OBJECTIVE: Tuberculosis (TB), caused by Mycobacterium tuberculosis (MTB), remains a leading cause of infectious mortality globally. Conventional diagnostic tools face limitations in sensitivity, specificity, cost, and differentiation between latent and active TB. Emerging molecular systems like Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-Cas12, especially when combined with isothermal amplification, offer a rapid, sensitive, and cost-effective alternative suitable for point-of-care settings. The aim of this study was to evaluate the diagnostic performance of CRISPR-Cas12 systems integrated with isothermal amplification techniques for MTB detection.

MATERIALS AND METHODS: A systematic review was conducted in PubMed, Scopus, ScienceDirect, Wiley, and SpringerLink to identify studies published between 2020 and 2025. Studies combining CRISPR-Cas12 with isothermal amplification were included. The Quality assessment of diagnostic accuracy studies-2 (QUADAS-2) tool was used to assess study quality.

RESULTS: Eight studies were included, employing various Cas12 systems and isothermal amplification strategies. Reported sensitivity ranged from 67.2% to 100%, and specificity from 95.2% to 100%. Several systems outperformed GeneXpert in some individual studies, especially in smear-negative samples.

CONCLUSIONS: CRISPR-Cas12 combined with isothermal amplification demonstrates high diagnostic potential for TB detection, offering excellent sensitivity and specificity, rapid turnaround time, and suitability for point-of-care testing.