Welcome to GeneProof website!

It is great to see you here. To see all contents of the website, please register or restore your access.
We believe you will come back gladly.

GeneProof Team

 

User account
Forgot your password?
Searching

GeneProof MTHFR A1298C MC PCR Kit

CE IVD myCROBE® line

On this page you will find order codestechnical specifications and documents for the selected product.

Order information

Product name Catalog no. Technology Packaging
GeneProof MTHFR A1298C MC PCR Kit M1298/MC/200 PCR for 180 tests

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
Test Principle Real-time polymerase chain reaction (PCR)
Type of Analysis Qualitative
Automated / Manual detection Automated
Target A1298C polymorphism in the gene of methylenetetrahydrofolate reductase (MTHFR)
Specificity Single nucleotide adenine/cytosine polymorphism in the gene of MTHFR in site 1298 (A1298C)
Concentration Range 10-90 ng/µl
Negative Percentage Agreement 98.04 % (CI95%: 88.21 % - 99.90 %)
Positive Percentage Agreement 100 % (CI95%: 93.69 % - 100 %)
Overall Percentage Agreement 99.19 % (CI95%: 94.89 % - 99.96 %)
Validated Specimen Whole blood
Validated Extraction Methods myCROBE/croBEE 2.0 Universal Extraction Kit
Instruments

myCROBE® Fully Automated Instrument

Detection Channels FAM, HEX
External Quality Assessment Regularly tested in INSTAND e.V. External Quality Assessment Panels - results at www.geneproof.com

Documentation

Instruction for Use

GP_MC_M1298_Instruction_for_Use_EN
pdf, [258.11 kB]

Declaration of Conformity

GP_MC_M1298_Declaration_of_Conformity_EN
pdf, [600.46 kB]
Files are available only for registered users.

News

GeneProof Adenovirus PCR Kit detects Adenovirus type 41

Association between acute, severe hepatitis in small children and Adenovirus infection is currently under…

GeneProof merges with American Laboratory Products Company

GeneProof merges with American Laboratory Products Company.