Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

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1 Public Health England, an executive agency of the Department of Health Clinical Microbiology and Public Health Laboratory Box 236, Addenbrookes Hospital Cambridge Biomedical Campus Hills Road Cambridge CB2 0QW Contact: Martin Strickland Tel: +44(0) Fax: +44(0) Website: Testing performed at the above address only DETAIL OF ACCREDITATION AND TISSUES Faeces Line/catheter tips Pus & other body fluids Sputum; respiratory tract Swab specimens Tissues & surgically explanted materials & other body fluids Isolation and identification of microorganisms of clinical significance Detection and enumeration of red & white blood cells in body fluids Microscopy & culture BSOP002 BSOP003 BSOP012 BSOP014 BSOP016 BSOP017 BSOP019 BSOP032 BSOP033 BSOP062 BSOP093 BSOP111 BSOP118 GSOP111 BD Kiestra automated systems for handling and management of samples, plates, images and data BSOP109 Cell count using Neubauer counting chamber and light microscopy. Differntial white cell staining using Turk s stain BSOP128 BSOP019 Assessment Manager: PW Page 1 of 10

2 Whole blood in blood culture bottles Sputum Blood Bone marrow Laryngeal swabs Gastric washings Pus Tissues (biopsy and autopsy) Detection of pathogenic microorganisms Detection and enumeration of red & white blood cells, epithelial cells and bacteria Detection of Mycobacterium spp Automated methods: BioMerieux BacT/Alert & BD BacTec FX BSOP005 BSOP124 A. Menarini sedimax automated urine microscopy BSOP014 BD Diagnostic Systems MGIT. Detects growth by fluorescent detection of oxygen. Manual methods: slope cultures. Microscopy Auramine fluorescent staining for primary samples. Ziehl- Neelsen method using light microscopy for positive cultures. BSOP029 Bacterial/yeast isolates General microbial identification Confirmation tests: Gram s stain, catalase, oxidase, coagulase, latex/particle agglutinations, agglutinating antisera, API tests, thermostable nuclease test GSOP111 BSOP118 BSOP005 Antimicrobial susceptibility testing and EMIC gradients Susceptibility by disc diffusion (BSAC standards) Sensitivity breakpoint strips (biomerieux E-Test, Oxoid M.I.C.Evaluators) BSOP043 Assessment Manager: PW Page 2 of 12

3 Bacterial/yeast/fungal isolates Microbial identification BRUKER / BD MALDI-TOF (Matrix Assisted Laser Desorption Ionisation Time of Flight mass spectrometry) BSOP115 Bacterial/yeast isolates Microbial identification and antibiotic sensitivity testing VITEK2 analyser Colorimetric BSOP113 Faeces Detection of Helicobacter pylori DS2 analyser using Oxoid microplate EIA VSOP064 BSOP012 Faeces Detection of Clostridium difficile GDH antigen and toxin Detection of Aspergillus galactomannan antigen Techlab C. DIFF QUIK CHEK COMPLETE Rapid Membrane Enzyme Immunoassay BSOP126 DS2 analyser using BioRad microplate EIA VSOP064 VSOP102 Detection of Legionella pneumophila antigen Alere immunochromogenic device BSOP014 Detection of Cryptococcus antigen Immunologics latex agglutination test BSOP019 Tissues Respiratory secretions/ washings Skin, Nails, Hair Detection and identification of pathogenic fungi Culture on agar plates, wet-film microscopy BSOP062 Assessment Manager: PW Page 3 of 12

4 Faeces Detection and identification of ova, cysts and parasites Detection of: - Hepatitis A Virus total ab - Hepatitis A Virus IgM - Hepatitis B surface antigen (HBsAg) - Hepatitis B core antibody (Anti-HBc) - Anti-HBc IgM - Hepatitis C Virus (HCV) antibody - Human Immunodeficiency virus (HIV) 1&2 ag/ab - Treponema pallidum total ab Detection and quantification of: - Hepatitis B surface ab (Anti-HBs) - Rubella virus IgG Macroscopic examination; Microscopic examination of concentrates BSOP088 GSOP111 Siemens ADVIA Centaur XP Immunoassay System: sandwich immunoassays using chemiluminometric technology VSOP063 VSOP046 VSOP047 VSOP054 Siemens ADVIA Centaur XP Immunoassay System: sandwich immunoassays using chemiluminometric technology VSOP063 VSOP046 VSOP050 Assessment Manager: PW Page 4 of 12

5 Detection of: - Epstein Barr virus (EBV) VCA IgG - EBV EBNA IgG - EBV VCA IgM - Erythrovirus B19 IgG - Erythrovirus B19 IgM - Cytomegalovirus (CMV) IgM - CMV IgG - Herpes simplex virus (HSV) IgG - VZV IgM - Measles virus IgG - Measles virus IgM - Rubella virus IgM - Mumps virus IgG - Mumps IgM - Toxoplasma gondii IgG - Human T-lymphotropic virus (HTLV) I/II antibody DiaSorin Liaison XL analyser: chemiluminescent immunoassay (CLIA) technology VSOP062 VSOP045 VSOP051 VSOP044 VSOP049 VSOP050 VSOP052 VSOP047 Detection and quantification of: - Varicella-zoster virus (VZV) IgG DiaSorin Liaison XL analyser: chemiluminescent immunoassay (CLIA) technology VSOP062 VSOP048 Detection and quantification of: - Borrelia burgdorferi total ab - HBsAg - anti-hbc - Hepatitis B e antigen (HBeAg) - Hepatitis B e antibody (Anti-HBe) - anti-hcv - CMV IgG - CMV IgM - HIV-1&2 ag/ab - Rubella IgM - VZV IgG BioMerieux VIDAS ELFA analyser VSOP071 VSOP066 VSOP046 VSOP044 VSOP047 VSOP050 VSOP048 Assessment Manager: PW Page 5 of 12

6 Detection of HCV ag/ab DS2 analyser using BioRad microplate EIA VSOP064 VSOP046 Detection of : - Hepatitis E Virus (HEV) IgG - Detection of HEV IgM DS2 analyser using Fortress microplate EIA VSOP064 VSOP046 Detection of Hepatitis D virus (HDV) antibody DiaSorin microplate EIA manual VSOP046 Detection of Helicobacter pylori IgG Meridian immunochromogenic device VSOP066 Detection and quantification of Antistreptolysin O (ASO) Biokit latex agglutination test VSOP053 Detection and quantification of Anti-DNase B BioMerieux colorimetric test VSOP053 Detection of Treponema pallidum antibody Detection and quantification of Treponema pallidum antibody Fujirebio TPPA agglutination tests VSOP054 Axis-Shield RPR agglutination tests VSOP054 Assessment Manager: PW Page 6 of 12

7 Swabs (cervical, urethral, vaginal, rectal) Blood Vitreous humour Vesicle fluid/swab Eye swab Genital swabs Skin swabs Lung biopsy tissue Sputum (induced) MOLECULAR Detection of Chlamydia trachomatis ribosomal RNA & Neisseria gonorrhoeae 16S rrna Detection of HSV & VZV DNA Detection of Pneumocystis jirovecii DNA Hologic Tigris DTS analyser: RNA extraction. Transcription-Mediated Amplification (TMA) and Hybridization Protection Assay (HPA) using Aptima test kit. VSOP095 VSOP085 DNA extraction by Biomerieux EasyMAG/ Qiagen QIAsymphony NAATS amplification using Roche Light Cycler/ Qiagen Rotorgene VSOP075 NAATS extraction by Biomerieux EasyMAG NAATS amplification/ detection using Qiagen Rotor-Gene. VSOP091 Assessment Manager: PW Page 7 of 12

8 Respiratory secretions Swab specimens (nose & throat) Sputum Blood Faeces Swab specimens Tissue Respiratory secretions Pernasal swab specimen Throat swab Sputum Respiratory secretions Detection and typing of respiratory virus nucleic acids using - Adenoviruses - Enterovirus - Human metapneumovirus - Influenza A viruses H1, H3, H5 & H7 - Influenza A with oseltamivirresistance gene - Influenza B virus - Parainfluenzavirus types 1, 2, 3 & 4 - Respiratory syncytial virus A & B - Rhinovirus Detection of enterovirus RNA Detection of Bordetella pertussis DNA NAATS extraction by Biomerieux EasyMAG NAATS amplification/ detection using Qiagen Rotor-Gene VSOP086 VSOP096 RNA extraction by EasyMAG/ QIAsymphony and amplification using Rotor-Gene. VSOP074 DNA extraction by Biomerieux EasyMAG/ Qiagen QIAsymphony and Qiagen Rotor-Gene. BSOP122 Assessment Manager: PW Page 8 of 12

9 Oral fluid Blood (/plasma) Respiratory secretions Throat swab specimens or serum Respiratory secretions Faeces Detection of measles virus RNA Detection and quantification of HIV-1 RNA HCV RNA Detection and quantification of: Adenovirus DNA CMV DNA EBV DNA Detection of Hepatitis E Virus RNA RNA extraction by Biomerieux EasyMAG and Qiagen Rotor-Gene VSOP106 RNA extraction by Qiagen QIAsymphony and Qiagen Rotor-Gene, using QIAGEN Artus VSOP105 DNA extraction by Qiagen QIAsymphony/ Biomerieux EasyMAG and Qiagen Rotor-Gene VSOP089 RNA extraction by Qiagen QIAsymphony and Qiagen Rotor-Gene. VSOP098 Assessment Manager: PW Page 9 of 12

10 Faeces Detection of Norovirus RNA RNA extraction by Qiagen QIAsymphony/ Biomerieux EasyMAG and Qiagen Rotor-Gene VSOP073 Tissue Tissue Detection and quantification of Polyomaviruses BK DNA Detection Polyomaviruses JC DNA DNA extraction by Qiagen QIAsymphony/ Biomerieux EasyMAG and Qiagen Rotor-Gene VSOP088 DNA extraction by Qiagen QIAsymphony/ Biomerieux EasyMAG and Qiagen Rotor-Gene VSOP088 Assessment Manager: PW Page 10 of 12

11 Bacterial isolates Identification of the Liverpool epidemic strain (LES) of Pseudomonas aeruginosa Manual DNA extraction by boiling and emplification/detection using Qiagen Rotor-Gene BSOP116 Extracted RNA Genotyping of HCV RNA Qiagen QIAsymphony extraction followed by amplification and genotyping using Taqman low density array (TLDA) card on Applied Biosystems ViiA 7 real time PCR system VSOP080 Genotyping of HIV-1 RNA Qiagen QIAsymphony extraction followed by RT-PCR DNA synthesis followed by Nested PCR amplification using a DNA engine thermocycler to provide a DNA product for referred NGS sequencing VSOP084 Sequence data produced (from DNA fragment product specified above) by accredited referral laboratory Analysis using Stanford University HIV resistance database for reporting result and associated automatically generated comments. Clinical interpretation of results VSOP084 Assessment Manager: PW Page 11 of 12

12 Bacterial cultures Ribotyping of Clostridium difficile Manual DNA extraction by boiling and amplification using a DNA engine thermocycler to provide a DNA product for referred fragment analysis BSOP108 Sequence data produced (from DNA fragment product specified above) by accredited referral laboratory Analysis using ABI peakscanner software for ribitype identification using CDRN database VSOP108 END Assessment Manager: PW Page 12 of 12