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Norwegian accreditation

Accreditation scope for

TEST 290

Helse Bergen HF, Haukeland universitetssjukehus

Laboratorieklinikken, Mikrobiologisk avdeling

Postboks 1400
5021 Bergen

Telephone: 55974700
E-mail: lene.henriksen.holm@helse-bergen.no
Internet: http://www.helse-bergen.no
The laboratory meets the requirements in

NS-EN ISO 15189:2012




Accreditation includes:
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The administrative / geographical unit:
Mikrobiologisk avdeling
Jonas Lies veg 87
5021 Bergen


Permanent facility
M1610 Medical microbiology, bacteriology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood cultures
Parameter
Bacteria & fungi
Reference standard
Internal method
Internal method identity
D21544, D26386
Comment
Culture, identification and antimicrobial resistance
Object
Feces
Parameter
Pathogenic bacteria & fungi
Reference standard
Internal method
Internal method identity
D24373, D57253
Comment
Culture, identification and antimicrobial resistance
Object
Faeces
Parameter
Toxin B- producing Clostridium difficile-DNA
Reference standard
Internal method
Internal method identity
D31183, D32637
Comment
Real time PCR
Object
Faeces
Parameter
ESBL-producing bacteria
Reference standard
Internal method
Internal method identity
D27928, D56420, D36806
Comment
Culture, identification, Real time PCR and antimicrobial resistance
Object
Faeces
Parameter
VRE
Reference standard
Internal method
Internal method identity
D22107, D17508, D36806
Comment
Real time PCR, culture, identification and antimicrobial resistance
Object
Faeces
Parameter
Campylobacter spp.-DNA
Reference standard
Internal method
Internal method identity
D48886, D49641
Comment
Real time PCR
Object
Faeces
Parameter
Salmonella spp.-DNA
Reference standard
Internal method
Internal method identity
D48886, D49641
Comment
Real time PCR
Object
Faeces
Parameter
Intestinal pathogenes E. coli-DNA
Reference standard
Internal method
Internal method identity
D49002, D48886, D49641
Comment
Real time PCR
Object
Faeces
Parameter
Yersinia enterocolitica-DNA
Reference standard
Internal method
Internal method identity
D48886, D49641
Comment
Real time PCR
Object
Amniotic fluid, genital samples (vagina, cervix) placenta, membranes, fetal surfaces fetal (nose, throat, ear, anus), fetal blood
Parameter
Pathogenic bacteria & fungi
Reference standard
Internal method
Internal method identity
D02325, D26297
Comment
Culture, identification and antimicrobial resistance
Object
Fenital samples (vagina, cervix)
Parameter
Pathogenic bacteria & fungi
Reference standard
Internal method
Internal method identity
D02324, D33426
Comment
Culture, identification and antimicrobial resistance
Object
Intravascular foreign objects
Parameter
Pathogenic bacteria & fungi
Reference standard
Internal method
Internal method identity
D18146, D33431
Comment
Culture, identification and antimicrobial resistance
Object
Joint fluid and cerebrospinal fluid
Parameter
Borrelia spp.-DNA
Reference standard
Internal method
Internal method identity
D35360, D28655
Comment
Real time PCR
Object
Respiratory tract
Parameter
Bordetella pertussis-DNA Bordetella parapertussis-DNA Bordetella holmesii-DNA
Reference standard
Internal method
Internal method identity
D17701, D29754
Comment
Real time PCR
Object
Respiratory tract
Parameter
Chlamydophila pneumoniae-DNA
Reference standard
Internal method
Internal method identity
D17453, D31729
Comment
Real time PCR
Object
Respiratory tract
Parameter
Legionella spp.-DNA
Reference standard
Internal method
Internal method identity
D18805, D24773
Comment
Real time PCR
Object
Respiratory tract, lower
Parameter
Pathogenic bacteria & fungi
Reference standard
Internal method
Internal method identity
D27022, D26403
Comment
Culture, identification and antimicrobial resistance
Object
Respiratory tract, ventricular rinsing liquid, liquid from serous cavities (pleura, pericardium, peritoneum), blood, bone marrow, spinal fluid, tissue / biopsies, urine feces, abscess
Parameter
Mycobacteria
Reference standard
Internal method
Internal method identity
D30886, D29328
Comment
Culture, identification and antimicrobial resistance
Object
Respiratory tract, upper
Parameter
Pathogenic bacteria & fungi
Reference standard
Internal method
Internal method identity
D26156, D26389
Comment
Culture, identification and antimicrobial resistance
Object
Breast milk, formula and sugar water
Parameter
Bacteria & fungi
Reference standard
Internal method
Internal method identity
D25062, D26402
Comment
Culture, identification and antimicrobial resistance
Object
Nails, skin scraping, hair
Parameter
Dermatofytt-DNA
Reference standard
Internal method
Internal method identity
D41216, D42075
Comment
Real time PCR
Object
Nose, throat, perineum, wounds, eczema lesions, scars/skin effects, insertion sites foreign bodies, urine
Parameter
MRSA
Reference standard
Internal method
Internal method identity
D10522, D36806, D69572
Comment
Culture, identification and antimicrobial resistance Real Time PCR
Object
Peritoneal dialysis fluid
Parameter
Bacteria & fungi
Reference standard
Internal method
Internal method identity
D28257, D32548
Comment
Culture, identification and antimicrobial resistance
Object
Pure culture of bacteria
Parameter
Resistance determination
Reference standard
Internal method
Internal method identity
D11147 D22148
Comment
Agardiffusion / BIOMIC EUCAST method
Object
Pure culture of bacteria
Parameter
Resistance determination
Reference standard
Internal method
Internal method identity
D01758
Comment
Agar gradient method
Object
Pure culture of bacteria and fungi
Parameter
Identification and resistance determination
Reference standard
Internal method
Internal method identity
D33538
Comment
Vitek 2
Object
Pure culture of bacteria and fungi
Parameter
Resistance determination
Reference standard
Internal method
Internal method identity
D45003
Comment
Macro- and micro broth dilution method
Object
Pure cultures, bacteria &fungi
Parameter
Identification
Reference standard
Internal method
Internal method identity
D24862
Comment
Mass spectrometry MALDI-TOF
Object
Cerebrospinal fluid
Parameter
Bacteria & fungi
Reference standard
Internal method
Internal method identity
D21543, D25034
Comment
Culture, identification and antimicrobial resistance
Object
Cerebrospinal fluid
Parameter
Streptococcus agalactiae (GBS)-DNA
Reference standard
Internal method
Internal method identity
D44053, D25034, D33429
Comment
Real time PCR
Object
Stem cell and blood products, bone, soft tissue, cornea, amniotic fluid, placenta
Parameter
Pathogenic bacteria & fungi
Reference standard
Internal method
Internal method identity
D29476, D33430
Comment
Culture, identification and antimicrobial resistance
Object
Semen
Parameter
Bacteria & fungi
Reference standard
Internal method
Internal method identity
D27515
Comment
Culture, identification and antimicrobial resistance
Object
Exudate, fluids and pus from sterile areas (abscesses, bursa, cysts, drains, hematoma, joints, pericardium, ascites)
Parameter
Bacteria & fungi
Reference standard
Internal method
Internal method identity
D28257, D26400
Comment
Culture, identification and antimicrobial resistance
Object
Urine
Parameter
Pathogenic bacteria & fungi
Reference standard
Internal method
Internal method identity
D24362, D26395
Comment
Culture, identification and antimicrobial resistance
Object
Urine
Parameter
Legionella pneumophila serogroup 1
Reference standard
Internal method
Internal method identity
D33684, D56662
Comment
Antigen detection
Object
Urine, cerebrospinal fluid
Parameter
Streptococcus pneumoniae
Reference standard
Internal method
Internal method identity
D02032, D33683
Comment
Antigen detection
Object
Urogenital samples rektalpensel, throat, conjunctiva
Parameter
Neisseria gonorrheae
Reference standard
Internal method
Internal method identity
D27513, D33427
Comment
Culture, identification and antimicrobial resistance
Object
Vaginal, cervical, urethral and urinary
Parameter
Mycoplasma genitalium
Reference standard
Internal method
Internal method identity
D43076 D38688
Comment
TMA Panther
Object
Vaginal secretions, cervical secretions, urethral secretions, anus secretions, throat secretions and urine
Parameter
Chlamydia trachomatis-DNA
Reference standard
Internal method
Internal method identity
D43076, D43392, D59791
Comment
TMA Panther
Object
Vaginal secretions, cervical secretions, urethral secretions, anus secretions, throat secretons and urine
Parameter
Neisseria gonorrhoeae-DNA
Reference standard
Internal method
Internal method identity
D43076, D43392
Comment
TMA Panther
Object
Vaginal secretions, faeces
Parameter
Streptococcus agalactiae (GBS)
Reference standard
Internal method
Internal method identity
D07973, D33429
Comment
Culture, identification and antimicrobial resistance
Object
Vaginasecretions, cervix, spiral, membrane residues, placenta, aspirate/pus, tube material
Parameter
Pathogenic bacteria & fungi
Reference standard
Internal method
Internal method identity
D27511, D33426
Comment
Culture, identification and antimicrobial resistance
Object
Tissue, joint fluid, orthopedic prosthetic material, wound and fistula secretion
Parameter
Pathogenic bacteria & fungi
Reference standard
Internal method
Internal method identity
D26155, D26404
Comment
Culture, identification and antimicrobial resistance
M1640 Medical microbiology, virology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Feces
Parameter
Sapovirus-RNA
Reference standard
Internal method
Internal method identity
D70186, D70174
Comment
Real time PCR
Object
Faeces
Parameter
Norovirus genogruppe 1-RNA Norovirus genogruppe 2-RNA
Reference standard
Internal method
Internal method identity
D36737, D25709, D48779, D49641
Comment
Real time PCR
Object
Faeces
Parameter
Adenovirus-DNA (intestinal pathogenes)
Reference standard
Internal method
Internal method identity
D48727, D49641
Comment
Real time PCR
Object
Faeces
Parameter
Astrovirus-RNA
Reference standard
Internal method
Internal method identity
D48727, D49641
Comment
Real time PCR
Object
Faeces
Parameter
Rotavirus -RNA
Reference standard
Internal method
Internal method identity
D48727, D49641
Comment
Real time PCR
Object
Respiratory tract
Parameter
Rhino virus-RNA
Reference standard
Internal method
Internal method identity
D46948, D45709
Comment
Real time PCR
Object
Respiratory tract
Parameter
Influenza virus A-RNA Influenza virus B-RNA
Reference standard
Internal method
Internal method identity
D66532, D64072, D64573, D30057, D70768
Comment
Real time PCR
Object
Respiratory tract
Parameter
SARS-CoV-2 RNA Influenza virus A-RNA Influenza virus B-RNA Respiratory syncytial virus RNA
Reference standard
Internal method
Internal method identity
D30057, D28667, D63935
Comment
Real time PCR
Object
Respiratory tract
Parameter
Respiratorisk syncytialvirus-RNA
Reference standard
Internal method
Internal method identity
D43165, D28667
Comment
Real time PCR
Object
Respiratory tract
Parameter
Human metapneumovirus-RNA
Reference standard
Internal method
Internal method identity
D43165, D28669
Comment
Real time PCR
Object
Respiratory tract
Parameter
Para influenza virus 1-RNA Para influenza virus 2-RNA Para influenza virus 3-RNA
Reference standard
Internal method
Internal method identity
D25518, D31477
Comment
Real time PCR
Object
Respiratory tract
Parameter
SARS-CoV-2 RNA Influenzavirus A-RNA Influenza virus B-RNA
Reference standard
Internal method
Internal method identity
D67018, D28667, D63935
Comment
Real time PCR
Object
Respiratory tract
Parameter
Human coronavirus OC43 Human coronavirus 229E Human coronavirus NL63 Human coronavirus HKU1
Reference standard
Internal method
Internal method identity
D70416, D70175
Comment
Real Time PCR
Object
Respiratory tract
Parameter
SARS-CoV-2 RNA
Reference standard
Internal method
Internal method identity
D63935, D64116, D62168, D66532, D64072, D64573, D70768
Comment
Real Time PCR
Object
Respiratory tract
Parameter
SARS-CoV-2 RNA Influenzavirus A-RNA Influenzavirus B-RNA
Reference standard
Internal method
Internal method identity
D62168, D70317, D30057
Comment
TMA Panther
Object
Resporatory tract
Parameter
Mycoplasma pneumoniae-DNA
Reference standard
Internal method
Internal method identity
D17453 D31598
Comment
Real time PCR
Object
Respiratory tract, cerebrospinal fluid, bone marrow, blood
Parameter
Adenovirus-DNA
Reference standard
Internal method
Internal method identity
D05547, D26414
Comment
Real time PCR
Object
Plasma
Parameter
Cytomegalovirus-DNA
Reference standard
Internal method
Internal method identity
D23962, D70766
Comment
Real time PCR
Object
Plasma
Parameter
HIV-RNA
Reference standard
Internal method
Internal method identity
D47386, D29874
Comment
TMA Panther
Object
Plasma
Parameter
Epstein-Barr virus DNA
Reference standard
Internal method
Internal method identity
D70767, D27399
Comment
Real time PCR
Object
Secretions, cerebrospinal fluid, amniotic fluid
Parameter
Herpes simplex-virus type 1- DNA Herpes simplex-virus type 2- DNA
Reference standard
Internal method
Internal method identity
D08592, D31082
Comment
Real time PCR
Object
Sekret, urine
Parameter
Measles virus PCR
Reference standard
Internal method
Internal method identity
D58168, D27439
Comment
Real-Time PCR
Object
Serum, amniotic fluid, blood, bone marrow, joint fluids
Parameter
Human parvovirus B19-DNA
Reference standard
Internal method
Internal method identity
D21220, D27424
Comment
Real time PCR
Object
Serum, plasma
Parameter
Hepatitt B-virus DNA
Reference standard
Internal method
Internal method identity
D26291, D47382
Comment
TMA Panther
Object
Serum, plasma
Parameter
Hepatitt C-virus RNA
Reference standard
Internal method
Internal method identity
D47387, D29467
Comment
TMA Panther
Object
Serum, plasma
Parameter
Zikavirus-RNA Denguevirus-RNA Chikungunyavirus-RNA
Reference standard
Internal method
Internal method identity
D51235, D49803, D52087, D25107
Comment
Real time PCR
Object
Cerebrospinal fluid
Parameter
Human Parecho Virus-RNA
Reference standard
Internal method
Internal method identity
D37897, D39156
Comment
Real time PCR
Object
Cerebrospinal fluid, bone marrow, blood
Parameter
Humant herpesvirus 6-DNA
Reference standard
Internal method
Internal method identity
D13275, D29070
Comment
Real time PCR
Object
Cerebrospinal fluid, secretions
Parameter
Varicella zoster-virus DNA
Reference standard
Internal method
Internal method identity
D21221, D29305
Comment
Real time PCR
Object
Cerebrospinal fluid, scretions, faeces
Parameter
Enterovirus-RNA
Reference standard
Internal method
Internal method identity
D20637, D30926
Comment
Real time PCR
M1650 Medical microbiology, parasitology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Faeces
Parameter
Entamoeba histolytica-DNA
Reference standard
Internal method
Internal method identity
D48741, D49641
Comment
Real time PCR
Object
Faeces
Parameter
Giardia lamblia-DNA
Reference standard
Internal method
Internal method identity
D48741, D49641
Comment
Real time PCR
Object
Faeces
Parameter
Cryptosporidium spp.
Reference standard
Internal method
Internal method identity
D21526, D31623
Comment
Microscopy
Object
Faeces
Parameter
Cysts and eggs
Reference standard
Internal method
Internal method identity
D30783, D31623
Comment
Microscopy
Object
Amniotic fluid
Parameter
Toxoplasma gondii
Reference standard
Internal method
Internal method identity
D61338, D24305
Comment
Real time PCR
Object
Faeces
Parameter
Cryptosporidium spp.-DNA
Reference standard
Internal method
Internal method identity
D48741, D49641
Comment
Real time PCR
Object
Urine
Parameter
Schistosomas hematobium eggs
Reference standard
Internal method
Internal method identity
D21078, D31623
Comment
Microscopy
M1660 Medical microbiology, infection immunolgy
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood
Parameter
TB spesific gamma-interferon (Quanitiferon))
Reference standard
Internal method
Internal method identity
D20490, D25164
Comment
Chemiluminescens immunoassay (CLIA), Liaison
Object
Serum
Parameter
Herpes simplex-virus IgG antibody (HSV-1 og HSV-2)
Reference standard
Internal method
Internal method identity
D20490 D31082
Comment
Chemiluminescens immunoassay (CLIA) Liaison
Object
Serum, plasma
Parameter
Humant immunsviktvirus (HIV) antigen and antibody
Reference standard
Internal method
Internal method identity
D29874, D53876, D53874
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
HIV p24 antigen
Reference standard
Internal method
Internal method identity
D15805, D29874
Comment
EIA
Object
Serum, plasma
Parameter
HIV 1 Immuno-blot (Western blot)
Reference standard
Internal method
Internal method identity
D01857, D29874
Comment
Immuno-blot Western blot
Object
Serum, plasma
Parameter
HTLV
Reference standard
Internal method
Internal method identity
D29875, D53876, D53874
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Measles virus IgG antibody
Reference standard
Internal method
Internal method identity
D20490, D27439
Comment
CLIA Liaison
Object
Serum, plasma
Parameter
Parotitis virus IgG antibody Parotitis virus IgM antibody
Reference standard
Internal method
Internal method identity
D20490, D28695
Comment
CLIA Liaison
Object
Serum, plasma
Parameter
Rubella virus IgG antibody Rubellavirus IgM-antibody
Reference standard
Internal method
Internal method identity
D28952, D53876
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Syfilis (Treponema pallidum)
Reference standard
Internal method
Internal method identity
D24777, D53876, D53874
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Syfilis (Treponema pallidum particle agglutination,TPPA)
Reference standard
Internal method
Internal method identity
D01912, D24777
Comment
Passive agglutination
Object
Serum, plasma
Parameter
Syfilis (Treponema pallidum) Rapid plasma reagin (RPR)
Reference standard
Internal method
Internal method identity
D22012, D24777
Comment
Agglutination
Object
Serum, plasma
Parameter
Toxoplasma gondii IgG-antibody Toxoplasma gondii IgM-antibody
Reference standard
Internal method
Internal method identity
D24305, D53876
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Varicella zoster-virus IgG-antibody Varicella zoster-virus IgM- antibody
Reference standard
Internal method
Internal method identity
D20490, D29305
Comment
CLIA Liaison
Object
Serum, plasma
Parameter
Epstein-Barr-virus VCA IgG-antibody Epstein-Barr-virus VCA IgM-antibody
Reference standard
Internal method
Internal method identity
D27399, D53876
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Hepatitis B virus core antibody (total)
Reference standard
Internal method
Internal method identity
D26291 D20490
Comment
Chemiluminescens immunoassay (CLIA), Liaison
Object
Serum, plasma
Parameter
SARS-Cov-2 IgG-antibody
Reference standard
Internal method
Internal method identity
D53876 D62168
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
SARS-Cov-2 IgG-antibody
Reference standard
Internal method
Internal method identity
D20490 D62168
Comment
CLIA Liaison
Object
Serum, Plasma
Parameter
Hepatitt D-virus antibody
Reference standard
Internal method
Internal method identity
D20490, D69282
Comment
Chemiluminescens immunoassay (CLIA) Liaison
Object
Serum, Plasma
Parameter
Cytomegalovirus IgM-antibody
Reference standard
Internal method
Internal method identity
D20490 D23962
Comment
Chemiluminescens immunoassay (CLIA) Liaison
Object
Serum, plasma
Parameter
Hepatitis E virus IgG-antibody
Reference standard
Internal method
Internal method identity
D20490, D71895
Comment
Chemiluminescens immunoassay (CLIA), Liaison
Object
Serum, plasma
Parameter
Hepatitis E virus IgM-antibody
Reference standard
Internal method
Internal method identity
D20490, D71895
Comment
Chemiluminescens immunoassay (CLIA), Liaison
Object
Serum, plasma
Parameter
Hepatitt B-virus s-antigen
Reference standard
Internal method
Internal method identity
D26291, D53876
Comment
CMIA, Quantitative Alinity
Object
Serum, plasma
Parameter
Humant parvovirus B19 IgG-antibody Humant parvovirus B19 IgM-antibody
Reference standard
Internal method
Internal method identity
D20490, D27424
Comment
CLIA Liaison
Object
Serum, plasma
Parameter
Puumalvirus IgM antibody
Reference standard
Internal method
Internal method identity
D33480, D24909
Comment
Immunochromatography
Object
Serum, plasma
Parameter
Herpes simplex-virus IgM antibody
Reference standard
Internal method
Internal method identity
D20490, D31082
Comment
CLIA Liaison
Object
Serum, plasma
Parameter
HIV-antibody
Reference standard
Internal method
Internal method identity
D56531, D29874
Comment
Immuno chromatography Geenius
Object
Serum, plasma
Parameter
Borrelia burgdorferi IgG-antibody Borrelia burgdorferi IgM- antibody
Reference standard
Internal method
Internal method identity
D20490, D28655
Comment
CLIA Liaison
Object
Serum, plasma
Parameter
Cytomegalovirus IgG-antibody Cytomegalovirus IgM- antibody
Reference standard
Internal method
Internal method identity
D23962, D53876
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Denguevirus NS1-antigen Denguevirus IgG-antibody Denguevirus IgM-antibody antibody
Reference standard
Internal method
Internal method identity
D22289, D25107
Comment
Immunochromatography
Object
Serum, plasma
Parameter
Epstein-Barr-virus EBNA-1 IgG-antibody
Reference standard
Internal method
Internal method identity
D27399, D53876
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Heterophile antibodies
Reference standard
Internal method
Internal method identity
D29177, D27399
Comment
Agglutination Clearview
Object
Serum, plasma
Parameter
Hepatitt C-virus Immuno-blot
Reference standard
Internal method
Internal method identity
D25316, D29467
Comment
Immuno-Blot RecomLine
Object
Serum, plasma
Parameter
Hepatitt A-virus IgG-antibody Hepatitt A-virus IgM-antibody
Reference standard
Internal method
Internal method identity
D29490, D53876
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Hepatitt B-virus s-antigen Hepatitt B-virus s-antibody
Reference standard
Internal method
Internal method identity
D26291, D53876
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Hepatitt B-virus e-antigen Hepatitt B-virus e-antibodyf
Reference standard
Internal method
Internal method identity
D26291, D53876
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Hepatitt B-virus core-antibody (total)
Reference standard
Internal method
Internal method identity
D26291, D53876, D53874
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Hepatitt B-virus core-IgM-antibody
Reference standard
Internal method
Internal method identity
D26291, D53876, D53874
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Hepatitis C-virus antibody
Reference standard
Internal method
Internal method identity
D29467, D53876, D53874
Comment
CMIA Alinity
M31 Flexible accreditation
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Respiratory tests Sterile liquids Biopsies and tissue Body secretions Body fluids Bacteria Urine Intravascular foreign bodies
Parameter
Bacteria Yeast and Mold Virus Parasites Antibodies
Reference standard
Internal method
Internal method identity
Measurement principle/analysis platforms which is accredited under medical microbiology (M16) Procedure for FA: D39497, D39926, D36707, D23505 ID log:
Comment
An updated list of accredited methods is available with the organization.