Tuberculosis (TB), primarily caused by Mycobacterium tuberculosis complex (MTBC), remains a global health challenge and can lead to severe pulmonary and extrapulmonary complications. Multidrug-resistant TB (MDR-TB) poses additional challenges, requiring advanced diagnostic and treatment strategies. This study evaluates the BD MAX MDR-TB molecular test for a rapid diagnosis of MDR-TB, detecting resistance to rifampicin (RIF) and isoniazid (INH). The BD MAX MDR-TB test, utilizing real-time PCR, was used to analyze specimens collected from TB-suspected patients, identifying MTB DNA and mutations associated with rifampicin and isoniazid resistance. Results were compared with traditional drug susceptibility testing, and 79 out of 638 samples tested were positive for MTB DNA, with 65 showing a sufficient amount of genetic material for resistance gene identification. The BD MAX test showed a 100% correlation with phenotypic rifampicin resistance, though discrepancies were noted for isoniazid resistance, with a 93% concordance. The BD MAX MDR-TB test is an effective tool for a rapid diagnosis of MDR-TB, especially for rifampicin resistance. However, it may not detect certain mutations related to isoniazid resistance. Complementary tests like Xpert MTB/XDR or whole-genome sequencing could improve diagnostic accuracy and support more effective TB control strategies.

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.