxL全自动生化分析仪及其配套试剂作了正常人的测试,建立了该系统的"本实验室参考范围",并探讨了使用与该仪器配套的试剂的优点及国内一些生化项目参考范围与本实验室上海地区正常人群参考范围间所存在的异同之处.     

Reference individuals,blood collection,treatment of samples and descriptive data from the questionnaire in the Nordic Reference Interval Project 2000

The rules for recruitment of reference individuals, inclusion and preparation of individuals, blood collection, treatment of samples (and control materials) and analysis at the 102 medical laboratories attending the Nordic Reference Interval Project (NORIP) are given as well as the rules for central exclusion of reference individuals. The individuals (18–91‐year‐olds) should be evenly distributed on age and gender groups. The 3002 reference individuals who contributed at least one reference value to the finally suggested reference intervals were characterized using the information in the questionnaire. Gender, age and country are the main entries in the tables. Other variables in the cross‐tables or figure are height, weight, body mass index, ethnic origin, heredity for diabetes, chronic disease, oestrogens or oral contraceptives, other medication, hard physical activity, previous blood donations, smoking habits, use of alcohol, hours since last meal and time of blood collection (hour, day of week, month, year). The Danes had the highest alcohol consumption and the Icelanders had the highest body mass index. The information in this article may interest potential users of the Nordic Reference Interval Project bio‐bank and database (NOBIDA) in which serum, Li‐heparin plasma and EDTA buffy coat from the mentioned individuals are stored below ?80°C.     

Reference individuals, blood collection, treatment of samples and descriptive data from the questionnaire in the Nordic Reference Interval Project 2000

The rules for recruitment of reference individuals, inclusion and preparation of individuals, blood collection, treatment of samples (and control materials) and analysis at the 102 medical laboratories attending the Nordic Reference Interval Project (NORIP) are given as well as the rules for central exclusion of reference individuals. The individuals (18-91-year-olds) should be evenly distributed on age and gender groups. The 3002 reference individuals who contributed at least one reference value to the finally suggested reference intervals were characterized using the information in the questionnaire. Gender, age and country are the main entries in the tables. Other variables in the cross-tables or figure are height, weight, body mass index, ethnic origin, heredity for diabetes, chronic disease, oestrogens or oral contraceptives, other medication, hard physical activity, previous blood donations, smoking habits, use of alcohol, hours since last meal and time of blood collection (hour, day of week, month, year). The Danes had the highest alcohol consumption and the Icelanders had the highest body mass index. The information in this article may interest potential users of the Nordic Reference Interval Project bio-bank and database (NOBIDA) in which serum, Li-heparin plasma and EDTA buffy coat from the mentioned individuals are stored below -80 degrees C.     

迈瑞BS-800生化分析仪血清指数参考区间的确立及性能评价

目的 制定迈瑞BS-800全自动生化分析仪血清指数的参考区间及评估血清指数的可靠性.方法 取正常健康体检标本985例,采用迈瑞BS-800全自动生化分析仪测定脂血指数（L）、溶血指数（H）、黄疸指数（Ⅰ）,制定血清指数的参考区间及线性范围.参考CLSI方法学评价方案,对血清指数的线性、精密度、准确度进行实验和统计分析.用能力对比（PT）实验评价方法的正确度.结果 迈瑞BS-800全自动生化分析仪L,H,I的参考区间分别为＜9.29,＜17.37,＜1.67;L,H,I的线性分别为1～230,2.17～1 200,0.099～40;三项指数批内、批间、天间及总不精密度均小于6％;L与FTU浊度、H与Hb（mg/dl）、Ⅰ与TBIL（mg/dl）具有很好的相关性（r全部＞0.975）,测量结果差异无统计学意义（P＞0.05,H经校正后）;能力对比（PT）试验结果显示Ⅰ测定TBIL准确度良好.结论 迈瑞B＆800全自动生化分析仪的血清指数线性宽,重复性好,通过制定参考区间,对血清混浊、溶血、黄疸程度提供了一个客观的参考.     

The Nordic Reference Interval Project 2000: recommended reference intervals for 25 common biochemical properties

Each of 102 Nordic routine clinical biochemistry laboratories collected blood samples from at least 25 healthy reference individuals evenly distributed for gender and age, and analysed 25 of the most commonly requested serum/plasma components from each reference individual. A reference material (control) consisting of a fresh frozen liquid pool of serum with values traceable to reference methods (used as the project "calibrator" for non-enzymes to correct reference values) was analysed together with other serum pool controls in the same series as the project samples. Analytical data, method data and data describing the reference individuals were submitted to a central database for evaluation and calculation of reference intervals intended for common use in the Nordic countries. In parallel to the main project, measurements of commonly requested haematology properties on EDTA samples were also carried out, mainly by laboratories in Finland and Sweden. Aliquots from reference samples were submitted to storage in a central bio-bank for future establishment of reference intervals for other properties. The 25 components were, in alphabetical order: alanine transaminase, albumin, alkaline phosphatase, amylase, amylase pancreatic, aspartate transaminase, bilirubins, calcium, carbamide, cholesterol, creatine kinase, creatininium, gamma-glutamyltransferase, glucose, HDL-cholesterol, iron, iron binding capacity, lactate dehydrogenase, magnesium, phosphate, potassium, protein, sodium, triglyceride and urate.     

The Nordic Reference Interval Project 2000: recommended reference intervals for 25 common biochemical properties

Each of 102 Nordic routine clinical biochemistry laboratories collected blood samples from at least 25 healthy reference individuals evenly distributed for gender and age, and analysed 25 of the most commonly requested serum/plasma components from each reference individual. A reference material (control) consisting of a fresh frozen liquid pool of serum with values traceable to reference methods (used as the project “calibrator” for non‐enzymes to correct reference values) was analysed together with other serum pool controls in the same series as the project samples. Analytical data, method data and data describing the reference individuals were submitted to a central database for evaluation and calculation of reference intervals intended for common use in the Nordic countries. In parallel to the main project, measurements of commonly requested haematology properties on EDTA samples were also carried out, mainly by laboratories in Finland and Sweden. Aliquots from reference samples were submitted to storage in a central bio‐bank for future establishment of reference intervals for other properties. The 25 components were, in alphabetical order: alanine transaminase, albumin, alkaline phosphatase, amylase, amylase pancreatic, aspartate transaminase, bilirubins, calcium, carbamide, cholesterol, creatine kinase, creatininium, γ‐glutamyltransferase, glucose, HDL‐cholesterol, iron, iron binding capacity, lactate dehydrogenase, magnesium, phosphate, potassium, protein, sodium, triglyceride and urate.     

D-二聚体检测参考区间的验证与分析

目的：对D-二聚体定量检测的参考区间进行验证,并分析年龄和性别因素对参考区间的影响。方法明确参考个体入组标准,招募参考个体男性60例,女63例,按年龄分为3组：20～39岁组（男女各20名）,40～59岁组（男性20名,女性23名）,≥60岁组（男女各20名）。采集参考个体枸橼酸钠抗凝静脉血,分别使用三种不同品牌的血液凝固分析仪及配套试剂检测D-二聚体浓度水平。参照美国临床和实验室标准协会（clinical and laboratory standards institute,CLSI）C28-A3文件,对试剂厂商提供的D-二聚体参考区间进行验证,并采用非参数统计比较不同年龄和性别组间的差异。结果对于40岁以下健康人群,三种检测系统的参考区间均验证通过;对于40岁以上健康人群,A检测系统≥60岁组的验证结果未通过,C检测系统40～59岁组的验证结果未通过。各检测系统不同年龄组的检测结果比较显示D-二聚体浓度随年龄增长呈升高趋势,20～39岁年龄组与40～59岁组、20～39岁年龄组与≥60岁年龄组的 D-二聚体浓度水平的差异均具有统计学意义（P＜0.05）。各检测系统20～39岁组及40～59岁组男女间 D-二聚体浓度水平的差异具有统计学意义（P＜0.05）,而≥60岁年龄组男女间D-二聚体浓度水平差异无统计学意义（P＞0.05）。结论 D-二聚体浓度水平与年龄和性别有关。对于40岁以下健康人群,三种检测系统的参考区间均通过验证,可直接采用;而对于40岁以上健康人群,部分检测系统的参考区间未通过验证,实验室应查找原因,必要时单独设置参考区间。     

Age- and sex-specific reference values for non-HDL cholesterol and remnant cholesterol derived from the Nordic Reference Interval Project (NORIP)

Objectives: Non-HDL-cholesterol (non-HDL-C) has been reported to be a better marker of cardiovascular risk than LDL-cholesterol (LDL-C) especially in individuals with high triglyceride values. Further, levels of remnant cholesterol have been suggested to in part explain residual risk not captured with LDL-C. The aim of the present study was to define reference values for non-HDL-C and remnant cholesterol based on data from the Nordic Reference Interval Project (NORIP).

Methods: We analyzed the test results for total cholesterol, HDL-cholesterol and triglycerides from 1392 healthy females and 1236 healthy males. Non-HDL-C was calculated as measured total cholesterol minus measured HDL-cholesterol. Remnant cholesterol was calculated using the Friedewald equation for LDL-C: measured total cholesterol minus measured HDL-cholesterol and minus calculated LDL-cholesterol. The 2.5th and 97.5th percentiles for these markers were calculated according to the International Federation of Clinical Chemistry guidelines on the statistical treatment of reference values.

Results: Age (18–<30, 30–49 and ≥50?years) and sex-specific reference intervals were calculated for non-HDL-cholesterol and remnant-cholesterol. Levels of non-HDL-C and remnant cholesterol differed between sex and age strata.

Conclusions: Age- and sex-specific reference intervals should be used for the triglyceride rich lipid variables non-HDL-C and remnant cholesterol. Since these markers may add information on risk burden beyond LDL-C, our hope is that these reference intervals will aid the introduction of automatic reporting of non-HDL-C by hospital laboratories.