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GeneProof Team
Product name | Catalog no. | Technology | Packaging |
GeneProof Mycobacterium tuberculosis PCR Kit | MT/ISEX/025 | real-time PCR | 25 reactions |
GeneProof Mycobacterium tuberculosis PCR Kit | MT/ISEX/100 | real-time PCR | 100 reactions |
Indication | in vitro diagnostic medical device |
Intended User | For professional use in laboratories with trained staff |
Regulatory Status | CE IVD |
Technology | Real-time PCR |
Type of Analysis | Qualitative |
Target Sequence | Multi-copy insertion sequence IS6110 and sequence for immunogenic protein MPB64 |
Analytical Specificity |
Mycobacterium tuberculosis complex (M. tuberculosis, M. africanum, M. bovis, M. microti, M. canettii, M. pinnipedi, M. caprae, M. orygis, M. mungi and vaccination strain Bacillus Calmette–Guérin, BCG), (MT) 100 % |
Analytical Sensitivity (LoD with 95% probability) |
0.09 cp/µl (performed on AmpliRun® Mycobacterium tuberculosis DNA control, Vircell) |
Extraction / Inhibition Control |
PCR inhibition and DNA extraction efficiency control by Internal Control (IC) |
Validated Specimen |
Sputum, BAL, swab, urine, CSF, plasma, stool |
Storage |
-20 ± 5 °C |
Validated Extraction Methods | croBEE 201A Nucleic Acid Extraction System GeneProof PathogenFree DNA Isolation Kit myCROBE/croBEE 2.0 Universal Extraction Kit QIAamp Fast Stool Mini Kit |
Instruments |
croBEE Real-Time PCR System* |
Required Detection Channels | FAM, HEX/JOE/VIC |
External Quality Control | Regularly tested in the QCMD and Instand e. V. External Quality Assessment Panels - results at www.geneproof.com |
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GeneProof offers a unique PCR testing solution that provides differential diagnostics of many pathogens
Our products’ quality, safety, and performance are fully compliant with the new rules for in vitro…