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Accreditation scope for

TEST 099

Oslo universitetssykehus HF

Hormonlaboratoriet og Norges laboratorium for dopinganalyse

Postboks 4959 Nydalen
0424 Oslo

Telephone: Tlf. 22 89 47 08 Faks. 22 15 87 96
E-mail: hormonlaboratoriet@ous-hf.no
Internet: http://www.hormonlaboratoriet.no
The laboratory meets the requirements in

NS-EN ISO/IEC 17025:2017




Accreditation includes:
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The administrative / geographical unit:
Oslo universitetssykehus HF, Aker, Hormonlaboratoriet
Trondheimsvn. 235
0586 OSLO


Permanent facility
M12 Medical biochemistry
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Plasma
Parameter
ACTH, (Adrenocorticotropin)
Reference standard
Internal method
Internal method identity
ML 38
Comment
ILMA Immulite 2000
Object
Plasma
Parameter
Metanephrine Normetanepherine Methoxytyramine
Reference standard
Internal method
Internal method identity
MI 87
Comment
LC-MS/MS
Object
Plasma
Parameter
Renin (mass measurement)
Reference standard
Internal method
Internal method identity
ML 70
Comment
CLIA, Liaison
Object
Plasma
Parameter
Copeptin
Reference standard
Internal method
Internal method identity
ML 86
Comment
FIA, TRACE-technology, BRAHMS Kryptor
Object
Serum
Parameter
IL2R (interleukin 2 Reseptor, CD25)
Reference standard
Internal method
Internal method identity
ML 62
Comment
ILMA, Immulite 2000
Object
Serum
Parameter
TSH (thyroid stimulating hormone)
Reference standard
Internal method
Internal method identity
ML 79
Comment
CMIA Alinity i
Object
Serum
Parameter
Prokollagen III (PIIINP)
Reference standard
Internal method
Internal method identity
MI 84
Comment
RIA
Object
Serum
Parameter
Cortisol
Reference standard
Internal method
Internal method identity
ML 75
Comment
ECLIA, Cobas e 601
Object
Serum
Parameter
25-OH Vitamin D total
Reference standard
Internal method
Internal method identity
MI 80
Comment
LC-MS/MS
Object
Serum
Parameter
Estradiol (E2)
Reference standard
Internal method
Internal method identity
ML 63
Comment
CLIA Liaison XL
Object
Serum
Parameter
Progesterone
Reference standard
Internal method
Internal method identity
ML 60
Comment
LIA Immulite 2000
Object
Serum
Parameter
Growth hormone (GH)
Reference standard
Internal method
Internal method identity
ML 61
Comment
ILMA Immulite 2000
Object
Serum
Parameter
Alkaline Phosphatase (bone-specific)
Reference standard
Internal method
Internal method identity
ML 49
Comment
CLIA Liaison XL
Object
Serum
Parameter
Androstendion
Reference standard
Internal method
Internal method identity
MI 83
Comment
LC-MS/MS
Object
Serum
Parameter
Deoxycortikosteron (DOC) 11-Deoxykortisol (11-DEO) 21-Deoxykortisol (21-DEO) Cortikosteron Cortisol 17OH-Progesteron Deksametason
Reference standard
Internal method
Internal method identity
MI 82
Comment
LC-MS/MS
Object
Serum
Parameter
Anti-Müllerhormon (AMH)
Reference standard
Internal method
Internal method identity
ML 65
Comment
ECLIA Cobas e 601
Object
Serum
Parameter
Anti-tyreoglobulin (Anti-Tg)
Reference standard
Internal method
Internal method identity
ML 88
Comment
CMIA Alinity
Object
Serum
Parameter
TPO antibody (anti-thyroid peroxidase antibody)
Reference standard
Internal method
Internal method identity
ML 87
Comment
CMIA Alinity
Object
Serum
Parameter
CTX-I (Kollagen I)
Reference standard
Internal method
Internal method identity
ML 55
Comment
ECLIA Cobas e601
Object
Serum
Parameter
Prokollagen I (PINP)
Reference standard
Internal method
Internal method identity
ML 54
Comment
ECLIA Cobas e601
Object
Serum
Parameter
Prolactin (PRL)
Reference standard
Internal method
Internal method identity
ML 71
Comment
ECLIA Cobas e 601
Object
Serum
Parameter
FSH (Follicle stimulating hormone)
Reference standard
Internal method
Internal method identity
ML 74
Comment
ILMA Immulite 2000
Object
Serum
Parameter
TRAS (Anti-TSH-receptor antibody)
Reference standard
Internal method
Internal method identity
ML 85
Comment
FIA, TRACE-technology, BRAHMS Kryptor
Object
Serum
Parameter
hCG (Chorionic gonadotropin + β)
Reference standard
Internal method
Internal method identity
ML 66
Comment
ECLIA Cobas e 601
Object
Serum
Parameter
DHEAS, (Dehydroepiandrosterone-sulphate)
Reference standard
Internal method
Internal method identity
ML 04
Comment
LIA Immulite 2000
Object
Serum
Parameter
Insulin
Reference standard
Internal method
Internal method identity
ML 53
Comment
ECLIA Cobas e601
Object
Serum
Parameter
C-peptide (Pro-insulin C-peptide)
Reference standard
Internal method
Internal method identity
ML 52
Comment
ECLIA Cobas e601
Object
Serum
Parameter
IGF-1, (Insulin-like growth factor 1)
Reference standard
Internal method
Internal method identity
ML 37
Comment
ILMA Immulite 2000
Object
Serum
Parameter
IGF-binding protein 3 (IGFBP-3)
Reference standard
Internal method
Internal method identity
ML 36
Comment
ILMA Immulite 2000
Object
Serum
Parameter
Proinsulin
Reference standard
Internal method
Internal method identity
MI 106
Comment
ELISA
Object
Serum
Parameter
Sex hormone-binding globulin (SHBG)
Reference standard
Internal method
Internal method identity
ML 31
Comment
ILMA Immulite 2000
Object
Serum
Parameter
Testosterone
Reference standard
Internal method
Internal method identity
MI 83
Comment
LC-MS/MS
Object
Serum
Parameter
Thyroxine (T4)
Reference standard
Internal method
Internal method identity
ML 83
Comment
CMIA Alinity i
Object
Serum
Parameter
T4, free, (FT4)
Reference standard
Internal method
Internal method identity
ML 80
Comment
CMIA Alinity i
Object
Serum
Parameter
TBG, (Thyroxine-binding globulin)
Reference standard
Internal method
Internal method identity
ML 14
Comment
LIA Immulite 2000
Object
Serum
Parameter
Triiodothyroninel (T3)
Reference standard
Internal method
Internal method identity
ML 82
Comment
CMIA Alinity i
Object
Serum
Parameter
T3, free, (free trijodtyronin)
Reference standard
Internal method
Internal method identity
ML 81
Comment
CMIA Alinity i
Object
Serum
Parameter
Chromogranin A
Reference standard
Internal method
Internal method identity
ML 84
Comment
FIA, TRACE-technology, BRAHMS Kryptor
Object
Serum
Parameter
PTH, (Parathyroid hormone)
Reference standard
Internal method
Internal method identity
ML 12
Comment
ILMA Immulite 2000
Object
Serum
Parameter
Erythropoietin (EPO)
Reference standard
Internal method
Internal method identity
ML 05
Comment
ILMA Immulite 2000
Object
Serum
Parameter
1,25-(OH)2 Vitamin D2 + D3
Reference standard
Internal method
Internal method identity
ML 78
Comment
CLIA, Liaison
Object
Serum
Parameter
DHEA, (Dehydroepiandrosterone) 17OH-Pregnenolon
Reference standard
Internal method
Internal method identity
MI 85
Comment
LC-MS/MS
Object
Serum Plasma
Parameter
Aldosteron
Reference standard
Internal method
Internal method identity
MI 96
Comment
LC-MS/MS
Object
Serum,
Parameter
Leptin
Reference standard
Internal method
Internal method identity
MI 90
Comment
ELISA
Object
Serum, plasma
Parameter
Anti-GAD
Reference standard
Internal method
Internal method identity
MI 99
Comment
ELISA
Object
Serum/ urine
Parameter
LH, (Luteinizing hormone)
Reference standard
Internal method
Internal method identity
ML 73
Comment
ILMA Immulite 2000
Object
Saliva
Parameter
Kortisol
Reference standard
Internal method
Internal method identity
MI 94
Comment
LC-MS/MS
Object
Urine
Parameter
Chorionic gonadotropin, screening (doping analysis)
Reference standard
Internal method
Internal method identity
ML 67
Comment
ECLIA Cobas e 601
Object
Urine
Parameter
Iodine
Reference standard
Internal method
Internal method identity
MI 40
Comment
Colorimetry
Object
Urine
Parameter
Cortisol
Reference standard
Internal method
Internal method identity
MI 88
Comment
LC-MS/MS
M15 Medical genetics
Object
Parameter
Reference standard
Internal method identity
Comment
Object
EDTA-whole blood
Parameter
HFE genotype (Hemochromatosis-related genes)
Reference standard
Internal method
Internal method identity
MF 12
Comment
Real-Time PCR
Object
EDTA-whole blood
Parameter
Lactose intolerance genotyping (C-13910T, rs4988235 C/T)
Reference standard
Internal method
Internal method identity
MF 11
Comment
Real-Time PCR
Object
EDTA whole blood or fully extracted DNA
Parameter
VHL. Copy number variation in selected parts of the genome
Reference standard
Internal method
Internal method identity
MF 17
Comment
MLPA
Object
EDTA whole blood or fully extracted DNA
Parameter
Sequencing of ALB (Albumin exon 7), AP2S1 (exon 2), CASR, CDKN1B (MEN4), MCM6 lactose intolerance, MEN1, RET (MEN2), THRB, VHL
Reference standard
Internal method
Internal method identity
MF 15
Comment
Sanger sequencing
M31 Flexible accreditation
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Body fluids Genetic material
Parameter
Hormone Laboratory’s routine analyses
Reference standard
Internal method
Internal method identity
Measurement principle/analysis platforms accredited under medical biochemistry (M12 and M15) Procedure for FA: PS 22 ID log: SS 25
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization. Flexibility is limited to analytical principles in the current accreditation scope.
M32 Opinions and interpretations
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Urine, blood, serum, plasma, genetic material and saliva
Parameter
Hormone Laboratory’s routine analyses
Reference standard
Internal Method
Internal method identity
Comment
The quality manual chapter 13.4.2. Method based on judgement of competence and documentation forming the basis for the opinions and interpretations. Methods with internal identity MF, MI and ML
The administrative / geographical unit:
Oslo universitetssykehus HF, Aker, Norges laboratorium for dopinganalyse
Trondheimsvn. 235
0586 OSLO


Permanent facility
M12 Medical biochemistry
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Dried blood spot
Parameter
Anabolic substances: Steroid esters
Reference standard
Internal method
Internal method identity
MD 52
Comment
Extraction from DBS, LC-HRMS. Screening
Object
Dried blood spot
Parameter
Anabolic substances, peptide hormones, growth factors, related substances and mimetics, beta-2 agonists, hormone and metabolic modulators, diuretics (diuretics) and masking agents
Reference standard
Internal method
Internal method identity
MD 50
Comment
Extraction from DBS, LC-HRMS. Screening
Object
Dried blood spot
Parameter
Anabolic substances, peptide hormones, growth factors, related substances and mimetics, beta-2 agonists, hormone and metabolic modulators, diuretics (diuretics) and masking agents
Reference standard
Internal method
Internal method identity
MD 51
Comment
Extraction from DBS, LC-HRMS. Confirmation
Object
Whole blood
Parameter
Haematological parameters
Reference standard
Internal method
Internal method identity
MD 35
Comment
Sysmex instrument: Spectrophotometrifluorescence / flow cytometry, measurement of electrical resistance / hydrodynamic focusing. quantitative determination of blood parameters
Object
Serum
Parameter
Recombinant growth hormone
Reference standard
Internal method
Internal method identity
MD 37
Comment
LIA, Determination of recombinant growth hormone
Object
Serum
Parameter
Endogenous steroids
Reference standard
Internal method
Internal method identity
MD 55
Comment
Protein precipitation with acetonitrile, LC-MS/MS. Quantitative screening.
Object
Serum
Parameter
PIIINP
Reference standard
Internal method
Internal method identity
MD 42
Comment
RIA, Determination of PIIINP
Object
Serum
Parameter
Insulin like growth factor 1 (IGF-1)
Reference standard
Internal method
Internal method identity
MD 47
Comment
IRMA, Determination of IGF-1
Object
Urine
Parameter
Ephedrines
Reference standard
Internal method
Internal method identity
MD 40
Comment
Dilute-and-inject, LC-MS / MS, Quantification of Ephedrine
Object
Urine
Parameter
Peptides
Reference standard
Internal method
Internal method identity
MD 46
Comment
Solid phase extraction, LC-MS / MS and HRAM LC-MS, Analysis of peptides
Object
Urine
Parameter
Cannabis metabolite (THC acid)
Reference standard
Internal method
Internal method identity
MD 32
Comment
Hydrolysis, solid-phase extraction, GC-MS / MS. Quantification of THC acid
Object
Urine
Parameter
Morphine
Reference standard
Internal method
Internal method identity
MD 33
Comment
Hydrolysis, solid-phase extraction, GC-MS. Quantification of morphine
Object
Urine
Parameter
Formoterol and salbutamol
Reference standard
Internal method
Internal method identity
MD 49
Comment
Solid phase extraction LC-MS / MS, Quantification of formoterol and salbutamol
Object
Urin
Parameter
Specific weight
Reference standard
Internal method
Internal method identity
MD 48
Comment
Refractometer, Specific weight measurement
Object
Urine
Parameter
Anabolic substances, peptide hormones, growth factors, related substances and mimetics, hormone and metabolic modulators, diuretics (diuretics) and masking agents, stimulants, narcotics
Reference standard
Internal method
Internal method identity
MD 27
Comment
Dilute-and-inject, LC-MS/MS. Screening V Doping agents
Object
Urine
Parameter
Beta blockers
Reference standard
Internal method
Internal method identity
MD 28
Comment
Dilute-and-inject, LC-MS/MS. Screening VII Doping agents
Object
Urine
Parameter
Endogenous steroids
Reference standard
Internal method
Internal method identity
MD 36
Comment
Solid phase extraction, hydrolysis, HPLC purification, GC-MS, GC-C-IRMS. Quantification, Isotopratio Mass Spectrometry (IRMS) of endogenous steroids
Object
Urine
Parameter
Anabolic substances, hypoxia-inducible factor (HIF) activating agents, diuretics (diuretics), masking agents and stimulants.
Reference standard
Internal method
Internal method identity
MD 53
Comment
Dilute-and-inject, LC-HRMS. Screening
Object
Urine
Parameter
Anabolic substances, beta-2 agonists, hormone and metabolic modulators, diuretics (diuretics) and masking agents, stimulants, narcotics, cannabinoids, glucocorticoids, beta blockers
Reference standard
Internal method
Internal method identity
MD 14
Comment
Solid-phase extraction with or without hydrolysis, liquid-liquid extraction, dilute & inject, GC-MS, GC-MS/MS, LC-MS/MS, LC-HRMS. Confirmation of doping agents
Object
Urine
Parameter
Anabole stoffer, beta-2 agonister, hormon- og metabolske modulatorer, diuretika (vanndrivende midler) og maskeringsmidler, stimulerende midler, narkotiske stoffer, cannabinoider, glukokortikoider
Reference standard
Internal method
Internal method identity
MD 10
Comment
Hydrolysis, liquid-liquid extraction followed by GC-MS / MS, LC-MS / MS. Screening of IV Doping agents
Object
Urine
Parameter
Endogenous steriods
Reference standard
Internal method
Internal method identity
MD 34
Comment
Solid phase extraction, hydrolysis, liquid-liquid extraction, GC-MS / MS. Quantification of endogenous steroids
Object
Urine
Parameter
Anabolic substances
Reference standard
Internal method
Internal method identity
MD 18
Comment
Liquid-liquid extraction, GC-MS/MS Analysis of unconjugated doping agents
Object
Urine
Parameter
19-Norandrosterone
Reference standard
Internal method
Internal method identity
MD 22
Comment
Solid phase extraction, hydrolysis and liquid-liquid extraction followed by GC-MS / MS. Confirmation of norandrosterone
Object
Urine and blood
Parameter
Erythropoietin (EPO) and recombinant analogues (eg NESP, EPO-Fc and CERA)
Reference standard
Internal method
Internal method identity
MD 25
Comment
Immunoaffinity purification, gelelektroforese, western blott, Chemiiluminescens. Determination of EPO and recombinant analogues
M31 Flexible accreditation
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Body fluids Dried blood spot
Parameter
Doping analysis
Reference standard
Internal method
Internal method identity
Measurement principle / analysis platforms that are accredited under medical biochemistry (M12) Procedure for FA: PD 41 ID log: SD 51
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization. Flexibility is limited to analytical principles in the current accreditation scope.