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Norwegian accreditation

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 15189:2012




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
PR21300
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
PR20659
Comment
Identification and resistance VITEK
Object
Bacterial and fungal cultures
Parameter
Identification of bacteria, yeasts and molds
Reference standard
Internal method
Internal method identity
PR32828
Comment
MALDI-TOF
Object
Bacteria colony from solid media
Parameter
Bacterial resistance genes
Reference standard
Internal method
Internal method identity
PR53385
Comment
LAMP. Easyplex
Object
Bacteria culture
Parameter
Mycobacteria
Reference standard
Internal method
Internal method identity
PR29377
Comment
Immunochromatography
Object
Bacterial culture
Parameter
Betalaktamase production Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidis
Reference standard
Internal method
Internal method identity
PR35543
Comment
Nitrocefin
Object
Bacteria culture
Parameter
Determination of antibiotic resistance in bacteria
Reference standard
Internal method
Internal method identity
PR29649
Comment
Determination of resistance by measurement of MIC in antibiotic gradients.
Object
Bacteria culture
Parameter
Beta-lactamase production
Reference standard
Internal method
Internal method identity
PR19845
Comment
Kløverblad
Object
Bacteria culture
Parameter
Vancomycin resistance in enterococci
Reference standard
Internal method
Internal method identity
PR20444
Comment
Resistance by culture on selective media
Object
Bacteria culture
Parameter
Anaerobic bacteria
Reference standard
Internal method
Internal method identity
PR21638
Comment
Culture and evaluation
Object
Bacteria culture from uricult
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
PR19978
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
PR23739
Comment
Resistance determination by agar diffusion
Object
Bone, bone tissue
Parameter
Pathogenic bacteria Fungus
Reference standard
Internal method
Internal method identity
PR21391
Comment
Culture and via enrichment
Object
Bone, tissue, prosthetic material, aspirate, cement
Parameter
Bakterier Fungus
Reference standard
Internal method
Internal method identity
PR21396
Comment
Culture on agar plate and enrichment media
Object
Blood, tissue fluid, secretion, tissue
Parameter
Listeria monocytogenes
Reference standard
Internal method
Internal method identity
PR20272
Comment
Culture on selective media, biochemical and enzymatic properties.
Object
Blood Culture
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
PB0267, PB0592 PB1999, PB2000
Comment
Virtuo and BacT/ALERT
Object
Different materials on eSwab, Urine
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
PB1504 PB1501
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
PR21363
Comment
Culture on selective media and evaluation
Object
Sputum, tracheal secretion, bronchoalveolar lavage fluid
Parameter
Bacteria Fungus Colonization flora
Reference standard
Internal method
Internal method identity
PR21375
Comment
Culture and evaluation
Object
Sputum, tracheal secretion, bronchoalveolar lavage fluid
Parameter
Bacteria Fungus Colonization flora
Reference standard
Internal method
Internal method identity
PR21399
Comment
Culture and evaluation
Object
Feces
Parameter
Campylobacter sp. Identification
Reference standard
Internal method
Internal method identity
PR20413
Comment
Cultivation on selectively media
Object
Feces
Parameter
Clostridoides difficile
Reference standard
Internal method
Internal method identity
PR20414
Comment
Culivation om special medium
Object
Feces
Parameter
Detection of Clostridoides difficile DNA
Reference standard
Internal method
Internal method identity
PR30705
Comment
Loop mediated isothermal amplification (LAMP)
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
PR50751
Comment
Molecular biology diagnostic (PCR) Qualitative, Allplex GI Bacteria I og II assay
Object
Feces
Parameter
Salmonella sp. Identification
Reference standard
Internal method
Internal method identity
PR21446
Comment
Cultivation on selectively media
Object
Feces
Parameter
Shigella sp identification
Reference standard
Internal method
Internal method identity
PR21452
Comment
Cultivation on selectively media
Object
Feces
Parameter
Yersinia sp identification
Reference standard
Internal method
Internal method identity
PR21453
Comment
Cultivation on selectively media
Object
Feces
Parameter
Enterohemorrhagic E. coli (EHEC)
Reference standard
Internal method
Internal method identity
PR20365
Comment
Culture
Object
Feces and bacteria cultures from feces
Parameter
Clostridoides difficile antigen and toxin A og B
Reference standard
Internal method
Internal method identity
PR20434
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
PR34552
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
PR48871
Comment
MIC with Micro broth dilution antibiotic gradients
Object
Throat secretion, material from tonsils
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
PR21554
Comment
Culture and evaluation
Object
Skin, hair, and nail samples
Parameter
Dermatophytes
Reference standard
Internal method
Internal method identity
PR19970
Comment
Culture and microscopy
Object
Catheters, drains
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
PR21372
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
PR27131
Comment
Gram coloring
Object
Respiratory tract secretion
Parameter
Bordetella pertussis DNA Chlamydophila pneumoniae DNA Mycoplasma pneumoniae DNA
Reference standard
Internal method
Internal method identity
PR31726
Comment
Molecular biological diagnostic (PCR). Qualitative. Hamilton
Object
Respiratory tract secretion, exudate
Parameter
Corynebacterium diphtheriae
Reference standard
Internal method
Internal method identity
PR20283
Comment
Culture on differentiating and selective media
Object
Material from genitalia, placenta, fetus/newborn
Parameter
Bacteria
Reference standard
Internal method
Internal method identity
PR24476
Comment
Culture and evaluation
Object
Material from genitalia, placenta, fetus/newborn
Parameter
Beta-hemolytic streptococci group B
Reference standard
Internal method
Internal method identity
PR23189
Comment
Culture and evaluation
Object
Nasopharynx secretion
Parameter
Bordtella pertussis
Reference standard
Internal method
Internal method identity
PR20280
Comment
Culture on selective medium
Object
Pneumococci
Parameter
Resistance determination of bacteria
Reference standard
Internal method
Internal method identity
PR55210
Comment
Determination of resistance by measuring MIC using microbroth dilution
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
PR19975
Comment
Culture, identification and evaluation
Object
Pus, secretions, body fluids, tissues
Parameter
Mycobacteria
Reference standard
Internal method
Internal method identity
PR21697 PR58287 PR27198 PR27199
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
PR20142
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
PR23184
Comment
Culture and evaluation
Object
Pus, exudate, aspirate and tissue
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
PR21367 PR43943
Comment
Culture and evaluation
Object
SAGMAN blood
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
PR28484
Comment
Culture
Object
Secretion from the lower respiratory tract
Parameter
Legionella pneumophilae
Reference standard
Internal method
Internal method identity
PR19984
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
PR27197
Comment
Culture and evaluation
Object
Secretion from the nose and nasopharynx
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
PR21377
Comment
Culture and evaluation
Object
Secret urethra, cervix, vagina, rectum, eye
Parameter
Neisseria gonorrhoeae
Reference standard
Internal method
Internal method identity
PR22147
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
PR21401
Comment
Culture and evaluation
Object
Fungal culture
Parameter
Yeast
Reference standard
Internal method
Internal method identity
PR32163
Comment
Culture and evaluation
Object
Spinal fluid
Parameter
Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae
Reference standard
Internal method
Internal method identity
PR50431
Comment
Bacterial meningitis PCR (In house)
Object
Spinal fluid
Parameter
Eazyplex CSF direct M
Reference standard
Internal method
Internal method identity
PR56918
Comment
LAMP. Easyplex Qualitative
Object
Cerebrospinal fluid
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
PR21388
Comment
Direct microscopy, microscopy of gram stains, and culture on agar plate and enrichment medium
Object
Cerebrospinal fluid, urine, sputum
Parameter
Cryptococcus neoformans
Reference standard
Internal method
Internal method identity
PR20140
Comment
Culture and microscopy
Object
Sputum, bronchial lavage fluid and colonies
Parameter
Mycobacterium tuberculosis complex
Reference standard
Internal method
Internal method identity
PR54866
Comment
Molecular biology diagnostics and resistance determination (PCR and melting point analysis) Qualitative. Allplex.
Object
Urine
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
PR21544
Comment
Culture on agar plate
Object
Urine
Parameter
Legionella pneumophila
Reference standard
Internal method
Internal method identity
PR19980
Comment
In vitro immunochromatography
Object
Urine, cerebrospinal fluid
Parameter
Streptococcus pneumoniae
Reference standard
Internal method
Internal method identity
PR19981
Comment
In vitro immunochromatography
Object
Tissue fluid
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
PR21357
Comment
Culture
Object
Eye secretion
Parameter
Bacteria Fungus
Reference standard
Internal method
Internal method identity
PR21402
Comment
Culture and evaluation
M1640 Medical microbiology, virology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Feces
Parameter
Noroviruse GI og GII, Adenoviruse og Rotaviruse, Sapoviruse og Astroviruse
Reference standard
Internal method
Internal method identity
PR50751
Comment
Molecular biology diagnostic (PCR) Qualitative, Allplex GI Virus assay
Object
Respiratory tract secretion
Parameter
Coronavirus (SARSCoV-2, OC43 og 229E) RNA, Influensa virus A og B RNA, Metapneumovirus RNA, Parainfluensa virus 1, 2 og 3 RNA, Respiratoric syncytialt virus RNA, Rhinovirus RNA
Reference standard
Internal method
Internal method identity
PR40627
Comment
Molecular biological diagnostic (PCR). Qualitative.
Object
Respiratory tract secretion, eye secretion
Parameter
Adenovirus DNA
Reference standard
Internal method
Internal method identity
PR22108
Comment
Molecular biological diagnostic (PCR). Qualitative.
Object
Nasopharynx
Parameter
Bordetella pertussis DNA
Reference standard
Internal method
Internal method identity
PR44620
Comment
Molecular biological diagnostic (PCR). Qualitative.
Object
Serum, plasma
Parameter
Hepatitis C virus RNA
Reference standard
Internal method
Internal method identity
PR21819
Comment
Genotyping using detection of RNA by hybridization.
Object
Cerebrospinal fluid, feces, exudate
Parameter
Enterovirus RNA
Reference standard
Internal method
Internal method identity
PR22158
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
PR35274
Comment
Molecular biological diagnostic (PCR). Qualitative.
Object
Eye secretion, cerebrospinal fluid, exudate
Parameter
Varicella zoster virus DNA
Reference standard
Internal method
Internal method identity
PR35274
Comment
Molecular biological diagnostic (PCR). Qualitative.
M1660 Medical microbiology, infection immunolgy
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Plasma
Parameter
TB Quantiferon
Reference standard
Internal method
Internal method identity
PR52867
Comment
CLIA Liason
Object
Plasma
Parameter
Schistosoma IgG- og IgM rapid test
Reference standard
Internal method
Internal method identity
PR52783
Comment
Immunochromatography qualitative
Object
Serum
Parameter
Echincoccus granulosus IgG
Reference standard
Internal method
Internal method identity
PR52785
Comment
ELISA qualitative
Object
Serum
Parameter
Echinococcus IgG
Reference standard
Internal method
Internal method identity
PR52831
Comment
Western blot Qualitative
Object
Serum
Parameter
Schistosoma mansoni IgG
Reference standard
Internal method
Internal method identity
PR52782
Comment
ELISA qualitative
Object
Serum
Parameter
Strongyloides ratti antibodies IgG
Reference standard
Internal method
Internal method identity
PR52408
Comment
ELISA qualitative
Object
Serum
Parameter
Filaria antistoffer IgG
Reference standard
Internal method
Internal method identity
PR52795
Comment
ELISA qualitative
Object
Serum
Parameter
Helicobacter pylori IgG
Reference standard
Internal method
Internal method identity
PR50319
Comment
CLIA Liasion
Object
Serum and plasma
Parameter
Hepatitis C virus antibody
Reference standard
Internal method
Internal method identity
PR56777
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Hepatitis B virus core antibody
Reference standard
Internal method
Internal method identity
PR55921
Comment
CLIA Liason
Object
Serum, plasma
Parameter
Hepatitis A virus antibody (IgG and IgM)
Reference standard
Internal method
Internal method identity
PR56469
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Treponema palladium antibody
Reference standard
Internal method
Internal method identity
PR56468
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Rubella virus antibody (IgG)
Reference standard
Internal method
Internal method identity
PR56472
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Cytomegalo virus antibodies (IgG and IgM)
Reference standard
Internal method
Internal method identity
PR56470
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
HIV antigen and HIV antibody
Reference standard
Internal method
Internal method identity
PR56467
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Cytomegalovirus IgM
Reference standard
Internal method
Internal method identity
PR50307
Comment
CLIA Liasion
Object
Serum, plasma
Parameter
Varicella zoster IgM og IgG
Reference standard
Internal method
Internal method identity
PR50259
Comment
CLIA Liasion
Object
Serum, plasma
Parameter
Hepatitt E IgM+IgG
Reference standard
Internal method
Internal method identity
PR56993
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
PR56464
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Trypanosoma cruzi antibody
Reference standard
Internal method
Internal method identity
PR57538 PR57778
Comment
ELISA kvalitativ CMIA Alinity
Object
Serum, plasma
Parameter
Toxoplasma gondii antibodies (IgG and IgM)
Reference standard
Internal method
Internal method identity
PR56473
Comment
CMIA Alinity
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
PR56476
Comment
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
PR56471
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Herpes simplex 1/2 IgM og IgG
Reference standard
Internal method
Internal method identity
PR50290
Comment
CLIA Liason
Object
Serum, plasma
Parameter
Bordetella pertussis-toxin- IgG
Reference standard
Internal method
Internal method identity
PR51192
Comment
CLIA Liason
Object
Serum, plasma
Parameter
SARS CoV-2 antibody IgG
Reference standard
Internal method
Internal method identity
PR56475
Comment
CMIA Alinity
Object
Serum, plasma
Parameter
Borrelia burgdorferi IgM og IgG
Reference standard
Internal method
Internal method identity
PR50163
Comment
CLIA Liasion
Object
Serum, plasma
Parameter
Parotitt IgM og IgG
Reference standard
Internal method
Internal method identity
PR50540
Comment
CLIA Liasion
Object
Serum, plasma
Parameter
Morbilli IgM og IgG
Reference standard
Internal method
Internal method identity
PR50292
Comment
CLIA Liasion
Object
Serum, plasma
Parameter
Parvovirus B19 IgM og IgG
Reference standard
Internal method
Internal method identity
PR50258
Comment
CLIA Liasion
Object
Serum, plasma
Parameter
Malaria antibody - Anti-plasmodium IgG
Reference standard
Internal method
Internal method identity
PR59216
Comment
ELISA qualitative
Object
Serum, plasma, full blood
Parameter
Heterophile antibodies
Reference standard
Internal method
Internal method identity
PR28718
Comment
Latex agglutination. Qualitative
Object
Serum, plasma, EDTA blood
Parameter
Hiv 1 antibodies
Reference standard
Internal method
Internal method identity
PR51985
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.