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:10.3788/fgxb20194001.0122

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全自动发光免疫分析仪性能评价技术研究

发光学应用及交叉前沿 | 更新时间：2020-08-12

- 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
- 发光学报 2019年40卷第1期页码：122-129
- 作者机构：
  
  北京市医疗器械检验所体外诊断检验室北京,101111
- 作者简介：
- 基金信息：
  
  国家后补助项目（战略性新兴医疗器械产业关键技术标准研究2015BAI44H00）资助()
- DOI：10.3788/fgxb20194001.0122
  中图分类号： TF068.2
- 收稿日期：2018-03-29，
  
  修回日期：2018-06-09，
  
  网络出版日期：2018-07-06，
  
  纸质出版日期：2019-01-05
- 稿件说明：
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王军, 代蕾颖, 杨忠等. 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): 122-129

WANG Jun, DAI Lei-ying, YANG Zhong etc. Study for Performance Evaluation Protocol of Automatic Luminescence Immunoassay Analyzer[J]. Chinese Journal of Luminescence, 2019,40(1): 122-129
王军, 代蕾颖, 杨忠等. 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): 122-129 DOI： 10.3788/fgxb20194001.0122.

WANG Jun, DAI Lei-ying, YANG Zhong etc. Study for Performance Evaluation Protocol of Automatic Luminescence Immunoassay Analyzer[J]. Chinese Journal of Luminescence, 2019,40(1): 122-129 DOI： 10.3788/fgxb20194001.0122.

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（370.5）℃，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 L到40 L，最大加注量从20 L到300 L，试剂针最小加注量从5 L到50 L，最大加注量从47 L到450 L。无论是样品针还是试剂针，当加注量

10 L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 L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 L）；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1010

-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 (370.5)℃

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 L to 40 L and the maximum volume is from 20 L to 300 L. The minimum volume of reagent jnjectors is from 5 L to 50 L and the maximum volume is from 47 L to 450 L. When the volume is

10 L

most instruments can meet bias

10% and CV

3%. When the volume is

50 L

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 L 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 1010

-6

. Conclusion:The performance evaluation method of important modules of LIA is established. The applicability and practicability of the ptotocol are proved by testing.

关键词

Keywords

references

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