结核杆菌抗体检测参考区间及临界值的临床研究  

Study on the reference interval and critical value of mycobacterium tuberculosis antibodyaided diagnosis system

作　　者：沈建雄[1] 杨晶 王瑛[1] 侯飞 李福刚[2] 

机构地区：[1]上海中医药大学附属岳阳中西医结合医院检验科,上海200437 [2]上海奥普生物医药有限公司,上海201201

出　　处：《中国医学装备》2016年第9期52-55,共4页China Medical Equipment

基　　金：上海浦东新区科技发展基金创新资金(PKJ2012-D09)“结核分支杆菌抗体定量检测系统的研究”

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。Objective To establish the reference interval and critical value of mycobacteriumtuberculosis antibody-aided diagnosis system. Methods： Two hundred and thirty-seven sampleswere detected （69 in tuberculosis group, 168 in healthy group）. The serum samples werecollected and the antibody to mycobacterium tuberculosis was detected by the colloidal goldmethod and a set of instruments （Q-Pad）. By analyzing statistically the data, the referenceinterval and critical value were determined. Results： The reference interval of mycobacteriumtuberculosis antibody-aided diagnosis system was less than or equal to 47.7 unit, and the critical value of antibody tomycobacterium tuberculosis diagnosis was 45 unit. The sensitivity was 88%, and the specificity was 92%. Conclusion：Establishing reasonable the reference interval and the critical value for testing antibody to mycobacterium tuberculosis,and testing the results can avoid visual differences arising from human factors by a Q-Pad instrument, in order toensure the results are reliable, scientific and applicable for diagnostic mycobacterium tuberculosis.

关 键 词：结核分枝杆菌抗体 辅助诊断 参考区间 临界值 

分 类 号：R378.911[医药卫生—病原生物学]