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Norwegian accreditation

Accreditation scope for

TEST 263

St. Olavs hospital HF

Laboratoriemedisinsk klinikk, Avdeling for medisinsk mikrobiologi

Postboks 3250 Sluppen
7006 Trondheim

Telephone: 72573200
E-mail: mikrobiologi@stolav.no
Internet: http://www.stolav.no/mikrobiologi
The laboratory meets the requirements in

NS-EN ISO 15189:2012




Accreditation includes:
The administrative / geographical unit:
Avd for medisinsk mikrobiologi
Erling Skjalgssonsgt 1
7006 Trondheim



Permanent facility
M1610 Medical microbiology, bacteriology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Abscess / Aspirate, Bronchial Fluid / Nasopharynx / Tracheal Aspirate, Expectorate, Biopsy / Tissue, Fixed Tissue (Paraffin Embedded / Formalin Fixed), Growth Cultures / Transmitted Strains, Growth Culture
Parameter
Francisella tularensis, DNA
Reference standard
Internal method
Internal method identity
20572
Comment
Real-time PCR, in house developed CFX
Object
Abscess, ascites, biopsy, tissues, breast milk, dialysis, dren liquid, lower respiratory tract (including BRS, EKS, TRS), upper respiratory tract (throat, mouth, naso nose), pleural fluid, spinal fluid, wound, pus, urine, urogenital samples (cervix, vagina , urethra), ear, eye, synovial fluid
Parameter
Fungi
Reference standard
Internal method
Internal method identity
14601, 16199, 16638 16639, 45743, 16746 16783, 18022, 18687, 16648, 37549, 43457, 20838
Comment
Culturing, identification and antimicrobial resistance
Object
Abscess fluid
Parameter
Pathogenic bacteria
Reference standard
Internal method
Internal method identity
14307 15524 15537 16369 14315 40911
Comment
Culturing, identification and antimicrobial resistance
Object
Ascites fluid
Parameter
Pathogenic bacteria
Reference standard
Internal method
Internal method identity
14307 14315 15524 16369 40911
Comment
Culturing, identification and antimicrobial resistance
Object
Bacteria strain
Parameter
Panton Valentine Leukocidin (PVL) gen. mecA gen. spa gen
Reference standard
Internal method
Internal method identity
15032 44692 39169
Comment
Qualitative PCR
Object
Bacteria strain
Parameter
spa typing
Reference standard
Internal method
Internal method identity
15032
Comment
Typing Staph. Aureus Protein A -gen repeted area
Object
Bacteria strain
Parameter
GBS capsule and protein typing
Reference standard
Internal method
Internal method identity
16350 16381 16985
Comment
PCR, qualitative Applied Biosystems 2720
Object
Bacteria strain
Parameter
16S rDNA
Reference standard
Internal method
Internal method identity
18705
Comment
PCR and sequencing, in house developed ABI 3500 XL
Object
Bacteria strain
Parameter
MRSA
Reference standard
Internal method
Internal method identity
17561
Comment
Real time PCR, in house developed CFX
Object
Bacterial strain from faeces
Parameter
E.coli (EHEC) Shiga-like toksin 1+2
Reference standard
Internal method
Internal method identity
18670
Comment
Multiplex real time PCR, in house CFX
Object
Bacterial strain from faeces
Parameter
E.coli (EPEC) intimin-gen, DNA
Reference standard
Internal method
Internal method identity
17886
Comment
Real time PCR, in house CFX
Object
Bone to/from bone bank
Parameter
Pathogenic bacteria
Reference standard
Internal method
Internal method identity
14307, 14315, 15537, 40911, 15524, 15924, 16369
Comment
Culturing, identification and antimicrobial resistance
Object
Bloodcluture
Parameter
Fungi
Reference standard
Internal method
Internal method identity
14601, 16199, 45743, 16638, 18022, 18687, 16648, 37549, 43457, 20838
Comment
Culturing and manual reading BactecFX
Object
Bloodcluture aerob & anaerob
Parameter
Pathogenic bacteria
Reference standard
Internal method
Internal method identity
8375 8406 33170
Comment
Culturing and manual reading BactecFX
Object
Bursa fluid / joint fluid
Parameter
Pathogenic bacteria
Reference standard
Internal method
Internal method identity
14307 14315 15537 15924
Comment
Culturing, identification and antimicrobial resistance
Object
Cervix, vaginal og urine
Parameter
Mycoplasma genitalium Trichomonas vaginalis
Reference standard
Internal method
Internal method identity
13710, 42405, 43126
Comment
Real time PCR, qualitative, Alinity m (Abbott)
Object
Cervix, vaginal, urine, throat and anus
Parameter
Chlamydia trachomatis Neisseria gonhoreaea
Reference standard
Internal method
Internal method identity
13710, 42405, 43126
Comment
Real time PCR, qualitative, Alinity m (Abbott)
Object
Cornea
Parameter
Pathogenic bacteria
Reference standard
Internal method
Internal method identity
7824
Comment
Culturing, identification and antimicrobial resistance
Object
Peritoneal fluid
Parameter
Pathogenic bacteria
Reference standard
Internal method
Internal method identity
15524 16369 14315 14307 40911
Comment
Culturing, identification and antimicrobial resistance
Object
Sputum, bronchial wash fluid, throat
Parameter
Legionella pneumophila
Reference standard
Internal method
Internal method identity
16649
Comment
Real time PCR, in house developed LightCycler 2.0
Object
Sputum, bronchial rinse liquid, nasopharynx
Parameter
Chlamydophila pneumoniae (TWAR)
Reference standard
Internal method
Internal method identity
21472
Comment
Multiplex real time PCR CFX
Object
Sputum, bronchial wash fluid, tissue, biopsies, abscess
Parameter
Mycobacterium tuberculosis
Reference standard
Internal method
Internal method identity
17885
Comment
Real time PCR, in house developed CFX
Object
Faeces
Parameter
Patogenic bacteria, screening: Salmonella, Shigella/EIEC, Campylobacter, Yersinia, Vibrio, C.difficile, EHEC, EPEC, ETEC, EAEC
Reference standard
Internal method
Internal method identity
32895 32907 46582
Comment
Allplex™ GI-bacteria(I) Assay + Allplex™ GI-bacteria(II) Assay QIAstat Dx Gastrointestinal Panel
Object
Faeces
Parameter
Pathogenic bacteria: Salmonella spp Shigella spp E.coli Campylobacter spp Yersinia spp Vibrio Aeromonas Plesiomonas
Reference standard
Internal method
Internal method identity
14131, 14566, 14723 9230, 18672, 18670, 17886, 15772, 14853
Comment
Culturing, identification and antimicrobial resistance
Object
Faeces
Parameter
Clostridium difficile toxin B
Reference standard
Internal method
Internal method identity
24255 16051
Comment
Multiplex real time PCR, in house developed CFX
Object
Skin, hair, nail
Parameter
Fungi
Reference standard
Internal method
Internal method identity
14601, 16199, 45743 16638, 16639, 18022 16783, 18687, 16746, 16648, 37549, 43457, 20838
Comment
Culturing, identification and antimicrobial resistance
Object
Rrespiratory samples, spinal fluid
Parameter
Mycoplasma pneumoniae
Reference standard
Internal method
Internal method identity
21472
Comment
Multiplex real time PCR CFX
Object
Stomach/intestinal biopsy, ventricle biopsy
Parameter
Helicobacter pylori
Reference standard
Internal method
Internal method identity
16650
Comment
Multiplex real time PCR, in house developed CFX
Object
Nasopharynx, throat
Parameter
Bordetella pertussis
Reference standard
Internal method
Internal method identity
21472
Comment
Multiplex real time PCR CFX
Object
Lower respiratory tract
Parameter
Pneumocystis jiroveci
Reference standard
Internal method
Internal method identity
17798
Comment
Real time PCR, in house developed CFX
Object
Lower respiratory tract
Parameter
Acid proof rods
Reference standard
Internal method
Internal method identity
9161 12849 12847 17650
Comment
Microscopy after Ziehl -Neelsen or Auramin dying
Object
Lower respiratory tract
Parameter
Mycobacteria
Reference standard
Internal method
Internal method identity
9155 18204 9161
Comment
Culture in liquid medium with automatic detection (Bactec MGIT, Becton Dickinson) and culture on Löwenstein-Jensen medium.
Object
Nose, throat, perineum, wounds, axilla, pus and secretions
Parameter
MRSA-screening
Reference standard
Internal method
Internal method identity
7109 17524
Comment
Culturing, identification and antimicrobial resistance
Object
Placenta, umbilical cord, membranes
Parameter
Pathogenic bacteria
Reference standard
Internal method
Internal method identity
14307, 14315, 15537, 17378, 15524, 16369, 40911
Comment
Culturing, identification and antimicrobial resistance
Object
Pleural fluid
Parameter
Pathogenic bacteria
Reference standard
Internal method
Internal method identity
14307 14315 15524 16369 40911
Comment
Culturing, identification and antimicrobial resistance
Object
Pus/wounds, surgical wounds, catheter tips
Parameter
Pathogenic bacteria
Reference standard
Internal method
Internal method identity
14307 14315 15537
Comment
Culturing, identification and antimicrobial resistance
Object
Pure culture of bacteria from human material
Parameter
Resistance determination
Reference standard
Internal method
Internal method identity
7509, 8496 9120, 9186, 16110, 19449, 19898, 18853
Comment
Agardiffusion EUCAST's
Object
Pure culture of bacteria from human material
Parameter
Resistance determination
Reference standard
Internal method
Internal method identity
8496 32415 32660 32475
Comment
Agardiffusjon and MIC/Phoenix
Object
Spinal fluid
Parameter
Pathogen bacteria
Reference standard
Internal method
Internal method identity
14307, 14315, 15537 15524, 16369, 40911
Comment
Culturing, identification and antimicrobial resistance
Object
Spinal fluid, bacterial strain
Parameter
Listeria moncytogenes
Reference standard
Internal method
Internal method identity
17300
Comment
Real time PCR, in house developed CFX
Object
Urine
Parameter
Screening of bacteria
Reference standard
Internal method
Internal method identity
42553
Comment
Flowcytometry Sysmex UF 5000
Object
Urine
Parameter
Legionella pneumophila antigen
Reference standard
Internal method
Internal method identity
12786
Comment
Antigen detection BinaxNow
Object
Urine
Parameter
Pathogene bacteria
Reference standard
Internal method
Internal method identity
9435, 14307, 14315 15965
Comment
Culturing, identification and antimicrobial resistance
Object
Urogenital samples
Parameter
Neisseria gonhoreaea
Reference standard
Internal method
Internal method identity
13213 14307 14315
Comment
Culturing, identification and antimicrobial resistance
Object
Urogenital samples, aerob growth
Parameter
Pathogene bacteria
Reference standard
Internal method
Internal method identity
14307 14315 15537
Comment
Culturing, identification and antimicrobial resistance
Object
Tissue, biopsy
Parameter
Pathogene bacteria
Reference standard
Internal method
Internal method identity
14307, 14315, 15524 15924, 16369, 18671 40911
Comment
Culturing, identification and antimicrobial resistance
Object
Upper & lower respiratory tract
Parameter
Pathogene bacteria
Reference standard
Internal method
Internal method identity
14307 14315 15537
Comment
Culturing, identification and antimicrobial resistance
Object
Eye
Parameter
Pathogene bacteria
Reference standard
Internal method
Internal method identity
14307 14315 15537
Comment
Culturing, identification and antimicrobial resistance
M1640 Medical microbiology, virology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood, serum, joint fluid
Parameter
Parvovirus B19
Reference standard
Internal method
Internal method identity
18748
Comment
Real time PCR, in house developed CFX
Object
Blood, spinal fluid
Parameter
Human herpesvirus 6
Reference standard
Internal method
Internal method identity
18515
Comment
Real time PCR, in house CFX
Object
Faeces
Parameter
Pathogenic virus, screening; Norovirus GI & GII Rotavirus A Adenovirus F Astrovirus Sapovirus
Reference standard
Internal method
Internal method identity
32908 46582
Comment
Multiplex, real time PCR Allplex GI-virus Assay QIAstat Dx Gastrointestinal Panel
Object
Faeces
Parameter
Pathogenic virus
Reference standard
Internal method
Internal method identity
14163 7605 14740 7612 27894 20256
Comment
Culturing and microscopy
Object
Faeces, vomit
Parameter
Norovirus
Reference standard
Internal method
Internal method identity
16409
Comment
Multiplex real time PCR, in house developed CFX
Object
Respiratory tract, eye, feces, full blood
Parameter
Adenovirus
Reference standard
Internal method
Internal method identity
13934
Comment
Real time PCR, in house developed CFX
Object
Respiratory tract
Parameter
Coronavirus OC43 Coronavirus NL63 Coronavirus 229E
Reference standard
Internal method
Internal method identity
16332 16351
Comment
Multiplex real time PCR, in house developed CFX
Object
Respiratory tract
Parameter
Parainfluenzavirus 1, 2, 3 og 4
Reference standard
Internal method
Internal method identity
14172 14125
Comment
Multiplex real time PCR, in house developed CFX
Object
Respiratory tract
Parameter
Respiratory syncytial virus (RSV)
Reference standard
Internal method
Internal method identity
15840
Comment
Multiplex real time PCR, in house developed CFX
Object
Respiratory tract
Parameter
Rhinovirus
Reference standard
Internal method
Internal method identity
15840
Comment
Multiplex real time PCR, in house developed CFX
Object
Respiratory tract
Parameter
Pathogenic virus
Reference standard
Internal method
Internal method identity
14163 7605 14740 7612 20256
Comment
Culturing and microscopy
Object
Respiratory fluids
Parameter
SARS CoV-2, influenza A/B, respiratoric syncytialt viruse (RSV)
Reference standard
Internal method
Internal method identity
42300
Comment
Real-Time PCR, Qualitative GeneXpert
Object
Respiratory tract, nasofarynx (SARS CoV-2)
Parameter
SARS CoV-2, influenza A/B, respiratoric syncytialt viruse (RSV)
Reference standard
Internal method
Internal method identity
42405 43209
Comment
Real time PCR, kvalitativ Alinity m
Object
Respiratory fluid, spinal fluid, feces
Parameter
Parechovirus
Reference standard
Internal method
Internal method identity
14096
Comment
Real time PCR, in house developed CFX
Object
Nasopharynx, lower respiratory tract
Parameter
Human metapneumovirus
Reference standard
Internal method
Internal method identity
12049
Comment
Real time PCR, in house developed CFX
Object
PCR-product
Parameter
Adenovirus, genotyping
Reference standard
Internal method
Internal method identity
14166
Comment
PCR/sequencing, in house developed ABI 3500 XL
Object
PCR-product
Parameter
Hepatitis C virus (HCV), genotyping
Reference standard
Internal method
Internal method identity
13662
Comment
PCR/Sequencing, in house developed ABI 3500 XL
Object
PCR-product
Parameter
Enterovirus, genotyping
Reference standard
Internal method
Internal method identity
15168
Comment
PCR and Sequencing, in house developed ABI 3500 XL
Object
Swab samples, wound secretion
Parameter
Pathogenic virus
Reference standard
Internal method
Internal method identity
14572 14163 7605 14740 7612 20256
Comment
Culturing and microscopy
Object
Plasma
Parameter
HIV-1
Reference standard
Internal method
Internal method identity
34593 42405
Comment
Real time PCR, quantitative Alinity
Object
Serum, plasma
Parameter
Hepatitis B virus (HBV)
Reference standard
Internal method
Internal method identity
34593 42405
Comment
Real time PCR, quantitative Alinity m
Object
Serum, plasma
Parameter
Hepatitis C virus (HCV)
Reference standard
Internal method
Internal method identity
34593 42405
Comment
Real time PCR, quantitative Alinity m
Object
Spinal fluid
Parameter
Pathogenic virus
Reference standard
Internal method
Internal method identity
14163 7605 14740 7612 20256
Comment
Culturing and microscopy
Object
Spinal fluid, Blood, serum, throat swab
Parameter
Epstein-Barr virus (EBV)
Reference standard
Internal method
Internal method identity
18544 18718 (quantitative)
Comment
Real time PCR, in house developed CFX
Object
Spinal fluid, blood, urine, throat, amniotic fluid
Parameter
Cytomegalovirus (CMV)
Reference standard
Internal method
Internal method identity
18533 18546 (quantitative)
Comment
Real time PCR, in house developed CFX
Object
Spinalfluid, faeces, respiratory tract, vesicle (hand-foot-mouth disease), eye, cellculture
Parameter
Enterovirus, (Coxackie-, Echo-, Entero-, Polio-virus)
Reference standard
Internal method
Internal method identity
18719
Comment
Real time PCR, in house developed CFX
Object
Spinal fluid, vesicle content
Parameter
Herpes simplex virus 1 & 2 (HSV)
Reference standard
Internal method
Internal method identity
18485
Comment
Multiplex real time PCR, in house developed CFX
Object
Urine
Parameter
Pathogenic virus
Reference standard
Internal method
Internal method identity
14572 14163 7605 14740 7612 20256
Comment
Culturing and microscopy
Object
Vesicle content, spinal fluid
Parameter
Varicella zoster virus
Reference standard
Internal method
Internal method identity
16352
Comment
Real time PCR, in house developed CFX
Object
Upper respiratory tract
Parameter
Influensa A & B virus
Reference standard
Internal method
Internal method identity
12396
Comment
Multiplex real time PCR, in house developed CFX
Object
Upper respiratory tract
Parameter
Influenza A H1N1 PDM09 RNA
Reference standard
Internal method
Internal method identity
16321
Comment
Real time PCR, in house developed CFX
M1650 Medical microbiology, parasitology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood smear
Parameter
Malaria parasites
Reference standard
Internal method
Internal method identity
12073
Comment
Giemsa staining & microscopy
Object
Faeces
Parameter
Cysts and eggs
Reference standard
Internal method
Internal method identity
15678, 17194 15677, 17488
Comment
Microscopy
Object
Fæces
Parameter
Paracites, screening: Giardia, Cryptosporidum and Entamoeba
Reference standard
Internal method
Internal method identity
40092 46582
Comment
Allplex™ GI-Parasitic Assay QIAstat Dx Gastrointestinal Panel
M1660 Medical microbiology, infection immunolgy
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood
Parameter
TB Quantiferon
Reference standard
Internal method
Internal method identity
42447
Comment
CLIA, kvantitativ QuantiFERON TB Gold, Liason XL
Object
Serum, plasma
Parameter
Rubellavirus IgG
Reference standard
Internal method
Internal method identity
38570 38668
Comment
CMIA, quantitative Alinity
Object
Serum, plasma
Parameter
Streptococcus pyogenes (gr.A) Anti-Dnase B Ig
Reference standard
Internal method
Internal method identity
37034, 16733
Comment
Automatic N Latex ADNase B - Atellica NEPH 630
Object
Serum, plasma
Parameter
Streptococcus pyogenes (gr.A) ASL (antistreptolysin-titer)
Reference standard
Internal method
Internal method identity
37034, 16733
Comment
Automatic N Latex ASL - Atellica NEPH 630
Object
Serum, plasma
Parameter
Treponema pallidum total
Reference standard
Internal method
Internal method identity
38531 38668
Comment
CMIA, qualitative Alinity
Object
Serum, plasma
Parameter
Treponema pallidum RPR
Reference standard
Internal method
Internal method identity
17612
Comment
Manual agglutination, qualitative
Object
Serum, plasma
Parameter
Treponema pallidum TPP
Reference standard
Internal method
Internal method identity
17613
Comment
Manual agglutination, semiquantitative
Object
Serum, plasma
Parameter
Herpes simplexs zoster virus IgM & IgG
Reference standard
Internal method
Internal method identity
33032 33895
Comment
CLIA, qualitative Liaison XL
Object
Serum, plasma
Parameter
Toxoplasma gondii IgG & IgM
Reference standard
Internal method
Internal method identity
38599 38668 38596
Comment
CMIA, qualititive Alinity
Object
Serum, plasma
Parameter
Hepatitis A virus IgM
Reference standard
Internal method
Internal method identity
38544 38668
Comment
CMIA, qualitative Alinity
Object
Serum, plasma
Parameter
Francisella tularensis IgM & IgG
Reference standard
Internal method
Internal method identity
16305 29599
Comment
ELISA, qualitative Dynex DSX
Object
Serum, plasma
Parameter
Cytomegalovirus IgG & IgM
Reference standard
Internal method
Internal method identity
39679 39696 38668
Comment
CMIA, qualitative Alinity
Object
Serum, plasma
Parameter
Epstein Barr virus VCA IgM, IgG & EBNA
Reference standard
Internal method
Internal method identity
39693 39694 39695 38668
Comment
CMIA, qualitative Alinity
Object
Serum, plasma
Parameter
Helicobacter pylori IgG
Reference standard
Internal method
Internal method identity
42375
Comment
CLIA, kvalitativ Liason XL
Object
Serum, plasma
Parameter
Hepatitis A virus IgG
Reference standard
Internal method
Internal method identity
38555 38668
Comment
CMIA, qualitative Alinity
Object
Serum, plasma
Parameter
Hepatitis B virus HBs-Ag
Reference standard
Internal method
Internal method identity
48239 38668
Comment
CMIA, qualitative Alinity
Object
Serum, plasma
Parameter
Hepatitis B virus Hbe-Ag & Anti Hbe
Reference standard
Internal method
Internal method identity
17110 34338
Comment
CLIA, qualitative Liaison XL
Object
Serum, plasma
Parameter
Hepatitis B virus HBc-total
Reference standard
Internal method
Internal method identity
38528 38668
Comment
CMIA, qualitative Alinity
Object
Serum, plasma
Parameter
Hepatitis C virus Anti-HCV
Reference standard
Internal method
Internal method identity
38526 38668
Comment
CMIA, qualitative Alinity
Object
Serum, plasma
Parameter
HIV 1+2 HIV Ag & Ab Combo
Reference standard
Internal method
Internal method identity
38251 38668
Comment
CMIA, qualitative Alinity
Object
Serum, plasma
Parameter
Human parvovirus B19 IgG og IgM
Reference standard
Internal method
Internal method identity
33042 33044
Comment
CLIA, qualitative Liaison XL
Object
Serum, plasma
Parameter
Measles virus IgM & IgG
Reference standard
Internal method
Internal method identity
42808 42809
Comment
CLIA, qualitative VirClia
Object
Serum, plasma
Parameter
Parotitis virus IgG & IgM
Reference standard
Internal method
Internal method identity
43145, 43146
Comment
ELISA, qualitative VirClia
Object
Serum, plasma
Parameter
Varicella zoster virus IgM & IgG
Reference standard
Internal method
Internal method identity
33687 33689
Comment
CLIA, qualitative Liaison XL
Object
Serum, plasma
Parameter
Hepatitis B virus anti-HBs
Reference standard
Internal method
Internal method identity
38569 38668
Comment
CMIA, quantitative Alinity
Object
Serum, plasma & spinal fluid
Parameter
Borrelia IgG & IgM
Reference standard
Internal method
Internal method identity
33018 33031
Comment
CLIA (IgGquantitative, IgM qualitative) Liaison XL
M31 Flexible accreditation
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Respiratory samples Body secretes Body fluids Biopsies and tissue Foreign body materials Cultures of bacteria and fungus
Parameter
Bacteria Viruse Fungus Paracites Antibodies
Reference standard
Internal method
Internal method identity
Analytical principles/ analyse platforms accredited under M16 Logg: ID 28384
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.