Hang Li,* Zhen Zhang,* Qian Li, Hao Huang, Chun-Yan Ma

Department of Laboratory Medicine, Kaifeng Central Hospital, Kaifeng, Henan, 475000, People’s Republic of China

*These authors contributed equally to this work

Correspondence: Hang Li, Department of Laboratory Medicine Kaifeng Central Hospital, Kaifeng, Henan, 475000, People’s Republic of China, Tel +86 10 13837894656, Email hang297li@126.com

Objective: This study aimed to analyze the participation and results of the interlaboratory quality assessment for serological biomarkers of infectious diseases, including a five-panel test for hepatitis B, hepatitis C antibodies, and syphilis spirochete antibodies in Kaifeng City, China.
Methods: The assessment conducted by the Center for Clinical Laboratories in Kaifeng City from 2021 to 2022 was retrospectively analyzed. Laboratories participating in the interlaboratory quality assessment activities received two batches of independent clinical laboratory quality control material. These samples were tested in accordance with the provided test instruction manual. The reported results were statistically compared and assessed against those obtained by the clinical testing center.
Results: Data analysis revealed no significant differences in report rates and passing rates among medical institutions of varying levels. However, a significant statistical difference was observed between primary and tertiary hospitals (X2 = 341.1, P < 0.05). Additionally, a similar significant difference was noted in the results obtained using different methodologies (X2 = 0.997, P < 0.05).
Conclusion: The retrospective analysis of interlaboratory quality assessment activities, along with the statistical assessment of test results, assists clinical laboratories in identifying potential systematic and random errors, as well as other factors contributing to control loss. This process facilitates the timely development of effective improvement measures, enhancing test quality and ensuring the provision of accurate and reliable laboratory data for clinical use.

Keywords: 5-panel hepatitis B test, external quality assessment, hepatitis C, retrospective analysis, serum quality control samples, syphilis