The EuDx™ MDR-TB Detection Kit is an in vitro diagnostic reagent intended for the qualitative detection of Mycobacterium tuberculosis complex and multidrug-resistant M. tuberculosis (MDR-TB) in human sputum and cultured specimens. The assay is performed using real-time polymerase chain reaction (PCR) to simultaneously detect the M. tuberculosis complex and genetic mutations associated with resistance to rifampicin (RIF) and isoniazid (INH). According to Sensitivity; The assay demonstrates positive detection rates of over 95% at 100 copies for all 12 target mutations. Furthermore, key mutations such as rpoB S531L, katG S315T, and inhA-15C are reliably detected at as low as 50 copies. According to Specificity; No cross-reactivity was observed with genomic DNAs from 13 non-tuberculous mycobacterial (NTM) species and 14 other pathogenic microorganisms. Additionally, common PCR inhibitors, including human genomic DNA and certain antibiotics, did not interfere with assay performance.