CERTIFICATE OF ACCREDITATION - PDF

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					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:-

PATHCARE GROUP
N1 REFERENCE, PCR LABORATORY Co. reg no: 1971/013873/21 Practice no: 5200539
Facility Accreditation Number:

M0001E

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 MOLECULAR BIOLOGY
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 Acting Chief Executive Officer Effective Date: Certificate Expires: 01 February 2008 31 January 2012

ANNEXURE A

SCHEDULE OF ACCREDITATION Testing Laboratory Number: M0001E

Permanent Address of Laboratory: PathCare Group PathCare Reference Laboratory PathCare Park Neels Bothma Street N1 City Goodwood 7460 Postal Address: Private Bag X107 N1 City Goodwood 7460

Signatories: Signatories as authorised by the Head of Laboratory

Contact Person: Ms J Wassüng

Tel : (021) 596-3549 Fax : (021) 596-3721 Discipline/ Sample Type PCR TESTING Plasma

Issue No. Date of issue Expiry date Types of Test

: 08 : 09 September 2009 : 31 January 2012 Equipment/ Method Manual Extraction / Automated Analyser Manual Method Automated-Abbott M2000 SP/RT Automated Extraction / Real-time Analysis Automated Extraction / Real-time Analysis Automated Extraction / Real-time Analysis Automated Extraction / Real-time Analysis Automated on the Roche AmpliPrep – Taqman & Abbott M2000 SP/RT Page 1 of 2

HIV-1 Monitor Quantitative PCR – Ultra Sensitive and Standard

Whole Blood Urine, Swab

HIV-1 DNA Qualitative Chlamydia Trachomatis / Neisseria Gonorrhoea Qualitative

Whole Blood

Detection of the Single Point Mutation ∆F508 patients with Cystic Fibrosis using the LightCycler Instruments Detection of a Single Point Mutation in Patients with Variegate Porphyria using the LightCycler Instrument Factor V Mutation Detection

Whole Blood

Whole Blood

Whole Blood

Factor II (Prothrombin)

Plasma

HIV Quantitative

Original date of accreditation: 01 April 2003

Field Manager

ANNEXURE A

Laboratory No: M0001E Date of issue: 09 September 2009 Expiry date: 31 January 2012
Discipline/ Sample Type PCR TESTING (CONTINUED) Whole Blood Whole Blood Whole Blood Sputum, Lavage Whole Blood, Urine, Serum, CSF CSF, Urine, Dry Swab, Vesicle Fluid Whole Blood, CSF Plasma Swab Swab Sputum, Culture Sputum, Culture Sputum, Culture Sputum, Culture Whole Blood Whole Blood Stool Whole Blood Whole Blood Whole Blood Whole Blood Whole Blood Serum, Whole Blood Sputum, Lavage Types of Test Equipment/ Method

Hereditary Haemachromatosis (HFE) HLA B27 HLS B5701 Pneumocystis jiroveci (PJP) Qualitative Cytomegalovirus (CMV) Quantitative Herpes Simplex Virus (HSV) – Type 1 & 2 Hepatitis B Virus (HBV) Quantitative HIV Resistance Human Papilloma Virus (HPV) High Risk Screen Human Papilloma Virus (HPV) Genotyping MTB1 TB Motts TB Identification Multi-Drug Resistant TB Hepatitis C Virus (HCV) Quantitative Hepatitis C Virus (HCV) Genotyping Clostridium Difficile (C.diff) Qualitative Malaria Screen Malaria Identification Rickettsia Qualitative Cystic Fibrosis – Extended Screen Epstein Barr (EBV) Quantitative Brucella Qualitative Bacterial Panel

Automated Extraction / Automated Analyser Automated Extraction / Real -Time Analysis Automated Extraction / Real -Time Analysis Automated Extraction / Real -Time Analysis Automated Extraction / Real -Time Analysis Automated Extraction / Real -Time Analysis Automated Extraction / Real -Time Analysis Manual Extraction / Automated Analyser Automated Extraction / Manual Analysis Automated Extraction / Automated Analyser Automated Extraction / Real -Time Analysis Automated Extraction / Real -Time Analysis Automated Extraction / Real -Time Analysis Automated Extraction / Automated Analyser Automated Extraction / Real -Time Analysis Automated Extraction / Real -Time Analysis Automated Extraction / Real -Time Analysis Automated Extraction / Real -Time Analysis Automated Extraction / Real -Time Analysis Automated Extraction / Real -Time Analysis Automated Extraction / Real -Time Analysis Automated Extraction / Real -Time Analysis Automated Extraction / Real -Time Analysis Automated Extraction / Real -Time Analysis Page 2 of 2

Original date of accreditation: 01 April 2003

ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM

Field Manager


				
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