Download ΕΠΙΣΗΜΟ ΠΕΔΙΟ ΕΦΑΡΜΟΓΗΣ της ΔΙΑΠΙΣΤΕΥΣΗΣ

Hellenic Accreditation System
Annex G1/1 to the Certificate No. 968
SCOPE of ACCREDITATION
of the
Clinical Laboratory
of
MMC – IATRIKI FRONTIDA S.A.
Materials/Products
tested
Types of test/Properties measured
Applied methods/Techniques used
Biochemical Tests
Biological Fluids
1. Glucose (GLU)
Automated biochemical analyzer Cobas
Integra 400, ROCHE*
Enzymatic hexokinase method
Blood Serum
2. Urea (BUN)
Kinetic with urease+GLDH
Blood Serum
3. Creatinine
Enzymatic Colorimetic
Blood Serum
Method (IFCC) with 5΄ pyridoxal phosphate
Blood Serum
4. Serum glutamic-oxaloacetic
transaminase (SGOT/AST)
5. Serum glutamic – pyruvic
transaminase (SGPT/ALT)
6. Lactate dehydrogenase (LDH)
Blood Serum
7. Creatinine kinase (CK/CPK)
Photometric UV (IFCC )
Blood Serum
8. Gamma-glutamyl transferase (γ-GT)
Enzymatic colorimetric
Blood Serum
9. Alkaline phosphatase
Colorimetric (IFCC
Blood Serum
10. Biliburin (total)
Colorimetric Diazo
Blood Serum
11. Amylase
Enzymatic Colorimetric (IFCC)
Blood Serum
12. Total protein
Colorimetric Biuret
Blood Serum
13. Albumin
Photometric BromCresolGreen
Blood Serum
16. Calcium
Photometric with ocresolphalein
Blood Serum
17. Phosphorus
Photometric Photomolybdate
Blood Serum
18. Iron
Colorimetric FERROZINE Method
Blood Serum
19. Magnesium
Colorimetric chlorophosphonazo III assay
Blood Serum
Blood Serum
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Determination of 21 parameters
Method (IFCC) with 5΄ pyridoxal phosphate
Photometric UV (IFCC )
Annex G1/1 to the Certificate ESYD No 968
23.05.2017
Materials/Products
tested
Types of test/Properties measured
Applied methods/Techniques used
Blood Serum
20. Cholesterol
Enzymatic Colorimetric CHOD-POP
Blood Serum
21. Triglycerides
Enzymatic Colorimetric
Blood Serum
22. Uric Acid
Enzymatic Colorimetric uricase - peroxidase
Blood Serum
23.HDL-Cholesterol
Homogenous Enzymatic Colorimetric
Determination of 2 parameters
Blood Serum
1. Sodium
Automated Electrolyte Analyzer ISE/
ROCHE 9180*
ISE Potensiometric
Blood Serum
2. Potassium
ISE Potensiometric
Immunochemical Tests
Biological Fluids
Determination of 7 parameters
Blood Serum
1. Thyrotropin Hormone (TSH)
Automated immunochemical analyzer
Cobas E 411 ROCHE*
Electroimmunofluorescence
Blood Serum
2. Triidothyronine total (T3)
Electroimmunofluorescence ECLIA
Blood Serum
3. Thyroxin total (T4)
Electroimmunofluorescence ECLIA
Blood Serum
4. Triidothyronine free (FT3)
Electroimmunofluorescence ECLIA
Blood Serum
5. Thyroxin free (FT4)
Electroimmunofluorescence ECLIA
Blood Serum
6. Antithyroglobulin antibodes
(ANTI – TG)
7. Antithyroid peroxidase antibodes
(ANTI – TPO)
Electroimmunofluorescence ECLIA
Blood Serum
Electroimmunofluorescence ECLIA
Hematological Tests
Biological Fluids
Determination of 8 parameters
Automated Hematological analyzer XT
1800i Sysmex *
Whole Blood
1. White Blood Cells (WBC)
Fluorescence flow cytometry
Whole Blood
2. Red Blood Cells (RBC)
Hydrodynamic focusing analysis
Whole Blood
3. Hemoglobin (HGB)
Photometric
Whole Blood
4. Hematocrit (HCT)
Flow cytometry with hydrodynamic focusing
Whole Blood
5. Mean Corpuscular Volume (MCV)
Automatic calculation from HCT and RBC
Whole Blood
6. Mean Corpuscular Hemoglobin (MCH) Automatic calculation from HGB and RBC
Whole Blood
7. Mean Corpuscular Hemoglobin
Concentration (MCHC)
Automatic calculation from HGB and RBC
Whole Blood
8. Thrombocytes
Flow cytometry with hydrodynamic focusing
*Reference to the commercial name of a specific analyzer/kit, refers to a specific analytical method and protocol.
IFCC: International Federation of Clinical Chemistry
DGKC: Deutsche Geselschaft fur Klinische Chemie
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Annex G1/1 to the Certificate ESYD No 968
23.05.2017
Site of assessment : Laboratory permanent premises, 64 Dekelias Street, 14343 N.Halkidona, Greece.
Approved signatories : V.Karabali, N.Marmaras.
This Scope of Accreditation replaces the previous one dated 16.02.2015.
The Accreditaton Certificate No. 968, to ELOT EN ISO 15189:2012, is valid until 15.02.2019.
Athens, 23.05.2017
Ioannis Sitaras
Director of the Laboratories Accreditation Division
Page 3 of 3
Annex G1/1 to the Certificate ESYD No 968
23.05.2017