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Norwegian accreditation

Accreditation scope for

TEST 296

Unilabs laboratoriemedisin AS

avd. for patologi, avd. for medisinsk biokjemi og avd. for medisinsk mikrobiologi

Silurveien 2
0380 Oslo

Telephone: 21 00 60 40
E-mail: laboratoriemedisin@unilabs.com
Internet: http://www.unilabs.no
The laboratory meets the requirements in

NS-EN ISO 15189:2012


*Partially suspended (Voluntary or involuntary)


Accreditation includes:
The administrative / geographical unit:
Avdeling for medisinsk biokjemi
Silurveien 2
0380 Oslo



Permanent facility
M12 Medical biochemistry
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood
Parameter
Hemoglobin
Reference standard
Internal method
Internal method identity
27888
Comment
Photometry, Advia 2120i
Object
Blood
Parameter
Erythrocyte indices: MCV, MCH, MCHC
Reference standard
Internal method
Internal method identity
27890
Comment
Calculated parameters, Advia 2120i
Object
Blood
Parameter
Leucocytes
Reference standard
Internal method
Internal method identity
27889
Comment
Cytochemical, light scattering and photometri Advia 2120i
Object
Blood
Parameter
Platelets
Reference standard
Internal method
Internal method identity
27892
Comment
Cytochemical and light scattering, Advia 2120i
Object
Blood
Parameter
Reticulocytes
Reference standard
Internal method
Internal method identity
27891
Comment
Cytochemical and light scattering, Advia 2120i
Object
Blood
Parameter
Erythrocytes
Reference standard
Internal method
Internal method identity
27886
Comment
Cytochemical and light scattering, Advia 2120i
Object
Blood
Parameter
EVF
Reference standard
Internal method
Internal method identity
27887
Comment
Calculated parameter, Advia 2120i
Object
Blood
Parameter
HbA1c
Reference standard
Internal method
Internal method identity
27751
Comment
Capillary electrophoresis Sebia Capillarys 3
Object
Plasma
Parameter
NT-pro-brain natriuretic peptide (1-76)
Reference standard
Internal method
Internal method identity
27740
Comment
Immunoassay, Immulite 2000 XPi
Object
Plasma
Parameter
Parathyroid Hormone (PTH)
Reference standard
Internal method
Internal method identity
27731
Comment
Immunoassay, Centaur XP
Object
Serum
Parameter
C-peptide
Reference standard
Internal method
Internal method identity
27713
Comment
Immunoassay, Centaur XP
Object
Serum
Parameter
Insulin
Reference standard
Internal method
Internal method identity
27723
Comment
Immunoassay, Centaur XP
Object
Serum
Parameter
Ferritin
Reference standard
Internal method
Internal method identity
27715
Comment
Immunoassay, Centaur XP
Object
Serum
Parameter
Cobalamin (Vitamin-B12)
Reference standard
Internal method
Internal method identity
27734
Comment
Immunoassay, Centaur XP
Object
Serum
Parameter
Folate
Reference standard
Internal method
Internal method identity
27716
Comment
Immunoassay, Centaur XP
Object
Serum
Parameter
Homocysteine (HCY)
Reference standard
Internal method
Internal method identity
27722
Comment
Immunoassay, Centaur XP
Object
Serum
Parameter
Thyroid Stimulating Hormone (TSH)
Reference standard
Internal method
Internal method identity
27733
Comment
Immunoassay, Centaur XP
Object
Serum
Parameter
Thyroxine, free (FT4)
Reference standard
Internal method
Internal method identity
27718
Comment
Immunoassay, Centaur XP
Object
Serum
Parameter
Triiodothyronine, free (FT3)
Reference standard
Internal method
Internal method identity
27717
Comment
Immunoassay, Centaur XP
Object
Serum
Parameter
Prolactin
Reference standard
Internal method
Internal method identity
27727
Comment
Immunoassay, Centaur XP
Object
Serum
Parameter
Luteinizing hormone (LH)
Reference standard
Internal method
Internal method identity
27725
Comment
Immunoassay, Centaur XP
Object
Serum
Parameter
FSH
Reference standard
Internal method
Internal method identity
27720
Comment
Immunoassay, Centaur XP
Object
Serum
Parameter
Estradiol
Reference standard
Internal method
Internal method identity
27735
Comment
Immunoassay, Centaur XP
Object
Serum
Parameter
Progesteron
Reference standard
Internal method
Internal method identity
27726
Comment
Immunoassay, Centaur XP
Object
Serum
Parameter
Testosterone
Reference standard
Internal method
Internal method identity
27732
Comment
Immunoassay, Centaur XP
Object
Serum
Parameter
Chorionic Gonadotropin (hCG)
Reference standard
Internal method
Internal method identity
27721
Comment
Immunoassay, Centaur XP
Object
Serum
Parameter
Cortisol
Reference standard
Internal method
Internal method identity
27724
Comment
Immunoassay, Centaur XP
Object
Serum
Parameter
Vitamine D (Calcifediol+ergocalciferol)
Reference standard
Internal method
Internal method identity
27712
Comment
Immunoassay, Centaur XP
Object
Serum
Parameter
Prostate Specific Antigen (PSA)
Reference standard
Internal method
Internal method identity
27728
Comment
Immunoassay, Centaur XP
Object
Serum
Parameter
Thyreoperoxidase antibodies (Anti-TPO)
Reference standard
Internal method
Internal method identity
27738
Comment
Immunoassay, Immulite 2000 XPi
Object
Serum
Parameter
Sex Hormone Binding Globulin (SHBG)
Reference standard
Internal method
Internal method identity
29634
Comment
Immunoassay, Centaur XP
Object
Serum
Parameter
IgE
Reference standard
Internal method
Internal method identity
27742
Comment
Immunoassay, Immulite 2000 XPi
Object
Serum
Parameter
IgE food panel (f1, f2, f3, f4, f13, f14)
Reference standard
Internal method
Internal method identity
27736
Comment
Immunoassay, Immulite 2000 XPi
Object
Serum
Parameter
Panel of inhalation IgE specific antigens, all year (d1, e1, e3, e5, e82)
Reference standard
Internal method
Internal method identity
27736
Comment
Immunoassay, Immulite 2000 XPi
Object
Serum
Parameter
Panel of inhalation IgE specific antigens, seasonal (g6, m2, m6, t3, w6)
Reference standard
Internal method
Internal method identity
27736
Comment
Immunoassay, Immulite 2000 XPi
Object
Serum
Parameter
Cyclic Citrullinated Peptide Antibodies IgG (CCP)
Reference standard
Internal method
Internal method identity
27737
Comment
Immunoassay, Immulite 2000 XPi
Object
Serum
Parameter
Urea
Reference standard
Internal method
Internal method identity
27696
Comment
Photometry, Advia 2400
Object
Serum
Parameter
Urate
Reference standard
Internal method
Internal method identity
27709
Comment
Photometry, Advia 2400
Object
Serum
Parameter
Alaninaminotransferase
Reference standard
Internal method
Internal method identity
27673
Comment
Photometry, Advia 2400
Object
Serum
Parameter
Aspartataminotransferase
Reference standard
Internal method
Internal method identity
27681
Comment
Photometry, Advia 2400
Object
Serum
Parameter
Alkaline phosphatase
Reference standard
Internal method
Internal method identity
27676
Comment
Photometry, Advia 2400
Object
Serum
Parameter
Glutamyltransferase (GT)
Reference standard
Internal method
Internal method identity
27687
Comment
Photometry, Advia 2400
Object
Serum
Parameter
Amylase, total
Reference standard
Internal method
Internal method identity
27678
Comment
Photometry, Advia 2400
Object
Serum
Parameter
Pancreatic Amylase
Reference standard
Internal method
Internal method identity
27677
Comment
Photometry, Advia 2400
Object
Serum
Parameter
Lipase
Reference standard
Internal method
Internal method identity
27956
Comment
Photometry, Advia 2400
Object
Serum
Parameter
Lactate Dedehydrogenase (LD)
Reference standard
Internal method
Internal method identity
27700
Comment
Photometry, Advia 2400
Object
Serum
Parameter
Chloride
Reference standard
Internal method
Internal method identity
27697
Comment
Potensiometri, Advia 2400
Object
Serum
Parameter
Phosphate
Reference standard
Internal method
Internal method identity
27686
Comment
Photometry, Advia 2400
Object
Serum
Parameter
CEA
Reference standard
Internal method
Internal method identity
27969
Comment
Immunoassay, Centaur XP
Object
Serum
Parameter
CA 125
Reference standard
Internal method
Internal method identity
27967
Comment
Immunoassay, Centaur XP
Object
Serum
Parameter
Rheumatoid Factor
Reference standard
Internal method
Internal method identity
27706
Comment
Immunoturbidimetry, Advia 2400
Object
Serum
Parameter
Transferrin
Reference standard
Internal method
Internal method identity
27707
Comment
Immunoturbidimetry, Advia 2400
Object
Serum
Parameter
Tissue Transglutaminase Antibodies (IgA)
Reference standard
Internal method
Internal method identity
28451
Comment
Immunoassay, Phadia 250
Object
Serum
Parameter
Deamidated Gliadin Antibodies (IgG)
Reference standard
Internal method
Internal method identity
27743
Comment
Immunoassay, Phadia 250
Object
Serum
Parameter
Disialotransferrin (Carbohydrate Deficient Transferrin - CDT)
Reference standard
Internal method
Internal method identity
27752
Comment
Capillary electrophoresis, Sebia Capillarys 2
Object
Serum
Parameter
TSI
Reference standard
Internal method
Internal method identity
29197
Comment
Immunoassay, Immulite 2000 Xpi
Object
Serum
Parameter
Creatin kinase (CK)
Reference standard
Internal method
Internal method identity
27684
Comment
Photometry, Advia 2400
Object
Serum
Parameter
Bilirubin
Reference standard
Internal method
Internal method identity
27682
Comment
Photometry, Advia 2400
Object
Serum
Parameter
Glucose
Reference standard
Internal method
Internal method identity
27688
Comment
Photometry, Advia 2400
Object
Serum
Parameter
Cholesterol
Reference standard
Internal method
Internal method identity
27698
Comment
Photometry, Advia 2400
Object
Serum
Parameter
HDL-Cholesterol
Reference standard
Internal method
Internal method identity
27690
Comment
Photometry, Advia 2400
Object
Serum
Parameter
LDL-Cholesterol
Reference standard
Internal method
Internal method identity
27701
Comment
Photometry, Advia 2400
Object
Serum
Parameter
Triglycerides
Reference standard
Internal method
Internal method identity
27708
Comment
Photometry, Advia 2400
Object
Serum
Parameter
Apolipoprotein B
Reference standard
Internal method
Internal method identity
27680
Comment
Immunoturbidimetry, Advia 2400
Object
Serum
Parameter
Apolipoprotein A1
Reference standard
Internal method
Internal method identity
27679
Comment
Immunoturbidimetry, Advia 2400
Object
Serum
Parameter
Lipoprotein (a)
Reference standard
Internal method
Internal method identity
27702
Comment
Immunoturbidimetry, Advia 2400
Object
Serum
Parameter
Protein
Reference standard
Internal method
Internal method identity
27705
Comment
Photometry, Advia 2400
Object
Serum
Parameter
Albumin
Reference standard
Internal method
Internal method identity
27674
Comment
Photometry, Advia 2400
Object
Serum
Parameter
Alfa-1 Antitrypsin
Reference standard
Internal method
Internal method identity
27675
Comment
Immunoturbidimetry, Advia 2400
Object
Serum
Parameter
Haptoglobin
Reference standard
Internal method
Internal method identity
27689
Comment
Immunoturbidimetry, Advia 2400
Object
Serum
Parameter
IgG
Reference standard
Internal method
Internal method identity
27692
Comment
Immunoturbidimetry, Advia 2400
Object
Serum
Parameter
IgA
Reference standard
Internal method
Internal method identity
27691
Comment
Immunoturbidimetry, Advia 2400
Object
Serum
Parameter
IgM
Reference standard
Internal method
Internal method identity
28843
Comment
Immunoturbidimetry, Advia 2400
Object
Serum
Parameter
C-reactive protein (CRP)
Reference standard
Internal method
Internal method identity
27685
Comment
Immunoturbidimetry, Advia 2400
Object
Serum
Parameter
C-Reactiv Protein micro (micro-CRP)
Reference standard
Internal method
Internal method identity
28007
Comment
Immunoturbidimetry, Advia 2400
Object
Serum
Parameter
Iron
Reference standard
Internal method
Internal method identity
27694
Comment
Photometry, Advia 2400
Object
Serum/ urine
Parameter
Magnesium
Reference standard
Internal method
Internal method identity
27703
Comment
Photometry, Advia 2400
Object
Serum/urine
Parameter
Calcium
Reference standard
Internal method
Internal method identity
27683
Comment
Photometry, Advia 2400
Object
Serum/urine
Parameter
Creatinine
Reference standard
Internal method
Internal method identity
27699
Comment
Photometry, Advia 2400
Object
Serum/urine
Parameter
Sodium
Reference standard
Internal method
Internal method identity
27704
Comment
Potensiometri, Advia 2400
Object
Serum/urine
Parameter
Potassium
Reference standard
Internal method
Internal method identity
27695
Comment
Potensiometri, Advia 2400
Object
Urine
Parameter
Protein
Reference standard
Internal method
Internal method identity
27711
Comment
Photometry, Advia 2400
Object
Urine
Parameter
Albumin
Reference standard
Internal method
Internal method identity
27710
Comment
Photometry, Advia 2400
M31 Flexible accreditation
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blod Serum Plasma Urin
Parameter
Hematologiske analytter Klinisk-kjemiske analytter Hormoner Vitaminer Allergener og antistoffer Enzymer
Reference standard
Internal method
Internal method identity
Måleprinsipp / analyseplattformer som er akkreditert under medisinsk biokjemi (M12) Prosedyre for FA: 537 ID logg: 28925
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.
The administrative / geographical unit:
Avdeling for medisinsk biokjemi, Ski
Unilabs Røntgen Ski
Åsenveien 3
1400 Ski



Field testing laboratory
M30 Sample collection
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Patients
Parameter
Blood
Reference standard
Internal method
Internal method identity
28012
Comment
Recognized procedures for venous puncture
The administrative / geographical unit:
Avdeling for medisinsk mikrobiologi Oslo
Silurveien 2
0380 Oslo



Permanent facility
M1610 Medical microbiology, bacteriology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Secretion from throat and nasopharynx
Parameter
Bordetella pertussis
Reference standard
Internal method
Internal method identity
30946
Comment
Real-Time PCR
Object
Urine and secretion from cervix, vagina and urethra
Parameter
Neisseria gonorrhoeae Chlamydia trachomatis Mycoplasma genitalium
Reference standard
Internal method
Internal method identity
28992
Comment
Nucleic acid amplification Panther System
M1640 Medical microbiology, virology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Secretion from throat and nasopharynx
Parameter
Human metapneumovirus (hMPV) and RS virus (RSV)
Reference standard
Internal method
Internal method identity
30946
Comment
Real-Time PCR Panther Fusion
Object
Secretion from throat and nasopharynx
Parameter
Influenza A/B
Reference standard
Internal method
Internal method identity
30946
Comment
Real-Time PCR Panther Fusion
Object
Secretion from throat and nasopharynx
Parameter
Parainfluenza 1-4
Reference standard
Internal method
Internal method identity
30946
Comment
Real-Time PCR Panther Fusion
Object
Secretion from throat and nasopharynx
Parameter
Adenovirus (ADV) and Rhino virus (RV)
Reference standard
Internal method
Internal method identity
30946
Comment
Real-Time PCR Panther Fusion
M1660 Medical microbiology, infection immunolgy
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Serum/plasma
Parameter
Hepatitis A IgM Hepatitt A IgG total As
Reference standard
Internal method
Internal method identity
5566
Comment
CLIA Liaison XL
Object
Serum/plasma
Parameter
Hepatitis Bs (surface) Ab
Reference standard
Internal method
Internal method identity
5539
Comment
CLIA Liaisn XL
Object
Serum/plasma
Parameter
Hepatitis Bc (core) IgM
Reference standard
Internal method
Internal method identity
5544
Comment
CLIA Liaison XL
Object
Serum/plasma
Parameter
Hepatitis Be (envelope) Ag/Ab
Reference standard
Internal method
Internal method identity
5830
Comment
CLIA Liaison XL
Object
Serum/plasma
Parameter
Hepatitis C Ab
Reference standard
Internal method
Internal method identity
5426
Comment
CLIA Liaison XL
Object
Serum/plasma
Parameter
HIV Ag/Ab
Reference standard
Internal method
Internal method identity
5538
Comment
CLIA Liaison XL
Object
Serum/plasma
Parameter
CMV IgM/IgG
Reference standard
Internal method
Internal method identity
21318
Comment
CLIA Liaison XL
Object
Serum/plasma
Parameter
Rubella IgG
Reference standard
Internal method
Internal method identity
11226
Comment
CLIA Liaison XL
Object
Serum/plasma
Parameter
Treponema screening
Reference standard
Internal method
Internal method identity
19191
Comment
CLIA Liaison XL
Object
Serum/plasma
Parameter
Borrelia IgM/IgG
Reference standard
Internal method
Internal method identity
18120
Comment
CLIA Liaison XL
Object
Serum/plasma
Parameter
EBV (EBNA IgG & VCA IgM/IgG)
Reference standard
Internal method
Internal method identity
18188
Comment
CLIA Liaison XL
Object
Serum/plasma
Parameter
Toxoplasma IgM/IgG
Reference standard
Internal method
Internal method identity
9935
Comment
CLIA Liaison XL
Object
Serum/plasma
Parameter
Hepatitis Bs (surface) Ag
Reference standard
Internal method
Internal method identity
5543
Comment
CLIA Liaison XL
Object
Serum/plasma
Parameter
Hepatitis Bc (core) total Ab
Reference standard
Internal method
Internal method identity
9957
Comment
CLIA Liaison XL
Object
Serum/plasma
Parameter
HSV 1/2 IgG
Reference standard
Internal method
Internal method identity
21398
Comment
CLIA Liaison XL
Object
Serum/plasma
Parameter
VZV IgG
Reference standard
Internal method
Internal method identity
21430
Comment
CLIA Liaison XL
Object
Serum/plasma
Parameter
H. pylori IgG
Reference standard
Internal method
Internal method identity
28290
Comment
CLIA Liaison XL
M31 Flexible accreditation
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Secretion
Parameter
Bacteria
Reference standard
Internal method
Internal method identity
Measurement principle / analysis platform which is accredited under medical microbiology - bacteriology (M1610) Procedure for FA: 537 ID log: 28925
Comment
Object
Secretion from throat and nasopharynx
Parameter
Virus
Reference standard
Internal method
Internal method identity
Measurement principle / analysis platform which is accredited under medical microbiology - virology (M1640) Procedure for FA: 537 ID log: 28925
Comment
Object
Serum Plasma
Parameter
Antistoffer og antigener
Reference standard
Internal method
Internal method identity
Måleprinsipp / analyseplattformer som er akkreditert under medisinsk mikrobiologi - infeksjonsimmunologi (M1660) Prosedyre for FA: 537 ID logg: 28925
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.
The administrative / geographical unit:
Avdeling for medisinsk mikrobiologi Skien
Leirvollen 19
3736 Skien



Permanent facility
M1610 Medical microbiology, bacteriology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Bacteria and fungi
Parameter
Identification
Reference standard
Internal method
Internal method identity
27432
Comment
Mass spectrometry Maldi-Tof MS
Object
Bacteria and fungi
Parameter
antibiotic resistance determination
Reference standard
Internal method
Internal method identity
577
Comment
agar diffusion (EUCAST)
Object
Secretion from the cervix and vagina
Parameter
Trichomonas vaginalis
Reference standard
Internal method
Internal method identity
28992
Comment
Nucleic acid amplification Panther System
Object
Secretions from the throat and nasopharynx
Parameter
Chlamydophila pneumoniae, Mycoplasma pneumoniae, Bordetella pertussis
Reference standard
Internal method
Internal method identity
25501
Comment
Real time PCR
Object
Urine and secretions from cervix, vagina and urethra
Parameter
Neisseria gonorrhoeae Chlamydia trachomatis Mycoplasma genitalium
Reference standard
Internal method
Internal method identity
28992
Comment
Nuclein Acid Amplification Panther System
Object
Urine and urine dipslide
Parameter
Bacteria and yeasts
Reference standard
Internal method
Internal method identity
9850
Comment
Culture
M1640 Medical microbiology, virology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Secretion from throat and nasopharynx
Parameter
Influenza A/B
Reference standard
Internal method
Internal method identity
25501
Comment
Realtime PCR
Object
Secretion from eye, throat and nasopharynx
Parameter
Adenovirus (ADV)
Reference standard
Internal method
Internal method identity
25501
Comment
Real-time PCR
Object
Secretion from the neck and nasopharynx
Parameter
Human metapneumovirus (hMPV) and RS virus (RSV)
Reference standard
Internal method
Internal method identity
25501
Comment
Real-time PCR
Object
Secretion from throat and nasopharynx
Parameter
Parainfluenza 1-4
Reference standard
Internal method
Internal method identity
25501
Comment
Real-time PCR
Object
Eye secretion and oral, genital, skin or cervical lesions
Parameter
Herpes simplex & Varicella virus
Reference standard
Internal method
Internal method identity
21931
Comment
Realtime PCR
M31 Flexible accreditation
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Luftveisprøver Kroppssekreter Hud
Parameter
Virus
Reference standard
Internal method
Internal method identity
Real-time PCR - Virology Nucleic acid amplification Panther System (M1640) Procedure for FA: 537 ID log: 20035
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.
Object
Luftveisprøver Kroppssekreter Urin
Parameter
Bakterier og sopp
Reference standard
Internal method
Internal method identity
Måleprinsipp / analyseplattformer som er akkreditert under medisinsk mikrobiologi - bakteriologi (M1610) Prosedyre for FA: 537 ID logg: 20035
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.
The administrative / geographical unit:
Avdeling for patologi
Silurveien 2
0380 Oslo



Permanent facility
M02 Anatomical pathology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Diagnostic tissue samples from breast tumors
Parameter
Diagnosis
Reference standard
Internal method
Internal method identity
ID 25778
Comment
Microscopic examination of tissue sections stained with histochemical and immunohistochemical methods as indicated under M0210
Object
Diagnostic tissue samples from prostate gland tumors
Parameter
Diagnosis
Reference standard
Internal method
Internal method identity
ID 25778
Comment
Macro- and microscopic examination as indicated under M0210
M0210 Anatomical pathology, histopathology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Tissue section
Parameter
Conducting immunohistochemistry
Reference standard
Internal method
Internal method identity
ID:28195
Comment
Immunohistochemistry (IHC) Ventana BenchMark
Object
Tissue section
Parameter
Tissue processing, including HE-dyed preparations
Reference standard
Internal method
Internal method identity
ID:25779 ID:25781 ID:25768 ID:25766 ID:25769 ID:25773 ID:25774 ID: 29167 ID:30128
Comment
Tissue preparation with macroscopic examination, carving, conveying, casting, slicing and HE-dye. Tissue sections preparations with Thermo Scientific and Milestone, Thermo Scientific casting station, Sakura dye and laying machine, and rotation microtome Thermo Scientific