Accreditation scope for

TEST 286

Oslo universitetssykehus HF

Avdeling for medisinsk genetikk

Postboks 4956 Nydalen
0424 Oslo

Telephone: 22119860/22119899
E-mail: graske@ous-hf,no
Internet: https://oslo-universitetssykehus.no/

The laboratory meets the requirements in

NS-EN ISO 15189:2022

Accreditation was first granted: 20/03/2015

Accreditation requires regular follow-up, and is valid to: 14/10/2029

Norwegian Accreditation is a signatory of the EA MLA for this area.

Accreditation includes:

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The administrative / geographical unit:
Avdeling for medisinsk genetikk
Oslo Universitetssykehus HF
Ullevål bygg 25
Kirkeveien 166
0450 Oslo

Permanent facility

M15 Medical genetics

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Object

Parameter

Reference standard

Internal method identity

Comment

Object

Cell free DNA from maternal blood

Parameter

Aneuploidies in chromosomes 13, 18, 21, X and Y

Reference standard

Internal method

Internal method identity

142390

Comment

VeriSeq NIPT Solution v2

Object

Cells from amniotic fluid, tissue or blood

Parameter

Karyotyping, the whole genome

Reference standard

Internal method

Internal method identity

82956

Comment

Karyo typing (G band)

Object

Cells from amniotic fluid, tissue or blood

Parameter

Chromosomal aberrations, in selected parts of the genome

Reference standard

Internal method

Internal method identity

84701

Comment

Karyo typing (Fluorescense In Situ Hybridization, FISH)

Object

DNA from blood

Parameter

Base substitutions and small duplications, deletions, insertions in mitrocondrial genome

Reference standard

Internal method

Internal method identity

140526

Comment

Sequencing, High throughput sequencing (HTS), mitochondrial genome. Does not apply to CNV calling.

Object

DNA extracted from amniotic fluid, tissue and blood

Parameter

Base substitutions and small duplications, deletions and insertions, and copy number variation in selected parts of the genome

Reference standard

Internal method

Internal method identity

131886 141830

Comment

Sequencing. High throughput sequencing (HTS), genome

Object

DNA extracted from amniotic fluid, tissue and blood

Parameter

Degree of methylation of chromosome X

Reference standard

Internal method

Internal method identity

129077

Comment

Fragment analyzes (X-chromosome inactivation)

Object

DNA from amniotic fluid, tissue, blood

Parameter

Expansions

Reference standard

Internal method

Internal method identity

117646 87724 145893

Comment

Fragment analysis (PCR, RP-PCR and AmplideX PCR/CE FMR1)

Object

DNA from amniotic fluid, tissue, blood

Parameter

Base substitutions and small duplications, deletions, insertions in selected parts of the genome

Reference standard

Internal method

Internal method identity

121110

Comment

Sequencing. High throughput sequencing (HTS), exome. Does not apply to CNV calling

Object

DNA extracted from amniotic fluid, tissue and blood

Parameter

Aneuploidies in chromosome 13, 18, 21, X and Y

Reference standard

Internal method

Internal method identity

56557

Comment

Fragment analysis (DNA based trisomy test)

Object

DNA extracted from amniotic fluid, tissue and blood

Parameter

Base substitutions and small dup, del, ins in selected parts of the genome

Reference standard

Internal method

Internal method identity

85926 86055 86349

Comment

Sequencing, Sanger

Object

DNA extracted from amniotic fluid, tissue and blood

Parameter

Copy number variants/ methylation analysis, in selected parts of the genome

Reference standard

Internal method

Internal method identity

83949

Comment

MLPA and methylation analysis MLPA

Object

DNA extracted from amniotic fluid, tissue and blood

Parameter

Copy number variants, whole genome

Reference standard

Internal method

Internal method identity

84542

Comment

Array CGH

Object

DNA from amniotic fluid, tissue, blood

Parameter

Deletion of AZFa, AZFb, AZFc, and sex chromosome aneuploidies

Reference standard

Internal method

Internal method identity

89118 111266

Comment

Fragment analysis (Y part Multiplex PCR)

Object

DNA from amniotic fluid, tissue, blood

Parameter

Base substitutions and small dublications, deletions, insertions in selected parts of the genome

Reference standard

Internal method

Internal method identity

88046

Comment

Fragment analysis CFTR

M31 Flexible accreditation

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Object

Parameter

Reference standard

Internal method identity

Comment

Object

DNA from blood, amniotic fluid or tissue Cell-free DNA from maternal blood Cells from amniotic fluid, tissue or blood

Parameter

Gene analysis Chromosome analysis

Reference standard

Internal method

Internal method identity

Måleprinsippp/analyseplattformer som er akkreditert under medisinsk genetikk (M15) Prosedyre for FA: Dok. ID 45338

Comment

An updated list of methods included in the flexible scope of accreditation, is available with the organization.