Untitled

Significance and Impact of the Study: An optimal primers/probe combination based on antigen 85B (Ag85B) was obtained for the detection of Mycobacterium tuberculosis via real-time recombinase polymerase amplification (RPA). The designed RPA could specifically differentiate and determine M. tuberculosis within 20 min at 39°C with high reliability. Particularly, the real-time RPA displayed wonderful sensitivity (90%, 95% CI: 80·0-96·0%) and specificity (98%, 95% CI: 89·0-100·0%) when testing clinical sputum samples. To the best of our knowledge, such an Ag85B-based RPA technology for the detection of M. tuberculosis has not been reported before, which provides a promising strategy for the rapid and efficient diagnosis of tuberculosis.