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:- LANCET LABORATORIES HEAD OFFICE LABORATORY Co reg no: 1996/006/950/07 Practice no: Facility Accreditation Number: M0025D is a South African National Accreditation System accredited laboratory provided that all SANAS 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 AND ENDOCRINOLOGY The facility is accredited in accordance with the recognised International Standard ISO/IEC 17025:2005 This accreditation demonstrates technical competency for a defined scope and the operation of a laboratory quality management system While this certificate remains valid, the Accredited Facility named above is authorised to use the relevant SANAS accreditation symbol to issue facility reports and/or certificates Mr R Josias Chief Executive Officer Effective Date: 27 January 2011 Certificate Expires: 31 January 2012
2 S C H E D U L E O F A C C R E D I T A T I O N Testing Laboratory Number: M0025D Permanent Address of Laboratory: Lancet Laboratories Cnr. Stanley & Menton Roads Richmond Johannesburg 2092 Postal Address: P O Box 8475 Johannesburg 2000 Tel : (011) Fax : (011) Signatories: Signatories as authorised by the Head of Laboratory Contact Person: Ms M de Wet Issue No. Date of issue Expiry date : 07 : 02 February 2011 : 31 January 2012 Serum Alanine Aminotransferase (ALT) Architect C8000 Serum, Urine Albumin Architect C8000 Serum Aldolase Architect C8000 Serum Alkaline Phosphatase (ALP) Architect C8000 Serum Alpha-1-Antitrypsin BN Prospec Serum Amikacin Integra Whole Blood Ammonium Integra Urine Ammonium Chloride Load Test Manual Urine Amphetamines Integra Serum, Urine Amylase Architect C8000 Serum Angiotensin-Converting Enzyme (ACE) Integra Serum Antistreptolysin O titre (ASOT) BN Prospec Serum Apolipoprotein (a) Architect C8000 Serum Apolipoprotein A Architect C8000 Serum Apolipoprotein B Architect C8000 Serum Aspartate Aminotransferase (AST) Architect C8000 Serum, Urine Barbiturates Integra Serum, Urine Benzodiazepine Integra CSF Beta Trace Protein (βtp) BN Prospec Urine Bile Pigments Manual Serum Bilirubin, Direct Architect C8000 Serum Bilirubin, Total Architect C8000 Serum Bicarbonate (CO2) (Total) Architect C8000 Serum C1 Estrase BN Prospec Serum Caeruloplasmin BN Prospec Serum, Urine Calcium (Total) Architect C8000 Urine Cannabinoids Integra Serum Carbamazepine Integra Serum, Urine Chloride Architect C8000 Serum Cholesterol (Total) Architect C8000 Whole Blood, Serum Cholinesterase Architect C8000 Urine Citrate Manual Original date of accreditation: 01 February 2000 Page 1 of 4
3 Date of issue 02 February 2011 Urine Cocaine Integra Serum Complement C3 Architect C8000 Serum Complement C4 Architect C8000 Serum C-Reactive Protein (CRP) Architect C8000 Serum C-Reactive Protein (CRP) Ultra Sensitive Architect C8000 Serum Creatine Kinase (CK) Architect C8000 Serum Creatine Kinase MB Mass (CKMB Mass) Mini Vidas Serum, Urine Creatinine Architect C8000 Serum Cryogloblin Manual Whole Blood Cyclosporin Integra Urine Cystine Manual Serum Deoxyribonuclease (Dnase) BN Prospec Serum Digoxin Integra Serum Ethanol Integra Watery Stool Faecal Osmolal Gap Manual Serum Ferritin Architect C8000 Serum Gamma Glutamyl Transferase (GGT) Architect C8000 Serum Gentamycin Integra Serum Glucose Architect C8000 Whole Blood Glucose-6-Phosphate Dehydrogenase (G-6-PD) Manual Serum Haptoglobin BN Prospec Whole Blood HbA1c Bio-Rad Variant CSF IgG Index BN Prospec Serum IgG Subclasses BN Prospec Serum, Urine Immunofixation Electrophoresis (IFE) Hydrases Isofocusing Serum Immunofixation Electrophoresis (IFE) Minicap Serum Immunoglobulin A (IgA) Architect C8000 Serum Immunoglobulin M (IgM) Architect C8000 Serum Immunoglobulin G (IgG) Architect C8000 Serum Iron Architect C8000 CSF Isofocusing Hydrases Isofocusing Serum Kappa BN Prospec Ammonitic Fluid L/S Ratio Manual Plasma Lactate Integra Serum Lactate Dehydrogenase (LDH) Architect C8000 Serum Lambda BN Prospec Serum Lithium Integra Serum, Urine Magnesium Architect C8000 Urine Methadone Integra Serum, Whole Blood Methaemalbumin Manual Urine Methaqualone Integra Urine Myoglobin Cardiac Reader Serum Opiates Integra Ammonitic Fluid Optical Density (OD450) Manual Serum, Urine, Stool Osmolality Osmometer Urine Oxalate Manual Serum Paracetamol Integra Original date of accreditation: 01 February 2000 Page 2 of 4
4 Date of issue: 02 February 2011 Urine Phencyclidine Integra Serum Phenobarbital Integra Serum Phenytoin Integra Serum, Urine Phosphate Architect C8000 Urine, Whole Blood Porphyrin Screen Manual Serum, Stool Potassium Architect C8000 Serum Prealbumin BN Prospec Serum Procalcitonin (PCT) Mini Vidas Urine Propoxyphene Integra CSF, Urine Protein Architect C8000 Serum Protein (Total) Architect C 8000 Serum Protein Eletrophorisis Minicap CSF Protein Eletrophorisis Hydrases Isofocusing Whole Blood Pyruvate Manual Urine, Stool Reducing Substances Manual Serum Rheumatoid Factor (RF) Architect C8000 Serum Salicylate Integra Serum, Stool Sodium Architect C8000 Serum Soluble Transferrin Receptor Integra Stool Stercobilinogen Manual Serum Theophylline Integra Serum Tobramycin Integra Serum Transferrin Architect C8000 Serum Tricyclic Antidepressants (TAD) Architect I 2000 Serum Triglycerides Architect C8000 Whole Blood Troponin T (Semi Quantitative) Cardiac Reader Serum, Urine Urate Architect C8000 Serum, Urine Urea Architect C8000 Urine Urine Dipstick Manual Serum Valproic Acid Integra Serum Vancomycin Integra ENDOCRINOLOGY Serum Adrenocorticotrophic Hormone (ACTH) Immulite 2000 Serum Aldosterone Immulite 2000 Amniotic Fluid Alpha Feto-Protein (AFP) Immulite 2000 / Kryptor Serum Alpha Feto-Protein (AFP) Immulite 2000 / Architect Serum Anti Thyroglobulin-Antibodies (ATG) Architect I 2000 Serum Anti-TPO Antibodies Architect I 2000 Serum C-Peptide Immulite 2000 Serum CA 125 Architect I 2000 Serum CA 153 Architect I 2000 Serum CA 19.9 Architect I 2000 Serum Carcinoembryonic Antigen (CEA) Architect I 2000 Serum Cotinine Architect I 2000 Serum Cortisol Architect I 2000 Original date of accreditation: 01 February 2000 Page 3 of 4
5 ENDOCRINOLOGY Serum Dehydroepiandrosterone Sulphate (DHEAS) Immulite 2000 Serum Eosinophil Cationic Protein (ECP) Unicap Serum Estradiol (E2) Architect I 2000 Serum Folate Architect I 2000 Serum Follicle Stimulating Hormone (FSH) Architect I 2000 Serum Free Thyroxine (F-T4) Architect I 2000 Serum Free Triiodothyronine (F-T3) Architect I 2000 Serum Growth Hormone Immulite 2000 Serum HCG-Free Kryptor Serum HCG-Total Architect I 2000 Plasma Homocysteine Architect I 2000 Serum Human Chorionic Gonadotropin (hcg) Immulite 2000 Serum IgF1 Immulite 2000 Serum Immunoglobulin E (IgE) Unicap 1000 Serum Insulin Architect I 2000 Serum Luteinising Hormone (LH) Architect I 2000 Serum Oestriol (E3) Immulite 2000 Serum Parathyroid Hormone (PTH) Architect I 2000 Serum Plasma Protein A (PAPP-A) Kryptor Serum Progesterone Architect I 2000 Serum Prolactin Architect I 2000 Serum Prostate Specific Antigen (PSA) Architect I 2000 Serum Prostate Specific Antigen (PSA-Free) Architect I 2000 Serum RAST Allergy Test Unicap 1000 Serum Sex Hormone Binding Globulin (SHGB) Immulite 2000 Whole Blood Sirolimus Architect I 2000 Whole Blood Tacrolimus Architect I 2000 Serum Testosterone (Total) Immulite 2000 Serum Thyroglobulin Immulite 2000 Serum Thyroid Stimulating Hormone (TSH) Architect I 2000 Serum Vitamin B12 Architect I 2000 Date of issue: 02 February 2011 Original date of accreditation: 01 February 2000 Page 4 of 4 ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM
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