CERTIFICATE OF ACCREDITATION

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Oswin Jacobs
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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:- NATIONAL HEALTH LABORATORY SERVICE (NHLS) NATIONAL INSTITUTE FOR COMMUNICABLE DISEASES (NICD) CLINICAL DIAGNOSTIC UNIT Practice no: PR Facility Accreditation Number: M0029A 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 VIROLOGY The facility is accredited in accordance with the recognised International Standard ISO 15189:2007 The 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: 01 June 2008 Certificate Expires: 31 May 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: M0029A Permanent Address of Laboratory: National Health Laboratory Service (NHLS) National Institute for Communicable Diseases (NICD) Clinical Diagnostic Unit 1 Modderfontein Road Sandringham Johannesburg 2138 Postal Address: Private Bag X 4 Sandringham 2138 Tel : (011) Fax : (011) Signatories: Signatories as authorised by the Head of Laboratory Contact Person: Ms K Fitchet Issue No. Date of issue Expiry date : 13 : 30 May 2011 : 31 May 2012 DIAGNOSTIC VIROLOGY Serum, Plasma Herpes Simplex Virus Type 2 (HSV-2) IgG Antibody Human Immunodeficiency Virus Type 1 and 2 (HIV- 1/2) Total Antibody HIV p24 Antigen Vironostika HIV-1 Antigen Measles Virus IgG and IgM Antibody Rubella Virus IgG and IgM Antibody Rubella Virus IgG Antibody Avidity Calypte HIV-1 BED Incidence EIA Hamilton Microlab AT+2 Dilutor Hamilton Microlab AT+2 Dilutor IMMUNOBLOTTING TECHNIQUES Serum, Plasma Human Immunodeficiency Virus Type 1 and 2 HIV-1 and HIV-2 Western Blot Original date of accreditation: 01 June 2000 Page 1 of 3

3 Laboratory No: M0029A Date of issue: 30 May 2011 Expiry date: 31 May 2012 VIRUS ISOLATION AND DETECTION TECHNIQUES Stool, Rectal Swab, Urine, Sputum, Throat Swab, Gargle, Cerebrospinal, Corneal Scraping/Eye Swab, Genital Secretion, Biopsy/Autopsy Material, Tears, BAL, Aspirates, Bronchial Washings Urine, Sputum, Throat Swab, Gargle, Genital Secretions, Saliva, Breast Milk, Biopsy/Autopsy Material, Tears, BAL Leucocytes, Stool, Rectal Swabs, Cerebrospinal, Nasopharyngeal and Aspirates Bronchial Washings Cerebrospinal, Skin/Lesion Swab, Saliva, Genital Secretion, Biopsy/Autopsy Material, Smears, Tissue Culture, Vesicle/Blister Adenovirus Isolation in Tissue Culture and Cytomegalovirus Isolation in Tissue Culture and Herpes Simplex Virus Isolation in Tissue Culture and Influenza Virus Type A, B Isolation in Tissue Culture and Influenza Virus Isolation Type A, B in Technique: Shell Vial / Cytospin Technique: Shell Vial / Cytospin CMV pp65 Antigen Technique: Embryonated Eggs HAI Mumps Virus Isolation in Tissue Culture and Measles Virus isolation in Tissue Culture and Parainfluenza Virus Type I, II, III Isolation in Tissue Culture and Original date of accreditation: 01 June 2000 Page 2 of 3

4 Laboratory No: M0029A Date of issue: 30 May 2011 Expiry date: 31 May 2012 VIRUS ISOLATION AND DETECTION TECHNIQUES (CONTINUED) Stool, Rectal Swab, Respiratory Polio Virus Type 1-3 Isolation in Tissue Virus Neutralization Technique Samples, Cerebrospinal Culture and Equipment: Light or Inverted Centrifuge Mechanical Shaker Incubator Vesicle, Skin/Lesion Swab, Biopsy/Autopsy Material, Tissue Culture, Aspirate Respiratory Syncytial Virus Isolation in Tissue Culture and Varicella Zoster Virus Isolation in Tissue Culture and VIRUS AND ANTIBODY NEUTRALISATION ASSAYS Serum, Plasma Polio Virus Type 1-3 Antibody Neutralisation Antibody Neutralisation Assay HAEMAGGLUTINATION / HAEMAGGLUTINATION INHIBITION ASSAYS Influenza Virus Type A, B Isolation Technique: HAI Serum, Plasma Influenza Virus Type A, B Antibody Technique: HAI RAPID PLASMA REAGIN FLOCCULATION ASSAY Serum, Plasma Syphilis Reagin Antibodies Test Rapid plasma Flocculation OTHER TESTS Dried Blood Spot, Dried Serum Spot Clinical Samples and Cultured Isolates Dried Blood Spot / Dried Serum Spot Collection and Elution Transmission Electon Microscopy Negative Staining Spot Test Manual -Transmission Electron Original date of accreditation: 01 June 2000 Page 3 of 3 ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM

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),