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Norwegian accreditation

Accreditation scope for

TEST 299

Helse Bergen HF, Haukeland universitetssjukehus

Laboratoriet, Avdeling for medisinsk genetikk og Seksjon for kreftgenomikk

Postboks 1400
5021 Bergen

Telephone: 55975475 / 55975479
E-mail: pablo.cortez@helse-bergen.no
Internet: http://www.medgen.no
The laboratory meets the requirements in

NS-EN ISO 15189:2012




Accreditation includes:
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The administrative / geographical unit:
Laboratoriet, Avdeling for medisinsk genetikk
Jonas Lies veg 87
5021 Bergen


Permanent facility
M15 Medical genetics
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Body fluids
Parameter
Chromosomal abnormalities in selected parts of the genome
Reference standard
Internal method
Internal method identity
72837
Comment
FISH (Fluorescens In Situ Hybridization) Meta phases/inter phases
Object
Body fluids
Parameter
Fragment lenghts
Reference standard
Internal method
Internal method identity
43231
Comment
Qualitative method based on PCR, Capillary electrophoresis
Object
Body fluids
Parameter
Fragment lengths (expansions)
Reference standard
Internal method
Internal method identity
43870
Comment
Southern blot Qualitative method based on Gel electrophoresis, hybridization
Object
Body fluids
Parameter
Copy number variations/methylation analysis in selected parts of the genome
Reference standard
Internal method
Internal method identity
43179
Comment
MLPA
Object
Body fluids
Parameter
Sequence variants in selected parts of the genome
Reference standard
Internal method
Internal method identity
42972
Comment
Sanger Sequencing
Object
Body fluids, tissue
Parameter
Copy number variations and control of homozygosity, whole genome
Reference standard
Internal method
Internal method identity
43820
Comment
SNP array Semi quantitative method based on hybridisation and fluorescense
Object
Body fluids, tissue
Parameter
Congenital chromosomal abnormalities, whole genome
Reference standard
Internal method
Internal method identity
53686 43223
Comment
G-band analysis of metaphase chromosomes
M31 Flexible accreditation
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Body fluids
Parameter
Mutation analyses
Reference standard
Internal method
Internal method identity
Measurement principle/analysis platforms which is accredited under medical genetics (M15). Exception: NGS analyses Procedure for FA: MGM D46950 ID log: 2023 R30275
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.
The administrative / geographical unit:
Seksjon for kreftgenomikk
Jonas Lies veg 87
5021 Bergen


Permanent facility
M0250 Anatomical pathology, molecular pathology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Tissue material, fixed and unfixed
Parameter
HPV sub tyiping/HPV status
Reference standard
Internal method
Internal method identity
820085 D57155 fHPV Multiplex Fluorescent PCR-kit
Comment
PCR and fragment analysis, ABI3500xl Genetic Analyzer
Object
Tissue material: tumor and normal tissue, fixed and unfixed
Parameter
Micro satellite instability (MSI)
Reference standard
Internal method
Internal method identity
820092 820093 820094 820095 D51464 MSI Analysis system v1.2
Comment
PCR and fragment analysis, ABI3500xl Genetic Analyzer
M15 Medical genetics
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Body fluids
Parameter
Hemochromatosis B-HFE gene: C282Y
Reference standard
Internal method
Internal method identity
27919
Comment
LAMP/melting curve analysis
Object
Body fluids
Parameter
Hemochromatosis B-HFE gene: H63D
Reference standard
Internal method
Internal method identity
27919
Comment
LAMP/melting curve analysis
Object
Body fluids
Parameter
JAK2-617F
Reference standard
Internal method
Internal method identity
10449
Comment
Real time PCR
Object
Body fluids
Parameter
DNA DPYD genotyping
Reference standard
Internal method
Internal method identity
68974
Comment
LAMP/melting curve analysis
Object
Body fluids
Parameter
Fusion transcript analysis on cDNA
Reference standard
Internal method
Internal method identity
51788
Comment
Real time PCR for quantitative analysis of number of BCR-ABL1 fusion transcript
Object
Body fluids, tissue
Parameter
Chromosome abnormalities i selected parts of the genome
Reference standard
Internal method
Internal method identity
48928
Comment
FISH (Fluorescence in situ hybridization) Metaphases/Interphases
Object
Body fluids
Parameter
JAK2-E12
Reference standard
Internal method
Internal method identity
52517
Comment
Real-time PCR / Melting point
Object
Body fluids
Parameter
MPL515L/K
Reference standard
Internal method
Internal method identity
25460
Comment
Real-time PCR/Allelic discrimination
Object
Body fluids
Parameter
Lactose intolerance
Reference standard
Internal method
Internal method identity
152
Comment
LAMP/melting curve analysis
Object
Body fluids
Parameter
Factor V Leiden mutation (R506Q)
Reference standard
Internal method
Internal method identity
29630
Comment
LAMP/melting curve analysis
Object
Body fluids
Parameter
Factor II Prothrombin mutation (g.20210G>A)
Reference standard
Internal method
Internal method identity
29630
Comment
LAMP/melting curve analysis
Object
Body fluids, tissue
Parameter
Fusion transcript on cDNA
Reference standard
Internal method
Internal method identity
77674
Comment
Realtime-PCR
Object
Body fluids, tissue
Parameter
Fragment lengths (Merger detection)
Reference standard
Internal method
Internal method identity
34576
Comment
Qualitative methodology based on PCR and agarose gel electrophoresis
Object
Body fluids, tissue
Parameter
Malignancy-specific chromosomal abnormalities
Reference standard
Internal method
Internal method identity
49043
Comment
G-band analysis of metaphase chromosomes
M31 Flexible accreditation
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Body fluids
Parameter
Mutation analyses
Reference standard
Internal method
Internal method identity
Measurement principle/analysis platforms which is accredited under medical genetics (M15). Exception: NGS analyses Procedure for FA: SKG D71903 ID log: 2023 R29755
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.
Object
Tissue
Parameter
Viruses - subtyping Mutation analyses
Reference standard
Internal method
Internal method identity
Measurement principle/analysis platforms which is accredited under Molecular Pathology (M0250) Procedure for FA: SKG D71903 ID logg: 2023 R29755
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.