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GeneProof MTHFR A1298C PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

EASY-TO-USE CONCEPT

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

SIMPLE LABORATORY WORKFLOW

  • Easily combinable with other GeneProof PCR kits in one 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
Regulatory Status CE IVD
Intended User For professional use in laboratories with trained staff
Technology Real-time PCR
Type of Analysis Qualitative
Target Sequence A1298C polymorphism in the gene for methylenetetrahydrofolate reductase (MTHFR), (rs1801131)
Analytical Sensitivity (LoD) Reaches up to 2 ng/µl
Positive Percentage Agreement  100 % (CI95%: 79.95 % - 100 %)
Negative Percentage Agreement  100 % (CI95%: 65.55 % - 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
AMPLilab 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® 480
LineGene 9600 Plus
Mic qPCR Cycler
Rotor-Gene 3000 / 6000 / Q

Required Detection Channels FAM, HEX/JOE
External Quality Assessment Regularly tested in 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_Advisory Notice_EN
pdf, [177.45 kB]
; GP_M1298_Instruction_for_Use_EN
pdf, [263.8 kB]
; GP_M1298_Instruction_for_Use_ES
pdf, [237 kB]
; GP_M1298_Instruction_for_Use_FR
pdf, [234.86 kB]
; GP_M1298_Instruction_for_Use_PT
pdf, [235.82 kB]

Declaration of Conformity

; GP_M1298_Declaration_of_Conformity_EN
pdf, [564.74 kB]

MSDS

; GP_M1298_Safety_Data_Sheet_EN
pdf, [275.09 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_THROMB_Leaflet_EN
pdf, [134.34 kB]

Manual

; Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [1.43 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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