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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. pinnipedi, M. caprae, M. orygis, M. mungi 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 REF 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

Product Leaflet

Product Leaflet

; GP_MT_Leaflet_EN
pdf, [104.28 kB]
Choose all

Publications

Publications

; GP_RESPIRATORY_Publications_10_2022_EN
pdf, [142.69 kB]
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EQA results

EQA results

; CR_MT_ QCMD_ 5_2023_EN_01
pdf, [122.43 kB]
; CR_MT_croBEE_ QCMD_ 5_2023_EN_01
pdf, [123.28 kB]
; 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

Files are available only for registered users.

Declaration of Verification

; Declaration of Verification of the kits with medical devices
pdf, [2.53 MB]

Instructions for Use & Advisory Notice

Instructions for Use are for informative purposes only

; GP_MP_MT_Advisory_Notice_04_24_CS_EN
pdf, [512.81 kB]
; GP_MT_Advisory_Notice_06_22_EN
pdf, [1.05 MB]
; GP_MT_Instructions_for_Use_EN
pdf, [659.38 kB]
; GP_MT_Instructions_for_Use_ES
pdf, [667.19 kB]
; GP_MT_Instructions_for_Use_FR
pdf, [528.46 kB]
; GP_MT_Instructions_for_Use_IT
pdf, [522.38 kB]

Declaration of Conformity

; GP_MT_Declaration of Change_EN_CZ
pdf, [172.59 kB]
; GP_MT_Declaration_of_Conformity_EN
pdf, [592.97 kB]

MSDS

; GP_MT_Safety_Data_Sheet_EN
pdf, [275.71 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]