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Instructions for Use
Declaration of Conformity
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.
|in vitro diagnostic medical device
|For professional use in laboratories with trained staff
|Type of Analysis
|Multi-copy insertion sequence IS6110 and sequence for immunogenic protein MPB64
|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)
|Sputum, BAL, swab, urine, CSF, plasma, stool
|-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
|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
|External Quality Control
|Regularly tested in the QCMD and Instand e. V. External Quality Assessment Panels – results at www.geneproof.com