The GeneProof Mycoplasma pneumoniae PCR Kit is a PCR-based solution designed for the accurate detection of Mycoplasma pneumoniae with high sensitivity and specificity. Its targeted multicopy sequence of the M181 gene ensures precise and dependable results, while its easy-to-use concept simplifies laboratory workflow. The Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs, which prevent carryover contamination, ensuring reliable and accurate results. The kit is also easily combinable with other GeneProof PCR kits, enabling the detection of multiple pathogens in one workflow. It is compatible with a wide range of real-time PCR devices, and as a CE IVD certified diagnostic test, it guarantees top-notch quality and reliability.
Instructions for Use
Declaration of Conformity
MSDS
Publications
Manual
PCR Templates
The GeneProof Mycobacterium tuberculosis PCR Kit is a state-of-the-art solution for detecting M. tuberculosis with unparalleled accuracy and reliability. This advanced PCR kit features dual target detection, which effectively prevents detection failures caused by mutations by targeting the multi-copy sequences of IS6110 and MPB64.
The kit boasts high specificity in detecting all species from the Mycobacterium tuberculosis complex, including M. tuberculosis, M. africanum, M. bovis, M. microti, M. canetti, M. caprae, M. orygis, M. mundi, and the Bacillus Calmmette-Guérin vaccination strain (BCG). The kit is also validated to detect M. tuberculosis from a wide range of clinical materials, including sputum, bronchoalveolar lavage, swabs, urine, cerebrospinal fluid, plasma, and stool.
The GeneProof Mycobacterium tuberculosis PCR Kit features an easy-to-use concept, with a single tube Ready-to-Use Master Mix containing all the necessary components for PCR amplification. No additional PCR reagents pipetting is necessary, thereby streamlining laboratory workflow. Additionally, the kit’s Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs, preventing carryover contamination, and ensuring accuracy and reliable results.
The kit is compatible with a wide range of real-time PCR devices, and as a CE IVD certified diagnostic test, it guarantees top-notch quality and reliability.
Laboratory technicians can rely on the GeneProof Mycobacterium tuberculosis PCR Kit for accurate and efficient detection of M. tuberculosis, simplifying their laboratory workflow and ensuring high-quality results every time.
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* AMPLilab 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 Gentier 96E/96R Real-Time PCR 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 |
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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