Schedule of ccreditation United Kingdom ccreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK ccredited to Kelvin Building Royal Group of Hospitals Grosvenor Road Belfast BT12 6B United Kingdom Contact: Mark McGimpsey Tel: +44 (0) 2890 634 125 / 7718 895 032 E-Mail: mark.mcgimpsey@belfasttrust.hscni.net Website:http://www.belfasttrust.hscni.net/services/Lab oratory-mortuaryservices.htm Laboratory location: details ctivity code ddress Kelvin Building Royal Group of Hospitals Grosvenor Road Belfast BT12 6B United Kingdom Local contact s above Bacteriology testing Molecular testing Serology testing Site activities performed away from the locations listed above: details ctivity code ddress: Genitourinary Medicine Clinic Level 3 Outpatients Department Royal Victoria Hospital Grosvenor Road Belfast BT12 6B Local Contact: s above Culture and microscopy for STDs B ssessment Manager: GB2 Page 1 of 14
Schedule of ccreditation United Kingdom ccreditation Service ccredited to DETIL OF CCREDITTION HUMN BODY FLUIDS ND TISSUES clinical diagnosis Bacteriology In house documented methods based on related PHE Standards for Microbiology Investigations (SMIs), incorporating manufacturers instructions where relevant Sputum, BL, CPD Fluid, Ear Swab, Female Genital Swab, Tissue / Biopsy, Non- Sterile Body Fluid, Sterile Body Fluid, Intravascular cannulas, Male Genital Swab, Nose Swab Sinus spirate, Skin / Wound Swabs, Upper respiratory tract swabs, Eye Swabs /Corneal Scrape, CSF, Prosthetic Joint samples General isolation and characterisation of microorganisms of clinical significance Using manual culture M-399 M-381 Cystic Fibrosis Sputum M-382 Routine Sputum M-383 BL M-384 Enteric Pathogens M-385 CPD Fluid M-386 Ear Infection M-387 Female Genital Tract Infection M-388 Tissues and Biopsies M-389 Non-sterile Fluids and ssociated Samples M-390 Sterile Fluids M-391 Investigation of intravascular cannulas M-392 Male Genital Tract Infection M-394 Nose Investigations M-395 Sinus spirates M-396 Skin and Soft Tissue M-397 Upper Respiratory Tract M-402 Eye Infection M-405 CSF Examination M-410 Samples from Prosthetic Joint Infections Whole blood Detection of microbial growth and general isolation of microorganisms of clinical significance Bio merieux Bact lert 3D M-403 ssessment Manager: GB2 Page 2 of 14
Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS ND TISSUES (cont d) Bacteriology (cont d) Cultures isolated in-house Identification of microorganisms of clinical significance utomated procedures: Vitek 2 (biochemical tests for gram positive and gram negative bacteria, anaerobic bacteria and yeast). Vitek MS MLDI-Tof (Matrixassisted laser desorption/ionisation) M -813 Manual procedures: Coagulase Latex and Tube Streptococcal Grouping Oxidase test Gono Gen ii X and V factors Blactamase activity M-401 Cultures isolated in-house ntimicrobial susceptibility testing of bacterial isolates of clinical significance Vitek 2 and disc diffusion (EUCST guidelines) M-400 Body fluid, tissue, bacterial culture isolates produced by laboratory culture Bacterial differentiation: gram positive /negative and morphology Gram stain and microscopy M-401 Male and female fluid specimens. smears from urethral, vaginal, cervix, throat and rectum Bacterial differentiation: gram positive /negative and morphology Gram stain and microscopy M-438 B Vaginal smears Diagnosis of Bacterial vaginosis Gram stain and microscopy in accordance with Nugent scoring. M-438 B ssessment Manager: GB2 Page 3 of 14
Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS ND TISSUES (cont d) Bacteriology (cont d) Male and female fluid specimens. smears from urethral, vaginal, cervix, throat and rectum Isolation of Neisseria gonorrhoeae Inoculated culture VCT plate M-438 B Isolation and identification of Trichomonas vaginalis Culture using Trichomonas broth medium Wet Preparation/microscopy M-438 B Nasal Swabs Groin swabs Wound and other relevant sites Urine Sputum MRS screening/confirmation Chromogenic agar culture and Vitek MS M-393 Nasal Swabs Groin swabs Rectal swabs Faeces Wound and other relevant sites Urine Sputum Carbapenemase producing organism screening/confirmation Culture and Vitek MS M-413 and M -813 Faeces Detection of Clostridium difficile PCR: SeroSep EntericBio M-505 Faeces Detection of C. difficile toxin and B Techlab Quik Chek rapid membrane enzyme immunoassay kit M-505 ssessment Manager: GB2 Page 4 of 14
Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS ND TISSUES (cont d) Bacteriology (cont d) Faeces Detection of Enteric Pathogens: Salmonella sp. Shigella spp. Escherichia coli O157 and other Enteropathogenic E. coli Campylobacter spp. Yersinia spp. Vibrio spp. PCR: SeroSep EntericBio M-384 Faeces Detection of cryptosporidium and giardia PCR: SeroSep EntericBio M-384 Faeces Isolation and identification of faecal ova, cysts and parasites. Faeces Urine Detection and quantification of red cells, white cells, epithelial cells, bacteria and yeasts Sedimax Urine analyser: automated microscopy image based urine sediment analysis M-380 CSF, CPD,scites, pleural, Knee fluids Differential Cell Count Reporting numbers of leucocytes and percentage Polymorphs & Lymphocytes when necessary. Microscopy using Haemocytometer M-569 Urine Detection of Legionella pneumophila Serogroup-1 ntigen TRU Legionella Meridian Bioscience Inc. manual immunochromatographic membrane assay M-807 Urine Detection of Streptococcus pneumonia antigen Unigold S pneumonia Trinity Biotech manual immunochromatographic membrane assay M-1038 ssessment Manager: GB2 Page 5 of 14
Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS ND TISSUES (cont d) Bacteriology (cont d) Serum, CSF Cryptococcal ntigen Detection IMMY Latex Crypytococcus ntigen Detection System M-477 Body fluid, tissue, sputum, faeces, swab ll sites were FB may be indicated including CF cough swabs Presence of acid fast bacilli uramine flourescent staining, microscopy M-508 Sputum Gastric spirates Bronchial Washings/BL Urine CSF spirated fluids and pus Tissue Blood Bone Marrow ny specimen indicating history of FB Culture, identification and sensitivity testing of Mycobacteria Liquid culture / ID Bactec/MGIT, Bact/lert M-418 Manual culture / ID Pyruvate LJ slopes M-406, M-407 Species identification via PCR Hain GT BLOT 48; identification of MTBC via Cepheid GeneXpert MTB/RIF and Bactec TBc M-408 First line sensitivity testing for MTBC via Bactec/MGIT, MTBC genotypic resistance screening via Cepheid GeneXpert MTB/rif and HIN MTBDR+ M-409 Mycology Keratinised Tissue Isolation and identification of fungi of clinical significance (dermatophytic) Culture, macroscopic examination and microscopy M-419 M-421 Body Fluid; Tissue; Sputum; Swabs Throat Swabs Ear Swabs Isolation, identification and susceptibility testing of nondermatophytic fungi / yeasts of clinical significance Culture M-420 PI and Vitek 2 M-422 M-424 Sensititre ssessment Manager: GB2 Page 6 of 14
Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS ND TISSUES (cont d) Miscellaneous Joint fluid Presence of crystals Centrifugation/ polarising Microscopy M-414 Molecular testing Endocervical swabs, vaginal swabs, male/female urine, Chlamydia trachomatis and Neisseria gonorrhoeae DN detection Nucleic acid amplification: Cobas 4800 Chlamydia trachomatis and Neisseria gonorrhoeae Test. Using cobas x480 instrument and cobas z480 analyser. M-516 EDT plasma EDT plasma and serum EDT plasma and serum HIV - RN quantitation HCV - RN quantitation HBV - DN quantitation Real time PCR: bbott RealTime ssays. Using bbott m2000sp extractor and bbott m2000rt analyser. M-556 (HIV) M-543 (HCV) M-551 (HBV) M-589 (m2000sp) M-588 (m2000rt) Respiratory samples (swabs, secretions and washings) Influenza Typing: H5 RN detection In-House Real Time PCR TaqMan ssays. Using easymg extractor and LightCycler 480 analyser. M-513 (Mastermix preparation) M-579 (easymg) M-523 (H5) Respiratory samples (swabs, secretions and washings) Influenza Typing: H1(2009)/H3 (currently circulating) RN detection FLOW (as described below). ssessment Manager: GB2 Page 7 of 14
Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS ND TISSUES (cont d) Molecular testing (cont d) Respiratory samples (swabs, secretions and washings) Coronavirus Typing: OC43/229E/NL63/ MERS RN detection In-House Real Time PCR TaqMan ssays. Using easymg extractor and LightCycler 480 analyser. M-513 (Mastermix preparation) M-579 (easymg ) M-554 (OC43/229E/NL63) M-566 (MERS) M-817 (Routine Manual testing) Respiratory samples (swabs, secretions and washings), faeces, EDT plasma, serum Meningeal and sepsis screen: Enterovirus (Coxsackie/Echo) Parechovirus (1-6) Neisseria meningitidis Streptococcus pneumoniae Haemophilus influenzae DN or RN detection FLOW: In-House Real Time PCR TaqMan ssays. Using Primary Sample Handling instrument, MagN Pure 96 extractor, PCR Set Up instrument, LightCycler 480 analyser and urora analysis software. M-513 (Mastermix preparation) M-823/M-824 (FLOW) Respiratory Samples Respiratory Typing H7 In-House Real Time PCR TaqMan ssay M-579 Easymag Extractor M-599 Pure Compact Extractor M-513 Mastermix Preparation M-523 vian Flu Testing M-817 (Routine Manual testing) Respiratory samples Respiratory Screen 16: Metapneumovirus ( and B) Parainfluenza (1,2 3, 4) denovirus Human rhinovirus Human Bocavirus Coronavirus In-house Real Time PCR Taqman ssays - FLOW: M-823 FLOW System M-824 FLOW nalysis Respiratory samples Respiratory Short Screen: Influenza virus Influenza B Virus Respiratory Syncytial Virus Respiratory Syncytial B Virus FLOW: s described above M-357 Cephid GeneXpert ssessment Manager: GB2 Page 8 of 14
Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS ND TISSUES (cont d) Molecular testing (cont d) Respiratory samples (cont d) Respiratory typical Screen: Mycoplasma pneumoniae Chlamydia pneumoniae Legionella pneumophilia FLOW: s described above Bordetella pertussis FLOW: s described above Pneumocystis jirovecii FLOW: s described above CSF Meningeal and Sepsis Screen: Enterovirus Parecovirus Neiserria meningitidis Strep pneumoniae Haemophilis influenzae FLOW: s described above Faeces, vomit Gastroenteritis screen: Rotavirus Norovirus denovirus strovirus DN or RN detection Genital swabs, skin swabs, conjunctival swabs, respiratory samples (swabs, secretions and washings) Herpes Simplex 1/2 Virus DN detection Skin swabs, conjunctival swabs, respiratory samples (swabs, secretions and washings) Varicella Zoster Virus DN detection EDT plasma, serum, respiratory samples (swabs, secretions and washings), post-mortem tissues Parvovirus B19 DN detection ssessment Manager: GB2 Page 9 of 14
Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS ND TISSUES (cont d) Molecular testing (cont d) Saliva, buccal swabs, throat swabs Mumps RN detection Respiratory samples (swabs, secretions and washings) Measles RN detection Endocervical swabs, vaginal swabs, male/female urine, vulval swabs, urethral swabs, rectal swabs, throat swabs, conjunctival swabs Chlamydia trachomatis DN detection Endocervical swabs, vaginal swabs, male/female urine, vulval swabs, urethral swabs, rectal swabs, throat swabs, conjunctival swabs Neisseria gonorrhoeae DN detection EDT plasma, serum, genital swabs, anal swabs, urine, post-mortem tissues, respiratory samples (swabs, secretions and washings) Treponema pallidum (Syphilis) DN detection Respiratory samples (swabs, secretions and washings) Coxiella burnetii (Q Fever) DN detection EDT plasma, serum Epstein-Barr Virus DN quantitation EDT plasma, urine, colon biopsies Cytomegalovirus DN quantitation FLOW cont d (as described above). EDT plasma, serum, conjunctival swabs, urine denovirus DN quantitation EDT plasma, serum, urine BK Virus DN quantitation ssessment Manager: GB2 Page 10 of 14
Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS ND TISSUES (cont d) Molecular typing Pseudomonas aeruginosa positive cultures Pseudomonas aeruginosa 5- locus MLV 5 Locus MLV Typing M-1193 C.difficile positive cultures C. difficile PCR Ribotyping M-535 Nucleic acid extracts from PCR positive specimen Neisseria meningitidis TaqMan PCR M-857 Serology Serum nti-streptolysin O - IgG/IgM Quantitation Latex agglutination M-426 Serum nti-hiv 1&2 INSTI Manual immunochromatographic membrane assays M-467 Serum Cobas 8000 e602 Syphilis Toxoplasma IgG Toxoplasma IgM HIV nti - HV nti-hv IgM HBsg II M-502 ELF M-503 μ-capture M-504 M-497 Competition Test M-488 μ-capture test M-487 M-489 ssessment Manager: GB2 Page 11 of 14
Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS ND TISSUES (cont d) Serology (cont d) Serum (cont d) Cobas 8000 e602 nti-hbs M-491 rhtlv 1 & 2 M-1157 nti - HBc nti - HBc IgM HBVe ntigen nti - HBe nti - HCV II CMV IgG CMV IgM Rubella IgG Rubella IgM Competition Test M-492 μ-capture test M-493 M-494 Competition Test M-495 M-496 M-498 μ-capture test M-499 M-500 μ-capture test M-501 ssessment Manager: GB2 Page 12 of 14
Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS ND TISSUES (cont d) Serology (cont d) Serum (cont d) ELIS; Dynex DS2 Leptospira IgM - detection M-430 Serion anti Rubella IgM M-470 Syphilis IgM M-435 Coxiella burnetti Phase 2 IgM M-596 M-468 Serum ELF; Vidas HIV DUO Quick p24,igg,igm M-460 nti HBc Total II M-457 CMV IgG vidity II M-459 VZV IgG M-462 HBsg Confirmation M-476 nti-hcv M-675 Toxoplasma IgM M-437 M-585 Rapid Plasma Reagin (RPR) TPP HIV 1 & 2 Confirmatory OMEG Diagnostics IMMUNOTREP RPR Kit M-471 Serodia TPP Kit M-434 Geenius M-1330 ssessment Manager: GB2 Page 13 of 14
Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS ND TISSUES (cont d) Serology (cont d) Serum (cont d) Liaison XL VZV IgG 2-step immunoassay M-1329 M-486 VZV IgM M-481 EBV VC IgG M-483 EBV IgM M-1326 B19 IgG M-482 B19 IgM M-484 Measles IgG M-480 Borrelia IgG M-478 Borrelia IgM M-479 END ssessment Manager: GB2 Page 14 of 14