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Norwegian accreditation

Accreditation scope for

TEST 301

Helse Førde HF

Mikrobiologisk avdeling

Postboks 1000
6807 FØRDE

Telephone: 57 83 93 47 / 57 83 90 91
E-mail: mikrobiologi@helse-forde.no
Internet: http://helse-forde.no/avdelinger/medisinsk-klinikk
The laboratory meets the requirements in

NS-EN ISO 15189:2012




Accreditation includes:
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The administrative / geographical unit:
Bakteriologisk eining, Serologisk eining og Molekylærbiologisk eining
Postboks 1000
6807 FØRDE


Permanent facility
M1610 Medical microbiology, bacteriology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Bacteria colonies, broth and feces
Parameter
Stx1, stx2 and eae
Reference standard
Internal method
Internal method identity
D20891
Comment
Realtime PCR
Object
Bacteria
Parameter
Detection of penicilinase production
Reference standard
Internal method
Internal method identity
D09104
Comment
Object
Bacterial culture
Parameter
Resistance determination
Reference standard
Internal method
Internal method identity
D00383 D00385 D18038 D09115
Comment
Agar diffusion Gradient test BD Phoenix
Object
Blood culture
Parameter
Bacteria Fungi
Reference standard
Internal method
Internal method identity
D00324 D06996
Comment
Cultivation, identification and resistance determination
Object
Faeces
Parameter
Helicobacter pylori antigene
Reference standard
Internal method
Internal method identity
D25900
Comment
Liason
Object
Faeces
Parameter
Salmonella spp.
Reference standard
Internal method
Internal method identity
D24414
Comment
Realtime PCR
Object
Faeces
Parameter
Campylobacter spp.
Reference standard
Internal method
Internal method identity
D24414
Comment
Realtime PCR
Object
Faeces
Parameter
Yersinia enterocolitica
Reference standard
Internal method
Internal method identity
D24414
Comment
Realtime PCR
Object
Faeces
Parameter
Clostridium difficile
Reference standard
Internal method
Internal method identity
D24414
Comment
Realtime PCR
Object
Faeces
Parameter
Clostridium difficile yoxin A/B
Reference standard
Internal method
Internal method identity
D24414
Comment
Realtime PCR
Object
Faeces
Parameter
eae
Reference standard
Internal method
Internal method identity
D24414
Comment
Realtime PCR
Object
Faeces
Parameter
stx
Reference standard
Internal method
Internal method identity
D24414
Comment
Realtime PCR
Object
Faeces
Parameter
ipaH
Reference standard
Internal method
Internal method identity
D24414
Comment
Realtime PCR
Object
Faeces, rectal sample
Parameter
Vancomycin resistance (VRE), VanA and VanB
Reference standard
Internal method
Internal method identity
D26903
Comment
Realtime-PCR
Object
Faeces
Parameter
Enterohaemorrhagic E. coli (EHEC)
Reference standard
Internal method
Internal method identity
D12845
Comment
Cultivation, identification and resistance determination
Object
Faeces
Parameter
Clostridium difficile
Reference standard
Internal method
Internal method identity
D00356
Comment
Immune chromatography
Object
Faeces
Parameter
Intestine pathogene bacteria
Reference standard
Internal method
Internal method identity
D00354
Comment
Cultivation, identification and resistance determination
Object
Faeces Rectal swab
Parameter
Vancomycine resistant enterococcus (VRE)
Reference standard
Internal method
Internal method identity
D25081
Comment
Cultivation, identification and resistance determination
Object
Genital samples
Parameter
Bacteria Fungi
Reference standard
Internal method
Internal method identity
D00348
Comment
Cultivation, identification and resistance determination
Object
Lower respiraratory tract Cystic fibrosis (CF) patients
Parameter
Pathogene bacteria Fungi
Reference standard
Internal method
Internal method identity
D00343
Comment
Cultivation, identification and resistance determination
Object
Nasopharynxsecretion Throatsample Perineum
Parameter
Multi resistant staphylococcus (MRSA)
Reference standard
Internal method
Internal method identity
D00337 D16654
Comment
Cultivation, identification and resistance determination Real time PCR
Object
Nasal secresions Throat sample Perineum
Parameter
MRSA
Reference standard
Internal method
Internal method identity
D21431
Comment
Real time PCR Rapid diagnostic test
Object
Exudate
Parameter
Bactera Fungi
Reference standard
Internal method
Internal method identity
D00329 D00330
Comment
Cultivation, identification and resistance determination
Object
Rectal brush
Parameter
ESBL-A and ESBL-CARBA in Enterobacterales
Reference standard
Internal method
Internal method identity
D25080 D25066 D25129
Comment
Chromogenic media / Realtime PCR rapid diagnostics
Object
Pure culture Blood culture
Parameter
Identiication
Reference standard
Internal method
Internal method identity
D20942 D20938
Comment
Mass spectrometry MALDI-TOF
Object
Respiratory tract Eye Ear
Parameter
Bacteria Fungi
Reference standard
Internal method
Internal method identity
D00338 D00339 D00346
Comment
Cultivation, identification and resistance determination
Object
Central venous cathether
Parameter
Bactera Fungi
Reference standard
Internal method
Internal method identity
D00333
Comment
Cultivation, identification and resistance determination (Maki method)
Object
Spinal Fluid
Parameter
Bacteria Fungi
Reference standard
Internal method
Internal method identity
D00326
Comment
Cultivation, identification and resistance determination
Object
Trombocyte concentrate
Parameter
Bacteria Fungi
Reference standard
Internal method
Internal method identity
D05292
Comment
Cultivation, identification and resistance determination
Object
Urin
Parameter
Pneumokokkantigen
Reference standard
Internal method
Internal method identity
D20099
Comment
Immunkromatografi SOFIA Analyzer
Object
Urin
Parameter
Legionella antigen
Reference standard
Internal method
Internal method identity
D20264
Comment
Immunkromatografi SOFIA Analyzer
Object
Urine Urine dip culture
Parameter
Bacteria Fungi
Reference standard
Internal method
Internal method identity
D00347
Comment
Cultivation, identification and resistance determination
Object
Urin, cervix, vagina, uretra
Parameter
Chlamydia trachomatis
Reference standard
Internal method
Internal method identity
D21627
Comment
Realtime PCR
Object
Urin, cervix, vagina, uretra
Parameter
Neisseria gonorrhoeae
Reference standard
Internal method
Internal method identity
D21627
Comment
Realtime PCR
Object
Upper respiratory tract secretion
Parameter
Bordetella species
Reference standard
Internal method
Internal method identity
D16769
Comment
Real time PCR
Object
Upper respiratory tract secretion
Parameter
Clamydia pneumoniae / Mycoplasma
Reference standard
Internal method
Internal method identity
D16782
Comment
Real time PCR
M1640 Medical microbiology, virology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Faeces
Parameter
Adenovirus
Reference standard
Internal method
Internal method identity
D24414
Comment
Realttime PCR
Object
Faeces
Parameter
Astrovirus
Reference standard
Internal method
Internal method identity
D24414
Comment
Realtime PCR
Object
Faeces
Parameter
Norovirus gr. 1
Reference standard
Internal method
Internal method identity
D24414
Comment
Realtime PCR
Object
Faeces
Parameter
Norovirus gr. 2
Reference standard
Internal method
Internal method identity
D24414
Comment
Realtime PCR
Object
Faeces
Parameter
Sapovirus
Reference standard
Internal method
Internal method identity
D24414
Comment
Realtime PCR
Object
Faeces
Parameter
Rotavirus
Reference standard
Internal method
Internal method identity
D24414
Comment
Realttime PCR
Object
Faeces
Parameter
Norovirus Genogroup 1 & 2
Reference standard
Internal method
Internal method identity
D21432
Comment
Real time PCR
Object
Nasofarynx
Parameter
Influenza A, influenza B, RSV og SARS-CoV-2
Reference standard
Internal method
Internal method identity
D25633
Comment
Realtime multiplex PCR
Object
Secretion
Parameter
Adeno virus
Reference standard
Internal method
Internal method identity
D19951
Comment
Real time PCR
Object
Spinal fluid Secretions
Parameter
HSV-1
Reference standard
Internal method
Internal method identity
D18267
Comment
Real time PCR
Object
Spinal fluid Secretions
Parameter
Varicella zoster virus
Reference standard
Internal method
Internal method identity
D18282
Comment
Real time PCR
Object
Spinal fluid Secretions
Parameter
Entero virus
Reference standard
Internal method
Internal method identity
D19173
Comment
Real ime PCR
Object
Spinal fluid Secretions
Parameter
HSV-2
Reference standard
Internal method
Internal method identity
D18267
Comment
Real time PCR
Object
Upper respiratory tract secretion
Parameter
Influenza virus type B
Reference standard
Internal method
Internal method identity
D16873
Comment
Real time PCR
Object
Upper respiratory tract secretion
Parameter
hMPV
Reference standard
Internal method
Internal method identity
D17437
Comment
Real time PCR
Object
Upper respiratory tract secretion
Parameter
Parainfluenza virus type 1-3
Reference standard
Internal method
Internal method identity
D19623
Comment
Real time PCR
Object
Upper respiratory tract secretion
Parameter
SARS-CoV-2 RNA
Reference standard
Internal method
Internal method identity
D24666
Comment
Realtime PCR
Object
Upper respiratory tract secretion
Parameter
Rhinovirus
Reference standard
Internal method
Internal method identity
D22158
Comment
Real time PCR
Object
Upper respiratory tract secretion
Parameter
Influenza virus type A
Reference standard
Internal method
Internal method identity
D16873
Comment
Real time PCR
Object
Upper respiratory tract secretion
Parameter
RSV
Reference standard
Internal method
Internal method identity
D17437
Comment
Real time PCR
M1650 Medical microbiology, parasitology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood
Parameter
Malaria
Reference standard
Internal method
Internal method identity
D00395 D09032
Comment
Micropscopy Immune chromatography
Object
Faeces
Parameter
Giardia lamblia
Reference standard
Internal method
Internal method identity
D24414
Comment
Realtime PCR
Object
Faeces
Parameter
Entamoeba histolytica
Reference standard
Internal method
Internal method identity
D24414
Comment
Realtime PCR
Object
Faeces
Parameter
Cryptosporidium spp.
Reference standard
Internal method
Internal method identity
D24414
Comment
Realtime PCR
Object
Faeces
Parameter
Intestinal parasites
Reference standard
Internal method
Internal method identity
D00394
Comment
Microscopy
M1660 Medical microbiology, infection immunolgy
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Whole blood
Parameter
Tb specifically γ-Interferon (Quantiferon)
Reference standard
Internal method
Internal method identity
D24524
Comment
CLIA/Liaison
Object
Serum
Parameter
HAV total
Reference standard
Internal method
Internal method identity
D26823
Comment
CLIA/Liason
Object
Serum
Parameter
CMV IgG
Reference standard
Internal method
Internal method identity
D26822
Comment
CLIA/Liason
Object
Serum
Parameter
CMV IgM
Reference standard
Internal method
Internal method identity
D26822
Comment
CLIA/Liason
Object
Serum and spinal fluid
Parameter
Borrelia antibody
Reference standard
Internal method
Internal method identity
D24523
Comment
CLIA/Liaison
Object
Serum Plasma
Parameter
HAV IgM
Reference standard
Internal method
Internal method identity
D26823
Comment
CLIA/Liason
Object
Serum Plasma
Parameter
Heterophile antibodies
Reference standard
Internal method
Internal method identity
D00426
Comment
Immune chromatography
Object
Serum Spinal fluid
Parameter
Borrelia intrathecal test
Reference standard
Internal method
Internal method identity
D17089
Comment
ELISA
Object
Serum/plasma
Parameter
Syfilis TP
Reference standard
Internal method
Internal method identity
D24988
Comment
CMIA/Alinity
Object
Serum/plasma
Parameter
Rubella IgG
Reference standard
Internal method
Internal method identity
D24988
Comment
CMIA/Alinity
Object
Serum/plasma
Parameter
HIV Ag/Ab
Reference standard
Internal method
Internal method identity
D24988
Comment
CMIA/Alinity
Object
Serum/plasma
Parameter
HCV
Reference standard
Internal method
Internal method identity
D24988
Comment
CMIA/Alinity
Object
Serum/plasma
Parameter
HBsAg
Reference standard
Internal method
Internal method identity
D24988
Comment
CMIA/Alinity
Object
Serum/plasma
Parameter
EBV
Reference standard
Internal method
Internal method identity
D24988
Comment
CMIA/Alinity
Object
Serum/plasma
Parameter
Anti-HBs
Reference standard
Internal method
Internal method identity
D24988
Comment
CMIA/Alinity
Object
Serum/plasma
Parameter
Anti-HB core
Reference standard
Internal method
Internal method identity
D24988
Comment
CMIA/Alinity
M31 Flexible accreditation
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Respiratory tests Body secretions Body fluids Bacterial and fungal cultures
Parameter
Bacteria Virus Fungus Parasites Antigen Antibody
Reference standard
Internal method
Internal method identity
Measurement principle/ Analysis platforms accredited under medical microbiology M16 Prosedure for flexible accreditation: D26460 Mandate for decision-makers in the validation group: D26461 Changing log: D26462
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.