PLASMA S.A. Private Diagnostic Laboratory

Hellenic Accreditation System

Annex G1/Β1 to the Certificate No. 934-2

SCOPE of ACCREDITATION

of the

Clinical Laboratory

of

PLASMA S.A. – Private Diagnostic Laboratory

PATRAS BRANCH

/ Materials/Products tested / Types of test/Properties measured / Applied methods/Techniques used /
Biochemical Testing
Determination of 59 parameters
serum / 1.  CRP highly sensitive / Turbidimetric/Aptec - Indiko Plus*
whole blood/EDTA / 2.  HbA1c (glycated hemoglobin) / HPLC/Menarini HA-8160*
serum or plasma / 3.  Glucose / Photometric/Thermo - Indiko Plus*
serum or plasma / 4.  Urea / Photometric/Thermo - Indiko Plus*
serum or plasma / 5.  Creatinine / Photometric/Thermo - Indiko Plus*
serum or plasma / 6.  Uric acid / Photometric/Thermo - Indiko Plus*
serum or plasma / 7.  Bilirubin total / Photometric/Thermo - Indiko Plus*
serum or plasma / 8.  Bilirubin direct / Photometric/Thermo - Indiko Plus*
serum or plasma / 9.  Bilirubin indirect / Calculation
serum or plasma / 10.  Protein total / Photometric/Thermo - Indiko Plus*
serum or plasma / 11.  Albumin / Photometric/Thermo - Indiko Plus*
serum or plasma / 12.  Globulins total / Calculation
serum or plasma / 13.  Triglycerids / Photometric/Thermo - Indiko Plus*
serum or plasma / 14.  Cholesterol / Photometric/Thermo - Indiko Plus*
serum or plasma / 15.  Cholesterol HDL / Photometric/Thermo - Indiko Plus*
serum or plasma / 16.  Cholesterol LDL / Calculation
serum or plasma / 17.  Cholesterol VLDL / Calculation
serum or plasma / 18.  Albumin/Globulin Index / Calculation
serum or plasma / 19.  γ-GT / Photometric/Thermo - Indiko Plus*
serum or plasma / 20.  ALT/SGOT / Photometric/Thermo - Indiko Plus*
serum or plasma / 21.  AST/SGPT / Photometric/Thermo - Indiko Plus*
serum or plasma / 22.  Amylase / Photometric/Thermo - Indiko Plus*
serum or plasma / 23.  Alkaline phosphatase / Photometric/Thermo - Indiko Plus*
serum / 24.  LDH / Photometric/Thermo - Indiko Plus*
serum or plasma / 25.  CPK / Photometric/Thermo - Indiko Plus*
serum / 26.  CK-ΜΒ / Photometric/Thermo - Indiko Plus*
serum or plasma / 27.  K - potassium / ISE/Thermo - Indiko Plus*
serum or plasma / 28.  Na - sodium / ISE/Thermo - Indiko Plus*
serum or plasma / 29.  Ca - Calcium total / Photometric/Thermo - Indiko Plus*
serum or plasma / 30.  Mg - Magnesium / Photometric/Thermo - Indiko Plus*
serum or plasma / 31.  P - Phosphate / Photometric/Thermo - Indiko Plus*
serum or plasma / 32.  Fe - Iron / Photometric/Thermo - Indiko Plus*
serum or plasma / 33.  Ferritin / CLIA/Siemens Centaur ΧP*
serum or plasma / 34.  Vitamin Β-12 / CLIA/Siemens Centaur ΧP*
serum / 35.  Folate / CLIA/Siemens Centaur ΧP*
serum / 36.  T3 / CLIA/Siemens Centaur ΧP*
serum / 37.  T4 / CLIA/Siemens Centaur ΧP*
serum or plasma / 38.  TSH / CLIA/Siemens Centaur ΧP*
serum / 39.  T3 free / CLIA/Siemens Centaur ΧP*
serum or plasma / 40.  T4 free / CLIA/Siemens Centaur ΧP*
serum or plasma / 41.  Anti-TG / CLIA/Siemens Centaur ΧP*
serum or plasma / 42.  Anti-TPO / CLIA/Siemens Centaur ΧP*
serum / 43.  PSA / CLIA/Siemens Centaur ΧP*
serum / 44.  PSA free / CLIA/Siemens Centaur ΧP*
serum / 45.  Index free/total PSA / Calculation
serum / 46.  AFP / CLIA/Siemens Centaur ΧP*
serum / 47.  CEA / CLIA/Siemens Centaur ΧP*
serum / 48.  CA 125 / CLIA/Siemens Centaur ΧP*
serum / 49.  CA 15.3 / CLIA/Siemens Centaur ΧP*
serum / 50.  CA 19.9 / CLIA/Siemens Centaur ΧP*
serum / 51.  bHCG / CLIA/Siemens Centaur ΧP*
serum / 52.  LH / CLIA/Siemens Centaur ΧP*
serum / 53.  FSH / CLIA/Siemens Centaur ΧP*
serum or plasma / 54.  Estradiol / CLIA/Siemens Centaur ΧP*
serum / 55.  Progesterone / CLIA/Siemens Centaur ΧP*
serum / 56.  Prolactin / CLIA/Siemens Centaur ΧP*
serum / 57.  Testosterone total / CLIA/Siemens Centaur ΧP*
ορός ή πλάσμα / 58.  DHEA-S / CLIA/Siemens Centaur ΧP*
ορός ή πλάσμα / 59.  SHBG / CLIA/Siemens Centaur ΧP*
Immunochemical Testing
Determination of 12 parameters
ορός ή πλάσμα / 1.  Toxoplasma IgG / CLIA/Siemens Centaur ΧP*
ορός ή πλάσμα / 2.  Toxoplasma IgM / CLIA/Siemens Centaur ΧP*
ορός ή πλάσμα / 3.  Rubella IgG / CLIA/Siemens Centaur ΧP*
ορός ή πλάσμα / 4.  Rubella IgM / CLIA/Siemens Centaur ΧP*
ορός ή πλάσμα / 5.  CMV IgG / CLIA/Siemens Immulite 2000*
ορός ή πλάσμα / 6.  CMV IgM / CLIA/Siemens Immulite 2000*
ορός ή πλάσμα / 7.  Syphilis (Treponema) IgG+IgM / CLIA/Siemens Centaur ΧP*
ορός ή πλάσμα / 8.  HIV Abs / CLIA/Siemens Centaur ΧP*
ορός ή πλάσμα / 9.  HCV Abs / CLIA/Siemens Centaur ΧP*
ορός ή πλάσμα / 10.  HBsAg / CLIA/Siemens Centaur ΧP*
ορός ή πλάσμα / 11.  HBs Abs / CLIA/Siemens Centaur ΧP*
ορός ή πλάσμα / 12.  HBc Abs total / CLIA/Siemens Centaur ΧP*

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

Site of assessement : Permanent Laboratory premises, 7 Aratou str 4, Patra, Greece.

Approved signatories: George Ikonomopoulos.

The Scope of Accreditation replaces the previous one dated 05.09.2016.

The Accreditation Certificate No. 934-2, to ELOT EN ISO 15189:2012, is valid until 19.10.2018.

Athens, 13.09.2017

Ioannis Sitaras

Director of the Laboratories Accreditation Division

Page 3 of 3 Annex G1/B1 to the Certificate No.934-2 13.09.2017