摘要
Abstract
Objective Background The AmpSure simultaneous amplification and testing method for the detection of Mycobacterium tuberculosis(SAT-TB assay) was designed to diagnose rapidly pulmonary tuberculosis(PTB).Unfortunately,the diagnostic advantage is unclear from previous small sample studies.Objective In the current inquiry,a large sample size was used to reevaluate the clinical accuracy of the SAT-TB assay using sputum specimens.Methods A total of 2 381 patients with suspected PTB were enrolled prospectively for diagnosis from sputum specimens using the SAT-TB assay.Of these,1 981 had a definite diagnosis of PTB confirmed by positive microbiology,or pathologic findings of TB in the lung,or clinical diagnosis of active PTB following anti-TB treatment with a favorable response.Results The sensitivity,specificity and accuracy of the SAT-TB assay were 57.09%,97.75%,and 63.92%,respectively.The sensitivity of SAT-TB was significantly higher than that of the sputum smear 29.83%) χ2=230.518,P=0.000),and sputum culture(44.07%)(χ2=119.963,P=0.000).The specificity of SAT-TB was no significantly higher than that of sputum smears(97.5%) and sputum cultures(100%).The sensitivity of SAT-TB for smear-negative PTB were 46.04%.Conclusion In summary,the SAT-TB assay is a fast,accurate method with high specificity for diagnosis of TB.It is a valuable method for managing smear negative/sputum scarce PTB suspects,and can be widely applied in the clinic,especially for fast diagnosis of smear-negative or sputum-scarce PTB suspects.关键词
RNA恒温扩增技术/痰标本/结核分枝杆菌Key words
RNA constant temperature amplification/sputum specimens/Mycobacterium tuberculosis
