结核杆菌抗体检测参考区间及临界值的临床研究.pdfVIP

学术论著 中国医学装备2016年9月第13卷第9期 China Medical Equipment 2016 September Vol.13 No.9 结核杆菌抗体检测参考区间及临界值的临床研究* 沈建雄① ② ① ② ②* 杨 晶 王 瑛 侯 飞 李福刚 [文章编号] 1672-8270(2016)09-0052-04 [中图分类号] R378.911 [文献标识码] A [摘要] 目的： 建立结核分枝杆菌抗体辅助诊断系统的参考区间及临界值，以保证检测结核杆菌 抗体结果的准确性。方法：选取经医院确诊为肺结核病的69例患者和168名健康体检者，同时采 集其血清标本。应用胶体金法并使用配套仪器检测血清标本结核分枝杆菌抗体含量，通过对数据 统计分析，建立结核分枝杆菌抗体辅助诊断系统的参考区间及临界值。结果：建立的结核分枝杆 菌抗体辅助诊断的参考区间为≤47.7 unit，结核分枝杆菌抗体诊断的临界值为45 unit，灵敏度为 88%，特异度为92%。结论：合理建立结核分枝杆菌抗体辅助诊断的参考区间及临界值，采用仪 器判读检测结果，可避免目测时由于人为因素而产生的差异，从而最大限度的保证结核杆菌抗体 检测结果的可靠性、科学性及适用性。 [关键词] 结核分枝杆菌抗体；辅助诊断；参考区间；临界值 DOI: 10.3969/J.ISSN.1672-8270.2016.09.016 作者简介 Study on the reference interval and critical value of mycobacterium tuberculosis antibody- aided diagnosis system/SHEN Jian-xiong, YANG Jing, WANG Ying, et al// China Medical 沈建雄,男,(1965- ), Equipment,2016,13(9):52-55. 本科学历，副主任医 [Abstract] Objective: To establish the reference interval and critical value of mycobacterium 师。上海中医药大学附 tuberculosis antibody-aided diagnosis system. Methods: Two hundred and thirty-seven samples 属岳阳中西医结合医院 were detected (69 in tuberculosis group, 168 in healthy group). The serum samples were 检验科，从事体外诊断 collected and the antibody to mycobacterium tuberculosis was detected by the colloidal gold method and a set of instruments (Q-Pad). By analyzing statistically the data, the reference 试剂评估及管理工作。 interval and critical value were determined. Results: The reference interval of mycobacterium tuberculosis antibody-aided diagnosis system was less than or equal to 47.7 unit, and the critical value of antibody to mycobacterium tuberculosis diagnosis was 45 unit. The sensitivity was 88%, and the specificity was 92%. Conclusion: Establishing reasonable