实时荧光核酸恒温扩增技术在肺结核诊断中的价值分析

摘要

Objective To evaluate the diagnostic value of simultaneous amplification and testing (SAT-TB) in patients with pulmonary tuberculosis. Methods A total of 1121 patients′ sputum samples were cultured or given sputum smear and SAT-TB assay, including 26 cases of non-tuberculous mycobacteria (NTM), 570 cases of pulmo-nary tuberculosis, and 525 cases infected with other pulmonary diseases. The positive rates were analyzed by chi-square test. Results The positive rate were 46. 7% (266 / 570) by SAT assay, followed by sputum culture method (46. 5% , 265 / 570), and sputum smear (34. 4% , 196 / 570) in the clinical diagnosis tuberculosis. The difference between SAT assay and smear was significant (χ2 = 17. 83, P < 0. 01). The positive rate of SAT was 19. 5% for smear negative patients. With the result of culture as the golden standard, the sensitivity and specificity of SAT-TB were 89. 4% and 96. 3% , the positive and negative likelihood ratio were 24. 2 and 0. 11, and the positive predictive value and negative value were 88. 4% and 96. 6% respectively. No positive samples was detected by SAT-assay in the NTM cases. Conclusion SAT assay is a rapid, sensitive and specific method for the early diagnosis of patients with pulmonary tuberculosis.%目的：评价实时荧光核酸恒温扩增技术(SAT-TB)在肺结核诊断中的价值。方法纳入1121例非相同患者痰标本,其中26例为非结核分枝杆菌。570例肺结核为观察组,525例其他肺部疾病患者为对照组。对治疗前的痰标本分别进行抗酸杆菌涂片、培养及鉴定和 SAT 法检测。阳性检出率的比较使用卡方检验。结果临床诊断肺结核570例,痰培养结核菌阳性率46．5%(265/570),SAT 法检测阳性率46．7%(266/570),痰涂片阳性率34．4%(196/570),SAT 与涂片法阳性率的差异有统计学意义(χ2=17．83,P <0．01)。在涂阴肺结核中,SAT 阳性率达19．5%。以培养阳性作为金标准,SAT 法诊断结核病的灵敏度为89．4%,特异度96．3%,阳性似然比为24．2,阴性似然比为0．11,一致率是94．6%,阳性预测值是88．4%,阴性预测值为96．6%。在非结核分枝杆菌肺病中 SAT 检测阳性率为零。结论 SAT-TB 法在肺结核的早期诊断中是一种快速、准确、敏感的方法,值得推广。