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GeneProof MTHFR A1298C 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 A1298C PCR Kit M1298/025 real-time PCR 25 reactions
GeneProof MTHFR A1298C PCR Kit M1298/100 real-time PCR 100 reactions

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 A1298C polymorphism in the gene of 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 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
LightCycler® 480
CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System
LineGene 9600 Plus
Rotor-Gene 3000/6000/Q
AMPLilab Real-Time PCR System
Gentier 96E/96R Real-Time PCR System

Required Detection Channels FAM, HEX/JOE
External Quality Assessment Tested by 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, [1.55 MB]
GP_Advisory Notice_EN
pdf, [177.45 kB]
GP_M1298_Instruction for Use_EN
pdf, [254.26 kB]
GP_M1298_Instruction_for_Use_ES
pdf, [313.45 kB]
GP_M1298_Instruction_for_Use_FR
pdf, [264.41 kB]

Declaration of Conformity

GP_M1298_Declaration of Conformity_EN
pdf, [244.68 kB]

MSDS

GP_M1298_Safety Data_Sheet_EN
pdf, [388.35 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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