全自动发光免疫分析仪性能评价技术研究
|
摘要
目的:建立全自动发光免疫分析仪关键模块的性能评价方法。方法:对市面上主流的15家企业生产的30个不同型号的全自动发光免疫分析仪的原理、结构、操作进行了调研,建立了仪器加样系统、孵育系统、清洗系统和检测系统各模块的性能评价方法,按该方法对各仪器进行了测试。结果:孵育系统:所有仪器温度控制正确度在(37±0. 5)℃,波动度不超过0. 5℃;加样系统:各型号仪器的样品针和试剂针量程差异大,样品针最小加注量从5μL到40μL,最大加注量从20μL到300μL,试剂针最小加注量从5μL到50μL,最大加注量从47μL到450μL。无论是样品针还是试剂针,当加注量> 10μL时,大部分仪器能满足偏倚不超过10%,CV不超过3%;当加注量> 50μL时,大部分仪器能满足偏倚不超过5%,CV不超过2%。加注量越小,对仪器要求越高,技术实现难度越大,少数仪器不能达到其声称的最小加注量(<10μL);检测系统:所有仪器均能满足声称的噪声要求,仪器的线性范围满足临床需要,均不小于3个发光值数量级,有的甚至达到6个数量级,少数仪器精密度(CV)超过3%、稳定性(偏倚)超过5%,需进一步改进;清洗系统:某些仪器的携带污染率超过10×10~(-6)。结论:建立了发光免疫分析仪关键模块的性能评价方法,通过测试证明了方法的适用性和可操作性。
Objective: To develop the performance evaluation protocol of automatic luminescence immunoassay analyzers. Methods: The principle,structure and operation of 30 different types of automatic luminescence immunoassay analyzers manufactured by 15 companies were investigated and tested to develop the performance evaluation protocol for sampling system: incubating system,cleaning system and optical system. Results: Incubating system: temperature control accuracy of all the instruments is( 37 ± 0. 5) ℃,and the fluctuation of temperature is not out of the range of 0. 5 ℃.Sampling system: the range of sample injectors and reagent injectors varies greatly. The minimum volume of sample injectors is from 5 μL to 40 μL and the maximum volume is from 20 μL to 300μL. The minimum volume of reagent jnjectors is from 5 μL to 50 μL and the maximum volume is from 47 μL to 450 μL. When the volume is > 10 μ L,most instruments can meet bias < 10% and CV < 3%. When the volume is > 50 μL,most instruments can meet bias < 5% and CV < 2%. The smaller the amount of sample is,the higher the requirement of instrument is,and the more difficultthe technical realization is. A few instruments cannot meet the requirement of minimum injection amount of < 10 μL as claimed. Optical system: all the instruments can satisfy the claimed noise requirements. The linear range meets the clinical needs of more than 3 luminescence magnitudes,and some even reach 6 magnitudes. A few instruments go beyond bounds of precision( CV) 3% and stability( bias) 5%,which need further improvement. Cleaning system: some instruments' carryover rate exceeds 10 × 10~(-6). Conclusion: The performance evaluation method of important modules of LIA is established. The applicability and practicability of the ptotocol are proved by testing.
Objective: To develop the performance evaluation protocol of automatic luminescence immunoassay analyzers. Methods: The principle,structure and operation of 30 different types of automatic luminescence immunoassay analyzers manufactured by 15 companies were investigated and tested to develop the performance evaluation protocol for sampling system: incubating system,cleaning system and optical system. Results: Incubating system: temperature control accuracy of all the instruments is( 37 ± 0. 5) ℃,and the fluctuation of temperature is not out of the range of 0. 5 ℃.Sampling system: the range of sample injectors and reagent injectors varies greatly. The minimum volume of sample injectors is from 5 μL to 40 μL and the maximum volume is from 20 μL to 300μL. The minimum volume of reagent jnjectors is from 5 μL to 50 μL and the maximum volume is from 47 μL to 450 μL. When the volume is > 10 μ L,most instruments can meet bias < 10% and CV < 3%. When the volume is > 50 μL,most instruments can meet bias < 5% and CV < 2%. The smaller the amount of sample is,the higher the requirement of instrument is,and the more difficultthe technical realization is. A few instruments cannot meet the requirement of minimum injection amount of < 10 μL as claimed. Optical system: all the instruments can satisfy the claimed noise requirements. The linear range meets the clinical needs of more than 3 luminescence magnitudes,and some even reach 6 magnitudes. A few instruments go beyond bounds of precision( CV) 3% and stability( bias) 5%,which need further improvement. Cleaning system: some instruments' carryover rate exceeds 10 × 10~(-6). Conclusion: The performance evaluation method of important modules of LIA is established. The applicability and practicability of the ptotocol are proved by testing.
引文
[1]王栩,林金明.化学发光免疫分析技术新进展[J].分析试验室,2007,26(6):111-122.WANG X,LIN J M. Progress on chemiluminescence immunoassay[J]. Chin. J. Anal. Lab.,2007,26(6):111-122.(in Chinese)
[2]许叔祥.医学超微量定量分析方法和计量技术进展[J].上海计量测试,2002,29(4):4-6.XU S X. Development of the medical ultra—micro quantitative analysis method and metrological techniques[J]. Shanghai Meas. Test.,2002,29(4):4-6.(in Chinese)
[3]马雪峰.自动化在临床免疫检验中的应用进展[J].临床医药文献电子杂志,2017,4(11):2046.MA X F. Progress of application of automation in clinical immunoassay[J]. J. Clin. Med.,2017,4(11):2046.(in Chinese)
[4]赵方戟,周康,房庆海.一种全自动化学发光免疫分析仪的研制[J].冶金自动化,2009(S1):501-503.ZHAO F J,ZHOU K,FANG Q H. Development of an automatic chemiluminescent immunoassay instrument[J]. Metall.Ind. Autmat.,2009(S1):501-503.(in Chinese)
[5]赵建文,陈艳宁,路士州.化学发光免疫检测仪涉及的关键技术[J].发光学报,2012,33(12):1381-1388.ZHAO J W,CHEN Y N,LU S Z. Key technologies of chemiluminescence immunoassay analyzer[J]. Chin. J. Lumin.,2012,33(12):1381-1388.(in Chinese)
[6]国家食品药品监督管理局. YY/T 1155-2009全自动发光免疫分析仪[S].北京:中国医药科技出版社,2011.China Food and Drug Administration. YY/T 1155-2009 Automatic Luminescence Immunoassay Analyzers[S]. Beijing:China Medical Science Press,2011.(in Chinese)
[7]国家质量监督检验检疫总局.全自动封闭型发光免疫分析仪校准规范(报批稿)[S].General Administration of Quality Supervision,Inspection and Quarantine of The PRC. Calibration Specification for Automatic Closed Luminescence Immunoassay Analyzers(Draft Standard for Approval)[S].(in Chinese)
[8]周强,张文,黄宪章,等. CENTAUR全自动化学发光免疫分析仪性能评价[J].实用医学杂志,2005,21(13):1469-1470.ZHOU Q,ZHANG W,HUANG X Z,et al.. Performance evaluation of CENTAUR automatic chemiluminescent immunoassay analyzer[J]. J. Pract. Med.,2005,21(13):1469-1470.(in Chinese)
[9]黄湘宁,郑春苏. Roche cobas e411全自动化学发光分析仪性能评价[J].检验医学与临床,2011,8(16):2028-2029.HUANG X N,ZHENG C S. Performance evaluation of Roche cobas e411 automatic chemiluminescent immunoassay analyzer[J]. Lab. Med. Clin.,2011,8(16):2028-2029.(in Chinese)
[10]郭楠,房亚哲,杨琦,等.雅培i2000全自动化学发光免疫分析仪性能评价方法研究[J].中国医药科学,2013,3(7):75-76.GUO N,FANG Y Z,YANG Q,et al.. Study on the performance evaluation of ARCHITECT i2000 automatic chemiluminescence immunoassay analyzer[J]. China Med. Pharm.,2013,3(7):75-76.(in Chinese)
[11]国家食品药品监督管理总局. YY/T 0654-2017全自动生化分析仪[S].北京:中国标准出版社,2017.China Food and Drug Administration. YY/T 0654-2017 Automatic Chemistry Analyzer[S]. Beijing:Standards Press of China,2017.(in Chinese)
[12]王耿媛,赖官铨.全自动化学发光免疫分析仪的校准方法研究及不确定度评定[J].医疗卫生装备,2016,37(3):100-101.WANG G Y,LAI G Q. Calibration method and uncertainty evaluation of automatic chemiluminescence immunoassay analyzer[J]. Chin. Med. Equip. J.,2016,37(3):100-101.(in Chinese)
[13]李兰英,徐勤,许丽,等.化学发光分析仪计量校准用生物化学反应标准体系研究[J].中国测试,2015,41(3):46-50.LI L Y,XU Q,XU L,et al.. Research of a biochemical reaction system for the calibration of the microplate luminometer[J]. China Meas. Test.,2015,41(3):46-50.(in Chinese)
[14]魏寿忠,康晓珍,陈依平,等.化学发光免疫分析仪加样针携带污染情况探讨[J].国际检验医学杂志,2017,38(15):2171-2172.WEI S Z,KANG X Z,CHEN Y P,et al.. Discussion on contamination of sample injection by chemiluminescent immunoassay analyzer[J]. Int. J. Lab. Med.,2017,38(15):2171-2172.(in Chinese)
[2]许叔祥.医学超微量定量分析方法和计量技术进展[J].上海计量测试,2002,29(4):4-6.XU S X. Development of the medical ultra—micro quantitative analysis method and metrological techniques[J]. Shanghai Meas. Test.,2002,29(4):4-6.(in Chinese)
[3]马雪峰.自动化在临床免疫检验中的应用进展[J].临床医药文献电子杂志,2017,4(11):2046.MA X F. Progress of application of automation in clinical immunoassay[J]. J. Clin. Med.,2017,4(11):2046.(in Chinese)
[4]赵方戟,周康,房庆海.一种全自动化学发光免疫分析仪的研制[J].冶金自动化,2009(S1):501-503.ZHAO F J,ZHOU K,FANG Q H. Development of an automatic chemiluminescent immunoassay instrument[J]. Metall.Ind. Autmat.,2009(S1):501-503.(in Chinese)
[5]赵建文,陈艳宁,路士州.化学发光免疫检测仪涉及的关键技术[J].发光学报,2012,33(12):1381-1388.ZHAO J W,CHEN Y N,LU S Z. Key technologies of chemiluminescence immunoassay analyzer[J]. Chin. J. Lumin.,2012,33(12):1381-1388.(in Chinese)
[6]国家食品药品监督管理局. YY/T 1155-2009全自动发光免疫分析仪[S].北京:中国医药科技出版社,2011.China Food and Drug Administration. YY/T 1155-2009 Automatic Luminescence Immunoassay Analyzers[S]. Beijing:China Medical Science Press,2011.(in Chinese)
[7]国家质量监督检验检疫总局.全自动封闭型发光免疫分析仪校准规范(报批稿)[S].General Administration of Quality Supervision,Inspection and Quarantine of The PRC. Calibration Specification for Automatic Closed Luminescence Immunoassay Analyzers(Draft Standard for Approval)[S].(in Chinese)
[8]周强,张文,黄宪章,等. CENTAUR全自动化学发光免疫分析仪性能评价[J].实用医学杂志,2005,21(13):1469-1470.ZHOU Q,ZHANG W,HUANG X Z,et al.. Performance evaluation of CENTAUR automatic chemiluminescent immunoassay analyzer[J]. J. Pract. Med.,2005,21(13):1469-1470.(in Chinese)
[9]黄湘宁,郑春苏. Roche cobas e411全自动化学发光分析仪性能评价[J].检验医学与临床,2011,8(16):2028-2029.HUANG X N,ZHENG C S. Performance evaluation of Roche cobas e411 automatic chemiluminescent immunoassay analyzer[J]. Lab. Med. Clin.,2011,8(16):2028-2029.(in Chinese)
[10]郭楠,房亚哲,杨琦,等.雅培i2000全自动化学发光免疫分析仪性能评价方法研究[J].中国医药科学,2013,3(7):75-76.GUO N,FANG Y Z,YANG Q,et al.. Study on the performance evaluation of ARCHITECT i2000 automatic chemiluminescence immunoassay analyzer[J]. China Med. Pharm.,2013,3(7):75-76.(in Chinese)
[11]国家食品药品监督管理总局. YY/T 0654-2017全自动生化分析仪[S].北京:中国标准出版社,2017.China Food and Drug Administration. YY/T 0654-2017 Automatic Chemistry Analyzer[S]. Beijing:Standards Press of China,2017.(in Chinese)
[12]王耿媛,赖官铨.全自动化学发光免疫分析仪的校准方法研究及不确定度评定[J].医疗卫生装备,2016,37(3):100-101.WANG G Y,LAI G Q. Calibration method and uncertainty evaluation of automatic chemiluminescence immunoassay analyzer[J]. Chin. Med. Equip. J.,2016,37(3):100-101.(in Chinese)
[13]李兰英,徐勤,许丽,等.化学发光分析仪计量校准用生物化学反应标准体系研究[J].中国测试,2015,41(3):46-50.LI L Y,XU Q,XU L,et al.. Research of a biochemical reaction system for the calibration of the microplate luminometer[J]. China Meas. Test.,2015,41(3):46-50.(in Chinese)
[14]魏寿忠,康晓珍,陈依平,等.化学发光免疫分析仪加样针携带污染情况探讨[J].国际检验医学杂志,2017,38(15):2171-2172.WEI S Z,KANG X Z,CHEN Y P,et al.. Discussion on contamination of sample injection by chemiluminescent immunoassay analyzer[J]. Int. J. Lab. Med.,2017,38(15):2171-2172.(in Chinese)