Εθνικό Σύστημα Διαπίστευσης

Annex G1/5to the Certificate No. 888-3
SCOPE of ACCREDITATION
ofthe
Clinical Laboratory
of
BIOTYPOS, Private diagnostic center, Medical S.A.
Evaluated sample type / Chemistry parameters / Methods
1.Blood serum
1.Blood serum (cont.) / Determination of 37 parameters / Automated Biochemical AnalyzerADVIA 1800, SIEMENS *
  1. Glucose
/ enzymatic hexokinase
  1. Calcium
/ colorimetric Arsenazo III
  1. Phosphate
/ colorimetric
UV- phosphomolybdate
  1. Albumin
/ colorimetric
Bromocresol green (BCG)
  1. Total protein
/ colorimetric Biuret
  1. Urea
/ enzymatic / colorimetric
UV-urease
  1. Creatinine
/ enzymatic / colorimetric
Jaffe, alkaline picrate, kinetic with blank rate correction
  1. Uric acid
/ enzymatic / colorimetric
Uricase colorimetric
  1. Magnesium
/ colorimetricXylidylblue
  1. Total Bilirubin
/ colorimetricVanadate Oxidation
  1. Iron
/ colorimetric Ferrozine
  1. Total Cholesterol
/ Enzymatic
  1. HDL-Cholesterol
/ Elimination/catalase
  1. triglycerides
/ GPO, Trinder without serum blank
  1. Amylase
/ Ethylidene Blocked-pNPG7
  1. Alkaline phosphatase ALP
/ enzymatic / colorimetricDEA
  1. Gamma-Glutamyltransferase γ-GT
/ enzymatic / colorimetric
Τροποποιημένη **IFCC
  1. Creatine kinase (CPK)
/ enzymatic / colorimetric
NAC Activated, **IFCC
  1. Lactate Dehydrogenase LDH
/ enzymatic/ colorimetricLDPL
  1. Alanine Aminotranferase ALT/SGPT
/ **IFCC modified, enzymatic
  1. Aspartate Aminotranferase AST/GOT

  1. Sodium
/ Ion Selective Electrode ISE
  1. Potassium

  1. Total globulin
/ calculated
  1. Total lipids

26. VLDL cholesterol
  1. LDL Cholesterol

  1. Total Chol/HDL Chol

  1. Rheumatoid Factor (RF)
/ Latex-enhanced immunoturbidimetric
  1. Direct Bilirubin
/ Vanadate oxidation
  1. Indirect Bilirubin
/ Calculated
  1. Chlorides
/ Potentiometric - ISE
2. Serum, plasma /
  1. Immunoglobulin IgG
/ PEG-enhanced immunoturbidimetric
  1. Immunoglobulin IgM

  1. Immunoglobulin IgA

  1. Supplement C3

  1. Supplement C4

Immunochemical testing
1.Blood serum
1.Blood serum (cont.) / Determination of 3parameters / Automated immunochemical chemiluminescence analyzerIMMULITE 2000, SIEMENS*
  1. α-Fetoprotein AFP
/ Solid state chemiluminescence
  1. Immunoglobulin ΕIgE

  1. Dihydroepiandrosterone Sulfate (DHEA-S)

Determination of 22 parameters / Automated immunochemical chemiluminescence analyzerADVIA CENTAUR XP, SIEMENS*
Directchemiluminescencewithparamagneticmicroparticles
  1. CarcinoembryonicAntigen (CEA)

  1. Cancer Antigen 125 (CA125)

  1. Cancer Antigen 15-3 (CA15-3)

  1. Cancer Antigen 19-9 (CA19-9)

  1. Prostate Specific Antigen (PSA)

  1. Free Prostate Specific Antigen (FPSA)

  1. Ferritin

  1. Thyroid-stimulating hormone (TSH)

  1. Free Triidothyronine (FT3)

  1. Free Thyroxine (FT4)

  1. Vitamin B12

  1. Folate

13. Cortisol
14. β-Human Chorionic Gonadotropineβ-HCG
15. Total Triidothyronine T3
16. Total Thyroxine T4
17. Follicle Stimulating Hormone FSH
18. Luteinizing Hormone LH
19. Estradiol (E2)
20. ProgesteronePRG
21. Testosterone total
22. Prolactin PRL
Hematological parameters
1. Whole Blood (anticoagulant EDTA)
1. Whole Blood (anticoagulant EDTA) cont. / Determination of 10 parameters / Automated hematological analyzerADVIA 2120ιSIEMENS*
  1. HCT
/ Calculated: % = RBC x MCV/10
  1. Haemoglobin (HBG)
/ photometric
  1. White blood cells (WBC)
/ laser
Light scattering
  1. Red blood cells (RBC)

  1. Platelets (PLTs)

  1. Mean corpuscular volume (MCV)

  1. Mean corpuscular haemoglobin (MCH)
/ Calculated: HBG / RBC
  1. Mean cell haemoglobin concentration (MCHC)
/ Calculated: (HBG / RBC) x MCV
  1. Red blood cell distribution width (RDW)
/ laser
Light scattering
  1. Mean platelet volume (MPV)

2. Whole Blood
(K2EDTAήK3EDTA) / Determination of 1 parameter / AnalyzerCAPILLARYS 2 FLEXPIERCING
Glycozylated Hemoglobin HbA1C / Capillary electrophoresis
3. WholeBlood (SodiumCitrate) / Determinationof3parameters / AnalyzerBCS, SIEMENS
1. PT-INR / Coagulometric
2. ΙΝΩΔΟΓΟΝΟ (FIB) / Coagulometric
3. a-PTT / Coagulometric

*Η αναφορά της εμπορικής ονομασίας του αναλυτή παραπέμπει σε συγκεκριμένη αναλυτική μέθοδο και ανάλογο πρωτόκολλο εργασίας

**IFCC: International Federation of Clinical Chemistry

Site of assessment: Laboratory permanent premises,Leof. Pentelis 13, Halandri, PC 15233

Authorised Signatories:G. Chronas, I. Kouseris, M. Zioga, B. Liapis, G. Kalogiannakis,I. Tsouma,I. Markou, I. Anastasakis, M. Gkika, A. Vourtsi .

Branches:CHOLARGOS: 39,Av. Perikleous, PC 15561, ATHENS: 123, Av. Patision, PC 11252

MELISSIA:2, A. Papandreou str.– 2, Serifou str., PC 15127, EGALEO:281, Iera Odos str– 1, Averof str, PC 12244.

This scope of Accreditation replaces the previous one dated 11.05.2016.

The Accreditation Certificate No. 888-3, to ELOT EN ISO 15189:2012, is valid until 03.10.2021.

Athens, 25.04.2018

Konstantinos Voutsinas

Managing Director of E.SY.D.

Σελ 1 από 4 Παράρτημα G1/5 του Πιστοποιητικού Ε.ΣΥ.Δ.Αρ.888-3 25.04.2018