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 Clinical Microbiology University Hospitals of Leicester NHS Trust Leicester Royal Infirmary Infirmary Square Leicester LE1 5WW Contact: Bud Dziombak Tel: +44 (0) Website: Testing performed at the above address only DETAIL OF ACCREDITATION AND TISSUES Aspirates Cellular and fluid material contained on swabs, cannulae, Fluids Genital samples Pus Samples from sterile sites Semen Tissues CSF Whole blood Cerebral fluid samples clinical diagnosis General isolation of microorganisms of clinical significance General isolation of microorganisms of clinical significance Quantification of white and red blood cells, bacteria and epithelial cells Quantification of white and red blood cells and bacteria Manual inoculation followed by culture using PM109 PM111 PM106 PM107 PM108 PM128 PM134 PM220 PM120 PM137 Automated culture using BacTalert 3D and; PM301 Automated urine analysis using UF1000: PM220 Microscopy (inc. Giemsa stain) using SOP: PM120 PM137 Assessment Manager: RBB Page 1 of 7

2 Swabs Sputum Endotracheal Aspirates Respiratory samples CSF Blood Bone Marrow MRSA Screening Isolation and presumptive identification of Acid-alcohol fast bacilli (inc. Mycobacterium spp.) Manual culture using: PM003 Manual culture and microscopy using PE 403 PE 404 PE 003 Staining using: Auramine screen confirmation by ZN SOP PE 003 Automated screening (Biomerieux Bactec 9050) and manual culture SOP PE007 Skin, Nail Cultures isolated in house from the above Bacterial cultures isolated in house from the above General isolation and characterisation of clinically significant fungi Identification of clinically significant bacteria Antimicrobial susceptibility testing of clinically significant bacteria Manual culture and fluorescent microscopy using calcofluor stain using SOP: PE 403 Automated Matrix-assisted laser desorption/ionisation (MALDITOF) using: SOP PM504 Equipment : Biomerieux Vitek MS Biochemical profile determination using: Biomerieux Vitek 2 Compact SOP PM 502 Biomerieux Vitek 2 Compact SOP PM 502 Manual disc diffusion and/or automated methods using BSAC methodology: SOP PM408 Gradient MIC determination by E-test SOP PM 414 Beta Lactamase detections using Oxoid ID sticks. SOP PM419 Assessment Manager: RBB Page 2 of 7

3 Yeast cultures isolated in house from the above Antimicrobial susceptibility testing of clinically significant Yeast Yeast One Sensititre Kit Manual Method SOP PM 810 MIC determination in yeast Isolates SOP PM 811 Reporting ID and MIC results of Yeast Isolates Cultures isolated in house from the above Cultures isolated in house from the above Clear adhesive tape slides Peri-anal swabs Whole blood Serological identification of groups A, B, C, D, F and G of the Lancefield groups of Streptococci Serotyping of Salmonella polyvalent O (PSO) and Salmonella polyvalent H (PSH); Shigella species; Vibrio species. Detection of ova, cysts and parasites (OCP) Detection of Schistosoma haematobium ova Detection of threadworms Detection of Cryptosporidium oocysts and Giardia Detection of C. difficile toxin A and B and GDH antigen Detection of M. tuberculosis IFN-γ test Pro-Lab Strep grouping kit PM501 Manual Culture and detection SOP PE 103 Concentration and light microscopic examination using : SOP - PE202 Concentration and light microscopic examination using : SOP - PE202 Light microscopic examination using SOP PE 202 Triturus 4 EIA followed by RIDA testing and modified ZN staining for Cryptosporidia and Microscopy for Giardia using: SOP PE116 SOP PE 202 Triturus 4 EIA SOP PE 123 QuantiFERON-TB Gold test SOP PE003 Assessment Manager: RBB Page 3 of 7

4 Serum Detection of Beta 1,3 Glucan Fungitell assay using SOP PM 815 Semi Automated using BioTek ECx808iu ultra microplate reader SOP PM 815 manufacturers instructions where relevant Using ADVIA Centaur XP: Clotted (Serum) EDTA blood (Plasma) DBS samples HIV Ag/Ab HBsAg AntiHBc PV 110 PV 022 PV 015 AntiHBs PV 020 HBeAg PV 017 AntiHBe PV 018 HBcIgM PV 016 HCV Ab PV 157 HAV IgM PV 208 HAV total Ab PV 209 Rubella IgG PV 408 Rubella IgM PV 409 Syphilis Ab PV 508 Clotted and/or EDTA Blood EBV EBNA IgG PV 458 EBV VCA IgG PV 460 EBV VCA IgM PV 459 CMV IgG PV 307 CMV IgM PV 306 Toxoplasma IgG PV 643 Parvovirus B19 IgG PV 283 Parvovirus B19 IgM PV 287 VZV IgG PV 353 HSV IgG PV 422 Mumps IgG PV 322 Mumps IgM PV 323 Measles IgG PV 372 manufacturers instructions where relevant using Siemens BEP3/Tecan Freedom Evo Liquid Handler: Assessment Manager: RBB Page 4 of 7

5 AND TISSUES (cont d) (cont d) Clotted and/or EDTA Blood HTLV 1&2 Ab PV 256 (cont d) HIV Ag/Ab (conf) PV 104 HBsAg (conf) PV 021 HCV Ag/Ab PV 158 AntiHBc (conf) PV 006 manufacturers instructions where relevant using Siemens BEP3/Tecan Freedom Evo Liquid Handler contd: manufacturers instructions where relevant : Clotted Blood Detection of Galactomannan antigen Documented in house semi-automated methods incorporating manufacturers instructions where relevant using Siemens BEP3 SOP PV 623 Detection of rotavirus antigen SOP PV 663 Clotted Blood Detection of adenovirus antigen Detection of Legionella pneumophilia serotype 1 Antigen Detection of Chlamydia group Ab C Burnetti Ph2 M.pneumonia Brucella SOP PV 663 Manual serology method using BINAX NOW kit incorporated into SOP PV 527 Manual Complement Fixation Test method using LAUNCH kit and SOP PV 703 Latex particle agglutination assays using a variety of cards Clotted Blood ASO titres PV 543 Cryptococcal Antigen PV 583 Syphilis confirmation PV 507 TPPA RPR (syphilis confirmation) PV 510 Assessment Manager: RBB Page 5 of 7

6 AND TISSUES (cont d) (cont d) manufacturers instructions where relevant : Serum Detection and typing of HIV 1 and HIV 2 Molecular examination clinical diagnosis Immunochromatographic detection of HIV1 and HIV2 using the BioRad Geenius card system SOP PV111 manufacturers instructions where relevant: EDTA blood (Whole) Respiratory samples Detection of CMV DNA Semi-automated quantitative RT-PCR by QIAsymphony SP/AS and rotorgene SOP PN 051 EDTA blood (Whole) EBV DNA SOP PN 051 Respiratory samples Detection of Influenza A & B, RSV A & B Paraflu 1,2,3,4 Semi-automated qualitative PCR by QIAsymphony SP and rotorgene SOP PN011 Adenovirus SOP PN 014 Influenza swine H1, N1, Human H1, H3 and H5 CSF HSV1 & 2 VZV Enterovirus Parechovirus SOPs PN 011 and PN 013 SOP PN 056 Genital swabs Detection of HSV 1 and 2 Semi automated strand displacement amplification using BD Viper SOP PN 062 EDTA Blood (Plasma) Detection of HIV-1 RNA and quantification of HIV viral load Automated quantitative RT-PCR using Abbott M2000 SOP PN 029 Blood (Serum from clotted blood) Blood (Serum from clotted blood preferred and DBS samples) Detection of HBV DNA SOP PN 048 Detection of HCV RNA SOP PN 029 Assessment Manager: RBB Page 6 of 7

7 Endocervical swabs, vaginal swabs, male/female urine, vulval swabs, urethral swabs Molecular examination Detection of Chlamydia trachomatis and Neisseria gonnorrhoeae DNA Confirmation of Chlamydia trachomatis and Neisseria gonnorrhoeae manufacturers instructions where relevant: Semi automated strand displacement amplification using BD Viper SOP PN 042 Automated qualitative PCR by Cepheid GeneXpert SOP PN 052 Detection of Norovirus Semi automated qualitative PCR by EasyMag and Rotorgene using SOP PN007 Sterile sites tissues, fluids, pus and culture isolates RNA sequence data EDTA Blood Detection of 16S RNA Identification of clinically significant species of bacteria Detection of bacterial and fungal DNA Manual in-house qualitative PCR (extraction by QiAgen, block PCR, gel electrophoresis. SOP PN008 Analysis and reporting of outsourced sequenced data SOP PN008 Semi automated Qualitative PCR by Roche MagNA pure compact extraction and Roche LightCycler system and Septifast Kit. SOP PN 054 END Assessment Manager: RBB Page 7 of 7