STANDARD M10 MDR-TB
STANDARD M10 MDR-TB is a multiplex real-time PCR test intended for use with STANDARD M10 system for the qualitative detection of M. tuberculosis complex nucleic acids and drug-resistance mutation in human normal sputum or sputum sediment sample. Positive results of IS1081 and IS6110 are indicative of the presence of M. tuberculosis complex. Positive results for rpoB, katG and inhA indicate that the detected M. tuberculosis complex have drug resistance for rifampicin (RIF) and/or isoniazid (INH).
Generally
STANDARD M10 MDR-TB is a molecular in vitro diagnostic assay that aids in the simultaneous detection and differentiation of IS1081 and IS6110 genes of M. tuberculosis complex strains and rpoB, katG and inhA gene as multi-drug resistant parameter based on nucleic acid amplification technology, real-time PCR. STANDARD M10 MDR-TB cartridge contains bacterial DNA extraction buffers and PCR reagents for the in vitro qualitative detection of IS1081 and IS6110 genes of M. tuberculosis complex strains and rpoB, katG and inhA gene as multi-drug resistant parameter in human normal sputum or sputum sediment specimen.
STANDARD M10 tests are used in combination with STANDARD M10 system consisting of a console (user interface) and one or more modules (cartridge analysis function). The system is a modular random access platform which can be easily scaled with up to 8 modules, offering a customized throughput.
Easy and simple test workflow
- All-in-one cartridge (nucleic acid extraction and PCR amplification)
- Minimal hands-on time, results available in 86 min
- Intuitive touch screen user interface
- Automated result interpretation, amplification curves provided
STANDARD M10 benefits
- Versatile and flexible solution ― suitable for any healthcare settings
- RT-PCR technology in one system
- Multiplex capability, with up to 11 targets + internal control
- Random access, scalable with up to 8 modules
Technical data
| Products available | SD BIOSENSOR STANDARD M10 MDR-TB Test |
| Use | For in vitro diagnostic use |
| Method | Real-time PCR amplification |
| Sample type | Pretreated sputum or pretreated sputum sediment |
| Instrument information | 155067 SD BIOSENSOR STANDARD M10 CONSOLE 155068 SD BIOSENSOR STANDARD M10 MODULE |
| Time to result | 86 minutes |
| Reading of the result | Automatic |
| Storage | Between +2 and +28 oC |
| Sensitivity | 100 % |
| Specificity | 100 % |
| Transportation | Between +2 and +28oC |
| Additionally needed | STANDARD M10 instrumentation, STANDARD M10 Sputum Pretreatment Kit, Sample container, Screw capped tube, 0.067 M Phosphate/H20 buffer, Micropipette with filter tips, |
| Country of origin | South Korea |
| Registration | CE IVDD |
About Tuberculosis (TB)
Tuberculosis (TB) is an infectious disease, which is caused by infection with M. tuberculosis complex organisms. It spreads to new hosts through the air from patients who have respiratory tuberculosis disease. Individuals newly infected would get symptoms from TB within weeks to months.
Rifampicin is a semisynthetic derivative of rifamycin B, and is widely used as the essential drug for the treatment of TB. Rifampicin binds to β-subunit of bacterial DNA dependent RNA polymerase (RNAP) and interferes with the initiation of RNA synthesis. Thus, rifampicin effectively functions as antibiotic by inhibiting essential bacterial activity. Mutation of the rpoB gene on the β-subunit causes a decrease the affinity of RNAP for rifampicin, and it causes bacteria to have resistance to rifampicin.
Isoniazid works effectively against active M. tuberculosis complex. Isoniazid is a prodrug that is activated by a strong catalase enzyme into acyl radical active form, the enzyme is named catalase-peroxidase (KatG) encoded by the katG gene. Active form of the compound disrupts the mycolic acid biosynthesis by inhibiting the NADH-dependent enoyl-acyl carrier protein reductase encoded by inhA gene. Mycolic acid is an essential building block of mycobacterial cell wall.
Mutations in the katG gene and inhA gene result in reduction or loss of isoniazid antibacterial activity by inactivation of KatG and structural changes in isoniazid compounds. In the case of multi-drug resistant tuberculosis (MDR-TB), which is resistant to rifampin and isoniazid at the same time, the effect of standard first-line treatment is not adequate. Thus, second-line anti-tuberculosis regimen is needed. For the effective treatment of tuberculosis patients, resistance tests of rifampicin and isoniazid should be performed simultaneously with the diagnosis of M. tuberculosis complex.