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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 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, [145 kB]
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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

; GP_MT_Advisory_Notice_06_22_EN
pdf, [1.05 MB]
; GP_MT_Instructions _for_Use_FR
pdf, [524.62 kB]
; GP_MT_Instructions_for_Use_IT
pdf, [144.53 kB]
; 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, [592.97 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]