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GeneProof MTHFR C677T PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

SINGLE TUBE READY-TO-USE MASTER MIX

  • Contains all components for PCR amplification
  • Reduces the need of qualified laboratory staff
  • Enables quick and reliable results


UNIVERSAL PCR PROFILE

  • Uniform reaction format
  • All PCR Kits from the group Thrombotic Mutations are easily combinable with each other
  • Simplifies laboratory workflow

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD CERTIFIED DIAGNOSTIC TEST

Order information

Product name Catalog no. Technology Packaging
GeneProof MTHFR C677T PCR Kit M677/025 real-time PCR 25 reactions
GeneProof MTHFR C677T PCR Kit M677/100 real-time PCR 100 reactions

EQA Panels

EQA results

GP_M677_Instand_04_21_EN
pdf, [915.1 kB]
Choose all

Technical specification

Indication in vitro diagnostic medical device
Regulatory Status CE IVD / EC Directive 98/79/EC
Intended User For professional use in laboratories with trained staff
Technology real-time PCR
Type of Analysis qualitative
Target Sequence C677T mutation in the gene for methylenetetrahydrofolate reductase (MTHFR)
Analytical Sensitivity (LoD) Reaches up to 2 ng/µl
Positive Percentage Agreement 100 % (CI95%: 78.12 % - 100 %)
Negative Percentage Agreement 100 % (CI95%: 69.87 % - 100 %)
Overall Percentage Agreement 100 % (CI95%: 85.87 % - 100 %)
Validated Specimen whole blood
Storage -20 ± 5 °C
Validated Extraction Methods croBEE 201A Nucleic Acid Extraction Kit
GeneProof PathogenFree DNA Isolation Kit
Instruments

croBEE Real-Time PCR System
AMPLilab
Applied Biosystems 7500 Real-Time PCR System
AriaMx Real-Time PCR System
CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System
LineGene 9600 Plus
Rotor-Gene 3000/6000/Q*

Required Detection Channels FAM, HEX
External Quality Assessment Tested by Instand e.V. External Quality Assessment Panels - results at www.geneproof.com

* In Rotor-Gene instruments leave all available detection channels on.

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.55 MB]
GP_M677T_Advisory Notice _EN
pdf, [543.68 kB]
GP_M677_Instruction for Use_EN
pdf, [248.96 kB]
GP_M677_Instruction_for_Use_ES
pdf, [286.05 kB]
GP_M677_Instruction_for_Use_FR
pdf, [258.33 kB]
GP_M677_Instruction_for_Use_GR
pdf, [298.45 kB]

Declaration of Conformity

GP_M677_Declaration of Conformity_EN
pdf, [244.51 kB]

MSDS

GP_M677_Safety Data_Sheet_EN
pdf, [399.19 kB]

PCR Template

GP_Genetics_ABI7500
edt, [11.02 kB]
GP_Genetics_AriaMX
amxt, [3.57 kB]
GP_Genetics_BioRad
prcl, [1.32 kB]
GP_Genetics_CroBee
fqt, [4.85 kB]
GP_Genetics_QS3
edt, [7.97 kB]
GP_Genetics_QS5
edt, [8.02 kB]
RG_Genetics
ret, [13.39 kB]

Product Leaflet

GP_Thrombotic_Mutations_Leaflet_EN
pdf, [129.06 kB]

Manual

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, [1.96 MB]
LightCycler 480/Instrument II_EN
pdf, [2.03 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]
Files are available only for registered users.

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