ULTRA M10 MTB RIF/INH

ULTRA M10 MTB-RIF/INH is a multiplex real-time PCR test intended for use with STANDARD M10 system for the qualitative detection of Mycobacterium tuberculosis complex (MTBC), nucleic acids and drug-resistance mutation in human sputum or sputum sediment specimen. Positive results of IS1081 and IS6110 are indicative of the presence of M. tuberculosis complex. Simultaneously, determining the mutation status through Melt assays for rpoB, katG, and inhA indicates that the detected MTB may have drug resistance to rifampicin (RIF) and/or isoniazid (INH). 

Intended use:

  • ULTRA M10 MTB RIF/INH
  • ULTRA M10 MTB RIF/INH
1 Cat no. RK175-10
2 Method All-in-one CartridgeBacterial DNA ExtractionNucleic Acid Amplification: qPCR + Melting curve analysis
3 Target gene • MTB Complex (IS1081, IS6110) • RIF (rpoB) • INH (katG, inhA) • Internal Control (IC)
4 Sample type Unprocessed sputum, Sputum sediment sample (0.5 ml)
5 Limit of Detection "Sputum sediment: M. tuberculosis (H37Rv) – 2.25 CFU/mL, M. bovis – 0.56 CFU/mL. RR/Hr-TB – 1.68 – 36.95 CFU/mL *Unprocessed sputum: M. tuberculosis (H37Rv) – 3.50 CFU/mL, M. bovis – 0.88 CFU/mL, RR/Hr-TB – 1.85 – 73.83 CFU/mL**Refer to the IFU for detailed LoD values of specific mutant strains"
6 Testing time 99 minutes
7 Storage temp. 2–28°C
8 Test / Kit 10 Tests
Catalogue No Product Storage Temperature Pack Size
RK175-10 ULTRA M10 MTB-RIF/INH 2–28°C 10 Test/ Kit