DI Mycobasterium Tuberculosis complex High Performances (DIMTB-HPE)
The DI Mycobacterium Tuberculosis Complex High Performance (DIMTB-HPE) kit is an in vitro diagnostic device intended for the qualitative detection of DNA from bacteria responsible for respiratory infections in human patients presenting clinical signs compatible with tuberculosis, without restriction of age or associated pathology.
This device is based on real-time PCR technology. It allows the detection, in a single well, of bacteria belonging to the Mycobacterium tuberculosis complex (MTB: M. tuberculosis, M. bovis, M. africanum, M. microti, M. canettii, M. caprae, and M. pinnipedii) without species distinction, as well as a non-target exogenous control, co-extracted with the samples. This control is used to evaluate extraction efficiency and to detect the presence of potential PCR inhibitors.
The device is designed for use on sputum, bronchoalveolar lavage, nasopharyngeal, or tongue swabs collected by a qualified healthcare professional. Prior to PCR amplification, nucleic acids (NA) must be extracted using validated methods.
| Samples |
Sputum, tongue swab, sputum swab, bronchoalveolar lavage |
| Targets |
3 different targets on the IS6110 gene and Mycobacterium smegmatis as NTPC |
| Controls | 3 different targets on the IS6110 gene and Mycobacterium smegmatis as NTPC |
| Duration | ~ 1 hour |
| Equipment | Nucleic acid extraction kit, thermocycler |
| Storage temperature | From -16°C to -26°C |
| Transport temperature | Room temperature |
| Reference | DIMTB-HPE-50 |