[1]高智俊,李建钧,蔡 茵,等.临床实验室ELISA检测采用随机位质控方法进行室内质控的实验评价[J].现代检验医学杂志,2025,40(03):199-202.[doi:10.3969/j.issn.1671-7414.2025.03.037]
　GAO Zhijun,LI Jianjun,CAI Yin,et al.Experimental Evaluation of the Clinical Laboratory ELISA Assay Using A Randomization Quality Control Method for Indoor Quality Control[J].Journal of Modern Laboratory Medicine,2025,40(03):199-202.[doi:10.3969/j.issn.1671-7414.2025.03.037]
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临床实验室ELISA检测采用随机位质控方法进行室内质控的实验评价()

《现代检验医学杂志》[ISSN:/CN:]

卷:
第40卷
期数:
2025年03期
页码:
199-202
栏目:
质量控制·实验室管理
出版日期:
2025-05-15

文章信息/Info

Title:
Experimental Evaluation of the Clinical Laboratory ELISA Assay Using A Randomization Quality Control Method for Indoor Quality Control
文章编号:
1671-7414（2025）03-199-04
作者:
高智俊，李建钧，蔡 茵，任亚娜，谢梦晨，郑 岚，周国平
（上海市血液中心，上海 200051）
Author(s):
GAO Zhijun, LI Jianjun, CAI Yin, REN Yana, XIE Mengchen, ZHENG Lan, ZHOU Guoping
(Shanghai Blood Center, Shanghai 200051, China)
关键词:
随机位质控; 室内质控; 酶联免疫吸附试验
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2025.03.037
文献标志码:
A
摘要:
目的为了将随机位质控逐步完善应用于ELISA的日常检测，评价ELISA随机位质控的应用，持续提高实验室检测能力及质量保证。方法收集乙型肝炎病毒表面抗原项目带有随机位质控的微孔板数据，比较随机位质控与固定位质控的差异。分组比较各行与各列随机位质控的差异。回顾性分析随机位质控数据并利用随机位质控数据建立质控图，分析比较其与固定位质控的失控情况。结果同一微孔板中的随机位质控S/CO值（2.831±0.343）与固定位质控S/CO值（2.651±0.260）两者差异具有统计学意义（t=5.970，P＜0.05）。第2列至第8列随机位质控与固定位质控两者差异有统计学意义（t=2.285~5.536，均P＜0.05），第9列至第12列随机位质控与固定位质控两者差异无统计学意义（t=0.031~1.605，均P>0.05）。各行之间随机位质控的差异无统计学意义（F=0.858，P＞0.05）。利用随机位质控数据建立质控图，在收集的数据所在的时间范围内随机位质控失控6次，均为大于+3s，失控率4.72%（6/127）。同期的固定位质控失控9次，均为大于+3s，失控率0.61%（9/1481）。结论随机位质控有更大的可能性能反映出微孔板上全部孔位标本的受影响因素。可利用随机位质控发现检测中可能存在的系统误差。随机位质控可逐步应用于日常室内质量控制，但失控率和变异系数可能会升高。
Abstract:
Objective To evaluate the application of ELISA randomized quality control, and continuously improve the laboratory testing capacity and quality assurance, in order to gradually improve the application of randomized quality control to the daily testing of ELISA. Methods Collected the quality control data of KEHUA HBsAg, compared the difference between randomized quality control data and immobilized quality control data. Group comparison of randomization quality control between rows and columns. The randomized quality control data were analyzed retrospectively and the quality control chart was established by using the randomized quality control data. Analyzed and compared the lost-control situation of randomized quality control and immobilized quality control. Results Randomized quality control S/CO value（2.831±0.343） and immobilized quality control S/CO value（2.651±0.260）in the same microplate, the difference between two was statistically significant（t=5.970, P＜0.05）. The differences between randomized quality control and immobilized quality control in columns 2 to 8 were statistically significant (t=2.285~5.536, all P < 0.05). There were no statistically significant differences between randomized quality control and immobilized quality control in column 9 to 12 (t=0.031~1.605, all P > 0.05). There was no statistically significant difference in randomization quality control among all lines (F=0.858, P＞0.05). The randomized quality control data was used to establish a quality control chart. Within the time range of the collected data, the randomized quality control was out of control for 6 times，all were greater than +3s, and the loss of control rate was 4.72% (6/127). Fixed position quality control lost control 9 times during the same period,all of which were greater than +3s,with a loss of control rate of 0.61%(9/1 481).Conclusion The randomized quality control has a greater possibility to reflect the factors affecting all the samples on the microporous plate. Random quality control can be used to find possible systematic errors in testing. Randomized quality control can gradually be fully applied to daily indoor quality control, but the loss of control rate and coefficient of variation may increase.

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备注/Memo

备注/Memo:
作者简介：高智俊（1988-），男，副主任技师，研究方向：血液筛查检测、血液筛查实验室质量控制，E-mail：gaozhijun@sbc.org.cn。
通讯作者： 周国平（1967-），男，主任技师，研究方向：血液筛查实验室质量管理及相关研究，E-mail：zhouguoping@sbc.org.cn。郑岚（1968-），女，主任技师，研究方向：血液筛查实验室质量管理及相关研究，E-mail：zhenglan@sbc.org.cn。
更新日期/Last Update: 2025-05-15