De accreditatie werd uitgereikt aan/ L'accréditation est délivrée à/ The accreditation is granted to/ Die akkreditierung wurde erteilt für:
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1 Bijlage bij accreditatie-certificaat Annexe au certificat d'accréditation Annex to the accreditation certificate Beilage zur Akkreditatierungszertifikat 299-TEST NBN EN ISO/IEC 17025:2005 Versie/Version/Fassung 13 Uitgiftedatum / Date d'émission / Issue date / Ausgabedatum: Geldigheidsdatum / Date limite de validité / Validity date / Gültigkeitsdatum: Nicole Meurée-Vanlaethem Voorzitster van het Accreditatiebureau La Présidente du Bureau d'accréditation Chair of the Accreditation Board Vorsitzende des Akkreditierungsbüro De accreditatie werd uitgereikt aan/ L'accréditation est délivrée à/ The accreditation is granted to/ Die akkreditierung wurde erteilt für: Lab Corp Clinical Trial Services bvba Intercity Business Park Generaal De Wittelaan, L11 A MECHELEN
2 Clinical Chemistry CT-BG-CHEM-SOP-113 Serum Alanine Aminotransferase (glutamate pyruvate transaminase) (ALT/GPT) UV test without pyridoxal phosphate activation (acc. to IFCC) on Hitachi CT-BG-SOP-CHEM-94 Serum Albumin Colorimetric assay (dye binding- BCG) on Hitachi CT-BG-CHEM-SOP-104 Serum Alkaline Phosphatase Colorimetric assay (reaction with p- nitrophenyl phosphate) (acc. to IFCC) on Hitachi CT-BG-CHEM-SOP-67 Serum Amylase Enzymatic colorimetric assay (with p-nitrophenol) (acc. To IFCC) on Hitachi CT-BG-CHEM-SOP-111 Serum Aspartate Aminotransferase (glutamate oxalacetate transaminase) (AST/GOT) UV test without pyridoxal phosphate activation (acc. To IFCC) on Hitachi CT-BG-IMMU-SOP-172 Serum Beta2-Microglobulin Chemiluminescent immunometric assay on Immulite 2000 CT-BG-CHEM-SOP-95 Serum Bilirubin, Total Colorimetric assay (diazonium salt/diazonium ion with blank) on Hitachi CT-BG-CHEM- SOP-158 Serum C Reactive Protein (CRP) Particle-enhanced Immunoturbimetric assay on Hitachi CT-BG-CHEM-SOP-119 Serum C Reactive Protein (CRP), High Sensitive Particle-enhanced Immunoturbimetric assay on Hitachi CT-BG-CHEM-SOP-96 Serum Calcium Colorimetric assay (cresolphtalein complexone) on Hitachi CT-BG-CHEM-SOP-98 Serum Carbon Dioxide Liquid (Bicarbonate) Enzymatic assay (PEPC) on Hitachi CT-BG-CHEM-SOP-115 Serum Chloride Ion selective electrode on Hitachi / CT-BG-CHEM-SOP-97 Serum Cholesterol, Total Enzymatic colorimetric assay (cholesterol esterase and cholesterol oxidase) on Hitachi CT-BG-CHEM-SOP-101 Serum Cholesterol, High Density Lipoprotein (HDL) CT-BG-CHEM-SOP-161 Serum Cholesterol, Low Density Lipoprotein (LDL) Homogeneous enzymatic colorimetric assay (using PEG) on Hitachi Homogeneous Enzymatic colorimetric assay on Hitachi Bijlage/Annexe/Annex/Beilage BELAC 299-TEST V. 13-2/7
3 CT-BG-CHEM-SOP-156 Serum Complement C3c Immunoturbidimetric assay on Hitachi CT-BG-CHEM-SOP-157 Serum Complement C4 Immunoturbidimetric assay on Hitachi CT-BG-CHEM-SOP-71 Serum Creatine Kinase (CK), Total UV test (acc. to IFCC) on Hitachi CT-BG-CHEM-SOP-99 Serum Creatinine Enzymatic, colorimetric method based on the established determination of sarcosine after conversion of creatinine with the aid of creatininase, creatinase and sarcosine oxidase on Hitachi /cobas integra 400 for urine CT-BG-CHEM-SOP-152 Urine Creatinine Enzymatic, colorimetric method based on the established determination of sarcosine after conversion of creatinine with the aid of creatininase, creatinase and sarcosine oxidase on Hitachi /cobas integra 400 for CT-BG-CHEM-SOP-112 Serum Gamma Glutamyl Transpeptidase (GGT) urine Enzymatic colorimetric assay (acc. to SZASZ) on Hitachi CT-BG-CHEM-SOP-100 Serum Glucose UV test (Hexokinase) (standardized against ID-MS method) on Hitachi CT-BG-CHEM-SOP-170 Whole blood Hemoglobin A1C HPLC used for the separation and determination of normal and abnormal hemoglobin on a cat ion exchange cartridge on Variant II turbo CT-BG-CHEM-SOP-160 Serum Immunoglobulin A (IgA) Immunoturbidimetric on Hitachi CT-BG-IMMU-SOP-182 Serum Immunoglobulin E total (IgE) Chemiluminometric Immunoassay CT-BG-CHEM-SOP-160 Serum Immunoglobulin G (IgG) Immunoturbidimetric on Hitachi CT-BG-CHEM-SOP-160 Serum Immunoglobulin M (IgM) Immunoturbidimetric on Hitachi CT-BG-CHEM-SOP-102 Serum Iron Colorimetric assay (based on the Ferrozine method without deproteinization) on Hitachi Bijlage/Annexe/Annex/Beilage BELAC 299-TEST V. 13-3/7
4 CT-BG-CHEM-SOP-110 Serum Lactate Dehydrogenase (LDH) UV assay (acc. to IFCC) on Hitachi CT-BG-CHEM-SOP-92 Serum Lipase Enzymatic colorimetric assay (with methylresorufin) on Hitachi CT-BG-CHEM-SOP-103 Serum Magnesium Colorimetric assay (color dyexylidyl magone) on Hitachi CT-BG-CHEM-SOP-148 Urine Microalbumin Immunoturbidimetric assay on Cobas Integra 400 CT-BG-CHEM-SOP-109 Serum Phosphorus (Inorganic phosphate) Colorimetric (phosphomolybdate UV) on Hitachi CT-BG-CHEM-SOP-115 Serum Potassium Ion selective electrode on Hitachi CT-BG-IMMU-SOP-283 Serum Prostate Specific Antigen ECLIA on Roche Cobas e602 (PSA) CT-BG-IMMU-SOP-117 Serum Protein fractions by electrophoresis Serum protein electrophoresis on Sebia Hydrasis CT-BG-CHEM-SOP-108 Serum Protein, Total Colorimetric assay (Biuret) on Hitachi CT-BG-CHEM-SOP-149 Urine Protein Total Quantitative Colorimetric on Cobas Integra 400 CT-BG-CHEM-SOP-115 Serum Sodium Ion selective electrode on Hitachi CT-BG-CHEM-SOP-163 Serum Transferrin Immunoturbidimetric on Hitachi CT-BG-CHEM-SOP-105 Serum Triglycerides Enzymatic, colorimetric on Hitachi. Enzymatic glycerol phosphate oxidase with glycerol blank without serum blank. CT-BG-CHEM-SOP-107 Serum Urea, Urea Nitrogen (BUN) Kinetic UV test on Hitachi. Urease with GLDH CT-BG-CHEM-SOP-106 Serum Uric Acid Enzymatic colorimetric on Hitachi (uricase) CT-BG-HEMA-SOP-14 Urine Urinalysis (specific gravity, Colorimetric on Clinitek Atlas ph, nitrite, glucose, protein, bilirubin, ketone, leukocyte esterase, occult blood, urobilinogen) CT-BG-HEMA-SOP-15 Urine Urine sediment Microscopic analysis Bijlage/Annexe/Annex/Beilage BELAC 299-TEST V. 13-4/7
5 Haematology, Immuno-Haematology and Coagulation CT-BG-HEMA-SOP-19 Whole blood Complete Blood Count (CBC): hemoglobin, hematocrit, MCH, MCHC, MCV, platelets, red blood cells (RBC), white blood cells (WBC) CT-BG-HEMA-SOP-19 Whole blood Manual WBC differential: basophils, eosinophils, lymphocytes, monocytes, neutrophils, abnormal cells, red blood cells and platelets morphology CT-BG-HEMA-SOP-19 Whole blood WBC Differential: basophils, eosinophils, lymphocytes, monocytes, neutrophils Hemoglobin via cyanmethemoglobin on Beckman Coulter LH 750. Other via impedance counting, VCS technology (individual cell volume, high frequency conductivity, laser light scatter) on Beckman Coulter LH750 Microscopic examination Impedance counting, VCS technology (individual cell volume, high frequency conductivity, laser light scatter) on Beckman Coulter LH750 CT-BG-HEMA-SOP-19 Whole blood Reticulocytes Impedance counting, VCS technology (individual cell volume, high frequency conductivity, laser light scatter) on Beckman Coulter LH750 CT-BW-FLOW-SOP-19 Whole Blood CD3 pan-t lymphocytes lymphocyte population) CT-BW-FLOW-SOP-19 Whole Blood CD3 pan-t lymphocytes lymphocyte population) CT-BW-FLOW-SOP-19 Whole Blood CD8 suppressor/cytotoxic T lymphocytes (Absolute and % of total lymphocyte population) CT-BW-FLOW-SOP-19 Whole Blood CD19 B-cells lymphocytes lymphocyte population) Bijlage/Annexe/Annex/Beilage BELAC 299-TEST V. 13-5/7
6 CT-BW-FLOW-SOP-19 Whole Blood CD16/56 Natural killer Lymphocytes (Absolute and % of total lymphocyte population) CT-BW-FLOW-SOP-38 Whole Blood CD34 progenitor cells lymphocytes population) CT-BG-HEMA-SOP-24 CT-BG-HEMA-SOP-24 Hormonology Na citrate Plasma Na citrate Plasma Activated Partial Thromboplastin time (APTT) Protrombine time (PT) Sample preparation followed by antibody staining and acquisition on Facs Calibur flow. Absolutes obtained by double platform (Hematology-analyzer and Flow ). Clotting time based assay on diagnostica stago STA COMPACT Clotting time based assay on diagnostica stago STA COMPACT CT-BG-IMMU-SOP-235 Serum FSH (follicle stimulating hormone) Chemiluminometric Immunoassay CT-BG-IMMU-SOP-239 Serum Human Growth Hormone (HGH) Chemiluminometric Immunoassay on Immulite 2000 CT-BG-IMMU-SOP-282 Serum HCG ECLIA on Roche Cobas e602 CT-BG-IMMU-SOP-297 Serum Insulin ECLIA on Roche Cobas e602 CT-BG-IMMU-SOP-184 Serum Luteinizing hormone (LH) Chemiluminometric Immunoassay CT-BG-IMMU-SOP-236 Serum Prolactin Chemiluminometric Immunoassay CT-BG-IMMU-SOP-278 Serum Testosterone ECLIA on Roche Cobas e602 CT-BG-IMMU-SOP-277 Serum Thyroid Stimulating ECLIA on Roche Cobas e602 Hormone (TSH) CT-BG-IMMU-SOP-176 Serum Thyroxine (T4), Total Chemiluminometric Immunoassay CT-BG-IMMU-SOP-292 Serum FT4 ECLIA on Roche Cobas e602 CT-BG-IMMU-SOP-177 Serum Tri-iodothyronine (T3) Chemiluminometric Immunoassay CT-BG-IMMU-SOP-293 Serum Tri-iodothyronine free (FT3) ECLIA on Roche Cobas e602 Bijlage/Annexe/Annex/Beilage BELAC 299-TEST V. 13-6/7
7 Infectious Serology CT-BG-IMMU-SOP-201 Serum Hepatitis A antibodies, Total (HAVAB) CT-BG-IMMU-SOP-202 Serum Hepatitis A IgM antibodies (IgM anti-hav) CT-BG-IMMU-SOP-203 Serum Hepatitis B surface antigen (HBsAg) CT-BG-IMMU-SOP-204 Serum Hepatitis B surface antigen (HBsAg) confirmation test CT-BG-IMMU-SOP-208 Serum Antibodies to Hepatitis B surface antigenrecombinant (AUSAB) CT-BG-IMMU-SOP-206 Serum Hepatitis B core antibodies, Total CT-BG-IMMU-SOP-207 Serum Hepatitis B core IgM antibodies (HBcAb-IgM) CT-BG-IMMU-SOP-205 Serum Hepatitis C Virus (HCV) antibodies CT-BG-IMMU-SOP-209 Serum HIV1/2 go antibodies Bijlage/Annexe/Annex/Beilage BELAC 299-TEST V. 13-7/7
Bureau of Laboratory Quality Standards Page 1 of 13
Clinical Chemistry 1. Lithium Heparin Plasma Glucose Glucose Hexokinase : Cobas c6000,c8000 2. Lithium Heparin Plasma BUN Urease,Kinetic : Cobas c6000,c8000 3. Lithium Heparin Plasma Creatinine Enzymatic
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Acetone Negative titer Alanine aminotransferase (ALT/SGPT) 10-49 U/L Albumin 3.2-4.8 g/dl Alcohol < 10 Alpha-fetoprotein (AFP) < 1.3-8.1 ng/ml Alkaline phosphatase 0 7 days 7 30 days 1 3 3 6 6 12 1 3 3
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TEST LIST SAMPLE REQUIREMENT. 1 ml serum None
ALBUMIN TEST NAME ALKALINE PHOSPHATASE ALLERGY PROFILE, FOOD 30 allergens ALLERGY PROFILE, INHALANT 30 Allergens ALT AMYLASE ANA ANTI- TG ANTI-GLIADIN IGG ANTI-GLIADIN IGA ANTI-HBS ANTI-HCV ANTI-TPO APOLIPOPROTEIN
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ATRYP Antitrypsin alpha 1 ERM-DA470k/IFCC 9 136 1.36 1.84 0.0184 GPROT Acid glycoprotein alpha 1 CRM 470 2 90.1 0.901 0.890 0.00890 ACP Acid phosphatase total 1-naphthyl phosphate 0.720 43.1 0.00703 0.421
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