Application and analysis of enzyme immunoassay quality monitoring indicators in blood station laboratories

Abstract

Objective To evaluate the quality of laboratory testing using anti-HIV ELISA quality monitoring indicators and continuously improve laboratory testing capabilities. Methods The data of our blood testing laboratory from July 1, 2020 to December 31, 2022 using laboratory quality monitoring indicators were analyzed, including the reaction sample size and reaction rate of initial test and the reaction sample size and compliance rate of retest. The indoor quality control data of two anti HIV ELISA reagents (Xinchuang and Wantai) during the above time period were collected. A line chart or scatter box chart was drawn to monitor the long-term trends and identify the reasons. Inter-laboratory capability comparison and evaluation with the data from the quality monitoring index evaluation report of the National Health Commission′s Clinical Inspection Center and the National Blood Station Blood Testing Laboratory during the same period was conducted. Results From July 1, 2020 to December 31, 2022, the initial reaction rates of Xinchuang and Wantai anti HIV ELISA reagents were 0.052% and 0.080%, respectively (P<0.05), and the retest compliance rates were 43.97% and 73.39%, respectively (P<0.001). The linear mean trend of the retest compliance rate of innovative reagents is close to the national average retest compliance rate of the same group, while the retest compliance rate of Wantai reagents is higher than the national average retest compliance rate of the same group reagents. The usage rates of the two reagents are lower than the national average for the same group of reagents. The average dispersion of indoor quality control values between different batches of innovative reagents is greater than that of Wantai reagents, but the dispersion of indoor quality control CV between different batches of reagents is similar. Conclusion Longitudinal analysis of long-term testing data in our laboratory through laboratory quality monitoring indicators and horizontal comparison of laboratories with the same reagents nationwide are able to promptly identify problems in the laboratory, therefore help correct the problems and continuously improve the laboratory′s quality management system, further enhancing the laboratory′s testing capabilities.

Keywords

• blood station laboratory
• quality monitoring indicators
• elisa
• anti-hiv