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 11 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-93 Serum Amylase-P (pancreatic) Enzymatic colorimetric assay (with p- nitrophenol) on Hitachi CT-BG-CHEM-SOP-154 Serum Apolipoprotein A-1 Immunoturbidimetric assay on Hitachi CT-BG-CHEM-SOP-155 Serum Apolipoprotein B Immunoturbidimetric assay 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-222 Serum B-Type Natriuretic peptide (BNP) Sandwich chemiluminescent Immunoassay on CT-BG-IMMU-SOP-172 Serum Beta2-Microglobulin Chemiluminescent immunometric assay on Immulite 2000 Bijlage/Annexe/Annex/Beilage BELAC 299-TEST V. 11-2/14

3 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. 11-3/14

4 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-IMMU-SOP-228 Serum Creatine Kinase Isoenzymes: MM, MB, Electrophoresis on Sebia Hydrasis BB (ISO-CK) CT-BG-IMMU-SOP-276 Serum CKMB ECLIA on Roche Cobas e602 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 urine Bijlage/Annexe/Annex/Beilage BELAC 299-TEST V. 11-4/14

5 CT-BG-IMMU-SOP-238 Serum Ferritin Chemiluminometric Immunoassay on CT-BG-IMMU-SOP-179 Serum Folic acid Chemiluminometric Immunoassay on CT-BG-CHEM-SOP-112 Serum Gamma Glutamyl Transpeptidase (GGT) 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 on 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-IMMU-SOP-306 Serum Interleukin-6 (IL-6) ECLIA on Roche Cobas 8000 e602 Bijlage/Annexe/Annex/Beilage BELAC 299-TEST V. 11-5/14

6 CT-BG-CHEM-SOP-102 Serum Iron Colorimetric assay (based on the Ferrozine method without deproteinization) on Hitachi 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 dye-xylidyl 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 (PSA) ECLIA on Roche Cobas e602 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 Bijlage/Annexe/Annex/Beilage BELAC 299-TEST V. 11-6/14

7 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-121 Serum Unsaturated Iron binding Capacity (UIBC) Direct determination with ferrozine on Hitachi 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, ph, nitrite, Colorimetric on Clinitek Atlas glucose, protein, bilirubin, ketone, leukocyte esterase, occult blood, urobilinogen) CT-BG-HEMA-SOP-15 Urine Urine sediment Microscopic analysis CT-BG-IMMU-SOP-234 Serum Vitamine B12 Chemiluminometric Immunoassay on Bijlage/Annexe/Annex/Beilage BELAC 299-TEST V. 11-7/14

8 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) 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 CT-BG-HEMA-SOP-19 Whole blood Manual WBC differential: basophils, eosinophils, lymphocytes, monocytes, neutrophils, abnormal cells, red blood cells and platelets morphology Microscopic examination CT-BG-HEMA-SOP-19 Whole blood WBC Differential: basophils, eosinophils, lymphocytes, monocytes, neutrophils Impedance counting, VCS technology (individual cell volume, high frequency conductivity, laser light scatter) on Beckman Coulter LH750 Bijlage/Annexe/Annex/Beilage BELAC 299-TEST V. 11-8/14

9 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 (Absolute and % of total lymphocyte population) CT-BW-FLOW-SOP-19 Whole Blood CD4 helper/inducer T lymphocytes (Absolute and % of total 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 (Absolute and % of total lymphocyte population) CT-BW-FLOW-SOP-19 Whole Blood CD16/56 Natural killerlymphocytes (Absolute and % of total lymphocyte population) Beckman Dickinson Trucount method on Facs Calibur flow cytometer Beckman Dickinson Trucount method on Facs Calibur flow cytometer Beckman Dickinson Trucount method on Facs Calibur flow cytometer Beckman Dickinson Trucount method on Facs Calibur flow cytometer Beckman DickinsonTrucount method on Facs Calibur flow cytometer Bijlage/Annexe/Annex/Beilage BELAC 299-TEST V. 11-9/14

10 CT-BW-FLOW-SOP-38 Whole Blood CD34 progenitor cells (Absolute and % of total lymphocytes population) Sample preparation followed by antibody staining and acquisition on Facs Calibur flow cytometer. Absolutes obtained by double platform (Hematology-analyzer and Flow cytometer). Clotting time based assay on diagnostica stago STA COMPACT CT-BG-HEMA-SOP-24 Na citrate Plasma Activated Partial Thromboplastin time (APTT) CT-BG-HEMA-SOP-24 Na citrate Plasma Fibrinogen Clotting time based assay on diagnostica stago STA COMPACT CT-BG-HEMA-SOP-24 Na citrate Plasma Protrombine time (PT) Clotting time based assay on diagnostica stago STA COMPACT Bijlage/Annexe/Annex/Beilage BELAC 299-TEST V /14

11 Hormonology CT-BG-IMMU-SOP-235 Serum FSH (follicle stimulating hormone) Chemiluminometric Immunoassay on 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 on CT-BG-IMMU-SOP-236 Serum Prolactin Chemiluminometric Immunoassay on CT-BG-IMMU-SOP-278 Serum Testosterone ECLIA on Roche Cobas e602 CT-BG-IMMU-SOP-277 Serum Thyroid Stimulating Hormone (TSH) ECLIA on Roche Cobas e602 CT-BG-IMMU-SOP-176 Serum Thyroxine (T4), Total Chemiluminometric Immunoassay on CT-BG-IMMU-SOP-292 Serum FT4 ECLIA on Roche Cobas e602 CT-BG-IMMU-SOP-177 Serum Tri-iodothyronine (T3) Chemiluminometric Immunoassay on CT-BG-IMMU-SOP-293 Serum Tri-iodothyronine free (FT3) ECLIA on Roche Cobas e602 Bijlage/Annexe/Annex/Beilage BELAC 299-TEST V /14

12 Infectious Serology CT-BG-IMMU-SOP-195 Serum Cytomegalo virus (CMV) IgG Enzyme labeled chemiluminescent immunoassay on Immulite 2000 CT-BG-IMMU-SOP-195 Serum Cytomegalo virus (CMV) IgM Enzyme labeled chemiluminescent immunoassay on Immulite 2000 CT-BG-IMMU-SOP-201 Serum Hepatitis A antibodies, Total (HAVAB) Chemiluminescent Immunoassay on CT-BG-IMMU-SOP-202 Serum Hepatitis A IgM antibodies (IgM anti- HAV) Chemiluminescent Immunoassay on CT-BG-IMMU-SOP-203 Serum Hepatitis B surface antigen (HBsAg) Chemiluminescent Immunoassay on CT-BG-IMMU-SOP-204 Serum Hepatitis B surface antigen (HBsAg) confirmation test Chemiluminescent Immunoassay on CT-BG-IMMU-SOP-208 Serum Antibodies to Hepatitis B surface antigen-recombinant (AUSAB) Chemiluminescent Immunoassay on CT-BG-IMMU-SOP-206 Serum Hepatitis B core antibodies, Total Chemiluminescent Immunoassay on CT-BG-IMMU-SOP-207 Serum Hepatitis B core IgM antibodies (HBcAb-IgM) Chemiluminescent Immunoassay on CT-BG-IMMU-SOP-205 Serum Hepatitis C Virus (HCV) antibodies Chemiluminescent Immunoassay on CT-BG-IMMU-SOP-209 Serum HIV1/2 go antibodies Chemiluminescent Immunoassay on Bijlage/Annexe/Annex/Beilage BELAC 299-TEST V /14

13 Non-Infectious serology CT-BG-HEMA-SOP-22 Serum Antinuclear auto-antibodies (ANA) Fluoresence microscopy with Axiolab CT-BG-IMMU-SOP-196 Serum Anti-ds-DNA auto-antibodies Immunofluorescence assay on the Athena Multi-Lyte instrument CT-BG-IMMU-SOP-125 Serum Antithyroid peroxidase autoantibodies Enzyme labeled chemiluminescent (Anti-TPO Ab) immunoassay on Immulite 1 CT-BG-IMMU-SOP-303 Serum Anti-CCP ECLIA on Roche Cobas e602 CT-BG-CHEM-SOP-162 Serum Rheumatoid Arthritis factor (RF) Immunoturbidimetric on Hitachi Mudular Toxicology CT-BG-CHEM-SOP-145 Urine Amphetamines Kinetic Interaction of micro-particles in a solution (KIMS) on Cobas Integra 400 CT-BG-CHEM-SOP-145 Urine Barbiturates Kinetic Interaction of micro-particles in a solution (KIMS) on Cobas Integra 400 CT-BG-CHEM-SOP-145 Urine Benzodiazepines Kinetic Interaction of micro-particles in a solution (KIMS) on Cobas Integra 400 CT-BG-CHEM-SOP-145 Urine Cannabinoids Kinetic Interaction of micro-particles in a solution (KIMS) on Cobas Integra 400 Bijlage/Annexe/Annex/Beilage BELAC 299-TEST V /14

14 CT-BG-CHEM-SOP-145 Urine Cocaine Kinetic Interaction of micro-particles in a solution (KIMS) on Cobas Integra 400 CT-BG-CHEM-SOP-145 Urine Methadone Kinetic Interaction of micro-particles in a solution (KIMS) on Cobas Integra 400 CT-BG-CHEM-SOP-145 Urine Opiates Kinetic Interaction of micro-particles in a solution (KIMS) on Cobas Integra 400 Bijlage/Annexe/Annex/Beilage BELAC 299-TEST V /14

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