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 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Infection Sciences St. Thomas Hospital Westminster Bridge Road London SE1 7EH Contact: Richard Scott Tel: +44 (0) Fax: +44 (0) Website: Testing performed at the above address only DETAIL OF ACCREDITATION Aspirates Cellular & fluid material contained on swabs, catheter tips, pacing wires and intra-uterine contraceptive devices Fluids Heart valve/vegetation Lymph node aspirate Pus Renal / Bladder stone Tissues Samples from sterile sites Genital samples Semen Aspirates Corneal scrapes Aqueous & vitreous tap Fluids Tissues General Bacteriology/Microbiology Isolation of clinically significant bacteria and fungi Detection, identification & quantification of: White blood cells Differential WBC count (CSF) Red blood cells Bacterial cells Yeast cells and fungal hyphae Isolation of clinically significant bacteria and fungi Manual culture IIM-SOP-Processing Specialist Specimens IIM-SOP-Reading Specialist Specimens Staining and microscopic examination IIM-SOP-Processing Specialist Specimens IIM-SOP- Specialist Area CAP Fluids Manual culture IIM-SOP- Methods IIM-SOP s Plate Reading Assessment Manager: MS2 Page 1 of 14

2 Blood Bone marrow Detection, identification & quantification of: White blood cells Red blood cells Squamous epithelial cells Bacterial cells Casts Isolation of clinically significant bacteria and fungi Automated urinalysis, Image capture and recognition IIM-SOP-Sedimax operation A.Menarini Diagnostics SediMAX Manual microscopy IIM-SOP- Methods Automated culture IIM-BD BACTEC FX: Use & Maintenance IIM-SOP-Blood Culture Processing and Reading Bench IIM-SOP-Auramine and ZN staining Becton Dickinson BacTec FX followed by manual subculture, identification & susceptibility testing as listed below Expressed breast milk Sterility check Manual culture: IIM-SOP-Processing Specialist Specimens IIM-SOP-Reading Specialist Specimens on swabs from nose, throat & groin/perineum on rectal & throat swabs on rectal swabs Screening for: Methicillin-Resistant Staphylococcus aureus (MRSA) Candida auris Screening for Gentamicin-resistant Enterobacteriaceae Screening for Vancomycin-resistant Enterococci (VRE) Manual culture IIM-SOP-Resistance Screening Manual culture IIM-SOP-Resistance Screening Manual culture IIM-SOP-Resistance Screening Assessment Manager: MS2 Page 2 of 14

3 Blood Bronchoalveolar lavage (BAL) Bronchial aspirate, brushings & washings on swabs Endotrachael tube specimen Nasopharyngeal aspirate (NPA) Sputum on swabs Bacterial & fungal isolates cultured in-house from the above Isolation of bacterial enteric pathogens: Clostridium difficile Escherichia coli O157 Salmonella sp. Shigella spp. Vibrio spp. Yersinia spp. Pleisiomonas sp. Isolation of Campylobacter spp. Isolation of clinically significant bacteria and fungi Isolation of Bordetella spp. Identification/ Biological classification Manual culture IIM-SOP- Processing IIM-SOP- Bench Reading Manual culture IIM-SOP- Bench Reading Manual culture IIM-SOP-Processing of Respiratory Samples IIM-SOP-Respiratory Plate Reading Manual culture IIM-SOP-Swabs Bench Reading Manual and/or automated identification Bruker Maldi-ToF IIM-SOP- Operation of the Bruker Microflex Biotyper (MALDI-TOF) BioMérieux Vitek IIM-SOP-VITEK2 Operation Bruker Microflex Biotyper BioMérieux Vitek2 Manual biochemical/enzymatic & staining/microscopic methods Assessment Manager: MS2 Page 3 of 14

4 Bacterial isolates cultured in-house from the above Yeast isolates cultured in-house from the above Clear adhesive tape slides Antibiotic susceptibility testing Antifungal susceptibility testing Detection of DNA from enteric pathogens: Salmonella sp. Shigella spp. E. coli O157 Campylobacter spp. Detection of ova, cysts & parasites (OCP) Detection of Cryptosporidium oocysts Detection of Enterobious vermicularis larvae and ova Disc diffusion & gradient minimum inhibitory concentration determination using current EUCAST methodology & interpretive breakpoints: IIM-SOP-EUCAST Antimicrobial susceptibility testing Automated IIM-SOP-VITEK 2 Operation BioMérieux Vitek2 Automated IIM-SOP-VITEK 2 Operation BioMérieux Vitek2 Realtime PCR IIM-SOP-BD Max Becton Dickinson BD Max System Unstained and iodine stained direct microscopic examination Formol-ether faecal concentration and microscopic examination IIM-SOP Parasite Methods Auramine phenol staining and fluorescence microscopy IIM-SOP-Parasite Methods Microscopic examination IIM-SOP- Parasite Methods Assessment Manager: MS2 Page 4 of 14

5 Bile Duodenal aspirates Jejunal aspirates Female genital tract swabs Respiratory samples Early morning urine (EMU) Gastric aspirates Fluids Tissues Pus Fine needle aspirates (FNA) Respiratory samples Early morning urine (EMU Gastric aspirates Fluids Tissues Pus Fine needle aspirates (FNA) Detection of OCP including: Strongyloides stercoralis larvae Giardia lamblia trophozoites Cryptosporidium oocysts Cyclospora cayetanesis oocysts Cystoisospora belli oocysts Microscopic diagnosis of bacterial vaginitis Detection of Trichomonas vaginalis Detection of: Legionella pneumophilia serotype 1 antigen Streptococcus pneumonia soluble antigen Detection of acid alcohol-fast bacilli (AAFB) Detection of: Mycobacterium tuberculosis DNA Rifampicin-resistance genes Microscopic examination IIM-SOP- Parasite Methods Gram stained microscopic examination IIM-SOP-Processing Swabs Membrane immunochromatographic assay IIM-SOP-Binax NOW Legionella and Pneunococcal urinary antigens Binax NOW kits Auramine Phenol staining followed by fluorescence microscopy IIM-SOP-Auramine and ZN Staining Realtime PCR IIM-SOP-Cepheid GeneXpert Assays Cepheid GeneXpert Assessment Manager: MS2 Page 5 of 14

6 Respiratory samples Serum Serum Detection of nucleic acids from: Influenza A Influenza B Respiratory Syncytial Virus Serology Microbial serology for: HIV Antibody / Antigen combo Hepatitis B surface Antigen Hepatitis B surface Antigen confirmation Hepatitis B surface Antibody Hepatitis B core Antibody Hepatitis B Core IgM Hepatitis B e Antigen Hepatitis B e Antibody Hepatitis A IgM Hepatitis A IgG Hepatitis C Antibody Hepatitis C Antigen Rubella IgG Cytomegalovirus IgG Syphilis total Antibody HTLV I & II Antibodies Microbial serology for: HSV 1&2 Antibodies Toxoplasma IgG Toxoplasma IgM Mycoplasma pneumonia IgM Cytomegalovirus IgM Epstein-Barr virus IgG Epstein-Barr virus IgM Varicella-zoster virus IgG Parvovirus IgM Parvovirus IgG Measles IgG Realtime PCR IIM-SOP-Cepheid GeneXpert Assays Cepheid GeneXpert Qualitative and quantitative chemiluminescent immunoassays IIV-SOP-Maintenance and Routine Use Of the Architect i2000sr IIV-SOP-Architect Assays Abbott Architect i2000sr Qualitative chemiluminescent assay IIV-SOP-Liaison Operation and Maintenance IIV-SOP-Liaison Assays DiaSorin LIAISON Assessment Manager: MS2 Page 6 of 14

7 Serum Microbial serology for: Rubella IgG (confirmation) Rubella IgM Cytomegalovirus IgG (confirmation) HIV-1 p24 Antigen HIV-1 p24 Antigen Neutralisation Borrelia burgdorferi Antibodies Mumps virus IgG Enzyme-linked fluorescent assay IIIV-SOP-VIDAS 3 Operation and Maintenance IIV-SOP-VIDAS 3 Assays and BioMérieux Vidas 3 Serum HIV-1/HIV-2 Antibody (confirmation) Manual immunochromatographic assay IIV-SOP-Geenius HIV Confirmatory BioRad Geenius HIV-1/2 Confirmatory kit Serum Hepatitis C antibody (confirmation) Manual ELISA IIV-SOP-Hepatits C Confirmation Biorad Monolisa anti-hcv Plus v3 Kit Serum Measles virus IgM Manual ELISA IIV-SOP-Measles IgM Enzygnost Anti-Masern Virus IgM EIA kit Serum Anti-streptolysin O titre (ASOT) Manual latex agglutination IIV-SOP-ASOT Biokit Rheumajet ASO Latex Kit Serum Anti-Streptococcal Dnase (ADN) Manual latex agglutination IIV-SOP-ASOT BioMérieux ASD kit Assessment Manager: MS2 Page 7 of 14

8 Serum Syphilis antibodies Manual passive partial agglutination IIV-SOP-TPPA Serodia TPPA kit Serum Rapid plasma reagin (Syphilis antibodies) Microbial serology for: Clostridium difficile glutamate dehydrogenase (GDH) Antigen C. difficile toxins A & B Helicobacter pylori Antigen Manual flocculation IIV-SOP-RPR BioMérieux RPR kit Automated DS2 ELISA IIM-SOP Use of the DS2 for CDT and HPylori Dynex DS2 H. pylori Antigen Rapid lateral flow immunochromatographic assay IIM-SOP-Helicobacter Immunocard ImmunoCard H. pylori C. difficile GDH Antigen C. difficile toxins A & B Membrane immunochromatographic assay IIM-SOP-C.difficile Quik check complete immunocard Alere C.DIFF QUIK CHEK Complete Detection of C. difficile tcdb gene Realtime PCR IIM-SOP-Use of Cepheid GeneXpert for detection of C. difficile Cepheid GeneXpert Assessment Manager: MS2 Page 8 of 14

9 Cellular & fluid material contained on Nose/Throat swab Nasopharyngeal aspirate (NPA) Bronchoalveolar lavage (BAL) Post-mortem lung swab Induced Sputum Bronchoalveolar lavage (BAL) Non-Directed BAL Induced sputum Detection of Rotavirus and Adenovirus Antigens Molecular Detection of respiratory pathogen nucleic acids: Influenza A&B Rhinovirus Respiratory syncytial virus (RSV) Human metapneumovirus (hmpv) Parainfluenza 1, 2, 3, & 4 Adenoviruses Enteroviruses Mycoplasma pneumonia Bordetella spp. Detection of respiratory pathogen nucleic acids: Legionella pneumophila Legionella longbeachae Mycoplasma pneumonia Chlamydophila pneumonia Chlamydophila psittaci Bordetella (B. pertussis & B. holmesii) Pneumocystis jiroveci Membrane immunochromatographic assay IIV-SOP-RIDA Quick Rota Adeno RIDA quick kit Dipstick combi Nucleic acid extraction and multiplex tandem PCR IIV-SOP-QIAsymphony SP (Qiagen) Operations & Maintenance Guide IIV-SOP-Operation of the Aus Diagnostics High Plex System IIV-SOP-Aus Diagnostics Respiratory Panel standard assay Aus Diagnostics High Plex System Nucleic acid extraction and multiplex tandem PCR IIV-SOP-QIAsymphony SP (Qiagen) Operations & Maintenance Guide IIV-SOP-QIAsymphony Extraction Procedure IIV-SOP-Operation of the Aus Diagnostics High Plex System IIV-SOP-Respiratory Panel LOWER TRACT (AusDiagnostics Pneumonia 16Plex) assay Aus Diagnostics High Plex System Assessment Manager: MS2 Page 9 of 14

10 Vomit Whole blood Whole blood Cerebrospinal fluid (CFS) Bronco alveolar lavage (BAL) Nasopharyngeal aspirate (NPA) Eye swab/vitreous humour Lesion swabs Genital swabs Throat swab Eye swab/vitreous humour Bronco alveolar lavage Nasopharyngeal aspirate Plasma Molecular detection of: Norovirus CMV Viral Load EBV Viral Load BK Viral Load CMV EBV HSV-1 & 2 Treponema pallidum Adenovirus Nucleic acid extraction and realtime PCR amplification IIV-SOP-QIAsymphony SP (Qiagen) Operations & Maintenance Guide IIV-SOP-QIAsymphony Extraction Procedure IIV-SOP-ABI 7500 Operation and Maintenance QIAsymphony ABI 7500 Real-Time Instrument IIV-SOP-Norovirus Realtime PCR IIV-SOP-In-House Qualitative and Quantitative PCR for BKV CMV EBV IIV-SOP-In-House Qualitative and Quantitative PCR for BKV CMV EBV IIV-SOP-HSV Syphilis Qualitative real-time PCR IIV-SOP-Qualitative Adenovirus real-time Assessment Manager: MS2 Page 10 of 14

11 Throat swab Nasal swab Bronco alveolar lavage Nasopharyngeal aspirate Skin swabs Mucosal swabs Skin swabs Mucosal swabs Lesion swabs Eye swab/vitreous humour Vitreous Humour Plasma Plasma Serum Eye swab/vitreous humour Plasma Serum Amniotic Fluid Viral Meningitis panel: Enterovirus Parechovirus HSV-1 & 2 VZV JC virus Toxoplasma gondii Parvovirus B19 Nucleic acid extraction and realtime PCR amplification (as above) IIV-SOP IIV-SOP-Qualitative Entero-Parechovirus real-time PCR IIV-SOP-HSV-1 & 2 Qualitative realtime PCR IIV-SOP-VZV Qualitative real-time PCR IIV-SOP-Qualitative JC and Toxoplasma gondii real-time PCR Assay IIV-SOP-Toxoplasma gondii realtime PCR Assay IIV-SOP-Qualitative parvovirus B19 real time PCR Assessment Manager: MS2 Page 11 of 14

12 on self-collected swabs: Rectal Genital Urethral Ulcer 3in1 in cervical, eye, high-vaginal, rectal and throat swabs on cervical, high-vaginal &, rectal swabs Detection of C. trachomatis LGVspecific DNA Detection of ribosomal RNA from: Chlamydia trachomatis Neisseria gonorrhoeae N. gonorrhoeae (confirmation) Trichomonas vaginalis Nucleic acid extraction and 5Plex real-time PCR IIV-SOP-QIAsymphony SP (Qiagen) Operations & Maintenance Guide IIV-SOP-QIAsymphony Extraction Procedure IIV-SOP-Rotor-gene Q Real-time PCR System Operations and Maintenance IIV-SOP-LGV PCR QIAsymphony Rotor-gene Q Nucleic acid amplification technique (NAAT) IIV-SOP-TIGRIS DTS (Gen-Probe) Operation and Maintenance IIV-SOP-Gen-Probe Panther Operation & Maintenance IIV-SOP-Results validation and reporting of GC CTTMA TV Assays Hologic Gen-Probe Panther system Hologic TIGRIS IIV-SOP-Aptima GC-CT Combo 2 & GC Confirmatory Assays IIV-SOP Gen Probe Aptima TV Assay Assessment Manager: MS2 Page 12 of 14

13 Plasma Buffy coat cells (BCC) Cerebrospinal fluid (CFS) HIV Tropism Nucleic acid extraction, gene sequencing and analysis IIV-SOP-QIAsymphony SP (Qiagen) Operations & Maintenance Guide IIV-SOP-QIAsymphony Extraction Procedure IIV-SOP-HIV 1 Tropism Prediction IIV-SOP-Generic Genotyping Sequence Analysis, Reporting & QA QIAsymphony Dyad Thermocycler ABI 3130XL genetic analyser Plasma Hepatitis B Genotyping Nucleic acid extraction, gene sequencing and analysis IIV-SOP-QIAsymphony SP (Qiagen) Operations & Maintenance Guide IIV-SOP-QIAsymphony Extraction Procedure IIV-SOP-HBV Genotyping Assay IIV-SOP-Generic Genotyping Sequence Analysis, Reporting & QA QIAsymphony Dyad Thermocycler ABI 3130XL genetic analyser Assessment Manager: MS2 Page 13 of 14

14 Plasma HIV-1 Viral Load Hepatitis B Viral Load Hepatitis C Viral Load In vitro nucleic acid amplification IIV-SOP-Roche COBAS AmpliPrep/Taqman HBV, HEPC and HIV-1 Detection and Quantification IIV-SOP-Roche COBAS AmpliPrep/Taqman Operation and Maintenance Hamilton P630 Roche Cobas Ampliprep & TaqMan END Assessment Manager: MS2 Page 14 of 14