Hellenic Accreditation System

Annex G1/3 to the Certificate No. 898-2
SCOPE of ACCREDITATION
of the
Clinical Laboratory
of
KYTTARO IATRIKI LTD
Materials/Products tested / Types of test/Properties measured / Applied methods/Techniques used
Biochemical Tests
1. Blood serum
Blood serum (continued) /
Determination of 27 parameters
/ Automated biochemical analyzer Cobas 6000 c501, Roche*
1. Glucose (GLU) / Enzymatic (Hexokinase)
2. Urea (UREA) / Kinetic - Enzymatic / UV
(urease - glutamate dehydrogenase)
3. Creatinine (CREA) / Kinetic – Colorimetric
(Jaffè rate blank and compensated)
4. Sodium (Na) / Ion Selective Electrode (ISE - indirect)
5. Potassium (K) / Ion Selective Electrode (ISE - indirect)
6. Total Protein (TP) / Colorimetric method (Biuret)
7. Albumin (ALB) / Colorimetric method (Bromcresol Green)
8. Total Globulines / Calculated from PROT and ALB (Colorimetric)
9. Cholesterol Total(CHOL) / Enzymatic - Colorimetric (CHOD-POD)
10. HDL-Cholesterol (HDLC) / Direct Homogeneous Enzymatic - Colorimetric
11. VLDL Cholesterol (VLDL-C) / Calculated from TRIG (Enzymatic - Colorimetric)
12. Triglycerides (TRIG) / Enzymatic - Colorimetric (GPO-PAP)
13. Total Lipids / Calculated from CHOL and TRIG (Enzymatic - Colorimetric)
14. Phospholipides / Calculated from CHOL (Enzymatic - Colorimetric)
15. Uric Acid (UA) / Enzymatic - Colorimetric (Uricase-Peroxidase)
16. Bilirubin Total (BILT) / Colorimetric DPDliquid
17. Calcium (Ca) / Colorimetric - Endpoint
5-nitro-5’-methyl-BAPTA (NM-BAPTA)
18. Phosphate (P) / Colorimetric endpoint method -
Molybdate UV.
19. Magnesium (Mg) / Colorimetric endpoint method(xylidyl blue)
20. Iron (Fe) / Colorimetric (Ferrozine)
21. Aspartate Aminotranferase (AST/SGOT) / ColorimetricUVacc. IFCC**withoutpyridoxal phosphate
22. AlanineAminotranferase
(ALT/SGPT) / Colorimetric UV acc. IFCC** without pyridoxal phosphate
23. Alkaline Phosphatase (ALP) / Colorimetric, liquid acc. IFCC**
24. Gamma-glutamyltransferase (GGT) / Enzymatic - Colorimetric
(GCNA Liquid stand SZASZ)
25. Lactate Dehydrogenase (LDH) / Enzymatic - Colorimetric, liquid acc. IFCC**
26. Creatine Kinase (CKL) / Colorimetric, liquid acc. IFCC**
27. Amylase (AMYL) / Enzymatic - Colorimetric, liquid acc. IFCC**
Determination of 4 parameters
/ Automated biochemical analyzer Cobas 6000 c501, Roche*
1. C-Reactive Protein (CRP) / Immunoturbidimetric
2. Bilirubin Direct (BIL-D) / Diazo method
3. BilirubinIndirect (BIL-I) / Calculated from BILT andι BILD
4. LDL- Cholesterol (LDLC) / Calculated from CHOL, TRIG and HDL-CHOL.
2. Whole Blood (EDTA) /
Determination of 1 parameter
/ Automated biochemical analyzer Cobas Integra 400 plus, Roche*
1. Glycated hemoglobin A1c / Turbidimetric inhibition
immunoassay (TINIA) for hemolyzed whole blood acc. to DCCT/NGSP
Immunochemical Tests
1. Blood serum
Blood serum (continued)
Blood serum (continued) / Determination of 13 parameters / Automated immunochemical analyzers Cobas 6000 e601 1,3, Roche*
1. Thyrotropin (TSH) / Electrochemiluminescence (ECLIA)
(Sandwich)
2. Triidothyronine Total (T3) / Electrochemiluminescence (ECLIA)
(Competitive)
3. ThyroxinTotal(T4) / Electrochemiluminescence (ECLIA)
(Competitive)
4. TriidothyronineFree (FT3) / Electrochemiluminescence (ECLIA)
(Competitive)
5. ThyroxinFree (FT4) / Electrochemiluminescence (ECLIA)
(Competitive)
6. VitamineB12 / Electrochemiluminescence (ECLIA)
(Competitive)
7. Ferritin (FERRITIN) / Electrochemiluminescence (ECLIA)
(Sandwich)
8. Folate (FOLATE) / Electrochemiluminescence (ECLIA)
(Competitive)
9. Thyroglobulin Antibodies (anti-TG) / Electrochemiluminescence (ECLIA)
(Competitive)
10. Thyroid Peroxidase Antibodies (anti-TPO) / Electrochemiluminescence (ECLIA)
(Competitive)
11. Hepatitis B surface antigen (HBsAg) / Electrochemiluminescence (ECLIA)
(Sandwich)
12. Antibodies to the hepatitis B surface antigen (HBsAb) / Electrochemiluminescence (ECLIA)
(Sandwich)
13. Antibodies to the hepatitis B core antigen (HBcAb) / Electrochemiluminescence (ECLIA)
(Competitive)
Determination of 19 parameters / Automated immunochemical analyzer Cobas 6000 e601, Roche*
1. Follicle Stimulating Hormone (FSH) / Electrochemiluminescence (ECLIA)
(Sandwich)
2. Luteinizing Hormone (LH) / Electrochemiluminescence (ECLIA)
(Sandwich)
3. Progesterone (PRG) / Electrochemiluminescence (ECLIA)
(Competitive)
4. Prolactin (PRL) / Electrochemiluminescence (ECLIA)
(Sandwich)
5. Estradiol (E2) / Electrochemiluminescence (ECLIA)
(Competitive)
6. TestosteroneTotal (TESTO) / Electrochemiluminescence (ECLIA)
(Competitive)
7. Dehydroepiandrosterone sulfate (DHEA-S) / Electrochemiluminescence (ECLIA)
(Competitive)
8. HumanChorionicGonadotropin + β Subunit (HCG+β) / Electrochemiluminescence (ECLIA)
(Sandwich)
9. α1-Fetoprotein (AFP) / Electrochemiluminescence (ECLIA)
(Sandwich)
10. Carcinoembryonic Antigen (CEA) / Electrochemiluminescence (ECLIA)
(Sandwich)
11.Cancer Antigen 19-9 (CA-19.9) / Electrochemiluminescence (ECLIA)
(Sandwich)
12. Cancer Antigen 15-3 (CA-15.3) / Electrochemiluminescence (ECLIA)
(Sandwich)
13. Cancer Antigen 125 (CA-125) / Electrochemiluminescence (ECLIA)
(Sandwich)
14.Prostate Specific Antigen (PSA) / Electrochemiluminescence (ECLIA)
(Sandwich)
15.Cortisol (CORT) / Electrochemiluminescence (ECLIA)
(Competitive)
16. Immunoglobulin Ε (IgE) / Electrochemiluminescence (ECLIA)
(Sandwich)
17. Parathormone (PTH) / Electrochemiluminescence (ECLIA)
(Sandwich)
18. Insulin (Insulin) / Electrochemiluminescence (ECLIA)
(Sandwich)
19. Calcitonin (Calcitonin) / Electrochemiluminescence (ECLIA)
(Sandwich)
Determination of 8 parameters / Automated immunochemical analyzer Architect i2000SR, Abbott*
1. Detection of IgG antibodies to Rubella virus (RubellaIgG) / Chemiluminescence Microparticle Immunoassay (CMIA)
2. Detection of IgM antibodies to Rubella virus (RubellaIgM) / Chemiluminescence Microparticle Immunoassay (CMIA)
3. Detection of IgG antibodies to Cytomegalovirus (CMV IgG) / Chemiluminescence Microparticle Immunoassay (CMIA)
4. Detection of IgM antibodies to Cytomegalovirus (CMV IgM) / Chemiluminescence Microparticle Immunoassay (CMIA)
5. Detection of IgG antibodies to Toxoplasma gondii (TOXO IgG) / Chemiluminescence Microparticle Immunoassay (CMIA)
6. Detection of IgM antibodies to Toxoplasma gondii (TOXOIgM) / Chemiluminescence Microparticle Immunoassay (CMIA)
7. Detection of antibodies to hepatitis C virus (anti-HCV) / Chemiluminescence Microparticle Immunoassay (CMIA)
8. Detection of HIV antigen p24 and antibodies to human immunodeficiency virus type 1 and/or type 2 (HIV1/HIV2) (HIVAg/AbCombo) / Chemiluminescence Microparticle Immunoassay (CMIA)

*Reference to the commercial name of a specific analyzer/kit, refers to a specific analytical method and protocol

**IFCC: International Federation of Clinical Chemistry

Site of assessment :Laboratory permanent premises, 7K.Palamastr., 54630 Thessaloniki, Greece.

Approved signatories : L.Vogiatzoglou, M.Papoutsa, E.Karagiannis.

This scope of Accreditation replaces the previous one dated 15.09.2014.

The Accreditation Certificate No. 898-2, to ELOT EN ISO 15189:2012, is valid until 29.12.2017.

Athens, June16, 2015

Ioannis Sitaras

Director of the Laboratories Accreditation Division

Σελ1 από4 Annex G1/3 to the Certificate ESYD No.898-2 16.06.2015