Evaluation of the Novel RITA MTBC Assay for Tuberculosis Detection: A Pilot Comparison with GeneXpert and BD MAX™

Tuberculosis is still one of the leading infectious causes of morbidity and mortality worldwide. Rapid diagnosis is essential for effective treatment and control of tuberculosis transmission. In recent years, nucleic acid amplification tests (NAATs), such as GeneXpert MTB/RIF, BD MAX™, Xpert MTB/RIF-Ultra, have significantly improved tuberculosis diagnostics. However, they mainly require expensive and advanced equipment. The aim of our study was to assess the usefulness of the novel RITA MTBC assay in this diagnostic context. A total of 61 clinical specimens were tested using the RITA MTBC assay in comparison with established molecular diagnostic platforms (GeneXpert and BD MAX™), used as molecular reference assays. Culture and microscopy were performed as part of initial clinical assessment, but the comparative analysis focused on molecular assays to provide a relevant evaluation of diagnostic performance. Among 31 samples previously identified as positive for M. tuberculosis DNA, the assay correctly detected 30 (LOT HPA01/20230601) and 29 (LOT HPA01/20230602). Of 30 negative samples, 28 and 30 were confirmed negative for the respective lots. These results correspond to an average sensitivity of 95% and an average specificity of 97%. The kit demonstrated diagnostic performance that meets requirements for molecular testing in tuberculosis, with sensitivity and specificity comparable to established platforms, although further validation on larger sample sets is necessary. Nevertheless, its excellent specificity, rapid turnaround time, and operational simplicity, make it especially well-suited for decentralized or resource-limited settings. These findings underscore the potential of RITA MTBC as a valuable diagnostic tool in both routine clinical settings and in populations with limited access to healthcare.