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中国开封不同医疗机构乙肝抗体、丙肝抗体和梅毒抗体检测能力的比较分析

Comparative Analysis of Detection Capabilities for Hepatitis B Antibody, Hepatitis C Antibody, and Syphilis Antibody in Different Medical Institutions in Kaifeng, China.

作者信息

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

机构信息

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

出版信息

Risk Manag Healthc Policy. 2025 Sep 10;18:3009-3016. doi: 10.2147/RMHP.S536815. eCollection 2025.

Abstract

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 ( = 341.1, < 0.05). Additionally, a similar significant difference was noted in the results obtained using different methodologies ( = 0.997, < 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.

摘要

目的

本研究旨在分析开封市传染病血清学标志物的实验室间质量评估的参与情况和结果,包括乙肝、丙肝抗体及梅毒螺旋体抗体的五项检测。

方法

对开封市临床检验中心2021年至2022年进行的评估进行回顾性分析。参与实验室间质量评估活动的实验室收到两批独立的临床实验室质量控制材料。这些样本按照提供的测试说明书进行检测。将报告结果与临床检测中心获得的结果进行统计学比较和评估。

结果

数据分析显示,不同级别医疗机构的报告率和合格率无显著差异。然而,一级医院和三级医院之间存在显著的统计学差异(χ² = 341.1,P < 0.05)。此外,使用不同方法获得的结果也存在类似的显著差异(χ² = 0.997,P < 0.05)。

结论

对实验室间质量评估活动的回顾性分析以及对检测结果的统计学评估,有助于临床实验室识别潜在的系统误差和随机误差以及导致失控的其他因素。这一过程有助于及时制定有效的改进措施,提高检测质量,并确保为临床提供准确可靠的实验室数据。

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