Experimental Evaluation of the Clinical Laboratory ELISA Assay Using A Randomization Quality Control Method for Indoor Quality Control
10.3969/j.issn.1671-7414.2025.03.037
- VernacularTitle: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
- Author:
Zhijun GAO
1
;
Jianjun LI
1
;
Yin CAI
1
;
Yana REN
1
;
Mengchen XIE
1
;
Lan ZHENG
1
;
Guoping ZHOU
1
Author Information
1. 上海市血液中心,上海 200051
- Publication Type:Journal Article
- Keywords:
randomized quality control;
indoor quality control;
ELISA
- From:
Journal of Modern Laboratory Medicine
2025;40(3):199-202
- CountryChina
- Language:Chinese
-
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.
