GeneProof Mycobacterium tuberculosis PCR Kit
CE IVD
PRODUCT DETAIL
The PCR kit is designed for Mycobacterium tuberculosis detection by the real-time Polymerase Chain Reaction (PCR) method.
The M. tuberculosis detection consists in amplification of a specific multi-copy insertion sequence IS6110 and in measurement of fluorescence increase. The kit specifically detects strains of the Mycobacterium tuberculosis complex (M. tuberculosis, M. bovis, M. africanum, M. microti, M. caprae and M. canettii) and also vaccination strain BCG. The M. tuberculosis presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative detection.
TECHNICAL SPECIFICATION
| Technology | real-time PCR |
| Type of Analysis | qualitative |
| Target Sequence | specific multi-copy insertion sequence IS6110 |
| Specificity | Mycobacterium tuberculosis complex (M. tuberculosis, M. bovis, M. africanum, M. microti, M. caprae, M. canetti and vaccine strain BCG), 100% |
| Sensitivity (LoD) | reaches up to 0.191 cp/µl with the probability 95 % (on Amplirun® Mycobacterium tuberculosis DNA control, Vircell) |
| Extraction / Inhibition Control | PCR inhibition control (ISIN version)
PCR inhibition and DNA extraction efficiency control (ISEX version) |
| Validated Specimen | BAL, CSF, sputum, stool, swab, urine |
| Storage | -20 ± 5 °C |
| Validated Extraction Methods | croBEE NA16 Nucleic Acid Extraction System
GeneProof PathogenFree DNA Isolation Kit |
| Validated instruments | croBEE Real-Time PCR System Applied Biosystems 7300 / 7500 Real-Time PCR System AriaMx Real-Time PCR System CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System LightCycler® 2.0 / 480 LineGene 9600 / 9600 Plus Mic qPCR Cycler QuantStudio™ 3 / 5 Real-Time PCR System Rotor-Gene 3000 / 6000 / Q SLAN® Real-Time PCR System StepOne™ / StepOnePlus™ Real-Time PCR System |
| Required Detection Channels | FAM, HEX |
| Quality Control | Quality management system is certified in compliance with the requirements of the standard ISO 13485 |
| External Quality Control | regularly tested by the QCMD and Instand e. V. External Quality Assessment Panels - results at www.geneproof.com |
| Certification | CE IVD for in vitro Diagnostics Use |
ORDER INFORMATION
| Product name | Cat. No. | Technology | Package |
| GeneProof Mycobacterium tuberculosis PCR Kit | MT/ISIN/025 | real-time PCR | 25 reactions |
| GeneProof Mycobacterium tuberculosis PCR Kit | MT/ISIN/05 | real-time PCR | 50 recations |
| GeneProof Mycobacterium tuberculosis PCR Kit | MT/ISIN/100 | real-time PCR | 100 reactions |
| GeneProof Mycobacterium tuberculosis PCR Kit | MT/ISEX/025 | real-time PCR | 25 reactions |
| GeneProof Mycobacterium tuberculosis PCR Kit | MT/ISEX/050 | real-time PCR | 50 reactions |
| GeneProof Mycobacterium tuberculosis PCR Kit | MT/ISEX/100 | real-time PCR | 100 reactions |