Hellenic Accreditation System
Annex G1/3 to the Certificate No. 805
SCOPE of ACCREDITATION
of the
Clinical Laboratory
of
Iatriki Diagnosi Ltd.
Materials/Products
tested
Types of test/Properties measured
Applied methods/Techniques used
Biochemical Tests
1. Blood serum
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Determination of 16 parameters
Automated biochemical analyzer
Dimension RXL, SIEMENS*
1. Glucose
Enzymatic Chromatometric Reaction:
Hexokinase
2. Urea
Enzymatic Chromatometric Reaction Kinetic:
Urease
3. Uric Acid
Enzymatic Chromatometric Reaction: Uricase
4. Serum glutamic-oxaloacetic
transaminase (SGOT)
Enzymatic Chromatometric Reaction:
Siemens/ Date, Standard nonIFCC
5. Serum glutamic-pyruvic
transaminase (SGPT)
Enzymatic Chromatometric Reaction:
Siemens/ Date, Standard nonIFCC
6. Gamma-glutamyl trasferase (γGT)
Chromatometric Reaction: Siemens/ Date,
Standard nonIFCC
7. Triglycerides
Enzymatic Chromatometric Reaction: Lipase
8. Creatinine
Enzymatic Chromatometric Reaction: Alkaline
Picrate no Deprot
9. C Reactive Protein (CRP)
Turbidimetric
10. Alkaline phosphatase (ALP)
Chromatometric Reaction: AMP buffer
11. HDL Cholesterol
Chromatometric Reaction: direct HDL, PPD
12. Iron
Chromatometric Reaction: without PPT
13. Total Cholesterol
Chromatometric Reaction: Siemens/ Date
Reagent
14. LDL Cholesterol
Calculated
15. Total Proteins
Chromatometric Reaction: Bichromatic
Endpoint
16. Total Iron Binding Capacity
Ferene Direct - Chromatometric Reaction:
Bichromatic Endpoint
Annex G1/3 to the Certificate ESYD No.805
09.01.2015
Materials/Products
tested
2. Whole blood
(EDTA)
Types of test/Properties measured
17. Determination of glycated
hemoglobin A1c ( HbA1C )
Applied methods/Techniques used
Turbidimetric (HB1C) & Alkaline Hematin
RXN (Hb)
Hematological Tests
1. Whole blood
(EDTA)
Determination of 12 parameters
Automated analyzers SYSMEX XS-1000i,
ROCHE*
1. Haemoglobin
Chromatometric Reaction: SLS Hb Detector
2. Red Blood Cells (RBC)
Hydrodynamic Focusing
3. Platelets (PLTs)
Hydrodynamic Focusing
4. White Blood Cells (WBC)
Flow Cytometry (Semiconductor Laser)
5. Hematocrit (HCT)
Hydrodynamic Focusing
6. Mean Red Cell Volume (MCV)
Calculated Based on Specific Equation (DC
Detection)
7. Mean Platelet Volume (MPV)
Calculated Based on Specific Equation (DC
Detection)
8. Mean Cell Hemoglobin
Calculated Based on Specific Equation (DC
Detection)
9.
Calculated Based on Specific Equation (DC
Detection)
Mean corpuscular hemoglobin
concentration
10. Red Cell Dist.Width CV
Calculated Based on Specific Equation (DC
Detection)
11. Red Cell Dist.Width SD
Calculated Based on Specific Equation (DC
Detection)
12. Plateletcrit
Calculated Based on Specific Equation (DC
Detection)
Determination of 2 parameters
Αnalyzer VARIANT II , BIORAD *
1. Hemoglobin A2 (HbA2)
HPLC (High Perfomance Liquid
Chromatography)
2. Hemoglobin F (HbF)
HPLC (High Perfomance Liquid
Chromatography)
3. Whole Blood
(EDTA)
Determination of 1 parameter
Αnalyzer VARIANT II TURBO, BIORAD *
1. Glycosylated Hemoglobin
(HBΑ1c)
HPLC (High Perfomance Liquid
Chromatography)
4. Blood Plasma
(Citrate)
Determination of 3 parameters
Semi-automated, Coagulation Analyzer
BFT II (SIEMENS) *
1. Prothrobin Time (PT sec)
Mechanical and photo-optical clot detection turbodensitometric
2. Whole Blood
(EDTA)
2. Prothrobin Time (INR)
3. Activated Partial
Thromboplastin Time (APTT)
*Reference to the commercial name of a specific analyzer/kit, refers to a specific analytical method and protocol
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Annex G1/3 to the Certificate ESYD No.805
09.01.2015
Site of assessment : Laboratory permanent premises, 48th Demokratias Av., 187 56 Keratsini, Attiki, Greece.
Approved signatories : A. Kotsigianni, M. Tsigka.
This scope of Accreditation replaces the previous one dated 30.09.2013
The Accreditation Certificate No. 805, to ELOT EN ISO 15189:2007, is valid until 16.04.2016.
Athens, January 09, 2015
Ioannis Sitaras
Director of the Laboratories Accreditation Division
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Annex G1/3 to the Certificate ESYD No.805
09.01.2015