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 Schedule of ccreditation United Kingdom ccreditation Service ccredited to Coventry and Warwick Pathology Service Department of Microbiology Clifford Bridge Road Walsgrave Coventry CV2 2DX Contact: Dr. Peter Munthali Tel: +44 (0) Website: Laboratory locations: below s covered by the organisation and their relevant activities details ctivity code ddress Department of Microbiology University Hospitals Coventry and Warwickshire NHS Trust Clifford Bridge Road Walsgrave Coventry CV2 2DX Local contact Helen Keyworth/ Ian Sturgess Laboratory Managers Tel: Tina Wotherspoon Molecular Pathology Manager Tel: Tina.Wotherspoon@u hcw.nhs.uk Bacteriology Virology Molecular testing Integrated Sexual Health Service (ISHS) Coventry Health centre CV4 4FH Detection of bacteria of clinical significance for purposes of sexual health screen B ssessment Manager: EB1 Page 1 of 11

2 Schedule of ccreditation United Kingdom ccreditation Service ccredited to DETIL OF CCREDITTION HUMN BODY FLUIDS ND TISSUES Microbiology examination Faeces, Tissues, Fluids (joint fluids, CSF, CPD fluid),swabs (ear, nose, throat, eye, mouth, genital, wound), line tips sputum, broncho-alveolar lavage, pleural fluid, plates inoculated in GUM clinic Isolation, identification and antibiotic susceptibility testing of microorganisms of clinical significance Manual culture using prepared manufacturers agar plates Identification using Bruker MLDI- TOF system. Supplementary tests and kits used to aid selection of colonies requiring MLDI (e.g. oxidase) or for confirmation or clarification of MLDI result (e.g. PI 20E). s: MI LPR52 MI LPR5 MI LPR39 MI LPR34 MI LPR12 MI LPR13 MI LPR14 MI LPR39 MI LPR53 MRS swab MRS screening Manual culture using prepared manufacturers chromogenic media agar plates Identification using Staph latex. Positives are confirmed by MLDI- TOF. s: MI LPR24 ssessment Manager: EB1 Page 2 of 11

3 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS ND TISSUES Microbiology examination Sputum, bronchoalveolar lavage, bronchial washing, trap sputum, Endotracheal tubes, Pleural fluid, ascitic fluid, aspirates, Lung tissue, lymph nodes, Curettings, Gastric lavage, Laryngeal swab, Urine, Faeces, Swabs, Bone marrow. Isolation and presumptive identification of cid-alcohol fast bacilli (inc. Mycobacterium spp.) Using BD MGIT system for liquid culture Using manufactured agar (LJ slopes) for solid culture Manual Ziehl-Neelsen staining using Kinyoun cold stain method Manual auramine staining : MI LPR33 Whole blood Isolation, identification and antibiotic susceptibility testing of microorganisms of clinical significance Using BacTlert analyser, CO2 detection system. MI LPR26 Urine Isolation, identification and antibiotic susceptibility testing of microorganisms of clinical significance MST Uri-system for culture/sensitivity Further identification using PI system and Bruker MLDI-TOF MI LPR29 Urine Detection, identification and quantification of: White blood cells Red blood cells Squamous epithelial cells Bacterial cells Casts Using IQ200 for urine microscopy MI LPR29 ssessment Manager: EB1 Page 3 of 11

4 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS ND TISSUES Microbiology examination Faeces Detection of rotavirus, adenovirus Using Biorapid ROT-DENO immuno-chromatographic kit (lateral flow method) MI LPR21 Faeces Detection of H pylori antigen Using Oxoid mplified IDEI StR kit on DS2 MI LPR64 Faeces Detection of Clostridium difficile toxin and Clostridium difficile GDH Using GDH and Toxin /B ELIS on DS2 Confirmation of positives by Cepheid PCR MI LPR65 CSF, CPD fluids, ascitic fluids, joint fluids Detection and quantification of red cells and white cells Manual cell counts and light microscope s MI LPR13 MI LPR14 MI WI98 ny genital sample, most commonly High vaginal or cervical swab. Detection and identification of Trichomonas Vaginalis Using manufacturer s trichomonas media followed by inverted microscopy MI LPR39 ssessment Manager: EB1 Page 4 of 11

5 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS ND TISSUES Microbiology examination Sterile fluids and tissues (joint fluids, pus, placental swabs, peritoneal fluids, maxillo-facial specimens) and any other specimen we receive from a normally sterile site. CSF, scitic and CPD fluids Blood cultures that flag positive from the BactLERT analyser Pleural fluids/tissue specimens and lymph nodes. Genital specimens requesting Bacterial vaginosis. Pre-inoculated eye slides from the eye department. (corneal scrapes). Detection of bacteria of clinical significance for purposes of sexual health screen Manual gram stain MI WI121 Genital samples- HVS, endocervical, penile, and urethral. Detection of bacteria of clinical significance for purposes of sexual health screen Manual gram stain MI WI121 B Parasitology examination Faeces Detection and identification of helminths, nematodes, flukes, parasitic larvae, protozoa, ova, amoebae and cysts of clinical significance Midi Parasep SF concentration method Modified Ziehl Neelsen stain for cryptosporidium MI LPR11 ssessment Manager: EB1 Page 5 of 11

6 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS ND TISSUES Mycology examination Skin, nails, hair Isolation and identification of fungi of clinical significance. Manual culture using prepared manufacturers agar plates Identification by macroscopic examination of colonies by eye and microscopic examination of colonies using lacto-fuschin or lactophenol cotton blue stains Manual microscopy of direct specimen using Potassium hydroxide. MI LPR18 Serology examination Blood Hepatitis B surface antigen, Hepatitis B surface antibody, Hepatitis B core antibody, Hepatitis B e antigen, Hepatitis B e antibody, Hepatitis B core IgM antibody Hepatitis IgG antibody Hepatitis IgM antibody Hepatitis C antibody HIV p24 antigen/antibody (HIV1/2) ROCHE E170 -Chemiluminescent ssay s VI LPR12 Hepatitis Serology VI LPR13 HIV Serology VI LPR4 CMV & RUBELL Serology VI LPR4 CMV & RUBELL VI LPR5 Syphilis CMV IgG & IgM antibody Rubella IgG & IgM antibody Syphilis total IgG & IgM antibody ssessment Manager: EB1 Page 6 of 11

7 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS ND TISSUES Serology examination Blood Hepatitis E IgG and IgM Fortress solid phase optical density EI Hepatitis E SOP Ref: VI LPR50 Blood Parvovirus IgG & IgM antibody Toxoplasma gondii IgG antibody Varicella-zoster IgG antibody Measles IgG antibody Herpes simplex 1 & 2 IgG antibody EBV EBN/VC IgG/IgM DISORIN X LIISON Chemiluminescent ssay VI LPR45 Parvovirus B19 VI LPR44 Toxoplasma VI LPR43 VZG VI LPR42 Measles VI LPR46 HSV Serology VI LPR47 EBV Blood Mumps IgG antibody Hepatitis B surface antigen confirmation HIV antigen/antibody confirmation Hepatitis B core antibody confirmation BIOMERIEUX VIDS - Enzyme-linked fluorescent assay VI LPR9 ssays performed on VIDS autoanalyser VI LPR4 CMV & Rubella CMV IgG vidity Blood, CSF SO antibody BIOKIT Latex agglutination VI LPR1 SO Serology ssessment Manager: EB1 Page 7 of 11

8 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS ND TISSUES Serology examination Blood, CSF Cryptococcal antigen LPH LBS Latex agglutination VI LPR16 Cryptococcal Urine Detection of legionella urinary antigen LERE Enzyme-linked immunoassay using the LUNCH ELX50 EI WSHER & LUNCH ELX800 EI REDER VI LPR3 Legionella ntigen Detection Urine Legionella urinary antigen confirmatory assay LERE Immunochromatographic assay Blood Syphilis RPR XIS-SHIELD Flocculation method VI LPR5 Syphilis Blood Syphilis Total ntibody MST Particle gglutination method VI LPR5 Syphilis Blood Syphilis IgM antibody Manual MIKROGEN immunoassay using the LUNCH ELX50 EI WSHER & LUNCH ELX800 EI REDER VI LPR5 Syphilis ssessment Manager: EB1 Page 8 of 11

9 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS ND TISSUES Serology examination Blood HIV 1/2 ntibody HIV1/2 Immunocomb BiSpot EI kit from Sterilab VI LPR13 HIV Blood Rheumatoid Factor SIEMENS Particle gglutination VI LPR7 Rheumatoid Factor Molecular diagnostic activities for the purpose of clinical diagnosis Blood, faeces, fluids, swabs, sputum/lavage samples, vomit, oral mouth swab, EDT plasma samples, coagulation tube samples, oropharyngeal swabs. DN/RN extraction Qiagen EZ1 dvanced (magnetic bead extraction system) BBOTT M2000 extraction system MD LPR16 MD LPR24 FFPE tissue sections, FFPE punch biopsies lung, colorectal and skin tissue Promega Maxwell system MD LPR53 Paraffin wax slides, tissue DN extraction Promega Maxwell system (magnetic bead extraction) MD LPR18 Genital swabs Urine samples Eye swabs (validated separately) s list below CT/GC/HSV identification BD Viper system (automated DN extraction and PCR) MD LPR21 MD LPR20 ssessment Manager: EB1 Page 9 of 11

10 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS ND TISSUES Molecular diagnostic activities for the purpose of clinical diagnosis Urine, Endocervial swabs, patient colected vaginal swabs, rectal swabs, eye swabs and urethral swabs Chlamydia trachomatis (CT) and or Neisseria gonorrhoea (NG) genomic DN differentiation profiles Cepheid CT/GC confirmation testing using Cephid GeneXpert real time PCR. MD LPR51 DN extracted in-house using methods above Identification of the following targets: Real-time PCR using Qiagen Rotorgene Q and Qiagility CMV EBV BK Norovirus Rotavirus denovirus rgene respiratory virus markers (DN/RN targets) s MD LPR22 MD LPR40 MD WI45 MD WI46 s MD LPR18 s MD LPR26 DN extracted in-house using methods above Quantification of viral load (HIV/HCV/HBV) Real time PCR using bbott M2000RT MD LPR24 DN extracted in-house using methods above Identification of norovirus/measles virus Real time PCR using Cepheid Smartcycler MD LPR17 MD LPR19 DN extracted in-house from oropharyngeal swabs Measles Virus Real time PCR using Cepheid Smartcycler MD LPR19 ssessment Manager: EB1 Page 10 of 11

11 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS ND TISSUES Molecular diagnostic activities for the purpose of clinical diagnosis DN extracted in-house using methods above Identification of the following genetic mutations: Real time PCR using Roche Lightcycler 2.0 JK2 V617F mutation (JK2) Prothrombin gene mutation (PGM) Factor V Leiden mutation (FVL) G HFE s MD LPR1 MD LPR2 MD LPR3 MD LPR4 MD LPR11 MD LPR 55 MD LPR56 MD LPR 52 FFPE tissue sections EGFR. KRS. NRS & BRF mutations Biocartis Idylla system. mplification refractory mutation system (RMS), and target sequences are detected by means of fluorescence. MD LPR53 DN extracted in house using methods above EGFR. KRS. NRS & BRF mutations TaqMan Low Density rray (TLD) mplification on Vii7Dx and usingtaqman PCR (castpcr ) technology END ssessment Manager: EB1 Page 11 of 11