MTB/MDR qPCR Panel

The "Bio-Speedy® MTB/MDR qPCR Panel" is a qualitative and non-automated in vitro medical device that detects the antimicrobial resistance mutations in Mycobacterium tuberculosis: “Rifampicin resistance (rpoB 513Leu, rpoB 513Glu, rpoB 516Val, rpoB 511Pro, rpoB 526Tyr, rpoB 526Asp, rpoB 526Leu, rpoB 531leu, rpoB 531Trp, rpoB 533Pro), Isoniazid resistance (inhA T(-8)C, inhA C(-15)T, katG 315Thr)". The kit functions as aid to diagnosis and requires "Sputum,BAL" samples. The kit is intended for use by laboratory professionals trained in the techniques of qPCR and in vitro diagnostic procedures.