TB-SA结核抗体检测的临床应用评价

Evaluation of TB-SA antibody test in clinical diagnosis of tuberculosis

目的评价结核分枝杆菌TB-SA抗体检测在结核病诊断中的应用效果。方法对440例结核病、非结核病的其他呼吸系统疾患患者及健康体检者同步进行抗酸杆菌涂片、培养及结核分枝杆菌TB-SA抗体检测。结果285例临床诊断的活动性结核患者,TB-SA抗体检测阳性199例,阳性率69.8%,检测58例非结核患者,假阳性7例,假阳性率12.1%,检测97例健康对照,假阳性13例,假阳性率13.4%;检测菌阳肺结核的敏感性为72.7%,菌阴肺结核的敏感性为66.9%;阳性检出率69.9%远远高于细菌学阳性检出率52.3%,2χ=17.2,P<0.001,具有统计学意义。结论结核分枝杆菌TB-SA抗体检测诊断结核病有较好的敏感性和特异性,是结核病诊断和鉴别诊断的可靠手段。

Objective To evaluate sera TB-SA antibody ELISA kits in diagnosis of tuberculosis. Methods Four hundred and forty cases of tuberculosis, other lung diseases and healthy people were enrolled and diagnosed by clinic, bacteriology and X-ray examination, and also detected by sera TB-SA antibody test by using enzyme linked immunosorbent assay （ELISA）. Results One hundred and ninety-nine patients of two hundred and eighty-five active tuberculosis patients showed positive results tested by using TB-SA antibody ELISA kits, the positive rate being 69.8%, 7 of 58 patients with other lung diseases and 13 of 97 healthy people showed false positive results, the false rate being 12.1% and 13.4% respectively. The sensitivities of TB-SA antibody in diagnosis of bacteriological positive and negative pulmonary tuberculosis patients were 72.7% and 66.9% respectively. With a total sensitivity of 69.9% ,which was higher than bacteriological patients tests of 52.3 %. The difference between two methods was significant （ P 〈 0.001 ）. Conclusion The results suggests that the measuring of sera TB-SA is a credible method in diagnosis and differential diagnosis of tuberculosis, which has a better sensitivity and specificity.