CERTIFICATE OF ACCREDITATION
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1 CERTIFICATE OF ACCREDITATION In terms of section 22(2) (b) of the Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act, 2006 (Act 19 of 2006), read with sections 23(1), (2) and (3) of the said Act, I hereby certify that:- VERMAAK AND PARTNERS INC Co. Reg. No.: 2001/007762/21 Practice No.: EUGENE MARAIS LABORATORY Facility Accreditation Number: M0251 is a South African National Accreditation System accredited facility provided that all conditions and requirements are complied with This certificate is valid as per the scope as stated in the accompanying schedule of accreditation, Annexure A, bearing the above accreditation number for MEDICAL TESTING LABORATORY CHEMISTRY, ENDOCRINOLOGY, HAEMATOLOGY, IMMUNOLOGY AND SEROLOGY The facility is accredited in accordance with the recognised International Standard ISO 15189:2012 The accreditation demonstrates technical competency for a defined scope and the operation of a quality management system While this certificate remains valid, the accredited facility named above is authorised to use the relevant accreditation symbol to issue facility reports and/or certificates Mr R Josias Chief Executive Officer Effective Date: 04 June 2015 Certificate Expires: 30 May 2019
2 ANNEXURE A SCHEDULE OF ACCREDITATION Facility Number: M0251 Permanent Address of Laboratory: Vermaak & Partners Inc. Signatories: Signatories as authorised by the Head of Laboratory Eugene Marais Laboratory 663 Keet Avenue Les Marais Pretoria 0182 Postal Address: P O Box Contact Person: Dr K Mostert Lynnwood Ridge 0040 Tel: (012) Issue No.: 13 Fax: Date of Issue: 04 May Kmostert@vpath.co.za Expiry Date: 30 May 2019 Discipline / Sample Type Type of Tests Equipment / Method Chemistry 25 (OH) Vitamin D Euroimmun Analyzer 1 Acetaminophen DxC 800, Plasma Adrenocorticotrophic Hormone (ACTH) Immulite 2000, CSF Adenosine Deaminase (ADA) DxC 800 Alanine Aminotransferase (ALT) DxC 800 Albumin DxC 800 Urine Albumin (Micro) Immage 800 CSF Albumin (Micro) c501 Aldosterone Diasorin Liason Alkaline Phosphatase (ALP) DxC 800 Amikacin DxC 800 Plasma Ammonium DxC 800 Urine Amphetamines Manual Method, Urine Amylase DxC 800 Aspartate Aminotransferase (AST) DxC 800 Urine Barbiturates Manual Method Urine Benzodiazepine Manual Method Beta Human Chorionic Gonadotrophin (βhcg) Downs Screening Beta Human Chorionic Gonadotrophin (βhcg) Quantitative Immulite 2000 e411 Page 1 of 6
3 Beta-2-microglobulin Immulite 2000 Bicarbonate (CO2) Total DxC 800 Bilirubin, Direct DxC 800 Bilirubin, Total DxC 800, Urine Calcium DxC 800, Urine, CSF Chloride DxC 800 Cholesterol (HDL) DxC 800 Cholesterol (LDL) Measured DxC 800 Cholesterol (Total) DxC 800 Cholinesterase DxC 800 Urine Cocaine Manual Method Cotinine Immulite 2000 Complement C3 c501 Complement C4 c501 C-Reactive Protein (CRP) DxC 800 Creatine Kinase (CK) DxC 800 Creatine Kinase MB (CKMB) e411, Urine Creatinine DxC 800 Ferritin e601 Gamma Glutamyl Transferase (GGT) DxC 800, Plasma, CSF Glucose DxC 800 Haptoglobin Immage Whole Blood HbA1c G8 HE4 e601 Iron DxC 800 IgG Subclasses Immage, Pleural Fluid, Peritoneal Fluid, Abdominal/Drain Fluid Lactate Dehydrogenase (LDH) DxC 800 Lipase DxC 800 Magnesium DxC 800 Urine Marijuana Manual Method Urine Methadone Manual Method Plasma Meta+normetanephrine Manual Method Urine Methamphetamines Manual Method Stool Occult Blood Manual Method, Urine Osmolality Osmometer Urine ph Manual Method Phosphate DxC 800, Urine Potassium DxC 800 Urine, CSF Protein (Micro) DxC 800 Protein (Total) DxC 800 Page 2 of 6
4 , Urine Sodium DxC 800 Triglycerides DxC 800 Urine Trypsinogen-3 Manual Method, Urine Urate DxC 800, Urine Urea DxC 800 Urine Urine Dipstick Combur Endocrinology Alpha Feto-protein (AFP) Immulite CA 125 e601 CA 15.3 e601 CA 19.9 e601 Carcinoembryonic Antigen (CEA) e601 Cortisol e601 Saliva Cortisol Luminescence C-Peptide Immulite Dehydroepiandrosterone Sulphate (DHEAS) Immulite Digoxin Immulite Estradiol (E2) e601 Estriol Immulite 2000 Ethanol DXC 800, Whole Blood Folate e601 Follicle Stimulating Hormone (FSH) e601 Free Thyroxine (F-T4) e601 Free Triiodothyronine (F-T3) e601 Growth Hormone Immulite Plasma Homocysteine Architect Insulin e601 Lipoprotein (a) Immage Luteinising Hormone (LH) e601 Myoglobin e411 Urine Opiates Manual Method Plasma, Parathyroid Hormone (PTH) e601 Urine Phencyclidine (PCP) Manual Method Procalcitonin (PCT) e601 Pro Brain Natriuretic Peptide (probnp) e411 Progesterone e601 Prolactin e601 Prostate Specific Antigen (PSA) Free e601 Prostate Specific Antigen (PSA) Total e601 Plasma Renin Diasorin Liason Rheumatoid Factor Alegria Page 3 of 6
5 Salicylate DXC 800 Sex Hormone Binding Globulin (SHBG) e601 Thyroid Stimulating Hormone (TSH) e601 Testosterone e601 Transferrin DXC 800 Urine Tricyclic Antidepressants (TAD) Manual Method Troponin T (Quantitative) e411 Vitamin B12 e601 Haematology Plasma Activated Partial Thromboplastin Time (APTT) ACL Elite Pro Whole Blood Blood Group Diamed Plasma D-Dimer ACL Elite Pro EDTA Whole Blood Differential Cell Count Manual Method / HmX EDTA Whole Blood Direct Coombs Test Diamed Whole Blood Erythrocyte Sedimentation Rate (ESR) Roller Whole Blood Full Blood Count (FBC) HmX Plasma International Normalised Ratio (INR) ACL Elite Pro Whole Blood Malaria Antigens Manual Method Whole Blood Malaria Smears Manual Method Whole Blood Malaria QBC Manual Method EDTA Whole Blood Neonatal Blood Groups Diamed Infectious Serology Chlamydia Pneumoniae IgA, IgG, IgM Euroimmun Chlamydia Trachomatis IgG, IgM Euroimmun Analyzer 1 Helicobacter Pylori antibodies Immulite 2000 Mycoplasma Pneumoniae Antibodies Euroimmun Analyzer 1 Rapid Plasma Reagin (RPR) Agglutination Manual Method Rickettsia Conorii IFA Toxoplasma IgG Euroimmun Toxoplasma IgM Euroimmun Immunology Treponema Pallidum Haemagglutination (TPHA) Lateral Flow Allergen Specific Immunoglobulin E Immulite ANCA IFA Anti-Centromere B Alegria Anti Jo-1 (Histidyl-Trna Synthetase) Alegria Anti Nuclear Antibodies (ANA) IFA / Alegria Anti RNP (Small Nuclear Ribonucleoproteins) Alegria Anti SCL-70 Antibodies Alegria Page 4 of 6
6 Anti Sm Antibodies Alegria Anti SSA Antibodies Alegria Anti SSB Antibodies Alegria Anti-CCP (Anti-Cyclic Citrullinated Peptide Antibody) Euroimmun Anti-Thyroglobulin IgG Euroimmun Analyzer 1 Anti-Thyroid Peroxidase IgG Euroimmun Analyzer 1 Beta 2-Glycoprotein Screen Alegria Beta-2-Glycoprotein (IgA, IgG, IgM) Alegria Cardiolipin Antibodies (IgG, IgM, IgA) Alegria Cardiolipin Screen Alegria DNA IgG Antibodies Alegria Histone Antibodies Alegria CSF IgG e601 Immunoglobulin A (IgA) DXC 800 Immunoglobulin M (IgM) DXC 800 Immunoglobulin G (IgG) c501 Immunoglobulin E (IgE) - Total Immulite Intrinsic Factor Antibodies Alegria Liver and Kidney Antibodies IFA Mitochondrial Antibodies IFA Mitochondrial M2 Antibodies Alegria MPO Alegria Nucleosome Antibodies Alegria Parietal Cell Antibodies IFA Proteinase-3 Alegria Smooth Muscle Antibodies IFA TSH Receptor Antibodies Euroimmun Analyzer 1 Serology Plasma Chromogranin A Manual Method Cytomegalovirus (CMV) IgG Euroimmun Analyzer 1 Cytomegalovirus (CMV) IgM Euroimmun Analyzer 1 Epstein-Barr Virus (EBV) EA IgG Euroimmun Analyzer 1 Epstein-Barr Virus (EBV) IgG and IgM Euroimmun Analyzer 1 Epstein Barr Virus (EBV) EBNA (IgG) Euroimmun Analyzer 1 Hepatitis A IgG Antibodies (HAVAB) Architect Hepatitis A IgM Architect Hepatitis B Surface Antigen (HBsAg) Architect Hepatitis B Surface Antibody (AUSAB) Architect Hepatitis B Core Antibody Architect Hepatitis B Core IgM e601 Hepatitis B Early Antigen (HbE) e601 Page 5 of 6
7 Hepatitis B Early Antibody e601 Hepatitis C Architect Herpes Simplex Virus (HSV) IgM 1 and IgG 1 Euroimmun Analyzer 1 Herpes Simplex Virus (HSV) IgM 2 and IgG 2 Euroimmun Analyzer 1 HIV (HIV Antibody, Antigen Combination) Architect / e601 Measles IgG, IgM Euroimmun Analyzer 1 Mumps Virus Antibodies (IgG, IgM) Euroimmun Analyzer 1 Rubella IgG and IgM e601 Varicella Zoster Antibodies (IgM, IgG) Euroimmun Analyzer 1 Original Date of Accreditation: 28 February 2004 ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM Accreditation Manager Page 6 of 6
CERTIFICATE OF ACCREDITATION
CERTIFICATE OF ACCREDITATION In terms of section 22(2) (b) of the Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act, 2006 (Act 19 of 2006), read with sections 23(1),
CERTIFICATE OF ACCREDITATION
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CERTIFICATE OF ACCREDITATION
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CERTIFICATE OF ACCREDITATION
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CERTIFICATE OF ACCREDITATION
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