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Accreditation scope for

TEST 078

Universitetssykehuset Nord-Norge HF

Avdeling for mikrobiologi og smittevern

Postboks 56
9038 TROMSØ

Telephone: Tlf. 77 62 70 10
E-mail: post@unn.no
Internet: http://www.unn.no
The laboratory meets the requirements in

NS-EN ISO 15189:2022




Accreditation includes:
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The administrative / geographical unit:
Avdeling for mikrobiologi og smittevern, mikrobiologisk laboratorium
Sykehusveien 38
9038 TROMSØ


Permanent facility
M1610 Medical microbiology, bacteriology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Scraping from mucous membranes and skin
Parameter
Methicillin-resistant Staphylococcus aureus (MRSA)
Reference standard
Internal method
Internal method identity
D06953
Comment
Culture on selective media
Object
Bacteria- and fungus culture
Parameter
Gram negative bacilli, Gram-positive cocci, Yeast
Reference standard
Internal method
Internal method identity
D06681
Comment
Identification and resistance VITEK
Object
Bacterial and fungal cultures Bacterial culture
Parameter
Identification of bacteria, yeasts and molds
Reference standard
Internal method
Internal method identity
D15911
Comment
MALDI-TOF
Object
Bacteria colony from solid media
Parameter
Bacterial resistance genes
Reference standard
Internal method
Internal method identity
D57036
Comment
LAMP. Easymini
Object
Bacterial culture
Parameter
Betalaktamase production Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidis
Reference standard
Internal method
Internal method identity
D18380
Comment
Nitrocefin
Object
Bacteria culture
Parameter
Determination of antibiotic resistance in bacteria
Reference standard
Internal method
Internal method identity
D14730
Comment
Determination of resistance by measurement of MIC in antibiotic gradients.
Object
Bacteria culture
Parameter
Mycobacteria
Reference standard
Internal method
Internal method identity
D10773
Comment
Immunochromatography
Object
Bacteria culture
Parameter
Beta-lactamase production
Reference standard
Internal method
Internal method identity
D06299
Comment
Kløverblad
Object
Bacteria culture
Parameter
Vancomycin resistance in enterococci
Reference standard
Internal method
Internal method identity
D06585
Comment
Resistance by culture on selective media
Object
Bacteria culture
Parameter
Anaerobic bacteria
Reference standard
Internal method
Internal method identity
D07151
Comment
Culture and evaluation
Object
Bacteria culture from uricult
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
D06335
Comment
Identification and resistance determination by means of culture and review
Object
Bacteria cultures
Parameter
Resistance determination of bacteria
Reference standard
Internal method
Internal method identity
D08151
Comment
Resistance determination by agar diffusion
Object
Bone, bone tissue
Parameter
Pathogenic bacteria Fungus
Reference standard
Internal method
Internal method identity
D07020
Comment
Culture and via enrichment
Object
Bone, tissue, prosthetic material, aspirate, cement
Parameter
Bakterier Fungus
Reference standard
Internal method
Internal method identity
D07022
Comment
Culture on agar plate and enrichment media
Object
Blood, tissue fluid, secretion, tissue
Parameter
Listeria monocytogenes
Reference standard
Internal method
Internal method identity
D06502
Comment
Culture on selective media, biochemical and enzymatic properties.
Object
Blood Culture
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
D05999 D46189
Comment
Virtuo and BacT/ALERT
Object
Different materials on eSwab, Urine
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
D24031 D23897
Comment
WASP
Object
Sputum, larynx secretion, and invasive samples from the lower respiratory tract of patients with cystic fibrosis
Parameter
Staphylococcus aureus, Burkholderia cepacia, Gram negative rods, Hemophilus influenzae, Streptococcus pneumoniae, Stenotrophomonas maltophila, Aspergillus sp, Candida sp, Mycobacteria
Reference standard
Internal method
Internal method identity
D07006
Comment
Culture on selective media and evaluation
Object
Sputum, tracheal secretion, bronchoalveolar lavage fluid
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
D07011
Comment
Culture and evaluation
Object
Sputum, tracheal secretion, bronchoalveolar lavage fluid
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
D07023
Comment
Culture and evaluation
Object
Feces
Parameter
Campylobacter sp. Identification
Reference standard
Internal method
Internal method identity
D06569
Comment
Cultivation on selectively medium
Object
Feces
Parameter
Salmonella sp. Identification
Reference standard
Internal method
Internal method identity
D07050
Comment
Cultivation on selectively media
Object
Feces
Parameter
Shigella sp identification
Reference standard
Internal method
Internal method identity
D07054
Comment
Cultivation on selectively media
Object
Feces
Parameter
Yersinia sp identification
Reference standard
Internal method
Internal method identity
D07055
Comment
Cultivation on selectively media
Object
Feces
Parameter
Shigella spp./Enteroinvasive E.coli (EIEC), Campylobacter spp, Yersinia enterocolitica, Vibrio spp, Aeromonas spp. Salmonella spp. Stx1/stx2 (Shiga toxin genes)
Reference standard
Internal method
Internal method identity
D35622
Comment
Molecular biology diagnostic (PCR) Qualitative, Allplex GI Bacteria I og II assay
Object
Feces
Parameter
Detection of Clostridoides difficile DNA
Reference standard
Internal method
Internal method identity
D11502
Comment
Loop mediated isothermal amplification (LAMP)
Object
Feces and bacteria cultures from feces
Parameter
Clostridoides difficile antigen and toxin A og B
Reference standard
Internal method
Internal method identity
D06581
Comment
Immunoassay (EIA)
Object
Genital secretions, vaginal secretion, Cervix/urethra, urine samples, anus, eye, throat
Parameter
Chlamydia Trachomatis DNA Mycoplasma genitalium DNA Neisseria gonorrhoeae DNA
Reference standard
Internal method
Internal method identity
D17453
Comment
Molecular biological diagnostic (PCR). Qualitative. Hamilton
Object
Yeast
Parameter
Determination of resistance in Candida sp, Cryptococcus sp. and other not demanding yeasts
Reference standard
Internal method
Internal method identity
D33023
Comment
MIC with Micro broth dilution antibiotic gradients
Object
Throat secretion, material from tonsils
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
D07099
Comment
Culture and evaluation
Object
Skin, hair, and nail samples
Parameter
Dermatophytes
Reference standard
Internal method
Internal method identity
D06331
Comment
Culture and microscopy
Object
Catheters, drains
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
D07010
Comment
Culture on agar plate and via enrichment medium
Object
Cultures, body fluids and preparations/smears
Parameter
Bakterier Sopp
Reference standard
Internal method
Internal method identity
D09558
Comment
Gram coloring
Object
Respiratory tract secretion
Parameter
Bordetella pertussis DNA Chlamydophila pneumoniae DNA Mycoplasma pneumoniae DNA
Reference standard
Internal method
Internal method identity
D17678
Comment
Molecular biological diagnostic (PCR). Qualitative. Hamilton
Object
Respiratory tract secretion, exudate
Parameter
Corynebacterium diphtheriae
Reference standard
Internal method
Internal method identity
D06509
Comment
Culture on differentiating and selective media
Object
Material from genitalia, placenta, fetus/newborn
Parameter
Bacteria
Reference standard
Internal method
Internal method identity
D08437
Comment
Culture and evaluation
Object
Material from genitalia, placenta, fetus/newborn
Parameter
Beta-hemolytic streptococci group B
Reference standard
Internal method
Internal method identity
D07965
Comment
Culture and evaluation
Object
Nasopharynx secretion
Parameter
Bordtella pertussis
Reference standard
Internal method
Internal method identity
D06508
Comment
Culture on selective medium
Object
Nail, hair and skin samples
Parameter
Dermatophyte DNA
Reference standard
Internal method
Internal method identity
D51451
Comment
Molecular biological diagnostics (PCR). Qualitative.
Object
Pus; secretion and samples from the respiratory tract, sinus, sterile areas, tissue, ear, and eye
Parameter
Mold
Reference standard
Internal method
Internal method identity
D06335
Comment
Culture, identification and evaluation
Object
Pus, secretions, body fluids, tissues
Parameter
Mycobacteria
Reference standard
Internal method
Internal method identity
D07172 D09590 D09591 D45837
Comment
Cultivation Auramine staining Direct microscopy Ziehl-Neelsen's color method
Object
Pus, secretion, tissue and body fluids, feces
Parameter
Yeast
Reference standard
Internal method
Internal method identity
D06418
Comment
Culture on selective media and identification by biochemical tests
Object
Pus, secretion, interstitial fluid, and tissue
Parameter
Actinomyces
Reference standard
Internal method
Internal method identity
D57311
Comment
Culture and evaluation
Object
Pus, exudate, aspirate and tissue
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
D07008 D26603
Comment
Culture and evaluation
Object
SAGMAN blood
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
D10313
Comment
Culture
Object
Secretion from the lower respiratory tract
Parameter
Legionella species
Reference standard
Internal method
Internal method identity
D06340
Comment
Microscopy and culture with or without acid treatment
Object
Secretion from the lower respiratory tract as a sterile protected brush sample
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
D09589
Comment
Culture and evaluation
Object
Secretion from the nose and nasopharynx
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
D07012
Comment
Culture and evaluation
Object
Secret urethra, cervix, vagina, rectum, eye, throat
Parameter
Neisseria gonorrhoeae
Reference standard
Internal method
Internal method identity
D07347
Comment
Identification and suceptability testing
Object
Secretion, pus, tissue from the middle and outer ear
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
D07025
Comment
Culture and evaluation
Object
Fungal culture
Parameter
Yeast
Reference standard
Internal method
Internal method identity
D15273
Comment
Culture and evaluation
Object
Cerebrospinal fluid
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
D07018
Comment
Direct microscopy, microscopy of gram stains, and culture on agar plate and enrichment medium
Object
Spinal fluid
Parameter
DNA from: E.coli H. influenzae, N. meningitidis, S. pneumoniae, S. agalactiae, L. monocytogenes
Reference standard
Internal method
Internal method identity
D57348
Comment
LAMP. Easymini Qualitative
Object
Spinal fluid Blood culture
Parameter
Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae
Reference standard
Internal method
Internal method identity
D35042
Comment
Bacterial meningitis PCR (In house)
Object
Cerebrospinal fluid, urine, sputum
Parameter
Cryptococcus neoformans
Reference standard
Internal method
Internal method identity
D06417
Comment
Culture and microscopy
Object
Sputum, bronchial lavage fluid and colonies
Parameter
Mycobacterium tuberculosis complex
Reference standard
Internal method
Internal method identity
D41069
Comment
Molecular biology diagnostics and resistance determination (PCR and melting point analysis) Qualitative. Allplex.
Object
Urine
Parameter
Legionella pneumophila
Reference standard
Internal method
Internal method identity
D06337
Comment
In vitro immunochromatography
Object
Urine
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
D07096
Comment
Culture on agar plate
Object
Urine, spinal fluid
Parameter
Streptococcus pneumoniae
Reference standard
Internal method
Internal method identity
D06338
Comment
In vitro immunochromatography
Object
Tissue fluid
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
D07004
Comment
Culture
Object
Eye secretion
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
D07026
Comment
Culture and evaluation
M1640 Medical microbiology, virology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
BAL, induced sputum
Parameter
Pneumocystis jirovecii
Reference standard
Internal method
Internal method identity
D57013
Comment
Molecular biological diagnostics (PCR). Qualitative.
Object
Feces
Parameter
Noroviruse GI og GII, Adenoviruse og Rotaviruse, Sapoviruse og Astroviruse
Reference standard
Internal method
Internal method identity
D35622
Comment
Molecular biology diagnostic (PCR) Qualitative, Allplex GI Virus assay
Object
Respiratory tract secretion
Parameter
Coronavirus (SARSCoV-2, OC43, 229E, NL63 og HKU1) RNA, Influensa virus A og B RNA, Metapneumovirus RNA, Parainfluensa virus 1, 2, 3 og 4 RNA, Respiratoric syncytialt virus RNA, Rhinovirus RNA
Reference standard
Internal method
Internal method identity
D23096
Comment
Molecular biological diagnostic (PCR). Qualitative.
Object
Respiratory tract secretion, eye secretion
Parameter
Adenovirus DNA
Reference standard
Internal method
Internal method identity
D07328
Comment
Molecular biological diagnostic (PCR). Qualitative.
Object
Nasopharynx
Parameter
Bordetella pertussis DNA
Reference standard
Internal method
Internal method identity
D27376
Comment
Molecular biological diagnostic (PCR). Qualitative.
Object
Cerebrospinal fluid, feces, exudate, nasopharynx, eye, throat
Parameter
Enterovirus RNA
Reference standard
Internal method
Internal method identity
D07351
Comment
Molecular biological diagnostic (PCR). Qualitative.
Object
Cerebrospinal fluid, eye secretion, exudate
Parameter
Herpes simplex virus 1 and 2 DNA
Reference standard
Internal method
Internal method identity
D18161
Comment
Molecular biological diagnostic (PCR). Qualitative.
Object
Eye secretion, cerebrospinal fluid, exudate
Parameter
Varicella zoster virus DNA
Reference standard
Internal method
Internal method identity
D18161
Comment
Molecular biological diagnostic (PCR). Qualitative.
M1660 Medical microbiology, infection immunolgy
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Plasma
Parameter
Schistosoma IgG- og IgM rapid test
Reference standard
Internal method
Internal method identity
D38004
Comment
Immunochromatography qualitative
Object
Plasma
Parameter
TB Quantiferon
Reference standard
Internal method
Internal method identity
D38093
Comment
CLIA Liason
Object
Serum
Parameter
Schistosoma mansoni IgG
Reference standard
Internal method
Internal method identity
D38003
Comment
ELISA qualitative
Object
Serum
Parameter
Echincoccus granulosus IgG
Reference standard
Internal method
Internal method identity
D38005
Comment
ELISA qualitative
Object
Serum
Parameter
Echinococcus IgG
Reference standard
Internal method
Internal method identity
D38057
Comment
Western blot Qualitative
Object
Serum
Parameter
Helicobacter pylori IgG
Reference standard
Internal method
Internal method identity
D34885
Comment
CLIA Liasion
Object
Serum
Parameter
Strongyloides ratti antibodies IgG
Reference standard
Internal method
Internal method identity
D38017
Comment
ELISA qualitative
Object
Serum
Parameter
Filaria antistoffer IgG
Reference standard
Internal method
Internal method identity
D38016
Comment
ELISA qualitative
Object
Serum
Parameter
Toxocara ELISA IgG
Reference standard
Internal method
Internal method identity
D49050
Comment
ELISA qualitative
Object
Serum
Parameter
Toxocara Western Blot IgG
Reference standard
Internal method
Internal method identity
D48999
Comment
Western blot qualitative
Object
Serum, plasma
Parameter
Hepatitis B virus core antibody
Reference standard
Internal method
Internal method identity
D42463
Comment
CLIA Liason
Object
Serum and plasma
Parameter
Hepatitis C virus antibody
Reference standard
Internal method
Internal method identity
D43784
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
HIV antigen and HIV antibody
Reference standard
Internal method
Internal method identity
D43365
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Cytomegalovirus IgM
Reference standard
Internal method
Internal method identity
D34871
Comment
CLIA Liasion
Object
Serum, plasma
Parameter
Varicella zoster IgM og IgG
Reference standard
Internal method
Internal method identity
D34807
Comment
CLIA Liasion
Object
Serum, plasma
Parameter
Bordetella pertussis-toxin- IgG
Reference standard
Internal method
Internal method identity
D36186
Comment
CLIA Liason
Object
Serum, plasma
Parameter
Herpes simplex 1/2 IgM og IgG
Reference standard
Internal method
Internal method identity
D34844
Comment
CLIA Liason
Object
Serum, plasma
Parameter
Hepatitt B virus envelope antigen Hepatitt B virus envelope antibody Hepatitt B virus core antibody (IgM)
Reference standard
Internal method
Internal method identity
D43374
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Toxoplasma gondii antibodies (IgG and IgM)
Reference standard
Internal method
Internal method identity
D43371
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Hepatitis A virus antibody (IgG and IgM)
Reference standard
Internal method
Internal method identity
D43367
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Treponema palladium antibody
Reference standard
Internal method
Internal method identity
D43366
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Rubella virus antibody (IgG)
Reference standard
Internal method
Internal method identity
D43370
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Cytomegalo virus antibodies (IgG and IgM)
Reference standard
Internal method
Internal method identity
D43368
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Borrelia burgdorferi IgM og IgG
Reference standard
Internal method
Internal method identity
D35254
Comment
CLIA Liasion
Object
Serum, plasma
Parameter
Parotitt IgM og IgG
Reference standard
Internal method
Internal method identity
D35256
Comment
CLIA Liasion
Object
Serum, plasma
Parameter
Morbilli IgM og IgG
Reference standard
Internal method
Internal method identity
D35255
Comment
CLIA Liasion
Object
Serum, plasma
Parameter
Parvovirus B19 IgM og IgG
Reference standard
Internal method
Internal method identity
D34805
Comment
CLIA Liasion
Object
Serum, plasma
Parameter
Hepatitt E IgM+IgG
Reference standard
Internal method
Internal method identity
D44111
Comment
CLIA Liason
Object
Serum, plasma
Parameter
Hepatitt B surface antigen, Hepatitt B virus surface antibody, Hepatitt B core antibody
Reference standard
Internal method
Internal method identity
D43363
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Trypanosoma cruzi antibody
Reference standard
Internal method
Internal method identity
D44848 D45258
Comment
ELISA kvalitativ CMIA Alinity
Object
Serum, plasma
Parameter
Epstein-Barr virus (EBNA-1-antibody (IgG) VCA-antibody (IgG og IgM))
Reference standard
Internal method
Internal method identity
D43369
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Malaria antibody - Anti-plasmodium IgG
Reference standard
Internal method
Internal method identity
D47392
Comment
ELISA qualitative
Object
Serum, plasma, full blood
Parameter
Heterophile antibodies
Reference standard
Internal method
Internal method identity
D10410
Comment
Latex agglutination. Qualitative
Object
Serum, plasma, EDTA blood
Parameter
Hiv 1 antibodies
Reference standard
Internal method
Internal method identity
D37078
Comment
Immunography Geenius HIV Confirmatory Assay
M31 Flexible accreditation
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Respiratory samples Body secretions Body fluids Biopsies ang tissue Foreign body materials Culture from bacteria and fungi
Parameter
Bacteria Virus Fungi Antibodies
Reference standard
Internal method
Internal method identity
Measurement principles/instruments accredited under medical microbiology M16
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.