STANDARD M10 MTB-NTM

STANDARD M10 MTB/NTM is a multiplex real-time PCR test intended for use with STANDARD M10 system for the qualitative detection of M. tuberculosis complex (MTBC), and non-tuberculous mycobacteria (NTM) nucleic acids in human normal sputum or sputum sediment sample. Positive results are indicative of the presence of MTBC, and/or NTM; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.  Negative results must be combined with clinical observations, patient history, and epidemiological information.

Intended use:

  • STANDARD M10 MTB-NTM
  • STANDARD M10 MTB-NTM
1 Cat. No. 11MTB20A
2 Method All-in-one Cartridge Bacterial DNA Extraction Nucleic Acid Amplification: qPCR
3 Target gene • MTBC (IS6110)• NTM (ITS)• Internal Control (IC) – Exogenous gene
4 Sample type Unprocessed sputum, Sputum sediment sample (0.5 ml)
5 Limit of detection Sputum sediment: M. tuberculosis – 0.255 CFU/ml, NTM (M. avium / M. kansasii, others) – 0.195 ~ 720 CFU/mL *Sputum: M. tuberculosis – 0.92 CFU/mL, NTM (M. avium / M. kansasii, others) – 0.28 ~ 754.92 CFU/mL**Refer to the IFU for detailed LoD values specific to each target species
6 Testing time In 77 minutes
7 Storage temp. 2–28°C
8 Test / Kit 10 Tests
Catalogue No Product Storage Temperature Pack Size
11MTB20A STANDARD M10 MTB/NTM 2–28°C 10 Test/Kit