全自动发光免疫分析仪性能评价技术研究

王军; 代蕾颖; 杨忠; 赵丙锋; 李正; 王会如

doi:doi:10.3788/fgxb20194001.0122

发光学报, 2019, 40 (1): 122, 网络出版: 2019-01-19

全自动发光免疫分析仪性能评价技术研究

Study for Performance Evaluation Protocol of Automatic Luminescence Immunoassay Analyzer

论文大纲

王军代蕾颖杨忠赵丙锋李正王会如

作者单位

北京市医疗器械检验所体外诊断检验室, 北京 101111

全自动发光免疫分析仪关键模块性能评价 automatic luminescence immunoassay analyzer system modules performance evaluation protocol

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5 μL到40 μL, 最大加注量从20 μL到300 μL, 试剂针最小加注量从5 μL到50 μL, 最大加注量从47 μL到450 μL。无论是样品针还是试剂针, 当加注量＞10 μL时, 大部分仪器能满足偏倚不超过10％, CV不超过3％; 当加注量＞50 μL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(＜10 μL); 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。

Abstract

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 300 μL. 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 difficult the 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’carry-over 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.

参考文献

[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)

王军, 代蕾颖, 杨忠, 赵丙锋, 李正, 王会如. 全自动发光免疫分析仪性能评价技术研究[J]. 发光学报, 2019, 40(1): 122. WANG Jun, DAI Lei-ying, YANG Zhong, ZHAO Bing-feng, LI Zheng, WANG Hui-ru. Study for Performance Evaluation Protocol of Automatic Luminescence Immunoassay Analyzer[J]. Chinese Journal of Luminescence, 2019, 40(1): 122.

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