Hellenic Accreditation System
Annex G1/1 to the Certificate No.1000
SCOPE of ACCREDITATION
of the
Clinical Laboratories
of
DIAGNOSTIC AND THERAPEUTIC CENTER OF ATHENS HYGEIA S. A.
Tested
materials/products
Types of test/Properties to be measured
Applied Standards/Techniques to be
used
BIOCHEMICAL TESTS
Determination of 9 parameters
Blood serum, CSF and
other biological fluids
Blood serum and urine
Blood serum
1. Glucose (GLUC)
Automated biochemical analyzers
Dimension Rxl 1 & 2 (Siemens)*
Enzymatic (HK/G-6P/NAD+/NADH)
2. Urea (BUN)
Enzymatic /urease NAD
3. Uric acid (URCA)
Enzymatic (Uricase)
4. Creatinine (CREA)
Jaffe Modified kinetic
5. Cholesterol (CHOL)
Cholesterol oxidase, esterase,
peroxidase
6. Triglycerides (TGL)
Enzymatic GPO-POD
7. Glutaminic-pyruvic transaminase
(SGOT/AST)
8. Glumaminic-oxaloacetic transaminase
(SGPT/ALT)
Enzymatic / aKG, P5P, NaDH+ /
NAD+
Enzymatic / L-aspartate + aketoglutarate / NADH / NAD
9. Gamma - glutamyl transferase (GGT)
Enzymatic GCNA, glycyloglycine
HAEMATOLOGY TESTS
Determination of 4 parameters
Whole blood in EDTA,
Cerebrospinal fluid,
Synovial fluid, Ascites,
Pleural effusion,
Peritoneal fluid
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1. Complete Blood Count (CBC) White Blood Cell Count (WBC)
2. Complete Blood Count (CBC) Red Blood Cell Count (RBC)
3. Complete Blood Count (CBC) Platelet Count (PLT)
Automated hematology analyzers
Advia 1, 2 & 3 (Siemens)*
Flow Cytometry & Light scatter
analysis
Light scatter analysis
Light scatter analysis
Annex G1/1 to the Certificate ESYD No. 1000
17.9.2015
Tested
materials/products
Types of test/Properties to be measured
4. Complete Blood Count (CBC) Hemoglobin (Hgb)
Applied Standards/Techniques to be
used
Photometric assay
COAGULATION TESTS
Determination of 4 parameters
Whole blood in Sodium
citrate
1. Prothrombin Time (PT)
Automated hemostasis analyzers
BCS XP 1 & 2 (Siemens)*
Coagulometric assay – Activation
of coagulation cascade
2. International Normalized Ratio (INR)
Calculated
3. Activated Partial Thromboplastin Time
(APTT)
Coagulometric assay – Activation
of coagulation cascade
Coagulometric assay – Activation
of coagulation cascade
4. Fibrinogen
IMMUNOLOGICAL TESTS
Determination of 2 parameters
Blood serum,
heparinized plasma,
EDTA plasma
Sandwich Immunoassay two-point
measurement technology that uses
direct chemiluminescence (CLIA)
1. Ferritin
2. Troponin (cTnI )
Determination of 3 parameters
Blood serum,
heparinized plasma,
EDTA plasma
Blood serum,
heparinized plasma
Blood serum, red blood
cells
Automated immunochemical
analyzers Centaur XP 1 & 3
(Siemens)*
Sandwich Immunoassay three-point
measurement technology that uses
direct chemiluminescence (CLIA)
Automated immunochemical
analyzer Centaur XP 1 (Siemens)*
Competitive immunoassay using
direct chemiluminescence (CLIA)
technology
1. VΒ12
Sandwich Immunoassay two-point
measurement technology that uses
direct chemiluminescence (CLIA)
2. CKMB
Competitive immunoassay using
direct chemiluminescence (CLIA)
technology
3. Folate
IMMUNOCHEMICAL TESTS
Determination of 5 parameters
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Automated immunochemical
analyzer Centaur XP 2 (Siemens)*
Annex G1/1 to the Certificate ESYD No. 1000
17.9.2015
Tested
materials/products
Types of test/Properties to be measured
1. Free Triidothyronine (Free T3)
Blood serum
2. Total Human Chorionic Gonadotropin
(T-HCG)
3. Prostate Specific Antigen (PSA)
Blood serum,
heparinized plasma,
EDTA plasma
4. Free Thyroxin (Free T4)
5. Thyrotropin Hormone (TSH)
Applied Standards/Techniques to be
used
Competitive immunoassay using
direct chemiluminescence (CLIA)
technology
Sandwich Immunoassay two-point
measurement technology that uses
direct chemiluminescence (CLIA)
Competitive immunoassay using
direct chemiluminescence (CLIA)
technology
Sandwich Immunoassay two-point
measurement technology that uses
direct chemiluminescence (CLIA)
CYTOLOGICAL TESTS
Conventional vaginal
and cervical smears
Qualitative and semi -quantitative
method
1 . Pap stain(automatic stain
machine Shandon VARISTAIN 24Morphologic examination.
4)
Detection of neoplasia and typing
2. Microscopic evaluation
(Microscopes NIKON 80i,50i)
3. The BETHESDA System for
reporting cervical cytology
(BETHESDA CLASSIFICATION)
Vaginal and cervical
smears by liquid-based
cytology (Thin Prep
Technique)
Qualitative and semi -quantitative
method
1. Pap stain(automatic stain machine
Shandon VARISTAIN 24-4)
Morphologic examination.
Detection of neoplasia and typing
2. THIN PREP CYTYC 2000*
3. Microscopic evaluation
(Microscopes NIKON 80i,50i)
4. The BETHESDA System for
reporting cervical cytology
(BETHESDA CLASSIFICATION)
PATHOLOGY TESTS
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Annex G1/1 to the Certificate ESYD No. 1000
17.9.2015
Tested
materials/products
FFPE tissue (formalin
Types of test/Properties to be measured
fixed and paraffin
embedded tissue)
Applied Standards/Techniques to be
used
Microscopic examination of gene
signals (qualitative and
In situ hybridization
semiquantitative assay) using probes
labeled with fluorochrome or
chromogen.
FFPE tissue (formalin
Microscopic examination of the
fixed and paraffin
expression of cellular antigens
embedded tissue)
Immunohistochemical examination
(proteins) ( qualitative and
semiquantitative assay) in the
nucleus, cytoplasm or cytoplasmic
membrane labeled with chromogen.
FFPE tissue (formalin
fixed and paraffin
Microscopic examination of the
Hematoxylin-eosin stain
embedded tissue)
morphology of tissues and cells
stained with hematoxylin (nuclei)
and eosin (cytoplasm).
*Reference to the commercial name of a specific analyzer, refers to a specific analytical method and protocol
Site of assessment: Permanent premises, Clinical Laboratories : 4, Erythrou Stavrou & Kifisias Ave., 15123
Maroussi, Athens, Greece
Approved signatories: H. Papadogeorgaki, H. Salla, S. Papadopoulos.
The Accreditation Certificate No.1000, to ELOT EN ISO 15189:2012, is valid until 16.9.2019
Athens, 17.9.2015
Ioannis Sitaras
Director of the Laboratories Accreditation Division
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Annex G1/1 to the Certificate ESYD No. 1000
17.9.2015