Hellenic Accreditation System

Annex G1/2 to the Certificate No. 908

SCOPE of ACCREDITATION

of the

Clinical Laboratory

of the

BIOFORMA SA – MEDICAL LABORATORIES

Materials/Products tested / Types of test/Properties measured / Applied methods/Techniques used /
Biochemical Testing
Determination of 1 parameter
WHOLE BLOOD/EDTA / 1.  HbA1c / HPLC - Menarini HA-8160*
Determination of 41 parameters
Serum, Plasma / 1.  Glucose / Photometric - KONELAB 60*
Urine / 2.  Glucose in urine / Photometric - KONELAB 60*
Serum, Plasma / 3.  Urea / Photometric - KONELAB 60*
Urine / 4.  Urea in urine / Photometric - KONELAB 60*
Serum, Plasma / 5.  Creatinine / Photometric - KONELAB 60*
Urine / 6.  Creatinine in urine / Photometric - KONELAB 60*
Serum + Urine / 7.  Creatinine clearance / Calculation
Serum, Plasma / 8.  eGFR / Calculation /NKDEP
Serum, Plasma / 9.  Uric acid / Photometric - KONELAB 60*
Urine / 10.  Uric acid in urine / Photometric - KONELAB 60*
Serum, Plasma / 11.  Τriglycerids / Photometric - KONELAB 60*
Serum, Plasma / 12.  Lipids total / Calculation
Serum, Plasma / 13.  Bilirubin total / Photometric - KONELAB 60*
Serum, Plasma / 14.  Bilirubin direct / Photometric - KONELAB 60*
Serum, Plasma / 15.  Bilirubin indirect / Calculation
Serum, Plasma / 16.  Cholesterol / Photometric - KONELAB 60*
Serum, Plasma/Heparin / 17.  Cholesterol HDL / Photometric - KONELAB 60*
Serum, Plasma/Heparin / 18.  Cholesterol LDL / Calculation
Serum, Plasma / 19.  Cholesterol VLDL / Calculation
Serum, Plasma / 20.  Albumin / Photometric - KONELAB 60*
Urine / 21.  Miroalbumin in urine / Turbidimetric Aptec/KONELAB 60*
Serum, Plasma / 22.  Protein total / Photometric - KONELAB 60*
Urine / 23.  Protein total in urine / Photometric - KONELAB 60*
Serum, Plasma / 24.  Globulins total / Calculation
Serum, Plasma / 25.  Amylase / Photometric - KONELAB 60*
Urine / 26.  Amylase in urine / Photometric - KONELAB 60*
Serum, Plasma / 27.  γ-GT / Photometric - KONELAB 60*
Serum, Plasma / 28.  CPK / Photometric - KONELAB 60*
Serum / 29.  LDH / Photometric - KONELAB 60*
Serum, Plasma / 30.  ALT/SGOT / Photometric - KONELAB 60*
Serum, Plasma / 31.  AST/SGPT / Photometric - KONELAB 60*
Serum, Plasma / 32.  Cholinesterase / Photometric - KONELAB 60*
Serum, Plasma / 33.  Potassium (K) / ISE - KONELAB 60*
Urine / 34.  Potassium (K)in urine / ISE - KONELAB 60*
Serum, Plasma / 35.  Sodium (Na) / ISE - KONELAB 60*
Urine / 36.  Sodium (Na)in urine / ISE - KONELAB 60*
Serum, Plasma / 37.  Calcium (Ca) total / Photometric - KONELAB 60*
Serum, Plasma / 38.  Magnesium (Mg) / Photometric - KONELAB 60*
Serum / 39.  Phosphorous inorganic (P) / Photometric - KONELAB 60*
Urine / 40.  Phosphorous in urine / Photometric - KONELAB 60*
Serum, Plasma / 41.  Iron (Fe) / Photometric - KONELAB 60*
Determination of 12 parameters
Serum / 1.  Transferrin / Turbidimetric Aptec/KONELAB 60*
Serum, Plasma/EDTA / 2.  Homocysteine / Photometric - ROCHE/KONELAB 60*
Serum / 3.  CRP high sensitivity / Turbidimetric Aptec/KONELAB 60*
Serum / 4.  Lp (a) / Turbidimetric Aptec/KONELAB 60*
Serum, Plasma / 5.  Apolipoprotein Α1 / Turbidimetric - KONELAB 60*
Serum, Plasma / 6.  Apolipoprotein Β / Turbidimetric - KONELAB 60*
Serum / 7.  Complement C3 / Turbidimetric Aptec/KONELAB 60*
Serum / 8.  Complement C4 / Turbidimetric Aptec/KONELAB 60*
Serum / 9.  Immunoglobulin IgA / Turbidimetric Aptec/KONELAB 60*
Serum / 10.  Immunoglobulin IgE / CLIA - Siemens Immulite 2000*
Serum / 11.  Immunoglobulin IgG / Turbidimetric Aptec/KONELAB 60*
Serum / 12.  Immunoglobulin IgM / Turbidimetric Aptec/KONELAB 60*
Determination of 5 parameters
Serum / 1.  Albumin / Agarose El/phoresis - Helena SAS 3+4*
Serum / 2.  Α1 globulins / Agarose El/phoresis - Helena SAS 3+4*
Serum / 3.  Α2 globulins / Agarose El/phoresis - Helena SAS 3+4*
Serum / 4.  Β globulins / Agarose El/phoresis - Helena SAS 3+4*
Serum / 5.  Γ globulins / Agarose El/phoresis - Helena SAS 3+4*
Immunochemical Testing
Determination of 43 parameters
Serum / 1.  Ferritin / CLIA - Siemens Centaur XP*
Serum / 2.  Vitamin Β-12 / CLIA - Siemens Centaur XP*
Serum / 3.  Folate / CLIA - Siemens Centaur XP*
Serum / 4.  Vitamin D [25-hydroxy] / CLIA - DIASORIN LIAISON*
Serum / 5.  T3 / CLIA - Siemens Centaur XP*
Serum / 6.  T4 / CLIA - Siemens Centaur XP*
Serum / 7.  TSH / CLIA - Siemens Centaur XP*
Serum / 8.  T3 free / CLIA - Siemens Centaur XP*
Serum / 9.  T4 free / CLIA - Siemens Centaur XP*
Serum / 10.  Anti-TG / CLIA - Siemens Centaur XP*
Serum / 11.  Anti-TPO / CLIA - Siemens Centaur XP*
Serum, Plasma/EDTA / 12.  PTH INTACT / CLIA - Siemens Centaur XP*
Serum / 13.  TG / CLIA - Siemens Immulite 2000*
Serum / 14.  CT / CLIA - Siemens Immulite 2000*
Serum / 15.  PSA / CLIA - Siemens Centaur XP*
Serum / 16.  PSA free / CLIA - Siemens Centaur XP*
Serum / 17.  AFP / CLIA - Siemens Centaur XP*
Serum / 18.  CEA / CLIA - Siemens Centaur XP*
Serum / 19.  CA 125 / CLIA - Siemens Centaur XP*
Serum / 20.  CA 15.3 / CLIA - Siemens Centaur XP*
Serum / 21.  CA 19.9 / CLIA - Siemens Centaur XP*
Serum / 22.  Β-2 microglobulin / CLIA - Siemens Immulite 2000*
Serum / 23.  Chromogranin-Α (CgA) / EIA-LDN*
Serum / 24.  Pregnancy-associated plasma protein A (PAPP-A) / Kryptor-Trace*
Serum / 25.  free b-HCG / Kryptor-Trace*
Serum / 26.  HCG / CLIA - Siemens Centaur XP*
Serum / 27.  LH / CLIA - Siemens Centaur XP*
Serum / 28.  FSH / CLIA - Siemens Centaur XP*
Serum / 29.  Estradiol (Ε2) / CLIA - Siemens Centaur XP*
Serum / 30.  Estriol (Ε3) / CLIA - Siemens Immulite 2000*
Serum / 31.  Progesterone / CLIA - Siemens Centaur XP*
Serum / 32.  Prolactin / CLIA - Siemens Centaur XP*
Serum / 33.  Testosterone total / CLIA - Siemens Centaur XP*
Serum / 34.  DHEA-S / CLIA - Siemens Centaur XP*
Serum / 35.  SHBG / CLIA - Siemens Centaur XP*
Serum / 36.  Androstenedione / CLIA - Siemens Immulite 2000*
Serum / 37.  17-Hydroxyprogesterone / RIA-Βeckman coulter-STRATEC SR-300*
Serum / 38.  Growth hormone / CLIA - DIASORIN LIAISON*
Serum / 39.  Ιnsulin / ECLIA - ROCHE ELECSYS*
Serum / 40.  C Peptide / ECLIA - ROCHE ELECSYS*
Serum / 41.  Cortisol / CLIA - Siemens Centaur XP*
Plasma/EDTA / 42.  ACTH / CLIA - Siemens Immulite 2000*
Serum / 43.  Aldosterone / RIA–Βeckman coulter-STRATEC SR-300*
Determination of 6 parameters
Urine / 1.  Amphetamines / Immunochromatography-Dialab*
Urine / 2.  Barbiturates / Immunochromatography-Dialab*
Urine / 3.  Benzodiazepines / Immunochromatography-Dialab*
Urine / 4.  Cocaine / Immunochromatography-Dialab*
Urine / 5.  Opiates / Immunochromatography-Dialab*
Urine / 6.  Cannabinoids / Immunochromatography-Dialab*
Determination of 5 parameters
Serum / 1.  Lithium (Li) / ISE - KONELAB 60*
Serum / 2.  Digoxin (Lanoxin) / ECLIA - ROCHE ELECSYS*
Serum / 3.  Valproic acid (Depakene) / CLIA - Siemens Immulite 2000*
Serum / 4.  Carbamazepin (Tegretol) / CLIA - Siemens Immulite 2000*
Serum / 5.  Phenytoin (Dilatin-Epanutin) / CLIA - Siemens Immulite 2000*
Determination of 27 parameters
Serum / 1.  HAV antibodies total / CLIA - Siemens Centaur XP*
Serum / 2.  HAV antibodies IgM / CLIA - Siemens Centaur XP*
Serum / 3.  HBs Ag / CLIA - Siemens Centaur XP*
Serum / 4.  HBs antibodies / CLIA - Siemens Centaur XP*
Serum / 5.  HBc antibodies total / CLIA - Siemens Centaur XP*
Serum / 6.  HBc antibodies IgM / CLIA - Siemens Centaur XP*
Serum / 7.  HBe Ag / CLIA - Siemens Centaur XP*
Serum / 8.  HBe antibodies / CLIA - Siemens Centaur XP*
Serum / 9.  HCV antibodies / CLIA - Siemens Centaur XP*
Serum / 10.  Syphilis antibodies (Treponema IgG+IgM) / CLIA - Siemens Immulite 2000*
Serum / 11.  HIV I+II antibodies / CLIA - Siemens Centaur XP*
Serum / 12.  Τoxoplasma IgG / CLIA - Siemens Immulite 2000*
Serum / 13.  Τoxoplasma IgM / CLIA - Siemens Immulite 2000*
Serum / 14.  Rubella IgG / CLIA - Siemens Immulite 2000*
Serum / 15.  Rubella IgM / CLIA - Siemens Immulite 2000*
Serum / 16.  CMV IgG / CLIA - Siemens Immulite 2000*
Serum / 17.  CMV IgM / CLIA - Siemens Immulite 2000*
Serum / 18.  EBV IgG / CLIA - Siemens Immulite 2000*
Serum / 19.  EBV IgM / CLIA - Siemens Immulite 2000*
Serum / 20.  Widal-TH / Latex - Omega*
Serum / 21.  Widal -BH / Latex - Omega*
Serum / 22.  Widal -TO / Latex - Omega*
Serum / 23.  Widal -BO / Latex - Omega*
Serum / 24.  Widal -AO / Latex - Omega*
Serum / 25.  Widal -AH / Latex - Omega*
Serum / 26.  Widal -CO / Latex - Omega*
Serum / 27.  Widal -CH / Latex - Omega*
Determination of 82 parameters
Allergen Specific IgE
Serum / 1.  drugs: penicilloyl G / CLIA - Siemens Immulite 2000*
Serum / 2.  drugs: penicilloyl V / CLIA - Siemens Immulite 2000*
Serum / 3.  drugs: AMPICILLIN / CLIA - Siemens Immulite 2000*
Serum / 4.  drugs: AMOXICILLIN / CLIA - Siemens Immulite 2000*
Serum / 5.  mite: DERMATOPHAG.PTERONYSSINUS / CLIA - Siemens Immulite 2000*
Serum / 6.  mite: DERMATOPHAG.FARINAE / CLIA - Siemens Immulite 2000*
Serum / 7.  animal: cat epithelium / CLIA - Siemens Immulite 2000*
Serum / 8.  animal: dog epithelium / CLIA - Siemens Immulite 2000*
Serum / 9.  animal: DOG DANDER / CLIA - Siemens Immulite 2000*
Serum / 10. food: EGG WHITE / CLIA - Siemens Immulite 2000*
Serum / 11. food: SESAME SEED / CLIA - Siemens Immulite 2000*
Serum / 12. food: CHOCOLATE / CLIA - Siemens Immulite 2000*
Serum / 13. food: PEANUT / CLIA - Siemens Immulite 2000*
Serum / 14. food: SOYBEAN / CLIA - Siemens Immulite 2000*
Serum / 15. food: HAZELNUT / CLIA - Siemens Immulite 2000*
Serum / 16. food: BRAZIL NUT / CLIA - Siemens Immulite 2000*
Serum / 17. food: MILK / CLIA - Siemens Immulite 2000*
Serum / 18. food: ALMOND / CLIA - Siemens Immulite 2000*
Serum / 19.  food: LENTIL / CLIA - Siemens Immulite 2000*
Serum / 20.  food: SHRIMP / CLIA - Siemens Immulite 2000*
Serum / 21.  food: TOMATO / CLIA - Siemens Immulite 2000*
Serum / 22.  food: WALNUT / CLIA - Siemens Immulite 2000*
Serum / 23.  food: PORK / CLIA - Siemens Immulite 2000*
Serum / 24.  food: BEEF / CLIA - Siemens Immulite 2000*
Serum / 25.  food: CODFISH / CLIA - Siemens Immulite 2000*
Serum / 26.  food: CARROT / CLIA - Siemens Immulite 2000*
Serum / 27.  food: ORANGE / CLIA - Siemens Immulite 2000*
Serum / 28.  food: WHEAT / CLIA - Siemens Immulite 2000*
Serum / 29.  food: TUNA / CLIA - Siemens Immulite 2000*
Serum / 30.  food: SALMON / CLIA - Siemens Immulite 2000*
Serum / 31.  food: STRAWBERRY / CLIA - Siemens Immulite 2000*
Serum / 32.  food: YEAST / CLIA - Siemens Immulite 2000*
Serum / 33.  food: APPLE / CLIA - Siemens Immulite 2000*
Serum / 34.  food: EGG YOLK / CLIA - Siemens Immulite 2000*
Serum / 35.  food: Αlpha lactalbumin / CLIA - Siemens Immulite 2000*
Serum / 36.  food: beta lactoglobulin / CLIA - Siemens Immulite 2000*
Serum / 37.  food: casein / CLIA - Siemens Immulite 2000*
Serum / 38.  food: gluten / CLIA - Siemens Immulite 2000*
Serum / 39.  food: CORN / CLIA - Siemens Immulite 2000*
Serum / 40.  food: CHEDDAR cheese / CLIA - Siemens Immulite 2000*
Serum / 41.  food: chicken / CLIA - Siemens Immulite 2000*
Serum / 42.  food: RICE / CLIA - Siemens Immulite 2000*
Serum / 43.  food: banana / CLIA - Siemens Immulite 2000*
Serum / 44.  grass: sweet vernal / CLIA - Siemens Immulite 2000*
Serum / 45.  grass: johson / CLIA - Siemens Immulite 2000*
Serum / 46.  grass: cultivated rye / CLIA - Siemens Immulite 2000*
Serum / 47.  grass: BERMUDA / CLIA - Siemens Immulite 2000*
Serum / 48.  grass: ORCHARD / CLIA - Siemens Immulite 2000*
Serum / 49.  grass: MEADOW FESCUE / CLIA - Siemens Immulite 2000*
Serum / 50.  grass: PERENNIAL rye / CLIA - Siemens Immulite 2000*
Serum / 51.  grass: TIMOTHY / CLIA - Siemens Immulite 2000*
Serum / 52.  grass: june / CLIA - Siemens Immulite 2000*
Serum / 53.  grass: RED TOP / CLIA - Siemens Immulite 2000*
Serum / 54.  house dust GREER / CLIA - Siemens Immulite 2000*
Serum / 55.  house dust HOLLISTER stier / CLIA - Siemens Immulite 2000*
Serum / 56.  insect: honey bee / CLIA - Siemens Immulite 2000*
Serum / 57.  insect: WHITE HORNET / CLIA - Siemens Immulite 2000*
Serum / 58.  insect: yellow jacket / CLIA - Siemens Immulite 2000*
Serum / 59.  insect: WASP / CLIA - Siemens Immulite 2000*
Serum / 60.  insect: YELLOW HORNET / CLIA - Siemens Immulite 2000*