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GeneProof Mycobacterium tuberculosis PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

DUAL TARGET DETECTION

  • Dual targeting prevents detection failures caused by occurrence of mutations
  • Secured by targeting the multi-copy sequence IS6110 and MPB64

HIGH SPECIFICITY

  • Detection of all species from Mycobacterium tuberculosis complex (M. tuberculosis, M. africanum, M. bovis, M. microti, M. canetti, M. caprae, M. orygis, M. mundi and vaccination strain Bacillus Calmmette-Guérin, BCG)

WIDE RANGE OF VALIDATED CLINICAL MATERIALS

  • Enables detection from a broad spectrum of respiratory and gastrointestinal samples
  • Sputum, BAL, swab, urine, CSF, plasma, stool

EASY-TO-USE CONCEPT

  • Single tube Ready-to-Use Master Mix contains all components for PCR amplification
  • No additional PCR reagents pipetting necessary
  • Simplifies laboratory workflow

CONTAMINATION PREVENTION

  • Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carryover contamination

 

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/100 real-time PCR 100 reactions

EQA Panels

EQA results

; GP_MT_QCMD_05_22_EN_02
pdf, [134.43 kB]
; GP_MT_QCMD_05_22_EN_01
pdf, [133.57 kB]
; GP_MT_QCMD_11_21_EN_02
pdf, [164.92 kB]
; GP_MT_QCMD_11_21_EN_01
pdf, [164.15 kB]
; GP_MT_QCMD_10_20_EN_croBEE_02
pdf, [127.55 kB]
; GP_MT_QCMD_10_20_EN_croBEE_01
pdf, [126.65 kB]
Choose all

Technical specification

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

Documentation

Instruction for Use

; Declaration of Verification of the kits with medical devices
pdf, [1.6 MB]
; GP_MT_Advisory_Notice_06_22_EN
pdf, [1.05 MB]
; GP_MT_Instruction_for_Use_EN
pdf, [110.61 kB]
; GP_MT_Instruction_for_Use_ES
pdf, [108.52 kB]

Declaration of Conformity

; GP_MT_Declaration of Change_EN_CZ
pdf, [172.59 kB]
; GP_MT_Declaration_of_Conformity_EN
pdf, [622.69 kB]

MSDS

; GP_MT_Safety_Data_Sheet_EN
pdf, [274.93 kB]

PCR Template

; GP_DNA_3CH_2CH_ABI7500
edt, [10.72 kB]
; GP_DNA_3CH_2CH_AriaMx
amxt, [3.61 kB]
; GP_DNA_3CH_2CH_croBEE
fqt, [4.91 kB]
; GP_DNA_3CH_2CH_QS5
edt, [8.14 kB]
; GP_DNA_BioRad
prcl, [1.33 kB]
; GP_Mycobacterium tuberculosis_Mic
micassay, [21.98 kB]
; RG_DNA_2CH_3CH_4CH
ret, [13.83 kB]

Product Leaflet

; GP_MT_Leaflet_EN
pdf, [145 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]
; LightCycler 2.0_EN
pdf, [1.8 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, [1.81 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]
Files are available only for registered users.