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 Microbiology Department Contact: Dr Michael Ford, Laboratory Manager Freeman Hospital Tel: +44 (0) Freeman Road Fax: +44 (0) Newcastle upon Tyne NE7 7DN Website: Testing performed at the above address only DETAIL OF ACCREDITATION HUMAN BODY TISSUES AND FLUIDS Serum unless otherwise stated HAV IgM HBsAg - Screening HBcAb - Screening HBsAb *Detected/Not Detected and titre reported. HCV ab- screening Rubella IgG - Screening Roche Modular Analytics E170 using ECLIA measurements: Elecsys Anti-HAV IgM BS-SOP-OP-Biochem-94 SEROLSOP032 Elecsys HBsAg II BS-SOP-OP-Biochem-85 Elecsys Anti-HBc BS-SOP-OP-Biochem-82 Elecsys Anti-HBs assay BS-SOP-OP-Biochem-81 Elecsys Anti-HCV BS-SOP-OP-Biochem-80 SEROLSOP033 Elecsys Rubella IgG BS-SOP-OP-Biochem-89 SEROLSOP021 Serum/CSF CMV IgG - Screening Elecsys CMV IgG BS-SOP-OP-Biochem-88 Serum/CSF CMV IgM Elecsys CMV IgM BS-SOP-OP-Biochem-91 Assessment Manager: KS Page 1 of 10

2 FLUIDS Serum unless otherwise stated Serum/CSF Serum Syphilis screening (detection of antibodies to Treponema pallidum) HIV - Screening Toxoplasma IgG ASOT *Titre reported HBeAg HBeAb Rubella IgM Roche Modular Analytics E170 using ECLIA measurements : Elecsys Syphilis.-ECLIA SEROLSOP005 SEROLSOP013 Elecsys HIV combi PT BS-SOP-OP-Biochem-87 SEROLSOP030 Elecsys Toxo IgG BS-SOP-OP-Biochem-90 Roche Modular analytics -COBAS ASLO assay-immunoturbidometric BS-SOP-OP-Biochem-84 Roche Modular Analytics E170 using ECLIA measurements: Elecsys HBeAg assay BS-SOP-OP-Biochem-86 Elecsys Anti-HBe assay BS-SOP-OP-Biochem-83 SEROLSOP020 Elecsys Rubella IgM BS-SOP-OP-Biochem-93 Assessment Manager: KS Page 2 of 10

3 FLUIDS Serum HAV IgG Parvovirus IgG Parvovirus IgM EBNA IgG EBV VCA IgM EBV VCA IgG Lyme Disease IgG Lyme Disease IgM Measles IgG Measles IgM DiaSorin Liaison XL analyser using CLIA measurement: Anti-HAV SEROLSOP032 Biotrin Parvovirus B19 IgG Biotrin Parvovirus B19 IgM EBNA IgG EBV VCA IgM EBV VCA IgG Borrelia IgG Borrelia IgM II Measles IgG SEROLSOP021 Measles IgM SEROLSOP021 Assessment Manager: KS Page 3 of 10

4 FLUIDS Serum Serum VZV IgG VZV IgM Herpes IgG Herpes IgM Mumps IgG Mumps IgM HTLV I/II HBsAg - Confirmation HBcAb - Confirmation Rubella IgG - Confirmation DiaSorin Liaison XL analyser using CLIA measurement VZV IgG SEROLSOP017 VZV IgM SEROLSOP017 HSV 1/ 2 IgG SEROLSOP017 HSV 1/ 2 IgM SEROLSOP017 Platelia Mumps IgG SEROLSOP021 SEROLSOP026 Platelia Mumps IgM SEROLSOP021 SEROLSOP026 HTLV I/II SEROLSOP009 BioMerieux mini VIDAS using ELFA measurement: HBsAg Ultra Anti-HBc Total II RUBIgG II Assessment Manager: KS Page 4 of 10

5 FLUIDS Serum Serum unless otherwise stated HBcIgM CMV IgG - Confirmation CMV IgG Avidity HIV - Confirmation Toxoplasma IgM HCV ab/ag - Confirmation Mycoplasma IgM BioMerieux mini VIDAS using ELFA measurement: HBc IgM II CMV IgG CMV IgG Avidity II HIV DUO, HIVP24 II, Immunocomb II HIV 1& 2, Alere BiSpot SEROLSOP035 Toxo IgM BioRad Evolis Twinplus analyser using ELISA: Monolisa Anti-HCV PLUS SEROLSOP013 SEROLSOP033 Platelia M. pneumonia IgM SEROLSOP013 Serum/BAL Galactomannan Platelia Aspergillus EIA SEROLSOP013 H.pylori Antibody Hepatitis E IgG Platelia H. pylori IgG SEROLSOP028 SEROLSOP01 Fortress Diagnostics HEV IgG SEROLSOP032 Assessment Manager: KS Page 5 of 10

6 FLUIDS Serum unless otherwise stated Serum Serum unless otherwise stated Hepatitis E IgM HCV Ag Antibiotic assay Amikacin, Gentamicin, Tobramycin, Vancomycin Syphilis Confirmation (IgM to Treponema pallidum) TPPA titre RPR titre BioRad Evolis Twinplus analyser using ELISA: Fortress Diagnostics - HEV IgM SEROLSOP032 Abbott Architect (ECLIA): Abbott HCV Ag SEROLSOP033 Roche Integra analyser using Fluorescent polarisation: SEROLSOP014 BioRad Evolis Twinplus - Syphilis IgM-ELISA SEROLSOP005 SEROLSOP013 Fujirebio Inc Serodia TPPA-Particle agglutination SEROLSOP005 Launch Diagnostics ASI RPR- Manual assay agglutination Urine samples Legionella Ag Trinity Biotech - Bartels ELISA Legionella Urinary Antigen SEROLSOP030 Serum/CSF Cryptococcal Ag Immy Latex-Cryptococcus antigenlatex agglutination SEROLSOP031 Urine Pneumococcal Ag Binax NOW Streptococcus pneumonia antigen card. - immunochromatography SEROLSOP015 Assessment Manager: KS Page 6 of 10

7 FLUIDS Serum HIV confirmation Biorad Geenius- Immunochromatography SEROLSOP035 Faeces Faecal Ag tests for H.pylori OXOID Amplified IDEIA Hp StAR - ELISA SEROLSOP028 Serum Anti DNase B Titre BioMerieux ASD kit- Inhibition of streptodornase SEROLSOP019 HUMAN TISSUE AND FLUIDS Swabs (various sites including Wound /Ear/ Eye/ Throat etc.), Tissue Samples (multiple types non-respiratory tract). Sputum, BAL, NPS, ETS, cough swabs, tissue and fluid samples (e.g. pleural fluids/biopsy and other respiratory tract fluids and tissues) Blood Sputum/BAL/NPS other respiratory samples Microbiological examination activities for the purpose of clinical diagnosis Isolation of microorganisms of Isolation of microorganisms of Isolation of microorganisms of Pneumocystis detection In house documented procedures following current Public Health England (PHE) Standards for Microbiological Investigations (SMIs) Standard bacteriological culture, identification and microscopy methods MICROSOP054 MICROSOP065 Standard bacteriological culture, identification and microscopy methods MICROSOP005 MICROSOP052 MICROSOP053 MICROSOP075 Blood culture with automated detection of positive growth Biomerieux BacT/Alert MICROSOP060 Qualitative IFAT: Axis Shield DETECT IF kit. MICROSOP050 Assessment Manager: KS Page 7 of 10

8 HUMAN TISSUE AND FLUIDS Intravascular IV lines Stool samples Stool samples Rectal swabs Stool, urine samples, liver abscesses Stool samples Microbiological examination activities for the purpose of clinical diagnosis Isolation of microorganisms of Enteric sample culture and sensitivity testing for Salmonella, Shigella, E.coli 0157, Campylobacter, Vibrio, Yersinia, other food poisoning organisms Carbapenemase Producing Enterobacteria Screening Testing for Rotavirus and Adenovirus antigens Detection of Ova, Cysts and parasites (OCP) Detection of Clostridium difficile glutamate dehydrogenase and Toxins A & B In house documented procedures following current Public Health England (PHE) Standards for Microbiological Investigations (SMIs) Standard bacteriological culture, identification and microscopy methods MICROSOP066 Standard bacteriological culture, identification and microscopy methods MICROSOP058 Manual culture using E&O Colorex msupercarba agar MICRODOC320 Coris Bio-Concept Combi-strip- Immunochromatographic MICROSOP058 MICROSOP077 Microscopic examination either direct and/or faecal concentration DIASYS Midi Parasep faecal parasite concentrator. Examination for ova and cysts of human parasites. MICROSOP071 Biomerieux GDH kit :VIDASantigen detection MICROSOP074 Biomerieux C.difficile toxin kit: VIDAS MICROSOP074 Stool samples Confirmation of C.difficle positives. PCR using Cepheid GeneXpert, Xpert C. difficile kit. MICROSOP074 Stool Samples Detection of Norovirus DNA PCR using Cepheid GeneXpert MICRODOC223 Assessment Manager: KS Page 8 of 10

9 HUMAN TISSUE AND FLUIDS Skin hair and nail samples. Respiratory samples, tissue and fluids including CSF samples, swabs. Oesophageal brushings. Urine Samples Nose, Throat, Perineal, Wound Swabs, Fluid Samples CSF Fluids (non-respiratory tract) Sputum, Fluids Auramine Phenol Stain Bacterial isolates/ Direct samples from Blood Cultures Bacterial isolates from samples listed above Microbiological examination activities for the purpose of clinical diagnosis Identification of Fungi of clinical significance and Fungal susceptibility testing. Urine cell counts, culture and identification of microorganisms of Staph.aureus screening and chromogenic culture for MRSA Quantitative cell counts, Bacteriological culture and identification of microorganisms of Identification of Acid Fast Bacilli (AFB) Bacterial Identification Susceptibility testing In house documented procedures following current Public Health England (PHE) Standards for Microbiological Investigations (SMIs) Microscopy and standard fungal culture methods. MICROSOP050 Instrumentation Laboratories IQ Sprint Analyser.Using Biomerieux Chromogenic CPSE agar MICROSOP018 MICROSOP063 E&O Colorex chromogenic S.aureus and Biomerieux Chrome ID MRSA MICROSOP059 MICRODOC198 Quantitative cell counts - KOVA slides. Standard bacteriological culture, identification and microscopy methods MICROSOP051 MICROSOP056 Fluroscent microscopy methodology MICROSOP038 Bruker MALDI-TOF MICROSOP076 By disc diffusion - EUCAST Testing and Zone sizes MICROSOP068 MICROSOP072 MIC: Oxoid M.I.C.E strips MICROSOP068 Bacterial Isolates Rapid detection of MRSA Alere - MRSA PBP2a Latex agglutination MICROSOP036 Assessment Manager: KS Page 9 of 10

10 HUMAN TISSUE AND FLUIDS Strepotococcal isolates Bacterial Isolates Microbiological examination activities for the purpose of clinical diagnosis Identification of Streptococcal groups A, B, C, D, F, G Rapid detection of Streptococcus pneumonia In house documented procedures following current Public Health England (PHE) Standards for Microbiological Investigations (SMIs) Oxoid Strep Grouping- Latex agglutination MICROSOP034 Wellcogen S.pneumo Ag Kit Latex agglutinationmicrodoc321 END Assessment Manager: KS Page 10 of 10