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Norwegian accreditation

Accreditation scope for

TEST 197

Sykehuset i Vestfold HF

Klinikk Medisinsk Diagnostikk

Postboks 2168 Postterminalen
3103 Tønsberg

Telephone: 33 34 30 50 / 33 34 39 42
E-mail: brukerkontakt.lab@siv.no
Internet: http://www.siv.no
The laboratory meets the requirements in

NS-EN ISO 15189:2012




Accreditation includes:
The administrative / geographical unit:
Klinikk Medisinsk Diagnostikk, Larvik
Greveveien 16
3257 Larvik



Permanent facility
M01 Immunology and transfusion medicine
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood
Parameter
ABO/D typing with serum control
Reference standard
Internal method
Internal method identity
703
Comment
Hemagglutination (saline technique-gel card, manual)
Object
Blood
Parameter
Hemoglobine
Reference standard
Internal method
Internal method identity
023c
Comment
Photometric method Hemocue
Object
Blood from donors
Parameter
Storage and delivery of virus inactivated plasma products
Reference standard
Internal method
Internal method identity
840
Comment
Object
Blood from donors
Parameter
Storage and delivery of thrombocyte concentrate
Reference standard
Internal method
Internal method identity
822
Comment
Object
Blood from donors
Parameter
Storage and delivery of erythrocytes consentrate
Reference standard
Internal method
Internal method identity
823
Comment
Object
Blood donor
Parameter
Drawing of whole blood
Reference standard
Internal method
Internal method identity
810
Comment
Object
Blood donor
Parameter
Registration, sample selection, and approval of blood donors
Reference standard
Internal method
Internal method identity
800
Comment
Object
Serum, plasma
Parameter
Antibody screening
Reference standard
Internal method
Internal method identity
725
Comment
Hemagglutination (indirect antiglobulin technique-gel card, manual)
M12 Medical biochemistry
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood
Parameter
B Neutrophil granulocytes
Reference standard
Internal method
Internal method identity
029
Comment
Flowcytometry Fluorescens Sysmex
Object
Blood
Parameter
B Monocytes
Reference standard
Internal method
Internal method identity
030
Comment
Flowcytometry Fluorescens Sysmex
Object
Blood
Parameter
B Lymphocytes
Reference standard
Internal method
Internal method identity
031
Comment
Flowcytometry Fluorescens Sysmex
Object
Blood
Parameter
B Eosinophilic granulocytes
Reference standard
Internal method
Internal method identity
032
Comment
Flowcytometry Fluorescens Sysmex
Object
Blood
Parameter
B Basophilic granulocytes
Reference standard
Internal method
Internal method identity
033
Comment
Flowcytometry Fluorescens Sysmex
Object
Blood
Parameter
B Reticulocytes
Reference standard
Internal method
Internal method identity
034
Comment
Flowcytometry Fluorescens Sysmex
Object
Blood
Parameter
Leukocytes
Reference standard
Internal method
Internal method identity
021
Comment
Flow cytometry, optical measurement, Sysmex
Object
Blood
Parameter
Erythrocytes (Ery)
Reference standard
Internal method
Internal method identity
022
Comment
Flow cytometry, impedance measurement, Sysmex
Object
Blood
Parameter
Hemoglobin
Reference standard
Internal method
Internal method identity
023
Comment
Photometry, Sysmex
Object
Blood
Parameter
Erythrocyte volume fraction
Reference standard
Internal method
Internal method identity
024
Comment
Impedance, Sysmex
Object
Blood
Parameter
MCV
Reference standard
Internal method
Internal method identity
025
Comment
Impedance, Sysmex
Object
Blood
Parameter
MCH
Reference standard
Internal method
Internal method identity
026
Comment
Calculated value, Sysmex
Object
Blood
Parameter
MCHC
Reference standard
Internal method
Internal method identity
027
Comment
Calculated value, Sysmex
Object
Blood
Parameter
Thrombocytes
Reference standard
Internal method
Internal method identity
028
Comment
Flowcytometry Impedance, Sysmex
Object
Blood
Parameter
INR
Reference standard
Internal method
Internal method identity
060
Comment
Clot method STA Satellite
Object
Serum, plasma
Parameter
CRP
Reference standard
Internal method
Internal method identity
213
Comment
Immunturbidimetry Cobas c111
Object
Serum, plasma
Parameter
Potassium
Reference standard
Internal method
Internal method identity
111
Comment
Indirekte ISE Cobas c111
Object
Serum, plasma
Parameter
Sodium
Reference standard
Internal method
Internal method identity
110
Comment
Indrect ISE Cobas e111
Object
Serum, plasma
Parameter
Glucose
Reference standard
Internal method
Internal method identity
086
Comment
Enzym photometry Cobas c111
Object
Serum, plasma
Parameter
Creatinine
Reference standard
Internal method
Internal method identity
080
Comment
Enzyma photometry Cobas c111
M30 Sample collection
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Patient and blood donor
Parameter
Blood for analysis (biochemistry, microbiology, immunology & transfusionmedicine)
Reference standard
Internal method
Internal method identity
D06950 D06953 D07068 D07100 D06981
Comment
Recognized procedures for venous or capillary puncture
M31 Flexible accreditation
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Body fluids
Parameter
Hematological analytes Medical Biochemical analytes
Reference standard
Internal method
Internal method identity
Measurement principle/analysis platforms that are accredited under medical biochemistry (M12) Procedure for FA: 24867 Accredited scope ID: D09619
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.
The administrative / geographical unit:
Klinikk Medisinsk Diagnostikk, Sandefjord Sandefjord Medisinske senter
Bugårdsgata 9b
3208 Sandefjord



Permanent facility
M01 Immunology and transfusion medicine
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood
Parameter
Hemoglobine
Reference standard
Internal method
Internal method identity
023c
Comment
Photometric method Hemocue
Object
Blood from donors
Parameter
Drawing of whole blood
Reference standard
Internal method
Internal method identity
810
Comment
Object
Blood donor
Parameter
Registration, sample selection and approval
Reference standard
Internal method
Internal method identity
800
Comment
M30 Sample collection
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Patient and blood donor
Parameter
Blood for analysis (biochemistry, microbiology, immunology & transfusionmedicine)
Reference standard
Internal method
Internal method identity
D06950 D06953 D07068 D07303 D07100
Comment
Recognized procedures for venous or capillary puncture
The administrative / geographical unit:
Klinikk Medisinsk Diagnostikk, Tønsberg
Halfdan Wilhelmsens Allé 17
3103 Tønsberg



Permanent facility
M01 Immunology and transfusion medicine
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood
Parameter
Fya-Fyb typing
Reference standard
Internal method
Internal method identity
742
Comment
Hemagglutination (Indirect antiglobulin technique gel card, IH 500/IH1000/manual)
Object
Blood
Parameter
Jka - Jkb typing
Reference standard
Internal method
Internal method identity
743
Comment
Hemagglutination (Enzyme technique gel card, IH500/IH-1000/manual)
Object
Blood
Parameter
Jka - Jkb typing
Reference standard
Internal method
Internal method identity
744
Comment
Hemagglutination (Saline glass technique, manual)
Object
Blood
Parameter
ABO typing
Reference standard
Internal method
Internal method identity
700
Comment
Hemagglutination (Saltwater technique glass, manual)
Object
Blood
Parameter
ABO/D typing with serum control
Reference standard
Internal method
Internal method identity
703
Comment
Hemagglutination Salt water technology gel card IH500/1000/manual)
Object
Blood
Parameter
ABO/D typing of blood donors
Reference standard
Internal method
Internal method identity
704
Comment
Hemagglutination (Salt water technology gel card IH500/IH1000/manual)
Object
Blood
Parameter
ABO/D typing and DAT on umbilical cord blood
Reference standard
Internal method
Internal method identity
701
Comment
Hemagglutination (Salt water technique/Direct antiglobulin technique gel card, manual)
Object
Blood
Parameter
Rh(D) typing
Reference standard
Internal method
Internal method identity
710
Comment
Hemagglutination (Saltwater technology glass, IH500/IH1000/manual)
Object
Blood
Parameter
Rh phenotyping and K-typing
Reference standard
Internal method
Internal method identity
713
Comment
Hemagglutination, (Saltwater technique gel card, IH500/IH1000/manual)
Object
Blood
Parameter
Direct antiglobulin test (DAT)
Reference standard
Internal method
Internal method identity
721
Comment
Hemagglutination (Direct antiglobulin technique gel card, IH 500/manual)
Object
Blood
Parameter
Direct antiglobulin test, anti-IgG and anti-C3d
Reference standard
Internal method
Internal method identity
722
Comment
Hemagglutination (Direct antiglobulin technique gel card, IH 500/manual)
Object
Blood
Parameter
Kpa and Lua typing
Reference standard
Internal method
Internal method identity
754
Comment
Hemagglutination (Indirect antiglobulin technique glass, manual)
Object
Blood
Parameter
Little-s typing
Reference standard
Internal method
Internal method identity
753
Comment
Hemagglutination (Indirect antiglobulin technique glass, manual)
Object
Blood
Parameter
P1 typing
Reference standard
Internal method
Internal method identity
747
Comment
Hemagglutination (Saline glass technique, manual)
Object
Blood
Parameter
Cw typing
Reference standard
Internal method
Internal method identity
755
Comment
Hemagglutination (Saline glass technique, manual)
Object
Blood
Parameter
Lea - Leb typing
Reference standard
Internal method
Internal method identity
735
Comment
Hemagglutination (Enzyme technique gel card, IH-500/IH1000/manual)
Object
Blood
Parameter
MN typing
Reference standard
Internal method
Internal method identity
746
Comment
Hemagglutination (Saline glass technique, manual)
Object
Blood
Parameter
Lea - Leb typing
Reference standard
Internal method
Internal method identity
748
Comment
Hemagglutination (Saline glass technique, manual)
Object
Blood
Parameter
S typing
Reference standard
Internal method
Internal method identity
749
Comment
Hemagglutination (Saline glass technique, manual)
Object
Blood
Parameter
Rh(D) typing with IAT gel
Reference standard
Internal method
Internal method identity
712
Comment
Hemagglutination (Indirect antiglobulin technique gel card, manually)
Object
Blood
Parameter
Hemoglobine
Reference standard
Internal method
Internal method identity
023c
Comment
Photometric method Hemocue
Object
Blood from donors
Parameter
Preparation of erythrocytes consentrate, plasma and buffy coat
Reference standard
Internal method
Internal method identity
820
Comment
Object
Blood from donors
Parameter
Drawing of whole blood
Reference standard
Internal method
Internal method identity
810
Comment
Object
Blood from donors
Parameter
Storage and delivery of erutrocyt consentrate
Reference standard
Internal method
Internal method identity
823
Comment
Object
Blood from donors
Parameter
Preparation of thrombocyte concentrate from buffy coat (BC)
Reference standard
Internal method
Internal method identity
821
Comment
Object
Blood from donors
Parameter
Storage and delivery of thrombocyte concentrate
Reference standard
Internal method
Internal method identity
822
Comment
Object
Blood from donors
Parameter
Storage and delivery of virus inactivated plasma products
Reference standard
Internal method
Internal method identity
840
Comment
Object
Blood donor
Parameter
Registration, sample selection, and approval
Reference standard
Internal method
Internal method identity
800
Comment
Object
Serum, plasma
Parameter
Antibody screening
Reference standard
Internal method
Internal method identity
725
Comment
Hemagglutination (Indirect antiglobulin technique gel card, IH500/IH1000/manual)
Object
Serum, plasma
Parameter
Antibody identification
Reference standard
Internal method
Internal method identity
729
Comment
Indirect antiglobulin technique and enzyme technique gel card, IH500/IH1000/manually)
Object
Serum, plasma
Parameter
Cross-match tests
Reference standard
Internal method
Internal method identity
732
Comment
Hemagglutination (Salt water technique and indirect antiglobulin technique gel card, IH500/IH1000/manual)
Object
Serum, plasma
Parameter
Cross-match tests
Reference standard
Internal method
Internal method identity
733
Comment
Hemagglutination (Salt water technology and indirect antiglobulin technique glass, manual)
Object
Serum, plasma
Parameter
Titration of blood type antibody
Reference standard
Internal method
Internal method identity
728
Comment
Hemagglutination (Indirect antiglobulin technique gel card, manually)
Object
Serum, plasma
Parameter
Antibody identification with modified IAT/PEG in gel technique
Reference standard
Internal method
Internal method identity
734
Comment
Hemagglutination, (Indirect antiglobulin technique/PEG gel card, manually)
M02 Anatomical pathology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Cervixcytological material
Parameter
Diagnosis
Reference standard
Internal method
Internal method identity
D09416, D19154
Comment
Diagnose of liquid based cervix cytology
Object
Tissue from lung
Parameter
Cancer diagnosis
Reference standard
Internal method
Internal method identity
09501, 22894
Comment
Macro pruning, microscopy
Object
Tissue from the mammae
Parameter
Diagnosis determination
Reference standard
Internal method
Internal method identity
10074, 20106
Comment
Macro grossing, microscopy
Object
Tissue from the prostate
Parameter
Diagnosis determination
Reference standard
Internal method
Internal method identity
10080, 22896
Comment
Macro grossing, microscopy
Object
Tissue from colon and rectum
Parameter
Cancer diagnosis
Reference standard
Internal method
Internal method identity
10081, 20406, 12580
Comment
Macro grossing, microscopy
M0210 Anatomical pathology, histopathology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Fixed tissue
Parameter
Production of sections
Reference standard
Internal method
Internal method identity
D10358, D16738, D10360, D09545, D21706, D09544
Comment
Tissue processing, embedding and cutting
Object
Paraffin embedded tissue
Parameter
Routine staining
Reference standard
Internal method
Internal method identity
D27177
Comment
HES, Tissue-Tek Prisma Plus staining machine with film
Object
Paraffin embedded tissue
Parameter
Special stains
Reference standard
Internal method
Internal method identity
D16984 D09990 D09991
Comment
BenchMark Special Stain
Object
Paraffin-embedded tissue
Parameter
IHC with antibody: View details at organization.
Reference standard
Internal method
Internal method identity
09964, 11902, 15691, 09965, 15693, 22260, 24118
Comment
IHC BenchMark Ultra
Object
Paraffin-embedded tissue
Parameter
Inform Her2 Dual ISH
Reference standard
Internal method
Internal method identity
15693
Comment
ISH BenchMark Ultra
M0230 Anatomical pathology, cytopathology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Cytological material from the lung
Parameter
Preparation and staining of lung cytology
Reference standard
Internal methods
Internal method identity
19611, 21384, 17325, 09412, 09452, 16935
Comment
ThinPrep 2000, Papanicolaous fargemetode, May Grűnewald Giemsa, Colorrapid, cellblock
Object
Fluid based cytologi
Parameter
Preperation and staing of liquid-based urine cytology
Reference standard
Internal methods
Internal method identity
D21384 D17325
Comment
ThinPrep 5000 T5 Autoloader Papanicolaous staining
Object
Fluid based cytology
Parameter
Preperation and satining of Liquid-based cervix cytology
Reference standard
Internal methods
Internal method identity
D15688 D17325 D09416 D19154
Comment
ThinPrep 5000 T5 Autoloader, Papanicolaous staining
M0250 Anatomical pathology, molecular pathology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Cell material, cervix
Parameter
HPV-status
Reference standard
Internal method
Internal method identity
18617 18687
Comment
Real-Time PCR Cobas 4800
Object
Parafine stoved formaline fixated tissue material and cytological materiale with tumore
Parameter
Somatic basesubstitutes, small duplicates, delesiones and insersiones and fusionesgenes relevant for solid tumor
Reference standard
Internal method
Internal method identity
D16097, D24592, D24816, D24818, D24854, D26226
Comment
Deep sequensing 52 genes (Oncomine Focus, Thermo Fisher Scientific)
Object
Paraffin embedded formalin fixed tissue material, cytological material, extracted DNA from paraffin-embedded tissue (eluate)
Parameter
EGFR, KRAS, NRAS, BRAF mutational status
Reference standard
Internal method
Internal method identity
22547 21748 21758
Comment
Real time PCR Idylla
Object
Paraffin embedded formalin fixed tissue material, extracted DNA from paraffin-embedded tissue (eluate)
Parameter
Microsatellite Instability Test (MSI)
Reference standard
Internal method
Internal method identity
24693
Comment
PCR-based test with melting point analysis Idylla
M04 Clinical pharmacology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Serum
Parameter
Lithium
Reference standard
Internal method
Internal method identity
287
Comment
Photometry Cobas 8000
Object
Serum
Parameter
Vankomycin
Reference standard
Internal method
Internal method identity
297
Comment
Immunochemical competitive, ECL Cobas 8000
Object
Serum
Parameter
Gentamicin
Reference standard
Internal method
Internal method identity
298
Comment
Immunochemical competitive, ECL Cobas 8000
Object
Serum, plasma
Parameter
Paracetamol
Reference standard
Internal method
Internal method identity
293
Comment
Enzymatic photometry Cobas 8000
Object
Serum, plasma
Parameter
Digoksin
Reference standard
Internal method
Internal method identity
281
Comment
Immunochemical competitive, ECL Cobas 8000
Object
Serum, plasma
Parameter
Salicylat
Reference standard
Internal method
Internal method identity
288
Comment
Enzymatic photometry Cobas 8000
M12 Medical biochemistry
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood
Parameter
Leukocytes (Lkc)
Reference standard
Internal method
Internal method identity
021
Comment
Flow cytometry, optical measurement Sysmex
Object
Blood
Parameter
Erythrocytes (Ery)
Reference standard
Internal method
Internal method identity
022
Comment
Flow cytometry, impedance measurement Sysmex
Object
Blood
Parameter
Hemoglobin
Reference standard
Internal method
Internal method identity
023
Comment
Photometry Sysmex
Object
Blood
Parameter
Erythrocyte volume fraction (EVF)
Reference standard
Internal method
Internal method identity
024
Comment
Impedance measurement Sysmex
Object
Blood
Parameter
MCV
Reference standard
Internal method
Internal method identity
025
Comment
Impedance measurement Sysmex
Object
Blood
Parameter
MCH
Reference standard
Internal method
Internal method identity
026
Comment
Calculated value Sysmex
Object
Blood
Parameter
MCHC
Reference standard
Internal method
Internal method identity
027
Comment
Calculated value Sysmex
Object
Blood
Parameter
Thrombocytes
Reference standard
Internal method
Internal method identity
028
Comment
Flow cytometry, impedance / optical measurement Sysmex
Object
Blood
Parameter
Reticulocytes
Reference standard
Internal method
Internal method identity
034
Comment
Flow cytometry, optical measurement Sysmex
Object
Blood
Parameter
B neutrophil granulocytes
Reference standard
Internal method
Internal method identity
029
Comment
Flow cytometry, fluorescence, Sysmex
Object
Blood
Parameter
B Monocyttes
Reference standard
Internal method
Internal method identity
030
Comment
Flow cytometry, fluorescence, Sysmex
Object
Blood
Parameter
B Lymfocyttes
Reference standard
Internal method
Internal method identity
031
Comment
Flow cytometry, fluorescence, Sysmex
Object
Blood
Parameter
B Eosinophilic granulocytes
Reference standard
Internal method
Internal method identity
032
Comment
Flow cytometry, fluorescence, Sysmex
Object
Blood
Parameter
B Basophilic granulocytes
Reference standard
Internal method
Internal method identity
033
Comment
Flow cytometry, fluorescence, Sysmex
Object
Blood
Parameter
HbA1c
Reference standard
Internal method
Internal method identity
090
Comment
Tosoh G8 (HPLC)
Object
Plasma
Parameter
Ammonia
Reference standard
Internal method
Internal method identity
088
Comment
Enzym phtometry Cobas 8000
Object
Plasma
Parameter
D-Dimer
Reference standard
Internal method
Internal method identity
063
Comment
Immunturbidimetry STA-R
Object
Plasma
Parameter
APPT (activated partial thromboplastin)
Reference standard
Internal method
Internal method identity
061
Comment
Clot method STA-R
Object
Plasma
Parameter
Fibrinogen
Reference standard
Internal method
Internal method identity
062
Comment
Clot method STA-R
Object
Plasma
Parameter
INR
Reference standard
Internal method
Internal method identity
060
Comment
Clot-metode STA-R
Object
Serum
Parameter
TIBC
Reference standard
Internal method
Internal method identity
219
Comment
Immunturbidimetry meseurment of transferrin Cobas 8000
Object
Serum
Parameter
Active B12
Reference standard
Internal method
Internal method identity
144
Comment
Sandwich methode. ECLIA Cobas 8000
Object
Serum
Parameter
ACE
Reference standard
Internal method
Internal method identity
188
Comment
Enzymatic photometry Cobas 8000
Object
Serum
Parameter
TRAS
Reference standard
Internal method
Internal method identity
263
Comment
Immunochemically competitive, ECL Cobas 8000
Object
Serum
Parameter
PSA
Reference standard
Internal method
Internal method identity
223
Comment
Sandwich methode. ECLIA Cobas 8000
Object
Serum
Parameter
S/P SHBG
Reference standard
Internal method
Internal method identity
264
Comment
Sandwich method. ECLIA Cobas 8000
Object
Serum
Parameter
S/P Testosterone
Reference standard
Internal method
Internal method identity
265
Comment
Immunochemically competitive, ECL Cobas 8000
Object
Serum
Parameter
S/P Østradio
Reference standard
Internal method
Internal method identity
266
Comment
Immunochemically competitive, ECL Cobas 8000
Object
Serum, plasma
Parameter
beta HCG
Reference standard
Internal method
Internal method identity
254
Comment
Sandwich methode. ECLIA Cobas 8000
Object
Serum, plasma
Parameter
IgG
Reference standard
Internal method
Internal method identity
216
Comment
Immunturbidimetry Cobas 8000
Object
Serum, plasma
Parameter
IgA
Reference standard
Internal method
Internal method identity
215
Comment
Immunturbidimetry Cobas 8000
Object
Serum, plasma
Parameter
IgM
Reference standard
Internal method
Internal method identity
217
Comment
Immunturbidimetry Cobas 8000
Object
Serum, plasma
Parameter
Haptoglobin
Reference standard
Internal method
Internal method identity
212
Comment
Immuno-turbidimetry Cobas 8000
Object
Serum, plasma
Parameter
Chloride
Reference standard
Internal method
Internal method identity
112
Comment
Indirect ISE Cobas 8000
Object
Serum, plasma
Parameter
HDL-cholesterol
Reference standard
Internal method
Internal method identity
162
Comment
Enzymatisk fotometri Cobas 8000
Object
Serum, plasma
Parameter
Cortisol
Reference standard
Internal method
Internal method identity
255
Comment
Immunochemical competitive, ECL Cobas 8000
Object
Serum, plasma
Parameter
NT-proBNP
Reference standard
Internal method
Internal method identity
261
Comment
Sandwich methode. ECLIA Cobas 8000
Object
Serum, plasma
Parameter
Ethanol
Reference standard
Internal method
Internal method identity
290
Comment
Enzyme phoometry Cobas 8000
Object
Serum, plasma
Parameter
Vitamin B12
Reference standard
Internal method
Internal method identity
140
Comment
Immunochemical competitive, ECL Cobas 8000
Object
Serum, plasma
Parameter
CEA
Reference standard
Internal method
Internal method identity
224
Comment
Sandwich methode. ECLIA Cobas 8000
Object
Serum, plasma
Parameter
CA125
Reference standard
Internal method
Internal method identity
225
Comment
Sandwich methode. ECLIA Cobas 8000
Object
Serume, plasma
Parameter
Myoglobine
Reference standard
Internal method
Internal method identity
231
Comment
Sandwich methode. ECLIA Cobas 8000
Object
Serum, plasma
Parameter
Osmolality
Reference standard
Internal method
Internal method identity
113
Comment
A2O Osmometer Freezing point depression
Object
Serum, plasma
Parameter
Folate
Reference standard
Internal method
Internal method identity
141
Comment
Immunochemical, competitive, ECL Cobas 8000
Object
Serum, plasma
Parameter
FSH
Reference standard
Internal method
Internal method identity
256
Comment
Sandwich methode. ECLIA Cobas 8000
Object
Serum, plasma
Parameter
PTH
Reference standard
Internal method
Internal method identity
260
Comment
Sandwich methode. ECLIA Cobas 8000
Object
Serum, plasma
Parameter
Karbamid
Reference standard
Internal method
Internal method identity
081
Comment
Enzymatisk fotometri Cobas 8000
Object
Serum, plasma
Parameter
Uric acid
Reference standard
Internal method
Internal method identity
082
Comment
Enzym photometry Cobas 8000
Object
Serum, plasma
Parameter
Bilirubin (total)
Reference standard
Internal method
Internal method identity
083
Comment
Photometry Cobas 8000
Object
Serum, plasma
Parameter
Glucose
Reference standard
Internal method
Internal method identity
086
Comment
Enzym phtometry Cobas 8000
Object
Serum, plasma
Parameter
Free T3
Reference standard
Internal method
Internal method identity
251
Comment
Immunochemical competitive, ECL Cobas 8000
Object
Serum, plasma
Parameter
TSH
Reference standard
Internal method
Internal method identity
252
Comment
Sandwich methode. ECLIA Cobas 8000
Object
Serum, plasma
Parameter
Ferritin
Reference standard
Internal method
Internal method identity
222
Comment
Sandwich methode. ECLIA Cobas 8000
Object
Serum, plasma
Parameter
LH
Reference standard
Internal method
Internal method identity
257
Comment
Sandwich methode. ECLIA Cobas 8000
Object
Serum, plasma
Parameter
Prolactin
Reference standard
Internal method
Internal method identity
258
Comment
Sandwich methode. ECLIA Cobas 8000
Object
Serum, plasma
Parameter
α1-antitrypsin
Reference standard
Internal method
Internal method identity
214
Comment
Atellica NEPH
Object
Serum, plasma
Parameter
Sodium
Reference standard
Internal method
Internal method identity
110
Comment
Indirect ISE Cobas 8000
Object
Serum, plasma
Parameter
Potassium
Reference standard
Internal method
Internal method identity
111
Comment
Indirect ISE Cobas 8000
Object
Serum, plasma
Parameter
Phosphate
Reference standard
Internal method
Internal method identity
114
Comment
Photometry Cobas 8000
Object
Serum, plasma
Parameter
Calcium
Reference standard
Internal method
Internal method identity
115
Comment
Photometry Cobas 8000
Object
Serum, plasma
Parameter
Magnesium
Reference standard
Internal method
Internal method identity
117
Comment
Photometry Cobas 8000
Object
Serum, plasma
Parameter
Iron
Reference standard
Internal method
Internal method identity
143
Comment
Photometry Cobas 8000
Object
Serum, plasma
Parameter
Triglycerides
Reference standard
Internal method
Internal method identity
160
Comment
Enzym photometry Cobas 8000
Object
Serum, plasma
Parameter
Cholesterol
Reference standard
Internal method
Internal method identity
161
Comment
Enzym photometry Cobas 8000 Vitros
Object
Serum, plasma
Parameter
ALP
Reference standard
Internal method
Internal method identity
180
Comment
Enzyme activity measurement Cobas 8000
Object
Serum, plasma
Parameter
ASAT
Reference standard
Internal method
Internal method identity
181
Comment
Enzyme activity measurement Cobas 8000
Object
Serum, plasma
Parameter
ALAT
Reference standard
Internal method
Internal method identity
182
Comment
Enzyme activity measurement Cobas 8000
Object
Serum, plasma
Parameter
LD
Reference standard
Internal method
Internal method identity
183
Comment
Enzyme activity measurement Cobas 8000
Object
Serum, plasma
Parameter
GT
Reference standard
Internal method
Internal method identity
184
Comment
Enzyme activity measurement Cobas 8000
Object
Serum, plasma
Parameter
Total protein
Reference standard
Internal method
Internal method identity
210
Comment
Photometry Cobas 8000
Object
Serum, plasma
Parameter
Albumin
Reference standard
Internal method
Internal method identity
211
Comment
Photometry Cobas 8000
Object
Serum, plasma
Parameter
CRP
Reference standard
Internal method
Internal method identity
213
Comment
Immunturbidimetry Cobas 8000
Object
Serum, plasma
Parameter
Troponin T
Reference standard
Internal method
Internal method identity
129
Comment
ECLIA Cobas 8000
Object
Serum, plasma
Parameter
CK
Reference standard
Internal method
Internal method identity
185
Comment
Enzyme activity measurement Cobas 8000
Object
Serum, plasma
Parameter
Anti-TPO
Reference standard
Internal method
Internal method identity
259
Comment
Immunochemical competitive, ECL Cobas 8000
Object
Serume, plasma
Parameter
Procalcitonin (PCT)
Reference standard
Internal method
Internal method identity
228
Comment
Sandwich metode, ECLIA Cobas 8000
Object
Serum, plasma
Parameter
Vitamin D
Reference standard
Internal method
Internal method identity
262
Comment
Immunochemically competitive, ECL Cobas 8000
Object
Serume, plasma
Parameter
S/P Cystatin C
Reference standard
Internal method
Internal method identity
233
Comment
Immunoturbidimetric Cobas 8000
Object
Serum, plasma
Parameter
LDL-kol
Reference standard
Internal method
Internal method identity
163
Comment
Enzymatic photometry Cobas 8000
Object
Serum, plasma
Parameter
Pancreasamylase
Reference standard
Internal method
Internal method identity
191
Comment
Enzyme activity measurement Cobas 8000
Object
Serum, plasma
Parameter
Creatinine
Reference standard
Internal method
Internal method identity
080
Comment
Enzym photometry Cobas 8000
Object
Serum, plasma
Parameter
Free T4
Reference standard
Internal method
Internal method identity
250
Comment
Immunochemical competitive, ECL Cobas 8000
M1610 Medical microbiology, bacteriology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Aerobic fast-growing gram negative rods
Parameter
Suseptability testing
Reference standard
Internal method
Internal method identity
B05
Comment
Turbidimetric Vitek 2
Object
Aerobic fast-growing gram-negative rods
Parameter
Identification
Reference standard
Internal method
Internal method identity
B04
Comment
Biochemical Vitek 2
Object
Bacteria and yeast colonies
Parameter
Identification of bacteria and yeast
Reference standard
Internal method
Internal method identity
B16
Comment
Mass spectroscopy MALDI-TOF MS
Object
Bacteria colonies, feces
Parameter
Enteropathogenic E.coli, EHEC-lost shiga toxin (eaeA)
Reference standard
Internal method
Internal method identity
G17
Comment
Real-time PCR, Proprietary Panther Fusion
Object
Bacterial stain
Parameter
Resistance determination broth dilution
Reference standard
Internal method
Internal method identity
B02
Comment
Broth dilution ComASP Colistin
Object
Bacterial strains
Parameter
Determination of resistance agardifusion
Reference standard
Internal method
Internal method identity
B01
Comment
Phenotypic
Object
Blood culture
Parameter
Pathogenic bacteria and fungus
Reference standard
Internal method
Internal method identity
B07
Comment
Culture, evaluation and identification Bactec FX
Object
Bronchial coolant, pleural fluid, induced sputum, biopsy
Parameter
Pneumocyctis jiroveci
Reference standard
Internal method
Internal method identity
G36
Comment
RT-PCR Panther Fusion
Object
Expectorate, rinsing fluid, BAL, lung biopsy
Parameter
Legionella
Reference standard
Internal method
Internal method identity
G34
Comment
RT-PCR Panther Fusion
Object
Feces
Parameter
Cryptosporidium, Entamoeba histolytica and Giardia lamblia
Reference standard
Internal method
Internal method identity
G28
Comment
Real-time PCR Qualitative In-house Panther Fusion
Object
Feces
Parameter
EHEC sub typing
Reference standard
Internal method
Internal method identity
G39
Comment
Real-time PCR In-house LightCycler
Object
Feces
Parameter
Shigella, Salmonella, Campylobacter, Yersinia, EHEC, EPEC,EIEC, Vibrio, Aeromonas, and Plesiomonas
Reference standard
Internal method
Internal method identity
B22
Comment
Cultivation and manual assessment / identification
Object
Feces
Parameter
Clostridioides difficile
Reference standard
Internal method
Internal method identity
B25
Comment
Membrane enzyme immunoassay test. Combined antigen and toxin detection
Object
Feces
Parameter
Clostridioides difficile
Reference standard
Internal method
Internal method identity
G26
Comment
Real-time PCR Qualitiative Cepheid GeneXpert
Object
Feces, bacterial colonies
Parameter
Yersinia, Campylobacter, Shigella / EIEC, and Salmonella
Reference standard
Internal method
Internal method identity
G27
Comment
Real-time PCR Qualitiative In-house Panther Fusion
Object
Feces, bacterial colony
Parameter
Enterotoxigen E.coli, Enterohemorrhagic E.coli, Enteroaggregative E.coli
Reference standard
Internal method
Internal method identity
G10
Comment
Real-time PCR, In-house developed Panther Fusion
Object
Skin scrape, hair and nails
Parameter
Dermatophytes
Reference standard
Internal method
Internal method identity
G32
Comment
Real-time PCR qualitiative In-house LightCycler
Object
Joint fluid
Parameter
Borrelia
Reference standard
Internal method
Internal method identity
G35
Comment
RT-PCR Panther Fusion
Object
Material from genitalia, rectum, newborn, fetus a.s
Parameter
Beta-hemolytic streptococcus group B
Reference standard
Internal method
Internal method identity
B20
Comment
Culture on selective chromogenic medium, manual evaluation
Object
Material from skin, soft tissue, knuckles, joints, inner organs, cavities, and foreign bodies
Parameter
Pathogenic bacteria and fungus
Reference standard
Internal method
Internal method identity
B18
Comment
Limit: with the exception of material from the respiratory tract, sinuses, mouth, ear, eye, urogenital mucosa, urine, blood, cerebrospinal fluid and feces
Object
Material from the respiratory tract, sinuses, mouth, ear, and eye
Parameter
Pathogenic bacteria and fungus
Reference standard
Internal method
Internal method identity
B17
Comment
Culture and manual evaluation
Object
Material from the lower respiratory tract
Parameter
Acid-fast rods
Reference standard
Internal method
Internal method identity
B21
Comment
Microscopy
Object
Material from urogenital mucosa
Parameter
Pathogenic bacteria and fungus
Reference standard
Internal method
Internal method identity
B19
Comment
Culture and manual evaluation
Object
Nasopharyngeal and throat secretions, expectorate
Parameter
Chlamydophila pneumoniae / Mycoplasma pneumoniae Bordetella pertussis/ Bordetella parapertussis/ Bordetella holmesii
Reference standard
Internal method
Internal method identity
G02
Comment
Real-time PCR, In-house Light Cycler Panther Fusion
Object
Secretion from rectum, urine, exudate
Parameter
ESBL producing gram-negative rods
Reference standard
Internal method
Internal method identity
B11
Comment
Culture, screening
Object
Secretion from rectum, urine, wounds
Parameter
Vancomycin-resistant enterococci (VRE)
Reference standard
Internal method
Internal method identity
B12
Comment
Culture, screening
Object
Secretion / surface samples
Parameter
Meticillin-resistant Staphylococci
Reference standard
Internal method
Internal method identity
G07
Comment
PCR GeneXpert
Object
Secretion / surface samples and bacterial isolates
Parameter
Methicillin-resistant Staphylococcus aureus (MRSA)
Reference standard
Internal method
Internal method identity
B13
Comment
Culture, screening
Object
Cerebrospinal fluid
Parameter
Pathogenic bacteria and fungus
Reference standard
Internal method
Internal method identity
B08
Comment
Culture, evaluation and identification
Object
Urine
Parameter
Legionella pneumophila antigen
Reference standard
Internal method
Internal method identity
B15
Comment
Immunochromatography membrane test Binax NOW
Object
Urine
Parameter
Urinary tract pathogenic bacteria and fungus
Reference standard
Internal method
Internal method identity
B03
Comment
Culture, evaluation and identification
Object
Urine
Parameter
Pneumococcal antigen
Reference standard
Internal method
Internal method identity
B14
Comment
Immunochromatography membrane test Binax NOW
Object
Urine on dip slide / uricult
Parameter
Urinary tract pathogenic bacteria and fungus
Reference standard
Internal method
Internal method identity
B09
Comment
Culture, evaluation and identification
Object
Urine, secrete from genitalia
Parameter
Neisseria gonorrhoeae
Reference standard
Internal method
Internal method identity
G19
Comment
APTIMA Qalitative Panther
Object
Urine, secretion from genitalia
Parameter
Mycoplasma genitalium
Reference standard
Internal method
Internal method identity
G14
Comment
APTIMA Qualitative. Panther
Object
Urine, secretion from genitalia, bacterial colonies
Parameter
Neisseria gonorrhoeae
Reference standard
Internal method
Internal method identity
G20
Comment
Real-time PCR, qualitative In-house Panther Fusion
Object
Urine, secretion from genitalia
Parameter
Chlamydia trachomatis
Reference standard
Internal method
Internal method identity
G15
Comment
APTIMA Qualitative, Panther
M1640 Medical microbiology, virology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Feces
Parameter
Enterovirus/Parechovirus
Reference standard
Internal method
Internal method identity
G41
Comment
Real-time PCR proprietary Panther Fusion
Object
Feces
Parameter
Rotavirus, Adenovirus, Norovirus, Sapovirus
Reference standard
Internal method
Internal method identity
G01
Comment
Real-time PCR, In-house Panther Fusion
Object
Nasopharynx- and throat secrete
Parameter
SARS-CoV-1-2
Reference standard
Internal method
Internal method identity
G37
Comment
Singleplex real-time PCR Luna RT-PCR (Luna RT-PCR)
Object
Nasopharyngeal and throat secretions, expectorate
Parameter
Influenza A Influenza B Parainfluenza 1, 2, 3, 4 SARS-CoV-1-2
Reference standard
Internal method
Internal method identity
G04
Comment
Real-time PCR, In-house Light Cycler Panther Fusion
Object
Nasopharyngeal and throat secretions, expectorate
Parameter
RS-virus hMPV Rhinovirus Adenovirus
Reference standard
Internal method
Internal method identity
G05
Comment
Real-time PCR Qualitativ In-house Light Cycler Panther Fusion
Object
Plasma
Parameter
CMV
Reference standard
Internal method
Internal method identity
G11
Comment
APTIMA Quantitative Panther Fusion
Object
Serum, plasma
Parameter
HCV
Reference standard
Internal method
Internal method identity
G33
Comment
APTIMA Quantitative Panther/Panther Fusion
Object
Spinal fluid, biopsy, saliva, urine
Parameter
CMV
Reference standard
Internal method
Internal method identity
G40
Comment
Real-time PCR qualitative LightCycler
Object
Cerebrospinal fluid, vesicle contents, eye, mucosal secretions
Parameter
VZV (Varizella)
Reference standard
Internal method
Internal method identity
G22
Comment
Real-time PCR, qualitative In-house Light Cycler
Object
Cerebrospinal fluid, vesicle contents, eye, mucosal secretions
Parameter
HSV (Herpes 1 and 2)
Reference standard
Internal method
Internal method identity
G21
Comment
Real-time PCR, qualitative In-house Light Cycler
Object
Cerebrospinal fluid, eye, and other samples
Parameter
Adenovirus
Reference standard
Internal method
Internal method identity
G16
Comment
Real-time PCR Qualitative In-house Light Cycler
Object
Urine, secretary, plasma, and cerebrospinal fluid
Parameter
Enterovirus and Parechovirus
Reference standard
Internal method
Internal method identity
G06
Comment
Real-time PCR, In-house developed Light Cycler
M1650 Medical microbiology, parasitology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Feces
Parameter
Mark and eggs
Reference standard
Internal method
Internal method identity
B23
Comment
Microscopy
M1660 Medical microbiology, infection immunolgy
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Plasma
Parameter
TB IGRA
Reference standard
Internal method
Internal method identity
S48
Comment
CLIA Liason
Object
Serum, plasma
Parameter
Mononucleosis IgM heterophile antibodies
Reference standard
Internal method
Internal method identity
S29
Comment
Rapid test Clearview IM II
Object
Serum, plasma
Parameter
Parvovirus B19 IgM
Reference standard
Internal method
Internal method identity
S40
Comment
CLIA Virclia
Object
Serum, plasma
Parameter
Parvovirus B19 IgG
Reference standard
Internal method
Internal method identity
S39
Comment
CLIA Virclia
Object
Serum, plasma
Parameter
Anti-TBE IgG
Reference standard
Internal method
Internal method identity
S23
Comment
CLIA, VirClia
Object
Serum, plasma
Parameter
Anti-TBE IgM
Reference standard
Internal method
Internal method identity
S24
Comment
CLIA, VirClia
Object
Serum, plasma
Parameter
Bordetella pertussis Toxin IgG
Reference standard
Internal method
Internal method identity
S41
Comment
CLIA Virclia
Object
Serum, plasma
Parameter
Epstein-Barr EBNA IgG
Reference standard
Internal method
Internal method identity
S45
Comment
ECLIA, Cobas e801
Object
Serum, plasma
Parameter
Epstein-Barr VCA IgM
Reference standard
Internal method
Internal method identity
S47
Comment
ECLIA, Cobas e801
Object
Serum, plasma
Parameter
Epstein-Barr VCA IgG
Reference standard
Internal method
Internal method identity
S46
Comment
ECLIA, Cobas e801
Object
Serum, plasma
Parameter
HCV IgG
Reference standard
Internal method
Internal method identity
S42
Comment
Immunoblot
Object
Serum, plasma
Parameter
HIV Ag/Ab Combo
Reference standard
Internal method
Internal method identity
S01
Comment
ECLIA Cobas e801
Object
Serum, plasma
Parameter
Anti-HCV
Reference standard
Internal method
Internal method identity
S02
Comment
ECLIA Cobas e801
Object
Serum, plasma
Parameter
HBsAg
Reference standard
Internal method
Internal method identity
S11
Comment
ECLIA Cobas e801
Object
Serum, plasma
Parameter
Anti-HBcll
Reference standard
Internal method
Internal method identity
S04
Comment
ECLIA Cobas e801
Object
Serum, plasma
Parameter
Anti-HBs
Reference standard
Internal method
Internal method identity
S05
Comment
ECLIA Cobas e801
Object
Serum, plasma
Parameter
HBeAg
Reference standard
Internal method
Internal method identity
S06
Comment
ECLIA Cobas e801
Object
Serum, plasma
Parameter
Anti-HBe
Reference standard
Internal method
Internal method identity
S07
Comment
ECLIA Cobas e801
Object
Serum, plasma
Parameter
HAV Ab IgM
Reference standard
Internal method
Internal method identity
S08
Comment
ECLIA Cobas e801
Object
Serum, plasma
Parameter
HAV Ab IgG
Reference standard
Internal method
Internal method identity
S09
Comment
ECLIA Cobas e801
Object
Serum, plasma
Parameter
Syphilis TP
Reference standard
Internal method
Internal method identity
S10
Comment
ECLIA Cobas e801
Object
Serum, plasma
Parameter
Borrelia IgG Borrelia IgM
Reference standard
Internal method
Internal method identity
S12
Comment
CLIA Liason
Object
Serum, plasma
Parameter
Borrelia IgG Borrelia IgM
Reference standard
Internal method
Internal method identity
S17
Comment
Immunoblot
Object
Serum, plasma
Parameter
CMV IgG
Reference standard
Internal method
Internal method identity
S18
Comment
ECLIA Cobas e801
Object
Serum, plasma
Parameter
CMV IgM
Reference standard
Internal method
Internal method identity
S19
Comment
ECLIA Cobas e801
Object
Serum, plasma
Parameter
Toxoplasma IgG
Reference standard
Internal method
Internal method identity
S20
Comment
ECLIA Cobas e801
Object
Serum, plasma
Parameter
Toxoplasma IgM
Reference standard
Internal method
Internal method identity
S21
Comment
ECLIA Cobas e801
Object
Serum, plasma
Parameter
Rubella IgG
Reference standard
Internal method
Internal method identity
S22
Comment
ECLIA Cobas e801
Object
Serum, plasma
Parameter
Varicella Zoster IgG
Reference standard
Internal method
Internal method identity
S43
Comment
CLIA Virclia
Object
Serum, plasma
Parameter
Helicobacter Pylori IgG
Reference standard
Internal method
Internal method identity
S44
Comment
CLIA Liason
M1690 Medical microbiology, others
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood
Parameter
Lactose intolerance
Reference standard
Internal method
Internal method identity
G30
Comment
Real-Time PCR LightCycler
Object
Blood
Parameter
Haemochromatosis
Reference standard
Internal method
Internal method identity
G31
Comment
Real-Time PCR LightCycler
Object
Whole blood EDTA/ACD
Parameter
HLA-B27
Reference standard
Internal method
Internal method identity
G09
Comment
Real-time PCR, In-house developed Light Cycler
Object
Serum
Parameter
Antinuclear antibodies (ANA), Subspesifisiteter
Reference standard
Internal method
Internal method identity
S38
Comment
CIA Bio-Flash
Object
Serum
Parameter
Antinuclear antibodies (ANA)
Reference standard
Internal method
Internal method identity
S37
Comment
CIA Bio-Flash
Object
Serum
Parameter
Anti-MPO (ANCA)
Reference standard
Internal method
Internal method identity
S28
Comment
CIA BioFlash
Object
Serum
Parameter
Anti-PR3 (ANCA)
Reference standard
Internal method
Internal method identity
S27
Comment
CIA BioFlash
Object
Serum
Parameter
RF IgM (Rheumatoid factor)
Reference standard
Internal method
Internal method identity
S35
Comment
CIA, Bio-Flash
Object
Serum, plasma
Parameter
Anti CCP and IgG antibody
Reference standard
Internal method
Internal method identity
S36
Comment
CIA, Bio-Flash
M30 Sample collection
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Patient and blood donor
Parameter
Blood for analysis (biochemistry, microbiology, immunology & transfusionmedicine)
Reference standard
Internal method
Internal method identity
D06950 D06953 D06981 D07068 D07100
Comment
Recognized procedures for venous or capillary puncture.
M31 Flexible accreditation
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Cell and tissue material
Parameter
Manufacturing, dyeing methods, immunohistochemistry and analyzes in molecular pathology
Reference standard
Internal method
Internal method identity
Measurement principle/analysis platforms which is accredited under histopathology (M0210), cytopathology (M0230) and molecular pathology (M0250). Procedure for FA: 24867 Accredited scope: ID D19518
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.
Object
Cell and tissue material
Parameter
Diagnostics
Reference standard
Internal method
Internal method identity
Diagnostics accredited under pathology (M02) Procedure for FA: 24867 Accredited scope: ID. 19518
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.
Object
Body fluids
Parameter
Hematological analytes Medical Biochemical analytes
Reference standard
Internal method
Internal method identity
Measurement principle/analysis platforms which is accredited under medical biochemistry (M12) Procedure for FA: 24867 Accredited scope ID: D09619
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.
Object
Respiratory tests Biopsies and tissue Body secretions Body fluids Bacterial and yeast strains Foreign bodies Skin scrapings, hair, nails
Parameter
Bacteria Virus Mushroom Parasites Antibodies Antigens Human genes/mutations
Reference standard
Internal method
Internal method identity
Measurement principle/analysis platforms which is accredited under medical microbiology (M16) Procedure for FA: 24867 Accredited Scope ID : D15998
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.