Hellenic Accreditation System Annex G1/7 to the Certificate No. 908-3 SCOPE of ACCREDITATION of the Clinical Laboratory of the BIOFORMA SA MEDICAL LABORATORIES Materials/ Biochemical tests Determination of 81 parameters serum, plasma 1 ACE Far-Advia-1800* Serum, Plasma 2 ALT/SGOT Siemens Advia-1800* Serum, Plasma 3 AST/SGPT Siemens Advia-1800* serum, plasma 4 CK-MB Siemens Advia-1800* Serum, Plasma 5 CPK Siemens Advia-1800* Serum 6 CRP high sensitivity Siemens Advia-1800* Serum 7 LDH Siemens Advia-1800* Serum 8 Lp (a) Siemens Advia-1800* serum 9 TIBC Calculation serum 10 Urea Nitrogen Calculation serum 11 Total/HDL Cholesterol Index Calculation Serum, Plasma 12 Albumin Siemens Advia-1800* serum, plasma 13 A-1-Antitrypsin Siemens Advia-1800* serum, plasma 14 A-1-Acid glycoprotein Siemens Advia-1800* plasma 15 Ammonia Siemens Advia-1800* Serum, Plasma 16 Amylase Siemens Advia-1800* Urine 17 Amylase in urine Siemens Advia-1800* Serum 18 Immunoglobulin IgA Siemens Advia-1800* Serum 19 Immunoglobulin IgE CLIA - Siemens Immulite 2000* Serum 20 Immunoglobulin IgG Siemens Advia-1800* Serum 21 Immunoglobulin IgM Siemens Advia-1800* Serum, Plasma 22 Apolipoprotein Α1 Siemens Advia-1800* Serum, Plasma 23 Apolipoprotein Β Siemens Advia-1800* serum 24 Haptoglobin Siemens Advia-1800* Serum, Plasma 25 Calcium (Ca) total Siemens Advia-1800* urine 26 Calcium (Ca)in urine Siemens Advia-1800* Serum, Plasma 27 γ-gt Siemens Advia-1800* Page 1 of 14 Annex G1/7 to the Certificate No. 908-3 14.06.2018
Page 2 of 14 Annex G1/7 to the Certificate No. 908-3 14.06.2018 plasma 28 Lactic acid Siemens Advia-1800* Serum, Plasma 29 Glucose Siemens Advia-1800* Urine 30 Glucose in urine Siemens Advia-1800* whole blood 31 HbA1c HPLC - Menarini HA-8160* whole blood 32 HbA1c HPLC - Menarini HA-8180* Serum + Urine 33 Creatinine clearance Calculation serum+urine 34 Urea clearance Calculation Serum, Plasma 35 Potassium (K) Siemens Advia-1800* Urine 36 Potassium (K)in urine Siemens Advia-1800* serum 37 Transferrin saturation Calculation Serum, Plasma 38 Creatinine Siemens Advia-1800* Urine 39 Creatinine in urine Siemens Advia-1800* serum 40 Albumin/Globulin Index Calculation serum, plasma 41 Lipase Siemens Advia-1800* Serum, Plasma 42 Lipids total Calculation serum 43 Ratio ApoA1/ApoB Calculation Serum, Plasma 44 Magnesium (Mg) Siemens Advia-1800* Urine 45 Magnesium (Mg) in urine Siemens Advia-1800* Urine 46 Miroalbumin in urine Siemens Advia-1800* Serum, Plasma 47 Sodium (Na) Siemens Advia-1800* Urine 48 Sodium (Na)in urine Siemens Advia-1800* Serum, Plasma 49 Urea Siemens Advia-1800* Urine 50 Urea in urine Siemens Advia-1800* Serum, Plasma 51 Uric acid Siemens Advia-1800* Urine 52 Uric acid in urine Siemens Advia-1800* Serum, Plasma 53 Protein total Siemens Advia-1800* Urine 54 Protein total in urine Siemens Advia-1800* Serum, Plasma 55 egfr Calculation /NKDEP serum 56 Ceruloplasmin Aptec-Advia-1800* Serum, Plasma 57 Iron (Fe) Siemens Advia-1800* Serum 58 Complement C3 Siemens Advia-1800* Serum 59 Complement C4 Siemens Advia-1800* Serum, Plasma 60 Globulins total Calculation Serum 61 Transferrin Siemens Advia-1800* Serum, Plasma 62 Τriglycerids Siemens Advia-1800* serum 63 Fructosamine Photometric - Konelab 60* serum, plasma 64 Alkaline Phosphatase Siemens Advia-1800* serum 65 Acid Phosphatase Photometry - Konelab 60* serum 66 Acid Phosphatase Non-Prostatic Photometry - Konelab 60* serum 67 Acid Phosphatase Prostatic Calculation serum 68 Phospholipids Calculation Serum 69 Phosphorous inorganic (P) Siemens Advia-1800* Urine 70 Phosphorous in urine Siemens Advia-1800* serum 71 Chloride (Cl) Siemens Advia-1800* Urine 72 Chloride (Cl) in urine Siemens Advia-1800* Serum, Plasma 73 Bilirubin direct Siemens Advia-1800* Serum, Plasma 74 Bilirubin indirect Calculation Serum, Plasma 75 Bilirubin total Siemens Advia-1800* Serum, Plasma 76 Cholesterol Siemens Advia-1800*
Page 3 of 14 Annex G1/7 to the Certificate No. 908-3 14.06.2018 Serum, Plasma 77 Cholesterol HDL Siemens Advia-1800* Serum, Plasma 78 Cholesterol LDL Calculation Serum, Plasma 79 Cholesterol VLDL Calculation Serum, Plasma 80 Cholinesterase Siemens Advia-1800* serum 81 Osmolality Calculation Determination of 5 parameters Serum 1 Albumin Agarose SPE - Helena SAS 3+4* Serum 2 Α1 globulins Agarose SPE - Helena SAS 3+4* Serum 3 Α2 globulins Agarose SPE - Helena SAS 3+4* Serum 4 Β globulins Agarose SPE - Helena SAS 3+4* Serum 5 Γ globulins Agarose SPE - Helena SAS 3+4* Determination of 59 parameters Serum 1 17-Hydroxyprogesterone RIA-Βeckman coulter-stratec SR-300* Plasma 2 ACTH CLIA - Siemens Immulite 2000* Serum 3 AFP CLIA - Siemens Centaur XP* Serum 4 C Peptide ECLIA - Roche Cobas e601* Serum 5 CA 15.3 CLIA - Siemens Centaur XP* Serum 6 CA 19.9 CLIA - Siemens Centaur XP* serum 7 CA 72.4 ECLIA - Roche Cobas e601* Serum 8 CA 125 CLIA - Siemens Centaur XP* Serum 9 CEA CLIA - Siemens Centaur XP* Serum 10 DHEA-S CLIA - Siemens Centaur XP* Serum 11 FSH CLIA - Siemens Centaur XP* Serum 12 LH CLIA - Siemens Centaur XP* serum 13 NSE ECLIA - Roche Cobas e601* Serum 14 Pregnancy-associated plasma protein A (PAPP- Kryptor-Trace* A) Serum 15 PSA CLIA - Siemens Centaur XP* Serum 16 PSA free CLIA - Siemens Centaur XP* serum 17 Ratio free/total PSA Calculation Serum 18 SHBG CLIA - Siemens Centaur XP* Serum 19 T3 CLIA - Siemens Centaur XP* Serum 20 T3 free CLIA - Siemens Centaur XP* Serum 21 T4 CLIA - Siemens Centaur XP* Serum 22 T4 free CLIA - Siemens Centaur XP* Serum 23 Anti-TG CLIA - Siemens Centaur XP* Serum 24 Anti-TPO CLIA - Siemens Centaur XP* Serum 25 TSH CLIA - Siemens Centaur XP* serum 26 TSH receptor AAB (TRAK) Kryptor-Trace* Serum 27 Aldosterone CLIA - Snibe Maglumi 1000* Serum 28 Androstenedione CLIA - Siemens Immulite 2000* Serum 29 Growth hormone CLIA - DIASORIN LIAISON* Serum 30 Β-2 microglobulin CLIA - Siemens Immulite 2000* Serum 31 HCG CLIA - Siemens Centaur XP* Serum 32 free b-hcg Kryptor-Trace* Serum 33 Vitamin Β-12 CLIA - Siemens Centaur XP* Serum 34 Vitamin D [25-hydroxy] Siemens Advia-1800* Serum 35 Gastrin CLIA - Siemens Immulite 2000*
Page 4 of 14 Annex G1/7 to the Certificate No. 908-3 14.06.2018 Serum 36 Free Androgen Index (FAI) Calculation Serum 37 ΗOΜΑ-IR Calculation Serum 38 TG CLIA - Siemens Immulite 2000* Serum 39 Ιnsulin ECLIA - Roche Cobas e601* Serum 40 CT CLIA - Siemens Immulite 2000* Serum 41 Risk Trisomy 21 (Down) - Α trimester Calculation - SsdwLab Serum 42 Risk Trisomy 21 (Down) - Β trimester Calculation - SsdwLab Serum 43 Risk NTD Calculation - SsdwLab Serum 44 Cortisol CLIA - Siemens Centaur XP* urine 45 Cortisol in urine CLIA - Siemens Centaur XP* Serum 46 Estradiol (Ε2) CLIA - Siemens Centaur XP* Serum 47 Estriol (Ε3) CLIA - Siemens Immulite 2000* serum, plasma 48 Osteocalcin CLIA - Diasorin Liaison* Serum, Plasma 49 PTH INTACT CLIA - Siemens Centaur XP* Serum 50 Progesterone CLIA - Siemens Centaur XP* Serum 51 Prolactin CLIA - Siemens Centaur XP* plasma 52 Renin CLIA - Snibe Maglumi 1000* serum 53 Somatomedin C (IGF-1) CLIA - Diasorin Liaison* Serum 54 Testosterone total CLIA - Siemens Centaur XP* serum, plasma 55 Troponin-I CLIA - Beckman Access-ΙΙ serum, plasma 56 Troponin-T ECLIA - Roche Cobas e601* Serum 57 Ferritin CLIA - Siemens Centaur XP* Serum 58 Folate CLIA - Siemens Centaur XP* Serum 59 Chromogranin-Α (CgA) EIA-LDN* Haematological tests Determination of 8 parameters whole blood 1 Reticulocyte analysis BCB stain whole blood 2 RBC morphology Blood Smear / Giemsa stain whole blood 3 PLT count Blood Smear / Giemsa stain whole blood 4 LY (%) Blood Smear / Giemsa stain whole blood 5 MO (%) Blood Smear / Giemsa stain whole blood 6 GR/NE (%) Blood Smear / Giemsa stain whole blood 7 ΕΟ (%) Blood Smear / Giemsa stain whole blood 8 ΒΑ (%) Blood Smear / Giemsa stain Determination of 22 parameters whole blood 1 HGB Beckman Coulter LH-500* whole blood 2 HCT Beckman Coulter LH-500* whole blood 3 WBC Beckman Coulter LH-500* whole blood 4 LY Beckman Coulter LH-500* whole blood 5 MO Beckman Coulter LH-500* whole blood 6 GR/NE Beckman Coulter LH-500* whole blood 7 ΕΟ Beckman Coulter LH-500* whole blood 8 ΒΑ Beckman Coulter LH-500* whole blood 9 LY (%) Beckman Coulter LH-500* whole blood 10 MO (%) Beckman Coulter LH-500* whole blood 11 GR/NE (%) Beckman Coulter LH-500* whole blood 12 ΕΟ (%) Beckman Coulter LH-500*
Page 5 of 14 Annex G1/7 to the Certificate No. 908-3 14.06.2018 whole blood 13 ΒΑ (%) Beckman Coulter LH-500* whole blood 14 RBC Beckman Coulter LH-500* whole blood 15 MCV Beckman Coulter LH-500* whole blood 16 MCH Beckman Coulter LH-500* whole blood 17 MCHC Beckman Coulter LH-500* whole blood 18 RDW Beckman Coulter LH-500* whole blood 19 PLT Beckman Coulter LH-500* whole blood 20 PCT Beckman Coulter LH-500* whole blood 21 MPV Beckman Coulter LH-500* whole blood 22 PDW Beckman Coulter LH-500* Determination of 3 parameters whole blood 1 Hemoglobin Α2 HPLC - Menarini HA-8160* whole blood 2 Hemoglobin F HPLC - Menarini HA-8160* whole blood 3 Hemoglobin electrophoresis HPLC - Menarini HA-8160* Determination of 9 parameters Serum, Plasma 1 Homocysteine Photometric ROCHE-KONELAB 60* Plasma/Citrate 2 D-dimers CLIA - Siemens Immulite 2000* Plasma/Citrate 3 Fibrinogen (activity) Dade/Sysmex CA1500* Plasma/Citrate 4 APTT Dade/Sysmex CA1500* Plasma/Citrate 5 PT - INR Dade/Sysmex CA1500* Plasma/Citrate 6 PT - Sec Dade/Sysmex CA1500* Plasma/Citrate 7 PT - % Dade/Sysmex CA1500* Plasma/Citrate 8 Antithrombin ΙΙΙ (Concentration) Turbidimetry Aptec/Konelab60* Plasma/Citrate 9 Lupus Anticoagulant (LAC) Dade CA1500* Immunological tests Determination of 10 parameters serum 1 HAV antibodies total CLIA - Siemens Centaur XP* serum 2 HAV antibodies IgM CLIA - Siemens Centaur XP* serum 3 HBs Ag Siemens Centaur XP* serum 4 HBs antibodies Siemens Centaur XP* serum 5 HBc antibodies total Siemens Centaur XP* serum 6 HBc antibodies IgM Siemens Centaur XP* serum 7 HBe Ag Siemens Centaur XP* serum 8 HBe antibodies Siemens Centaur XP* serum 9 HCV antibodies Siemens Centaur XP* Serum, Plasma 10 HCV antibodies ECLIA - Roche Cobas e411 Determination of 46 parameters serum 1 EBV IgG CLIA - Siemens Immulite 2000* serum 2 EBV IgM CLIA - Siemens Immulite 2000* serum 3 HIV Ag/Ab Siemens Centaur XP* Serum, Plasma 4 HIV I+II antibodies ECLIA - Roche Cobas e411 serum 5 Adenovirus IgG EIA Demeditec* serum 6 Adenovirus IgM EIA Demeditec* serum 7 VZV IgG EIA Demeditec* serum 8 VZV IgΜ EIA Demeditec* serum 9 Aspergilus IgG EIA Demeditec*
Page 6 of 14 Annex G1/7 to the Certificate No. 908-3 14.06.2018 serum 10 Brucella IgG EIA Demeditec* serum 11 Brucella IgM EIA Demeditec* serum 12 Yersinia IgG EIA Demeditec* serum 13 Helicobacter pylori IgΑ EIA Demeditec* serum 14 Helicobacter pylori IgG CLIA - Siemens Immulite 2000* serum 15 Enterovirus IgG EIA Serion* serum 16 Enterovirus IgM EIA Serion* serum 17 HSV 1 IgG CLIA - Diasorin Liaison* serum 18 HSV 2 IgG CLIA - Diasorin Liaison* serum 19 HSV 1/2 IgM CLIA - Diasorin Liaison* serum 20 Rubella IgG Siemens Centaur XP* serum 21 Rubella IgM Siemens Centaur XP* serum 22 Measles IgG EIA Demeditec* serum 23 Measles IgM EIA Demeditec* serum 24 Candida IgG EIA Demeditec* serum 25 Candida IgM EIA Demeditec* serum 26 Coxsackie IgG EIA Serion* serum 27 Coxsackie IgM EIA Serion* serum 28 Coxiella burnetii IgG EIA Vircell* serum 29 Coxiella burnetii IgM EIA Vircell* serum 30 CMV IgG Siemens Immulite 2000* serum 31 CMV IgM Siemens Immulite 2000* serum 32 Bordetella IgG EIA Demeditec* serum 33 Borrelia IgG EIA Demeditec* serum 34 Borrelia IgM EIA Demeditec* serum 35 Mycoplasma pneumonia IgG EIA Demeditec* serum 36 Mycoplasma pneumonia IgM EIA Demeditec* serum 37 Parvovirus IgG EIA Demeditec* serum 38 Parvovirus IgM EIA Demeditec* serum 39 Mumps IgG EIA Demeditec* serum 40 Mumps IgM EIA Demeditec* serum 41 Syphilis antibodies (Treponema IgG+IgM) Siemens Centaur XP* serum 42 TPHA IHA - Hemagen* serum 43 Tetanus IgG EIA Demeditec* serum 44 Τoxoplasma IgG Siemens Centaur XP* serum 45 Τoxoplasma IgM Siemens Centaur XP* serum 46 Chlamydia trachomatis IgG EIA Vircell* Determination of 10 parameters serum 1 ASTO Siemens Advia-1800 serum 2 Wright Latex agglutination - Omega* serum 3 Widal-TH Latex - Omega* serum 4 Widal-BH Latex - Omega* serum 5 Widal-TO Latex - Omega* serum 6 Widal-BO Latex - Omega* serum 7 Widal-AO Latex - Omega* serum 8 Widal-AH Latex - Omega* serum 9 Widal-CO Latex - Omega* serum 10 Widal-CH Latex - Omega*
Page 7 of 14 Annex G1/7 to the Certificate No. 908-3 14.06.2018 Determination of 35 parameters Serum, Plasma 1 RF quantitative Siemens Advia-1800* serum 2 CCP autoantibodies ECLIA - Roche Cobas e411 serum 3 AMA autoantibodies - IFA IFA Menarini-Zenit* serum 4 ΑΝΑ autoantibodies CLIA - Diasorin Liaison* serum 5 ΑΝΑ autoantibodies - IFA titre IFA Menarini-Zenit* serum 6 ΑΝΑ autoantibodies - IFA pattern IFA Menarini-Zenit* serum 7 ANCA-C autoantibodies - IFA IFA Menarini-Zenit* serum 8 ANCA-P autoantibodies - IFA IFA Menarini-Zenit* serum 9 APCA autoantibodies EIA Demeditec* serum 10 ASMA autoantibodies - IFA IFA Menarini-Zenit* serum 11 ENA autoantibodies CLIA - Diasorin Liaison* serum 12 DNA DS autoantibodies CLIA - Diasorin Liaison* serum 13 CENP autoantibodies CLIA - Diasorin Liaison* serum 14 GAD autoantibodies EIA - Medipan* serum 15 Histones autoantibodies Immunoblot - Testline serum 16 Jo autoantibodies EIA Demeditec* serum 17 LKM autoantibodies IFA Menarini-Zenit* serum 18 RNP antibodies EIA Demeditec* serum 19 Scl-70 autoantibodies EIA Demeditec* serum 20 SM antibodies EIA Demeditec* serum 21 SSA (Ro) antibodies EIA Demeditec* serum 22 SSB (La) antibodies EIA Demeditec* serum 23 GBM autoantibodies EIA - Aesku serum 24 Striated Muscle autoantibodies IFA SCIMEDX serum 25 ADR Cortex autoantibodies IFA SCIMEDX serum 26 ICA autoantibodies IFA SCIMEDX serum 27 AchR autoantibodies RIA - IBL serum 28 Β2 Glycoprotein IgG EIA Demeditec* serum 29 Β2 Glycoprotein IgM EIA Demeditec* serum 30 Gliadin IgA EIA Demeditec* serum 31 Gliadin IgG EIA Demeditec* serum 32 Tissue Transglutaminase autoantibodies IgA EIA Demeditec* serum 33 Tissue Transglutaminase autoantibodies IgG EIA Demeditec* serum 34 Cardiolipin IgG EIA Demeditec* serum 35 Cardiolipin IgM EIA Demeditec* Determination of 169 parameters Serum 1 Α. C1 - Penicilloyl G CLIA - Siemens Immulite 2000* Serum 2 Α. C2 - Penicilloyl V CLIA - Siemens Immulite 2000* Serum 3 Α. C203 - Ampicillin CLIA - Siemens Immulite 2000* Serum 4 Α. C204 - Amoxicilin CLIA - Siemens Immulite 2000* Serum 5 Α. D1 - Dermatophag.Pteronyssinus CLIA - Siemens Immulite 2000* Serum 6 Α. D2 - Dermatophag.Farinae CLIA - Siemens Immulite 2000* Serum 7 Α. D3 Dermatophag.microceras CLIA - Siemens Immulite 2000* Serum 8 Α. D70 - Acarus Siro CLIA - Siemens Immulite 2000* Serum 9 Α. D71 - Lepidoglyphus destructor CLIA - Siemens Immulite 2000* Serum 10 Α. D73 - Glucophagus domesticus CLIA - Siemens Immulite 2000* Serum 11 Α. E1 - cat epithelium CLIA - Siemens Immulite 2000*
Page 8 of 14 Annex G1/7 to the Certificate No. 908-3 14.06.2018 Serum 12 Α. E2 - dog epithelium CLIA - Siemens Immulite 2000* Serum 13 Α. E3 - horse epithelium CLIA - Siemens Immulite 2000* Serum 14 Α. E5 - Dog Dander CLIA - Siemens Immulite 2000* Serum 15 Α. E6 - Guinea pig epithelium CLIA - Siemens Immulite 2000* Serum 16 Α. E7 - Pigeon droppings CLIA - Siemens Immulite 2000* Serum 17 Α. E70 - Goose feathers CLIA - Siemens Immulite 2000* Serum 18 Α. E81 - Sheep epithelium CLIA - Siemens Immulite 2000* Serum 19 Α. E82 - Rabbit epithelium CLIA - Siemens Immulite 2000* Serum 20 Α. E85 - Chicken feathers CLIA - Siemens Immulite 2000* Serum 21 Α. E86 - Duck feathers CLIA - Siemens Immulite 2000* Serum 22 Α. F1 - Egg white CLIA - Siemens Immulite 2000* Serum 23 A. F2 - Milk CLIA - Siemens Immulite 2000* Serum 24 A. F3 - Codfish CLIA - Siemens Immulite 2000* Serum 25 A. F4 - Wheat CLIA - Siemens Immulite 2000* Serum 26 Α. F5 - Rye CLIA - Siemens Immulite 2000* Serum 27 Α. F6 - Barley CLIA - Siemens Immulite 2000* Serum 28 A. F7 - Oat CLIA - Siemens Immulite 2000* Serum 29 A. F8 - Corn CLIA - Siemens Immulite 2000* Serum 30 A. F9 - Rice CLIA - Siemens Immulite 2000* Serum 31 A. F10 - Sesame seed CLIA - Siemens Immulite 2000* Serum 32 Α. F12 - Green Pea CLIA - Siemens Immulite 2000* Serum 33 A. F13 - Peanut CLIA - Siemens Immulite 2000* Serum 34 A. F14 - Soybean CLIA - Siemens Immulite 2000* Serum 35 Α. F15 - White bean CLIA - Siemens Immulite 2000* Serum 36 A. F17 - Hazelnut CLIA - Siemens Immulite 2000* Serum 37 A. F18 - Brazil nut CLIA - Siemens Immulite 2000* Serum 38 A, F20 - Almond CLIA - Siemens Immulite 2000* Serum 39 Α. F23 - Crab CLIA - Siemens Immulite 2000* Serum 40 A. F24 - Shrimp CLIA - Siemens Immulite 2000* Serum 41 A. F25 - Tomato CLIA - Siemens Immulite 2000* Serum 42 A. F26 - Pork CLIA - Siemens Immulite 2000* Serum 43 A. F27 - Beef CLIA - Siemens Immulite 2000* Serum 44 A. F31 - Carrot CLIA - Siemens Immulite 2000* Serum 45 A. F33 - Orange CLIA - Siemens Immulite 2000* Serum 46 Α. F35 - Potato CLIA - Siemens Immulite 2000* Serum 47 Α. F36 - Coconut CLIA - Siemens Immulite 2000* Serum 48 Α. F37 - Blue Mussel CLIA - Siemens Immulite 2000* Serum 49 A. F40 - Tuna CLIA - Siemens Immulite 2000* Serum 50 A. F41 - Salmon CLIA - Siemens Immulite 2000* Serum 51 A. F44 - Strawberry CLIA - Siemens Immulite 2000* Serum 52 A. F45 - Yeast CLIA - Siemens Immulite 2000* Serum 53 Α. F47 - Garlic CLIA - Siemens Immulite 2000* Serum 54 Α. F48 - Onion CLIA - Siemens Immulite 2000* Serum 55 A. F49 - Apple CLIA - Siemens Immulite 2000* Serum 56 Α. F61 - Sardine CLIA - Siemens Immulite 2000* Serum 57 A. F75 - Egg yolk CLIA - Siemens Immulite 2000* Serum 58 A. F76 - Αlpha lactalbumin CLIA - Siemens Immulite 2000* Serum 59 A. F77 - Beta lactoglobulin CLIA - Siemens Immulite 2000*
Page 9 of 14 Annex G1/7 to the Certificate No. 908-3 14.06.2018 Serum 60 A. F78 - Casein CLIA - Siemens Immulite 2000* Serum 61 A. F79 - Gluten CLIA - Siemens Immulite 2000* Serum 62 Α. F80 - Lobster CLIA - Siemens Immulite 2000* Serum 63 A. F81 - Cheddar cheese CLIA - Siemens Immulite 2000* Serum 64 Α. F82 - Cheese, Mold CLIA - Siemens Immulite 2000* Serum 65 A. F83 - Chicken CLIA - Siemens Immulite 2000* Serum 66 Α. F84 - Kiwi fruit CLIA - Siemens Immulite 2000* Serum 67 Α. F85 - Celery CLIA - Siemens Immulite 2000* Serum 68 Α. F87 - Melon CLIA - Siemens Immulite 2000* Serum 69 Α. F88 - Lamb CLIA - Siemens Immulite 2000* Serum 70 Α. F89 - Mustard CLIA - Siemens Immulite 2000* Serum 71 Α. F90 - Malt CLIA - Siemens Immulite 2000* Serum 72 A. F92 - Banana CLIA - Siemens Immulite 2000* Serum 73 Α. F95 - Peach CLIA - Siemens Immulite 2000* Serum 74 A. F105 - Chocolate CLIA - Siemens Immulite 2000* Serum 75 Α. F201 - Pecan Nut CLIA - Siemens Immulite 2000* Serum 76 Α. F202 - Cashew CLIA - Siemens Immulite 2000* Serum 77 Α. F203 - Pistachio CLIA - Siemens Immulite 2000* Serum 78 Α. F214 - Spinach CLIA - Siemens Immulite 2000* Serum 79 A. F215 - Lettuce CLIA - Siemens Immulite 2000* Serum 80 Α. F216 - Cabbage CLIA - Siemens Immulite 2000* Serum 81 Α. F221 - Coffee CLIA - Siemens Immulite 2000* Serum 82 Α. F232 - Ovalbumin CLIA - Siemens Immulite 2000* Serum 83 Α. F233 - Ovomucoid CLIA - Siemens Immulite 2000* Serum 84 A. F235 - Lentil CLIA - Siemens Immulite 2000* Serum 85 Α. F245 Egg CLIA - Siemens Immulite 2000* Serum 86 A. F256 - Walnut CLIA - Siemens Immulite 2000* Serum 87 Α. F258 - Squid CLIA - Siemens Immulite 2000* Serum 88 Α. F259 - Grape CLIA - Siemens Immulite 2000* Serum 89 Α. F291 - Cauliflower CLIA - Siemens Immulite 2000* Serum 90 Α. F299 - Chestnut CLIA - Siemens Immulite 2000* Serum 91 Α. F300 - Pinto bean CLIA - Siemens Immulite 2000* Serum 92 Α. F343 Raspberry CLIA - Siemens Immulite 2000* Serum 93 A. G1 - Sweet vernal grass CLIA - Siemens Immulite 2000* Serum 94 A. G2 - BERMUDA grass CLIA - Siemens Immulite 2000* Serum 95 A. G3 - ORCHARD grass CLIA - Siemens Immulite 2000* Serum 96 A. G4 - MEADOW FESCUE CLIA - Siemens Immulite 2000* Serum 97 A. G5 - PERENNIAL rye grass CLIA - Siemens Immulite 2000* Serum 98 A. G6 - TIMOTHY grass CLIA - Siemens Immulite 2000* Serum 99 Α. G7 - Common reed grass CLIA - Siemens Immulite 2000* Serum 100 A. G8 - June grass CLIA - Siemens Immulite 2000* Serum 101 A. G9 - Red Top grass CLIA - Siemens Immulite 2000* Serum 102 A. G10 - Johson grass CLIA - Siemens Immulite 2000* Serum 103 Α. G11 - Brome grass CLIA - Siemens Immulite 2000* Serum 104 A. G12 - Cultivated rye grass CLIA - Siemens Immulite 2000* Serum 105 Α. G13 - Velvet grass CLIA - Siemens Immulite 2000* Serum 106 Α. G14 - Cultivated Oat grass CLIA - Siemens Immulite 2000* Serum 107 Α. G15 - Cultivated Wheat grass CLIA - Siemens Immulite 2000*
Page 10 of 14 Annex G1/7 to the Certificate No. 908-3 14.06.2018 Serum 108 Α. G16 - Meadow Foxtail grass CLIA - Siemens Immulite 2000* Serum 109 Α. G17 - Bahia grass CLIA - Siemens Immulite 2000* Serum 110 A. H1 - house dust Greer CLIA - Siemens Immulite 2000* Serum 111 A. H2 - house dust Hollister stier CLIA - Siemens Immulite 2000* Serum 112 Α. H6 - House Dust Japan CLIA - Siemens Immulite 2000* Serum 113 A. I1 - Honey bee CLIA - Siemens Immulite 2000* Serum 114 A. I2 - White hornet CLIA - Siemens Immulite 2000* Serum 115 A. I3 - Yellow jacket CLIA - Siemens Immulite 2000* Serum 116 A. I4 - Wasp CLIA - Siemens Immulite 2000* Serum 117 A. I5 - Yellow hornet CLIA - Siemens Immulite 2000* Serum 118 A. I6 - Cockroach CLIA - Siemens Immulite 2000* Serum 119 Α. I70 - Ant CLIA - Siemens Immulite 2000* Serum 120 Α. I71 - Mosquito CLIA - Siemens Immulite 2000* Serum 121 A. I75 - European hornet CLIA - Siemens Immulite 2000* Serum 122 A. K82 - Latex CLIA - Siemens Immulite 2000* Serum 123 Α. M1 - Penicillium Notatum CLIA - Siemens Immulite 2000* Serum 124 Α. M2 - Cladosporium Herbarum CLIA - Siemens Immulite 2000* Serum 125 Α. M3 - Aspergillus Fumigatus CLIA - Siemens Immulite 2000* Serum 126 Α. M4 - Mucor Racemosus CLIA - Siemens Immulite 2000* Serum 127 Α. M5 - Candida Albicans CLIA - Siemens Immulite 2000* Serum 128 Α. M6 - Alternaria Tenuis CLIA - Siemens Immulite 2000* Serum 129 Α. M7 - Botrytis Cinerea CLIA - Siemens Immulite 2000* Serum 130 Α. M8 - Helminthosporium Halodes CLIA - Siemens Immulite 2000* Serum 131 Α. M9 - Fusarium Moniliforme CLIA - Siemens Immulite 2000* Serum 132 Α. M10 - Stemphylium Botryosum CLIA - Siemens Immulite 2000* Serum 133 Α. M11 - Rhizopus Nigricans CLIA - Siemens Immulite 2000* Serum 134 Α. M13 - Phoma Betae CLIA - Siemens Immulite 2000* Serum 135 Α. M14 - Epicoccum Purpurascens CLIA - Siemens Immulite 2000* Serum 136 Α. M15 - Trichoderma Viride CLIA - Siemens Immulite 2000* Serum 137 Α. M16 - Curvularia Lunata CLIA - Siemens Immulite 2000* Serum 138 Α. T1 - Malpe CLIA - Siemens Immulite 2000* Serum 139 Α. T2 - Alder CLIA - Siemens Immulite 2000* Serum 140 A. T3 - Birch CLIA - Siemens Immulite 2000* Serum 141 A. T4 - Hazelnut CLIA - Siemens Immulite 2000* Serum 142 A. T6 - Mountain Cedar CLIA - Siemens Immulite 2000* Serum 143 A. T7 - Oak CLIA - Siemens Immulite 2000* Serum 144 A. T8 - Elm CLIA - Siemens Immulite 2000* Serum 145 A. T9 - Olive CLIA - Siemens Immulite 2000* Serum 146 A. T10 - Walnut CLIA - Siemens Immulite 2000* Serum 147 A. T11 - Sycamore CLIA - Siemens Immulite 2000* Serum 148 A. T12 - Willow CLIA - Siemens Immulite 2000* Serum 149 A. T14 - Cottonwood CLIA - Siemens Immulite 2000* Serum 150 A. T16 - White pine CLIA - Siemens Immulite 2000* Serum 151 A. T18 - Eucalyptus CLIA - Siemens Immulite 2000* Serum 152 A. T19 - Acacia CLIA - Siemens Immulite 2000* Serum 153 A. T20 - Mesquite CLIA - Siemens Immulite 2000* Serum 154 A. T21 - Melaleuca CLIA - Siemens Immulite 2000* Serum 155 A. T23 - Italian Cypress CLIA - Siemens Immulite 2000*
Page 11 of 14 Annex G1/7 to the Certificate No. 908-3 14.06.2018 Serum 156 Α. T70 - White Mulberry CLIA - Siemens Immulite 2000* Serum 157 A. W1 - Artemisifolia CLIA - Siemens Immulite 2000* Serum 158 A. W2 - Western Ragweed CLIA - Siemens Immulite 2000* Serum 159 Α. W3 - Giant Ragweed CLIA - Siemens Immulite 2000* Serum 160 Α. W5 - Wormwood CLIA - Siemens Immulite 2000* Serum 161 A. W6 - Mugwort CLIA - Siemens Immulite 2000* Serum 162 A. W7 - Ox-Eye Daisy CLIA - Siemens Immulite 2000* Serum 163 A. W8 - Dandelion CLIA - Siemens Immulite 2000* Serum 164 A. W9 - English Plantain CLIA - Siemens Immulite 2000* Serum 165 A. W10 - Lambs Quarter CLIA - Siemens Immulite 2000* Serum 166 A. W11 - Russian Thistle CLIA - Siemens Immulite 2000* Serum 167 A. W19 - Parietaria Officinalis CLIA - Siemens Immulite 2000* Serum 168 A. W20 - Nettle CLIA - Siemens Immulite 2000* Serum 169 A. W21 - Parietaria judaica CLIA - Siemens Immulite 2000* Microbiological tests Determination of 32 parameters urine 1 Urinalysis, Macroscopic: Appearance Macroscopic urine 2 Urinalysis, Macroscopic: Colour Macroscopic urine 3 Urinalysis, Macroscopic: Sediment Macroscopic urine 4 Urinalysis, Microscopic: White blood cells Microscopic urine 5 Urinalysis, Microscopic: Erythrocytes Microscopic urine 6 Urinalysis, Microscopic: Epithelial cells Microscopic urine 7 Urinalysis, Microscopic: Mucus Microscopic urine 8 Urinalysis, Microscopic: Crystals Microscopic urine 9 Urinalysis, Microscopic: Cylinders Microscopic urine 10 Urinalysis, Microscopic: Amorphous salts Microscopic urine 11 Urinalysis, Microscopic: Microorganisms Microscopic urine 12 Urinalysis, Microscopic: Mucus Menarini sedimax urine 13 Urinalysis, Microscopic: Red blood cells Menarini sedimax urine 14 Urinalysis, Microscopic: Crystals Menarini sedimax urine 15 Urinalysis, Microscopic: Pathological casts Menarini sedimax urine 16 Urinalysis, Microscopic: Non-Squamous Menarini sedimax epithelial cells urine 17 Urinalysis, Microscopic: Bacteria Menarini sedimax urine 18 Urinalysis, Microscopic: Yeasts Menarini sedimax urine 19 Urinalysis, Microscopic: Squamous epithelial Menarini sedimax cells urine 20 Urinalysis, Microscopic: White blood cells Menarini sedimax urine 21 Urinalysis, Biochemical: ph Menarini AuctionMAX-4280 urine 22 Urinalysis, Biochemical: Hemoglobin Menarini AuctionMAX-4280 urine 23 Urinalysis, Biochemical: Glucose Menarini AuctionMAX-4280 urine 24 Urinalysis, Biochemical: Specific gravity Menarini AuctionMAX-4280 urine 25 Urinalysis, Biochemical: Turbidity Menarini AuctionMAX-4280 urine 26 Urinalysis, Biochemical: RBC Menarini AuctionMAX-4280 urine 27 Urinalysis, Biochemical: Nitrates Menarini AuctionMAX-4280 urine 28 Urinalysis, Biochemical: Protein total Menarini AuctionMAX-4280
Page 12 of 14 Annex G1/7 to the Certificate No. 908-3 14.06.2018 urine 29 Urinalysis, Biochemical: Ketones Menarini AuctionMAX-4280 urine 30 Urinalysis, Biochemical: Urobilinogen Menarini AuctionMAX-4280 urine 31 Urinalysis, Biochemical: Color tone Menarini AuctionMAX-4280 urine 32 Urinalysis, Biochemical: Bilirubin Menarini AuctionMAX-4280 Determination of 3 parameters urine 1 Culture: Urine Culture stool 2 Culture: Stool Culture vaginal 3 Culture: Vaginal Culture Determination of 9 parameters biological 1 Gram stain Gram stain vaginal 2 Direct wet mount slide preparation Microscopic isolate 3 Identification: Gram(-) Beckman Coulter Microscan* isolate 4 Identification: Gram(+) Beckman Coulter Microscan* isolate 5 Identification: Streptococcus Latex agglutination Omega* isolate 6 Identification: Staphylococcus spp Biochemical isolate 7 Identification: Enterococcus spp Latex agglutination Omega* isolate 8 Identification: Yeasts Beckman Coulter Microscan* isolate 9 Identification: Anaerobes Beckman Coulter Microscan* Determination of 2 parameters isolate 1 Antibiotic sensitivity testing: Gram(-) Beckman Coulter Microscan* isolate 2 Antibiotic sensitivity testing: Gram(+) Beckman Coulter Microscan* Molecular Genetics tests Determination of 6 parameters whole blood 1 Detection HLA-B27 PCR (ΤΠ7/03) whole blood 2 Mutation detection Factor V-Leiden G1691A PCR-RFLP (ΤΠ6/04) whole blood 3 Mutation detection MTHFR C677T PCR-RFLP (ΤΠ6/04) whole blood 4 Mutation detection Prothrombin G20210A PCR-RFLP (ΤΠ6/04) whole blood 5 Mutation detection MTHFR A1298C PCR-RFLP (ΤΠ27/01) whole blood 6 Mutation detection PAI-1 PCR-RFLP (ΤΠ28/01) Determination of 4 parameters whole blood 1 Mutation detection CFTR: df508 PCR-ARMS, ΤΠ5/03 whole blood 2 Mutation detection CFTR: G542X PCR-RFLP (ΤΠ6/04) whole blood 3 Mutation detection CFTR: N1303K PCR-RFLP (ΤΠ6/04) whole blood 4 Mutation detection CFTR: 621+1G>T PCR-RFLP (ΤΠ6/04) Determination of 51 parameters whole blood 1 Mutation detection CFTR: df508 ABI-3500 / Elucigene CF-EU2* whole blood 2 Mutation detection CFTR: G542X ABI-3500 / Elucigene CF-EU2* whole blood 3 Mutation detection CFTR: N1303K ABI-3500 / Elucigene CF-EU2* whole blood 4 Mutation detection CFTR: 621+1G>T ABI-3500 / Elucigene CF-EU2* whole blood 5 Mutation detection CFTR: 1078delT ABI-3500 / Elucigene CF-EU2* whole blood 6 Mutation detection CFTR: 1677delTA ABI-3500 / Elucigene CF-EU2* whole blood 7 Mutation detection CFTR: 1717-1G>A ABI-3500 / Elucigene CF-EU2* whole blood 8 Mutation detection CFTR: 1811+1.6kbA>G ABI-3500 / Elucigene CF-EU2* whole blood 9 Mutation detection CFTR: 1898+1G>A ABI-3500 / Elucigene CF-EU2* whole blood 10 Mutation detection CFTR: 2143delT ABI-3500 / Elucigene CF-EU2* whole blood 11 Mutation detection CFTR: 2184delA ABI-3500 / Elucigene CF-EU2* whole blood 12 Mutation detection CFTR: 2347delG ABI-3500 / Elucigene CF-EU2*
whole blood 13 Mutation detection CFTR: 2789+5G>A ABI-3500 / Elucigene CF-EU2* whole blood 14 Mutation detection CFTR: 3120+1G>A ABI-3500 / Elucigene CF-EU2* whole blood 15 Mutation detection CFTR: 3272-26A>G ABI-3500 / Elucigene CF-EU2* whole blood 16 Mutation detection CFTR: 3659delC ABI-3500 / Elucigene CF-EU2* whole blood 17 Mutation detection CFTR: 3849+10kbC>T ABI-3500 / Elucigene CF-EU2* whole blood 18 Mutation detection CFTR: 3905insT ABI-3500 / Elucigene CF-EU2* whole blood 19 Mutation detection CFTR: 394delTT ABI-3500 / Elucigene CF-EU2* whole blood 20 Mutation detection CFTR: 444delA ABI-3500 / Elucigene CF-EU2* whole blood 21 Mutation detection CFTR: 711+1G>T ABI-3500 / Elucigene CF-EU2* whole blood 22 Mutation detection CFTR: A455E ABI-3500 / Elucigene CF-EU2* whole blood 23 Mutation detection CFTR: CFTRdele2,3 ABI-3500 / Elucigene CF-EU2* whole blood 24 Mutation detection CFTR: D1152H ABI-3500 / Elucigene CF-EU2* whole blood 25 Mutation detection CFTR: E60X ABI-3500 / Elucigene CF-EU2* whole blood 26 Mutation detection CFTR: G551D ABI-3500 / Elucigene CF-EU2* whole blood 27 Mutation detection CFTR: G85E ABI-3500 / Elucigene CF-EU2* whole blood 28 Mutation detection CFTR: I507del ABI-3500 / Elucigene CF-EU2* whole blood 29 Mutation detection CFTR: L206W ABI-3500 / Elucigene CF-EU2* whole blood 30 Mutation detection CFTR: M1101K ABI-3500 / Elucigene CF-EU2* whole blood 31 Mutation detection CFTR: P67L ABI-3500 / Elucigene CF-EU2* whole blood 32 Mutation detection CFTR: Q890X ABI-3500 / Elucigene CF-EU2* whole blood 33 Mutation detection CFTR: R1066C ABI-3500 / Elucigene CF-EU2* whole blood 34 Mutation detection CFTR: R1158X ABI-3500 / Elucigene CF-EU2* whole blood 35 Mutation detection CFTR: R1162X ABI-3500 / Elucigene CF-EU2* whole blood 36 Mutation detection CFTR: R117C ABI-3500 / Elucigene CF-EU2* whole blood 37 Mutation detection CFTR: R117H ABI-3500 / Elucigene CF-EU2* whole blood 38 Mutation detection CFTR: R334W ABI-3500 / Elucigene CF-EU2* whole blood 39 Mutation detection CFTR: R347H ABI-3500 / Elucigene CF-EU2* whole blood 40 Mutation detection CFTR: R347P ABI-3500 / Elucigene CF-EU2* whole blood 41 Mutation detection CFTR: R553X ABI-3500 / Elucigene CF-EU2* whole blood 42 Mutation detection CFTR: R560T ABI-3500 / Elucigene CF-EU2* whole blood 43 Mutation detection CFTR: S1251N ABI-3500 / Elucigene CF-EU2* whole blood 44 Mutation detection CFTR: S549N ABI-3500 / Elucigene CF-EU2* whole blood 45 Mutation detection CFTR: V520F ABI-3500 / Elucigene CF-EU2* whole blood 46 Mutation detection CFTR: W1282X ABI-3500 / Elucigene CF-EU2* whole blood 47 Mutation detection CFTR: W846X ABI-3500 / Elucigene CF-EU2* whole blood 48 Mutation detection CFTR: Y1092X(C>A) ABI-3500 / Elucigene CF-EU2* whole blood 49 Mutation detection CFTR: Y122X ABI-3500 / Elucigene CF-EU2* whole blood 50 Mutation detection CFTR: S549R(T>G) ABI-3500 / Elucigene CF-EU2* whole blood 51 Polymorphism detection CFTR: IVS8 ABI-3500 / Elucigene CF-EU2* Molecular Biology tests Determination of 2 parameters urogenital 1 Chlamydia trachomatis In house multiplex PCR urogenital 2 Neisseria gonorrhoeae In house multiplex PCR Page 13 of 14 Annex G1/7 to the Certificate No. 908-3 14.06.2018
Drug level tests Determination of 7 parameters serum 1 Valproic acid (Depakene) Siemens Advia-1800* serum 2 Digoxin (Lanoxin) Siemens Advia-1800* serum 3 Theophylline Siemens Advia-1800* serum 4 Carbamazepin (Tegretol) Siemens Advia-1800* serum 5 Lithium (Li) Siemens Advia-1800* serum, plasma 6 Phenobarbital Siemens Advia-1800* serum 7 Phenytoin (Dilatin-Epanutin) Siemens Advia-1800* Clinical Toxicology tests Determination of 6 parameters Urine 1 Amphetamines Immunochromatography-Dialab* Urine 2 Barbiturates Immunochromatography-Dialab* Urine 3 Benzodiazepines Immunochromatography-Dialab* Urine 4 Cannabinoids Immunochromatography-Dialab* Urine 5 Cocaine Immunochromatography-Dialab* Urine 6 Opiates Immunochromatography-Dialab* Determination of 6 parameters whole blood 1 Manganese (Mn) GF-AAS - ΤP29/01 whole blood 2 Lead in blood GF-AAS - TP2/01 Serum 3 Copper in blood GF-AAS - TP1/01 Urine 4 Copper in urine GF-AAS - TP3/01 Serum 5 Zinc in blood F-AAS - TP4/01 urine 6 Zinc (Zn) in urine F-AAS - ΤP53/01 *Reference to the commercial name of a specific analyzer/kit, refers to a specific analytical method and protocol Site of assessement : Permanent Laboratory premises, 145 Byzantiou str, 142 33 N.Ionia, Athens, Greece. Approved signatories: Harris Heliopoulos, Sofia Dokou. This scope of Accreditation replaces the previous one dated 08.03.2018. The Accreditation Certificate No. 908-3, to ELOT EN ISO 15189:2012, is valid until 18.03.2022. Athens, June 14, 2018 Konstantinos Voutsinas Managing Director of ESYD Page 14 of 14 Annex G1/7 to the Certificate No. 908-3 14.06.2018