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Accreditation scope for

MED/TEST 306

Universitetssykehuset Nord-Norge HF

Medisinsk genetisk avdeling

Universitetssykehuset Nord-Norge
9038 Tromsø

Telephone: 77 79 83 00
E-mail: medgen@unn.no
Internet: https://unn.no
The laboratory meets the requirements in

NS-EN ISO 15189:2022




Accreditation includes:
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The administrative / geographical unit:
Medisinsk genetisk avdeling
Universitetssykehuset Nord-Norge
9038 Tromsø


Permanent facility
M15 Medical genetics
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Cell-free DNA from maternal blood
Parameter
Aneuploidy in chromosomes 13,18,21,X and Y
Reference standard
Internal method
Internal method identity
D51732
Comment
VeriSeq NIPT Solution v2
Object
Cells from blood
Parameter
Congenital chromosomal abnormalities, whole genome
Reference standard
Internal method
Internal method identity
D29874
Comment
G-banding analysis of metaphase chromosomes Karyotyping Qualitative
Object
DNA from blood
Parameter
Copy number variations /methylation analysis in selected parts of the genome
Reference standard
Internal method
Internal method identity
D29732
Comment
MLPA/MS-MLPA, Semiquantitative
Object
DNA from blood
Parameter
Repeat expansion analysis
Reference standard
Internal method
Internal method identity
D29731
Comment
Fragment analysis based on PCR and capillary electrophoresis (PCR, RP-PCR) Semiquantitative
Object
DNA from blood
Parameter
Allele specific PCR
Reference standard
Internal method
Internal method identity
D20544
Comment
Fragment size based on PCR and agarose gel electrophoresis, Qualitative
Object
DNA from blood
Parameter
Base substitutions and small duplications, deletions and insertions in the exome.
Reference standard
Internal method
Internal method identity
D31577
Comment
Illumina Nextseq 500 High throughput (HTS) sequencing Qualitative
Object
DNA from blood
Parameter
Base substitutions and small duplications, deletions and insertions in a selection of approximately 113 cancer related genes. A defined selection of these is analyzed.
Reference standard
Internal method
Internal method identity
D31579
Comment
Ilumina Miseq High throughput (HTS) sequencing Qualitative
Object
DNA from blood
Parameter
Copy number variation in a selection of approximately 113 cancer-related genes. A defined selection of these is analyzed. related genes. One defined selection of these are analyzed.
Reference standard
Internal method
Internal method identity
D31579
Comment
Ilumina Miseq High throughput (HTS) sequencing Semiquantitative
Object
DNA from blood and tissue
Parameter
Deletion of AZFa, AZFb and AZFc, and sex chromosome aneuploidy
Reference standard
Internal method
Internal method identity
D29872
Comment
Fragment analysis (Y delMultiplexPCR)  QF-PCR Qualitative
Object
DNA from blood, tissue
Parameter
Base substitutions and small duplications, deletions and insertions in selected parts of the genome.
Reference standard
Internal method
Internal method identity
D29733
Comment
Sanger sequencing Qualitativ
Object
DNA from blood, tissue and amniotic fluid
Parameter
Aneuploidies in chromosomes 13, 18, 21, X and Y
Reference standard
Internal method
Internal method identity
D29872
Comment
Fragment analysis (DNA based trisomy test) QF-PCR Semiquantitative
Object
DNA from blood, tissue and amniotic fluid
Parameter
Copy number variations and control of homozygosity, whole genome.
Reference standard
Internal method
Internal method identity
D29873
Comment
SNP array Semiquantitative methodbasedon hybridizationand fluorescencesignals
M31 Flexible accreditation
Object
Parameter
Reference standard
Internal method identity
Comment
Object
DNA from blood, amniotic fluid and tissue Cells from blood Cell-free DNA from maternal blood
Parameter
Gene analyses Chromosome analyses
Reference standard
Internal method
Internal method identity
Measurement principle / analysis platforms which is accredited under medical genetics (M15) Procedure for FA: RL7073 Log ID: SJ12797
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.