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GeneProof Mycobacterium tuberculosis PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

HIGH SENSITIVITY

  • Secured by targeting the multi-copy sequence IS6110 found only in the species within the M. tuberculosis complex

CONTAMINATION ELIMINATION

  • Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible contamination with amplification products

HIGH SPECIFICITY

  • Detection of all species from Mycobacterium tuberculosis complex (M. tuberculosis, M. bovis, M. africanum, M. microti, M. caprae, M. canetti)

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD CERTIFIED DIAGNOSTIC TEST

Order information

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/050 real-time PCR 50 reactions
GeneProof Mycobacterium tuberculosis PCR Kit MT/ISEX/100 real-time PCR 100 reactions

EQA Panels

EQA results

GP_MT_QCMD_2018_EN
pdf, [145.52 kB]
GP_MT_QCMD_C2.2019_EN
pdf, [124.61 kB]
GP_MT_QCMD_croBEE_2019_EN
pdf, [130.15 kB]
GP_MT_QCMD_manual_2019_EN
pdf, [129.3 kB]
Choose all

Technical specification

Technology real-time PCR
Type of Analysis qualitative
Target Sequence specific multi-copy insertion sequence IS6110
Analytical Specificity

Mycobacterium tuberculosis complex (M. tuberculosis, M. bovis, M. africanum, M. microti, M. caprae, M. canetti and vaccine strain BCG), 100%

Analytical 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
External Quality Control regularly tested by the QCMD and Instand e. V. External Quality Assessment Panels - results at www.geneproof.com
Certification CE IVD

*Validated instruments

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.45 MB]
GP_MT_Instruction for Use_EN
pdf, [544.22 kB]

Declaration of Conformity

GP_MT_Declaration of Change_EN_CZ
pdf, [172.59 kB]
GP_MT_Declaration of Conformity_EN
pdf, [320.28 kB]

MSDS

GP_Safety Data Sheet_EN
pdf, [148.84 kB]

Manual

AriaMx Real-Time PCR System_EN
pdf, [2.31 MB]
Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [1.43 MB]
croBEE Real-Time PCR System_EN
pdf, [5.9 MB]
LightCycler 2.0_EN
pdf, [1.94 MB]
LightCycler 480/480 Instrument II_EN
pdf, [2.18 MB]
LineGene 9600_9600Plus_K_EN
pdf, [4.6 MB]
Mic qPCR Cycler_EN
pdf, [2.33 MB]
QuantStudio 3/5 Real-Time PCR System_EN
pdf, [2.29 MB]
Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
SLAN Real-Time PCR System_EN
pdf, [1.56 MB]
StepOne/StepOne Plus Real-Time PCR System_EN
pdf, [4.42 MB]
ThermoFisher ABI 7500/7500 Fast Real-Time PCR System_EN
pdf, [4.2 MB]

Product Leaflet

GP_MT_Leaflet_EN
pdf, [143.14 kB]

PCR Template

GP_Mycobacterium tuberculosis_Mic_1
micassay, [21.98 kB]
Files are available only for registered users.