全自动血凝仪CA-7000性能及生物参考区间的验证与评价
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摘要
目的了解攀钢集团总医院检验科实验室新购SYSMEX全自动血凝仪CA-7000的性能指标是否符合相关要求以及上海太阳试剂厂商提供的参考区间能否直接应用于临床。方法(1)批内不精密度:取新鲜混合血浆[凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、纤维蛋白原(FIB)为3个浓度水平,凝血酶时间(TT)、D-二聚体、纤维蛋白原降解产物(FDP)为正常浓度水平]连续测定各20次,计算标准偏差(SD)、变异系数(CV)。(2)日间不精密度:采用两个水平的质控品,每天测定1次,连续20 d,计算SD、CV。(3)携带污染率:测定稀释的血浆3次后,测定原浓度血浆3次,再测定稀释的血浆3次,计算携带污染率。(4)线性范围:测定5个浓度的样本,与理论值作比较,计算y=ax+b。(5)准确性:重复测定蒸馏水复溶后的FIB定值血浆、D-二聚体、FDP质控品(低值、高值)10次,计算均值和FIB的相对偏差。(6)正确度评价:选用国家卫生和计划生育委员会凝血5个批次室间质控品为正确度评价物,计算偏倚率。(7)生物参考区间的验证:选择20个健康体检人群进行生物参考区间转移的验证,计算R值。结果(1)批内不精密度:不同水平PT、APTT、FIB的CV分别为0.46%~1.06%、0.47%~2.66%、1.99%~3.92%,正常水平TT、D-二聚体、FDP的CV分别为0.71%、4.24%、7.05%。(2)日间不精密度:正常水平PT、APTT、FIB、TT的CV分别为2.62%、2.1%、8.9%、2.0%,异常水平PT、APTT的CV分别为2.85%、3.1%。(3)携带污染率:FIB为0.42%,D-二聚体为3.58%,FDP为1.96%。(4)检测线性范围:FIB为0.8~5.7 g/L,D-二聚体为0.50~30.00 mg/L,FDP为12.50~110.00 mg/L。(5)准确性:FIB相对偏差为7.15%,CV<15%,D-二聚体/FDP均在质控范围内。(6)生物参考区间的验证:总样本R值为0.96。(7)正确度评价结果:除一个批号的APTT偏倚处在上限外(15.28%),其余各指标均合格。结论本实验室新购的全自动血凝仪SYSMEX CA-7000各项性能指标基本符合要求,太阳试剂厂商提供的参考区间可以使用。
Objective To verify whether the performance indexes of the newly purchased SYSMEX automatic coagulation analyzer CA-7000 conform to the relevant standards and whether the reference interval provided by SUNBIO Shanghai can be directly applied to the clinic.Methods(1) Within-run imprecision:freshly mixed plasma [prothrombin time(PT),activated partial thromboplastin time(APTT),fibrinoge(FIB),three different concentration respectively;thrombin time(TT),D-Dimer,fibrin degradation product(FDP),normal concentration],measured 20 times in a row,then computed the standard deviation(SD),the coefficient of variation(CV).(2) Daytime imprecision:by using the quality control materials with two different concentration,measured once per day for 20 days,then calculate SD and CV.(3) Carryover rates:after the diluted plasma samples were measured by three times,the plasma samples in original concentration were measured three times again,then the first step was repeated,and then calculated carryover rate.(4) Linear range:measured the samples with five different concentrations and comparedthe measured value with theoretical values,then calculated y=ax+b.(5) Accuracy:dissolved by double distilled water,the standard plasma samples with fixed FIB value,D-Dimer and FDP quality control materials(low value and high value) were repeatedly measured 10 times,then calculate mean and relative deviation of the FIB.(6) Accuracy rating:choose 5 different batches of quality control material came from 5 different blood coagulation laboratories,which was accredited by NHFPC,as the correct assessment products to calculate bias.(7) Validation of biological reference interval:20 healthy volunteers were enrolled for validating the biological reference interval transfer,calculated R-values.Results(1) In-batch imprecision:in different level of PT,APTT and FIB,the CV were 0.46%-1.06%,47%-2.66%,and 1.99%-3.92%,respectively;in normal level of TT,D-Dimer and FDP,the CV were 0.71%,4.24%,and 7.05%,respectively.(2) Daytime imprecision:CV of normal level PT,APTT,FIB,and TT were 2.62%,2.1%,8.9%,and 2.0%,respectively;CV of abnormal level PT and APTT were 2.85% and 3.1%.(3) Carryover rates:FIB was 0.42%,D-Dimer was 3.58%,FDP was 1.96%.(4) Detection of linear range:FIB was 0.8-5.7 g/L,D-Dimer was 0.5-30.00 mg/L,FDP was 2.50-110.00 mg/L.(5) Accuracy:the relative deviation of FIB was 7.15%,CV < 15%,the ratio of D-Dimer/FDP was in the context of quality control.(6) Validation of biological reference interval:the total sample R value was 0.96.(7) Accuracy evaluation results:all the indexes were qualified except that a bias from a batch of APTT which exceeded the upper limit.Conclusion The performance indicators of our new full-automatic blood coagulation analyzer,SYSMEX CA-7000,conform to the relevant standards;and the reference range provided by SUNBIO can be used directly.Key words
Objective To verify whether the performance indexes of the newly purchased SYSMEX automatic coagulation analyzer CA-7000 conform to the relevant standards and whether the reference interval provided by SUNBIO Shanghai can be directly applied to the clinic.Methods(1) Within-run imprecision:freshly mixed plasma [prothrombin time(PT),activated partial thromboplastin time(APTT),fibrinoge(FIB),three different concentration respectively;thrombin time(TT),D-Dimer,fibrin degradation product(FDP),normal concentration],measured 20 times in a row,then computed the standard deviation(SD),the coefficient of variation(CV).(2) Daytime imprecision:by using the quality control materials with two different concentration,measured once per day for 20 days,then calculate SD and CV.(3) Carryover rates:after the diluted plasma samples were measured by three times,the plasma samples in original concentration were measured three times again,then the first step was repeated,and then calculated carryover rate.(4) Linear range:measured the samples with five different concentrations and comparedthe measured value with theoretical values,then calculated y=ax+b.(5) Accuracy:dissolved by double distilled water,the standard plasma samples with fixed FIB value,D-Dimer and FDP quality control materials(low value and high value) were repeatedly measured 10 times,then calculate mean and relative deviation of the FIB.(6) Accuracy rating:choose 5 different batches of quality control material came from 5 different blood coagulation laboratories,which was accredited by NHFPC,as the correct assessment products to calculate bias.(7) Validation of biological reference interval:20 healthy volunteers were enrolled for validating the biological reference interval transfer,calculated R-values.Results(1) In-batch imprecision:in different level of PT,APTT and FIB,the CV were 0.46%-1.06%,47%-2.66%,and 1.99%-3.92%,respectively;in normal level of TT,D-Dimer and FDP,the CV were 0.71%,4.24%,and 7.05%,respectively.(2) Daytime imprecision:CV of normal level PT,APTT,FIB,and TT were 2.62%,2.1%,8.9%,and 2.0%,respectively;CV of abnormal level PT and APTT were 2.85% and 3.1%.(3) Carryover rates:FIB was 0.42%,D-Dimer was 3.58%,FDP was 1.96%.(4) Detection of linear range:FIB was 0.8-5.7 g/L,D-Dimer was 0.5-30.00 mg/L,FDP was 2.50-110.00 mg/L.(5) Accuracy:the relative deviation of FIB was 7.15%,CV < 15%,the ratio of D-Dimer/FDP was in the context of quality control.(6) Validation of biological reference interval:the total sample R value was 0.96.(7) Accuracy evaluation results:all the indexes were qualified except that a bias from a batch of APTT which exceeded the upper limit.Conclusion The performance indicators of our new full-automatic blood coagulation analyzer,SYSMEX CA-7000,conform to the relevant standards;and the reference range provided by SUNBIO can be used directly.Key words
引文
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2 卢根林,吴爱兵,王宏宾.急性胰腺炎患者内源性硫化氢水平的变化及与凝血功能的关系[J].中华危重病急救医学,2016,28(3):217-220.
3 尚红,王毓三,申子瑜.全国临床检验操作规程[M].4版.北京:人民卫生出版社,2014:86-117.
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5 兰秀凤,孙元君.妊娠期糖尿病和妊娠期高血压患者的凝血功能检测及其临床意义[J].实用检验医师杂志,2016,8(3):159-161.
6 International Organization for Standardization.ISO15189 Medical laboratories:particular requirements for quality and competence[S].Geneva:ISO,2003.http://www.iso-15189.com/index.html.
7 杨有业,张秀明.临床检验方法学评价[M].北京:人民卫生出版社,2009:139-140.
8 Clinical and Laboratory Standards Institute.CLSI C28-A2 How to define and reference intervals in the clinical laboratory[S].Wayne:CLSI,2000.
9 王薇,钟堃,何法霖,等.2012年全国凝血试验检验项目参考区间现状调查分析[J].中华血液学杂志,2015,36(1):39-43.
10 Solberg HE.International Federation of Clinical Chemistry.Scientific committee,Clinical Section.Expert Panel on Theory of Reference Values and International Committee for Standardization in Haematology Standing Committee on Reference Values.Approved recommendation(1986)on the theory of reference values.Part 1.The concept of reference values[J].Clin Chim Acta,1987,165(19):111-118.
11 Fuentes-Arderiu X,Mas-Serra R,Alumà-Trullàs A,et al.Guideline for the production of multicentre physiological reference values using the same measurement system.A proposal of the Catalan Association for Clinical Laboratory Sciences[J].Clin Chem Lab Med,2004,42(7):778-782.
12 米玛央宗,赵旭宏,侯军林,等.建立高原地区成年人红细胞相关参数参考区间的研究[J].实用检验医师杂志,2015,7(1):32-35.
13 中华人民共和国国家卫生和计划生育委员会.医疗机构临床实验室管理办法[R].北京:中华人民共和国国家卫生和计划生育委员会.http://www.moh.gov.cn/mohyzs/s3577/200804/18468.shtml
14 孔建新,姚丽娟,李洁.CA-7000血凝分析仪性能评估及临床参考范围建立[J].临床输血与检验,2011,13(3):240-244.
2 卢根林,吴爱兵,王宏宾.急性胰腺炎患者内源性硫化氢水平的变化及与凝血功能的关系[J].中华危重病急救医学,2016,28(3):217-220.
3 尚红,王毓三,申子瑜.全国临床检验操作规程[M].4版.北京:人民卫生出版社,2014:86-117.
4 胡冰红.采血时抗凝比例不准确对凝血4项测定结果的影响[J].实用检验医师杂志,2016,8(3):186-187.
5 兰秀凤,孙元君.妊娠期糖尿病和妊娠期高血压患者的凝血功能检测及其临床意义[J].实用检验医师杂志,2016,8(3):159-161.
6 International Organization for Standardization.ISO15189 Medical laboratories:particular requirements for quality and competence[S].Geneva:ISO,2003.http://www.iso-15189.com/index.html.
7 杨有业,张秀明.临床检验方法学评价[M].北京:人民卫生出版社,2009:139-140.
8 Clinical and Laboratory Standards Institute.CLSI C28-A2 How to define and reference intervals in the clinical laboratory[S].Wayne:CLSI,2000.
9 王薇,钟堃,何法霖,等.2012年全国凝血试验检验项目参考区间现状调查分析[J].中华血液学杂志,2015,36(1):39-43.
10 Solberg HE.International Federation of Clinical Chemistry.Scientific committee,Clinical Section.Expert Panel on Theory of Reference Values and International Committee for Standardization in Haematology Standing Committee on Reference Values.Approved recommendation(1986)on the theory of reference values.Part 1.The concept of reference values[J].Clin Chim Acta,1987,165(19):111-118.
11 Fuentes-Arderiu X,Mas-Serra R,Alumà-Trullàs A,et al.Guideline for the production of multicentre physiological reference values using the same measurement system.A proposal of the Catalan Association for Clinical Laboratory Sciences[J].Clin Chem Lab Med,2004,42(7):778-782.
12 米玛央宗,赵旭宏,侯军林,等.建立高原地区成年人红细胞相关参数参考区间的研究[J].实用检验医师杂志,2015,7(1):32-35.
13 中华人民共和国国家卫生和计划生育委员会.医疗机构临床实验室管理办法[R].北京:中华人民共和国国家卫生和计划生育委员会.http://www.moh.gov.cn/mohyzs/s3577/200804/18468.shtml
14 孔建新,姚丽娟,李洁.CA-7000血凝分析仪性能评估及临床参考范围建立[J].临床输血与检验,2011,13(3):240-244.