ViennaLab Diagnostics has completed the IVDR conformity assessment for a further part of its portfolio. As a result, 21 of the ViennaLab assays we supply now carry a CE-IVDR mark under Regulation (EU) 2017/746, including the complete thalassaemia StripAssay range, the haemochromatosis and thrombophilia assays, and the CYP2C19 and CYP2D6 pharmacogenetic tests.
For laboratories this matters in two ways. IVDR sets stricter requirements for clinical evidence, performance evaluation and post-market surveillance than the IVDD it replaces, so an IVDR-marked assay comes with a more thoroughly documented performance file. And because IVDD certificates are being withdrawn as the transitional provisions expire, laboratories that want to keep a validated method in routine use are better off moving to the IVDR version of an assay while there is still time to run the verification work.
CAH PCR Assay, CYP21A2 copy number analysis for congenital adrenal hyperplasia
CAH StripAssay, CYP21A2 mutation analysis for congenital adrenal hyperplasia
CVD StripAssay T, nine mutations for cardiovascular and thrombosis risk assessment
CYP2C19 StripAssay, CYP2C19 genotyping for clopidogrel and proton pump inhibitor pharmacogenetics
CYP2D6 PCR Assay, common CYP2D6 variants and copy number changes
CYP2D6 StripAssay, CYP2D6 genotyping including duplications and deletions
Cystic Fibrosis StripAssay, CFTR mutation analysis
FMF StripAssay, MEFV mutations in familial Mediterranean fever
FMF-SAA1 StripAssay, MEFV mutations combined with SAA1 genotyping
FV Leiden PCR Assay, the 1691G>A mutation in the coagulation Factor V gene
FV-PTH PCR Assay, Factor V Leiden and prothrombin G20210A in one run
HFE C282Y PCR Assay, the C282Y mutation in hereditary haemochromatosis
HFE H63D PCR Assay, the H63D mutation in hereditary haemochromatosis
HLA-B27 PCR Assay, HLA-B27 typing
Haemochromatosis StripAssay A, early identification of hereditary haemochromatosis
Hemochromatosis mpx PCR kit, multiplex HFE genotyping for C282Y, H63D and S65C
Lactose Intolerance StripAssay, LCT variant analysis for adult-type hypolactasia
PTH Factor II PCR Assay, the prothrombin G20210A mutation
Sugar Intolerance StripAssay, genetic variants associated with sugar intolerance
α-Globin StripAssay, the most common HBA1 and HBA2 deletions and mutations in alpha-thalassaemia
β-Globin StripAssay, the most common HBB gene mutations in beta-thalassaemia
The remaining ViennaLab assays in our range continue to be supplied with their current status, which is stated on every product page.
If you would like the Declaration of Conformity, the instructions for use, or the current REF numbers for any of these kits, or if you want to discuss what a switch to the IVDR version means for your existing validation, please do not hesitate to contact us.