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

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

*Validated instruments

ORDER INFORMATION

Product name

Cat. No. Technology Package
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