St. James s Hospital

Transcription

1 St. James s Hospital James s Street, Dublin 8. Registration number: 327MT is accredited by the Irish National Board () to undertake testing as detailed in the Schedule bearing the Registration detailed above, in compliance with the International Standard ISO/IEC 15189:2012 3rd Edition Medical laboratories Particular requirements for quality and competence (This Certificate must be read in conjunction with the Annexed Schedule of ) Date of award of accreditation: 28:October:2014 Date of last renewal of accreditation: 28:October:2014 Expiry date of this certificate of accreditation: 28:October:2019 This shall remain in force until further notice subject to continuing compliance with accreditation criteria, ISO/IEC and any further requirements specified by the Irish National Board. Manager: Chairperson: Dr Adrienne Duff Mr Tom O Neill Issued on 28 October 2014 Organisations are subject to annual surveillance and are re-assessed every five years. The renewal date on this Certificate confirms the latest date of renewal of accreditation. To confirm the validity of this Certificate, please contact the Irish National Board. is a signatory of the European co-operation for (EA) Multilateral Agreement (MLA) and the International Laboratory Cooperation (ILAC) Mutual Recognition Arrangement, for Testing. Edition 7, 19/10/ MT Page 1 of 83

2 Schedule of (Annex to Certificate) St. James s Hospital Dublin 8 Department: Initial Registration Date : Postal Address: (Address of other locations as they apply) 28-October James s Street Dublin 8 Telephone: +353 (1) Fax: Contact Name: Facilities: bkelleher@stjames.ie Mr Brian Kelleher (Quality Manager) Public testing service Telephone: +353 (1) Fax: Contact Name: Facilities: jgibbons@stjames.ie Mr John Gibbons (Laboratory Manager) Public testing service Edition 7, 19/10/ MT Page 2 of 83

3 Schedule of THE IRISH NATIONAL ACCREDITATION BOARD () is the Irish body for the accreditation of organisations including laboratories. Laboratory accreditation is available to testing and calibration facilities operated by manufacturing organisations, government departments, educational institutions and commercial testing/calibration services. Indeed, any organisation involved in testing, measurement or calibration in any area of technology can seek accreditation for the work it is undertaking. Each accredited laboratory has been assessed by skilled specialist assessors and found to meet criteria which are in compliance with ISO/IEC or ISO/IEC (medical laboratories). Frequent audits, together with periodic inter-laboratory test programmes, ensure that these standards of operation are maintained. Testing and Calibration Categories: : Permanent laboratory calibration and testing where the laboratory is erected on a fixed location for a period expected to be greater than three years. Category B: Category C: Category D: Site calibration and testing that is performed by staff sent out on site by a permanent laboratory that is accredited by the Irish National Board. Site calibration and testing that is performed in a site/mobile laboratory or by staff sent out by such a laboratory, the operation of which is the responsibility of a permanent laboratory accredited by the Irish National Board. Site calibration and testing that is performed on site by individuals and organisations that do not have a permanent calibration/testing laboratory. Testing may be performed using (a) (b) (c) (d) portable test equipment a site laboratory a mobile laboratory or equipment from a mobile or site laboratory Standard Specification or Test Procedure Used: The standard specification or test procedure that is accredited is the issue that is current on the date of the most recent visit, unless otherwise stated. Glossary of Terms Facilities: Public calibration/testing service: Conditionally available for public calibration/testing: Normally not available for public calibration/testing: Commercial operations which actively seek work from others. Established for another primary purpose but, more commonly than not, is available for outside work. Unavailable for public calibration/testing more often than not. Laboratory users wishing to obtain assurance that calibration or test results are reliable and carried out to the Irish National Board criteria should insist on receiving an accredited calibration certificate or test report. Users should contact the laboratory directly to ensure that this scope of accreditation is current. will on request verify the status and scope. Edition 7, 19/10/ MT Page 3 of 83

4 Microbiology Laboratory General Microbiology 1011 Bacteriology Investigation of Blood Cultures for organisms other than Mycobacterium species using the BioMerieux BacTALERT 3D System Blood & Fluids Microscopy, Culture, Identification & Susceptibility BioMerieux BacTALERT 3D System BioMerieux Vitek MS BioMerieux Vitek 2 LM-MICRO-0030 LP-MICRO-0030 LP-MICRO-0195 LP-MICRO-0086 Microbiological Investigation of Cryobiology Specimens Cryobiology Products Microscopy, Culture, Identification & Susceptibility BioMerieux BacTALERT 3D System BioMerieux Vitek MS BioMerieux Vitek 2 LM-MICRO-0032 Microbiological Investigation of Blood Transfusion Products Blood Transfusion Products Microscopy, Culture, Identification & Susceptibility BioMerieux BacTALERT 3D System BioMerieux Vitek MS BioMerieux Vitek 2 LM MICRO-0033 Microbiological Investigation of iv cannulae & associated specimens Tips Microscopy, Culture, Identification & Susceptibility BioMerieux Vitek MS BioMerieux Vitek 2 LM-MICRO-0015 Edition 7, 19/10/ MT Page 4 of 83

5 Microbiology Laboratory General Microbiology 1011 Bacteriology Investigation of Skin & Superficial Wound Swabs, Ear swabs associated Specimens, Swabs & other Specimens for MRSA, Cardiac(pre/post OP Staphylococci screening Swabs) Deep Seated infections & abscesses, Bile, Fluid from normally Sterile Sites, Tissues & Biopsies Investigation of Cerebrospinal Fluid. Investigation of Cerebrospinal Fluid For Cryptococcal Antigen using The CrAg Lateral Flow immunochromato graphic Assay Skin swabs Wound swabs Ear swabs Pus Fluids Tissues Biopsies Artificial devices Cerebrospinal Fluid CSF and Serum Microscopy, Culture, Identification & Susceptibility Microscopy, Culture, Identification & Susceptibility CrAg Lateral Flow Immunochromatographic Assay (IMMY) BioMerieux Vitek MS BioMerieux Vitek 2 BioMerieux BacTALERT 3D System Previ Isola BioMerieux Vitek MS BioMerieux Vitek 2 N/A LM-MICRO-0006 LM-MICRO-0010 LM-MICRO-0014 LM-MICRO-0016 LM-MICRO-0007 LM-MICRO-0008 LM-MICRO-0011 LM-MICRO-0009 LP-MICRO-0195 LP-MICRO-0086 LP-MICRO-0030 LP-MICRO-0180 LP-MICRO-0195 LP-MICRO-0086 LM-MICRO-0020 LM-MICRO-0052 Edition 7, 19/10/ MT Page 5 of 83

6 Microbiology Laboratory General Microbiology 1011 Bacteriology Investigation of Genital tract and associated specimens. Genital Specimen investigation and Handling in the GUIDE Laboratory for Microbiology High Vaginal swabs Endocervical swabs Cervical swabs Urethral swabs Male urethral swabs Rectal swabs Pharyngeal swabs NYC Plates Microscopy, Culture, Identification & Susceptibility BioMerieux Vitek MS LM-MICRO-0013 LM-MICRO-0048 LP-MICRO Growth promotion studies on BacTALERT Blood Culture bottles, 55mm TSA Contact Plates with neutralisers & Tryptic Soy Broth used in the Cryobiology Department BacTAlert Aerobic (SA) & Anaerobic (SN) bottles. Tryptic Soy Broth, 55mm TSA Contact Plates with Neutralisers Culture BioMerieux BacTALERT 3D System LM-MICRO-0037 LP-MICRO-0030 Edition 7, 19/10/ MT Page 6 of 83

7 Microbiology Laboratory General Microbiology 1011 Bacteriology Investigation of Sputum. Investigation of Respiratory Specimens for Legionella pneumophila, Investigation of Bronchoalaveolar Lavage and Assoc. Specimens, Investigation of Nasal Swabs Throat Swabs Mouth Swabs & Eye Swabs Sputum, Respiratory Specimens, BAL Eye swabs Throat swabs Nasal swabs Mouth swabs Microscopy, Culture, Identification & Susceptibility BioMerieux Vitek MS BioMerieux Vitek 2 LP-MICRO-0195 LP-MICRO-0086 LM-MICRO-0023 LM-MICRO-0004 LM-MICRO-0028 LM-MICRO-0024 LM-MICRO-0025 LM-MICRO-0026 LM-MICRO Investigation of Urine Specimens: using flow cytometry on the Uf-1000i Urine Analyser for microscopy and the Previ Isola for the inoculation of cultures Urine Microscopy, Culture and Susceptibility testing, Uf-1000i Urine Analyser Previ Isola BioMerieux Vitek MS BioMerieux Vitek 2 LM-MICRO-0019 LP-MICRO-0185 LP-MICRO-0180 LP-MICRO-0195 LP-MICRO-0086 Detection of pneumococcal urinary antigen Immunochromatographic assay using the BinaxNOW Streptococcus pneumoniae Antigen Card N/A LP-MICRO-0054 Edition 7, 19/10/ MT Page 7 of 83

8 Microbiology Laboratory General microbiology 1011 Bacteriology Investigation of faeces specimens for bacterial pathogens Screening of Specimens for Vancomycin Resistant Enterococci Screening of Specimens for Carbapenem resistance in Enterobacteriaceae Faeces Rectal Swabs Colonic aspirates Detection & characterisation of microbial DNA using EntericBio Real- Time Gastro Panel I assay & EntericBio Real-Time C. difficile assay Culture, Identification, serotyping & Susceptibility Culture, Identification & Susceptibility Roche Light Cycler 480 II BioMerieux Vitek MS BioMerieux Vitek 2 LP-MICRO-0198 LM-MICRO-0029 LP-MICRO-0195 LP-MICRO-0086 Edition 7, 19/10/ MT Page 8 of 83

9 Antibiotic susceptibility testing using: Disc diffusion Bacterial Isolates Zone measurements Calipers BioMerieux Vitek 2 LM-MICRO-0003 LP-MICRO-0094 Antibiotic susceptibility testing using: Using BioMerieux Vitek 2 Broth MIC Determination of MICs using gradient MIC method. Minimum inhibitory concentration strip diffusion Rapid detection of β-lactamase Resistance determination of CRE chromogenic detection of β-lactamase. Susceptibility testing Edition 7, 19/10/ MT Page 9 of 83

10 Microbiology Laboratory General Microbiology - Parasitology 1012 Parasitology Investigation of specimens other than blood for parasites Faeces, Worms, Sellotape slides, Duodenal/Jejunal Aspirates, Urine, Liver and Spleen Aspirates, Sputum, Tissues & Biopsies, Bile, CSF, Corneal scrapings Contact lenses Microscopy Microscope LM-MICRO-0021 LP-MICRO-0017 Edition 7, 19/10/ MT Page 10 of 83

11 Microbiology Laboratory General Microbiology Mycology 1014 Mycology Investigation of Specimens for Superficial Mycoses. Investigation of Clinical specimens for Systemic Mycoses. Skin, Hair, Nail. Biopsies, Tissue, Any sample specifically requesting prolonged fungal culture. Microscopy & Culture Microscope LM-MICRO-0022 LP-MICRO-0017 LM-MICRO-0041 Antifungal susceptibility testing of Yeasts using E-test and or Yeast One Sensititre Fungal isolates Broth MIC & Minimum inhibitory concentration strip diffusion LM MICRO-0039 Calcofluor White Stain Microscopy LM-MICRO-0034 Edition 7, 19/10/ MT Page 11 of 83

12 Microbiology Laboratory Virology Serology 1016 Serology of Infection.02 Qualitative detection of Hepatitis B virus surface antigen using Abbott Architect HBsAg Qualitative assay & Chemiluminescent Microparticle Immunoassay Quantitative detection of Hepatitis B virus surface antibody using Abbott Architect Anti-HBs Assay Qualitative detection of antibody to Hepatitis C virus using Abbott Architect Anti- HCV Assay Blood: Serum Blood: Serum Blood: Serum Qualitative Serology testing Using Abbott Architect HBsAg Qualitative assay & Chemiluminescent Microparticle Immunoassay (CMIA) technology Quantitative Serology testing Using Abbott Architect Anti-HBs Assay & Chemiluminescent Microparticle Immunoassay (CMIA) technology Qualitative Serology testing Using Abbott Architect Anti-HCV Assay & Chemiluminescent Microparticle Immunoassay (CMIA) technology Abbott Architect i4000 SR Abbott Architect i4000 SR Abbott Architect i4000 SR LM-SERO-0017 LP-MICRO-0102 LM-SERO-0017 LP-MICRO-0102 LM-SERO-0017 LP-MICRO-0102 Edition 7, 19/10/ MT Page 12 of 83

13 Microbiology Laboratory Virology Serology 1016 Serology of Infection.02 Qualitative detection of antibody to Treponema pallidum Using the Abbott Architect Syphilis TP assay & Chemiluminescent Microparticle Immunoassay Blood: Serum Qualitative Serology testing Using the Abbott Architect Syphilis TP assay & Chemiluminescent Microparticle Immunoassay (CMIA) technology Abbott Architect i4000 SR LM-SERO-0017 LP-MICRO-0102 Qualitative detection of HIV p24 antigen, HIV- 1 antibody & HIV- 2 antibody. Qualitative detection of Hepatitis B core Antibody, using the Abbott Architect Anti- HBc II assay, & CMIA technology Blood: Serum Blood: Serum Qualitative Serology testing using the Abbott Architect HIV Ag/Ab Combo assay, & Chemiluminescent Microparticle Immunoassay (CMIA) technology & the Biomerieux HIV DUO Enzyme Linked Fluorescent Assay Qualitative Serology testing using the Abbott Architect Anti-HBc II assay & Chemiluminescent Microparticle Immunoassay (CMIA) technology Abbott Architect i4000 SR Biomerieux Mini Vidas Abbott Architect i4000 SR LM-SERO-0017 LP-MICRO-0102 LM-SERO-0026 LP-MICRO-0209 LM-SERO-0017 LP-MICRO-0102 Edition 7, 19/10/ MT Page 13 of 83

14 Microbiology Laboratory Virology Serology 1016 Serology of Infection.02 Qualitative detection of Hepatitis C Antigen, using the Abbott Architect HCV Ag assay, & CMIA technology Non-Treponemal test for the qualitative & semi-quantitative detection of syphilis using the BioKit RPR Reditest Kit. Semi-quantitative detection of antibodies to Treponema pallidum. Blood: Serum Blood: Serum Blood: Serum Qualitative Serology testing using the Abbott Architect HCV Ag assay & Chemiluminescent Microparticle Immunoassay (CMIA) technology Particle agglutination using BioKit RPR Semi-quantitative Serology testing using the Serodia-TP-PA particle agglutination test Abbott Architect i4000 SR N/A N/A LM-SERO-0017 LP-MICRO-0102 LM-SERO-0007 LM-SERO-0008 Detection of IgM specific antibodies to Treponema pallidum Blood: Serum Serology testing using Lab 21 Syphilis IgM EIA N/A LM-SERO-0006 Edition 7, 19/10/ MT Page 14 of 83

15 Microbiology Laboratory Virology - Serology 1016 Serology of Infection.02 A Line Immuno Assay to confirm the presence of antibodies against Treponema pallidum - supplementary test on specimens. Enzyme immuno assay for the detection of antibodies to human Hepatitis C virus (HCV) Qualitative & semi-quantitative determination of Anti-Streptolysin O (ASO) Detection of Aspergillus Galactomannan antigen. Blood: Serum Blood: Serum Blood: Serum Blood: Serum Serology testing using INNOGENETICS INNO-LIA Syphilis Score Serology testing using INNOGENETICS INNOTEST HCV Ab IV kit. Latex agglutination slide test using Randox ASO Latex test. Immunoenzymatic sandwich microplate assay using the BIO-RAD Platelia Aspergillus Ag kit N/A N/A N/A N/A LM-SERO-0009 LM-SERO-0018 LM-SERO-0015 LM-SERO-0016 Edition 7, 19/10/ MT Page 15 of 83

16 Microbiology Laboratory Virology Serology 1016 Serology of Infection.02 Qualitative detection of Legionella pneumophila serogroup 1 antigen (used as an adjunct to culture for the presumptive diagnosis of past or current Legionnaires' disease) Qualitative detection of Hepatitis A virus IgM antibody using the Abbott Architect HAVAb-IgM assay & Chemiluminescent Microparticle Immunoassay. Urine Blood: Serum Serology testing: Enzyme immuno assay test using the BINAX Legionella Urinary Antigen EIA kit. Qualitative Serology testing using the Abbott Architect HAVAb-IgM assay & Chemiluminescent Microparticle Immunoassay (CMIA) technology N/A Abbott Architect i4000 SR LM-SERO-0013 LM-SERO-0020 LP-MICRO-0102 Edition 7, 19/10/ MT Page 16 of 83

17 Microbiology Laboratory Virology - Serology 1016 Serology of Infection.02 Qualitative detection of Hepatitis A virus IgG antibody. Qualitative detection of IgG antibodies to Epstein-Barr Nuclear Antigen-1 (EBNA-1) using the Abbott Architect EBV EBNA-1 IgG assay & Chemiluminescent Microparticle Immunoassay Blood: Serum Blood: Serum Qualitative Serology testing using the Abbott Architect HAVAb-IgG assay & Chemiluminescent Microparticle Immunoassay (CMIA) technology Qualitative Serology testing using the Abbott Architect EBV EBNA-1 IgG assay & Chemiluminescent Microparticle Immunoassay (CMIA) technology Abbott Architect i4000 SR Abbott Architect i4000 SR LM-SERO-0020 LP-MICRO-0102 LM-SERO-0022 LP-MICRO-0102 Edition 7, 19/10/ MT Page 17 of 83

18 Microbiology Laboratory Virology - Molecular Diagnostics 1013 Virology.04 Detection of Hepatitis B virus (HBV) DNA using the Abbott m2000 HBV Quantitative assay Detection of Cytomegalovirus DNA using the Argene CMV R- gene assay Blood: EDTA Plasma Blood: EDTA Plasma Detection & characterisation of viral DNA Detection & characterisation of viral DNA using Argene CMV R-gene assay. Abbott m2000 System NucliSENS easymag instrument Applied Biosystems 7500 PCR System LM-MOL-0022 LP-MICRO-0109 LM-MOL-0033 LP-MICRO-0188 LP-MICRO-0091 LP-MICRO-0205 Roche LightCycler 480 Detection of Epstein Barr virus DNA using Argene EBV R-gene assay. Blood: EDTA Plasma Detection & characterisation of viral DNA using Argene EBV R-gene assay. NucliSENS easymag instrument Applied Biosystems 7500 PCR System LM-MOL-0033 LP-MICRO-0188 LP-MICRO-0091 LP-MICRO-0205 Roche LightCycler 480 Edition 7, 19/10/ MT Page 18 of 83

19 Microbiology Laboratory Virology Molecular Diagnostics 1013 Virology.04 Detection of Adenovirus DNA using Argene ADV R-gene Blood: EDTA Plasma Detection & characterisation of viral DNA NucliSENS easymag instrument Applied Biosystems 7500 PCR System LM-MOL-0033 LP-MICRO-0188 LP-MICRO-0091 LP-MICRO-0205 Detection & typing of Herpes simplex virus (HSV) DNA using an In-house Realtime PCR Assay. Detection of Influenza A/B, RSV, hmpv and HPIV using the Argene r-gene Real Time PCR assay Genital swabs Perianal swabs Mouth swabs Nasopharyngeal aspirate (NPA) and Nose / Throat swabs. Detection & characterisation of viral DNA Real time PCR Roche LightCycler 480 NucliSENS easymag instrument Applied Biosystems 7500 PCR System Applied Biosystems 7500 PCR System NucliSENS easymag instrument LM-MOL-0034 LP-MICRO-0188 LP-MICRO-0091 LP-MICRO-0188 LP-MICRO-0091 LM-MOL-0032 Detection of Varicella-zoster (VZV) DNA using an In-house Realtime PCR Assay Dermal swabs Ocular swabs Detection & characterisation of viral DNA NucliSENS easymag instrument Applied Biosystems 7500 PCR System LM-MOL-0034 LP-MICRO-0188 LP-MICRO-0091 Edition 7, 19/10/ MT Page 19 of 83

20 Microbiology Laboratory Molecular Diagnostics 1011 Bacteriology.08 Qualitative detection of Chlamydia trachomatis & Neisseria gonorrhoeae DNA using the Abbott CT/NG Real-time Assay Endocervical, vaginal, urethral, pharyngeal, rectal, urine samples Detection & characterisation of microbial DNA using the Abbott CTNG Real-time Assay Abbott m2000 System LM-MOL-0014 LP-MICRO-0109 Qualitative detection of Neisseria gonorrhoeae DNA using an In-house Real-time PCR Assay. Endocervical, vaginal, urethral, pharyngeal, rectal, urine samples Detection & characterisation of microbial DNA using an In-house Real-time PCR Assay. Abbott m2000 System Applied Biosystems 7500 PCR System LM-MOL-0015 LP-MICRO-0109 LP-MICRO Qualitative detection of LGV DNA using Realtime PCR Assay Rectal swabs Detection of Chlamydia trachomatis serovar L1-L3 DNA using a lab-developed Real-time PCR Assay. Nucleic acid extraction performed using the Abbott m2000sp instrument and real-time PCR performed using the AB 7500 SDS. Abbott m2000 System Applied Biosystems 7500 PCR System LM-MOL-0036 LP-MICRO-0109 LP-MICRO-0091 Edition 7, 19/10/ MT Page 20 of 83

21 Microbiology Laboratory National MRSA Reference Laboratory 1011 Bacteriology.05 Identification of microorganisms Bacterial cultures Biochemical tests N/A LM-MRSA-0002 LM-MICRO-0001 LP-MICRO-0086 LP-MICRO Antimicrobial susceptibility testing using disk diffusion Specialised antibiotic procedures Minimum inhibitory concentrations using E-tests.08 Detection and characterisation of microbial DNA/ RNA Bacterial cultures Bacterial Cultures Bacterial cultures Bacterial cultures Zone measurements N/A LM-MRSA-0002 LM-MRSA-0003 Screening and broth microdilution Minimum inhibitory concentration strip diffusion PCR and sequencing N/A N/A Applied Biosystems 7500 PCR system LM-MRSA-0007 and LM-MRSA LM-MRSA-0005 LM-MRSA-0011 LM-MRSA-0012 Edition 7, 19/10/ MT Page 21 of 83

22 Microbiology Laboratory Irish Mycobacteria Reference Laboratory 1015 Myco- Bacteriology Investigation of specimens for Mycobacterium species using Auramine Stain & the BACTEC MGIT 960 system and the Bactec 9050 (Blood Cultures) from Becton Dickinson in conjunction with Lowenstein- Jenson Medium (with pyruvate and with glycerol) Sputum, induced sputum Bronchiallavage, washings, brushings, biopsies Gastric washings Early morning urine Cerebrospinal fluid Body fluidspleural, peritoneal, synovial, pericardial Skin and tissue specimens Abscess contents and aspirated pus Wound swabs Blood cultures Bone Marrow EBUS Microscopy & Culture, Detection by fluorescent sensor technology Becton Dickinson BACTEC MGIT 960 system Becton Dickinson Bactec 9050 LM-IMRL-0001 LM-IMRL-0002 LM-IMRL-0008 LP-IMRL-0001 LP-IMRL-0005 LP-IMRL-0026 LP-IMRL-0050 Edition 7, 19/10/ MT Page 22 of 83

23 Microbiology Laboratory Irish Mycobacteria Reference Laboratory Test / Assay Name Specimen Type Method 1015 Myco- Bacteriology.03 Microscopic examination of Ziehl-Neelsen preparations of culture positive material. Positive Cultures Microscopy N/A LM-IMRL-0002 LM-IMRL-0008 Identification of M. tuberculosis complex using the Becton Dickinson MGIT TBc Identification test.04 Molecular identification of Mycobacterium species using the GenoType Mycobacterium assays (HAIN LifeScience). GenoType Mycobacterium CM (Common Mycobacteria) GenoType Mycobacterium AS (Additional Species) GenoType Mycobacterium MTBC (M. tuberculosis complex) Positive Cultures Detection by fluorescent sensor technology Immunochromatographic assay Identification by amplification & detection of target DNA. Becton Dickinson BACTEC MGIT 960 system Veriti Thermal Cyclers GT-Blot 48 LM-IMRL-0012 LP-IMRL-0001 LP-IMRL-0005 LM-IMRL-0009 LP-IMRL-0005 LP-IMRL-0035 LP-MICRO-0117 LM-IMRL-0015 LM-IMRL-0014 Speciation within the MAC complex using 16S and ITS sequencing Identification of Non Tuberculosis Mycobacteria in the IMRL by sequencing the 65kd heat Shock Protein (hsp65) Gene Edition 7, 19/10/ MT Page 23 of 83

24 Microbiology Laboratory Irish Mycobacteria Reference Laboratory 1015 Myco- Bacteriology.05 Susceptibility testing of first and second line anti-tuberculous drugs (streptomycin, isoniazid, rifampicin, ethambutol, pyrazinamide, moxifloxacin, ofloxacin, capreomycin, amikacin and kanamycin) using the BACTEC MGIT 960 system (Becton Dickinson). Positive Cultures Susceptibility testing by fluorescent sensor technology Becton Dickinson BACTEC MGIT 960 system LM-IMRL-0006 LP-IMRL-0005 LP-IMRL-0050 Molecular detection of M. tuberculosis complex and resistance conferring mutations to rifampicin, isoniazid, fluoroquinolone, aminoglycoside/cyclic peptide and ethambutol using the GenoType MTBDRplus and MTBDRsl assay (HAIN LifeScience) Molecular detection of M. tuberculosis complex and rifampicin resistance in clinical specimens using the GeneXpert system (Cepheid) Positive Cultures pulmonary and extrapulmonary specimens Amplification and detection of target DNA Amplification and detection of target DNA Veriti Thermal Cyclers GT-Blot 48 Cepheid GeneXpert System LM-IMRL-0009 LP-IMRL-0035 LP-MICRO-0117 LM-IMRL-0013 LP-IMRL-0052 Edition 7, 19/10/ MT Page 24 of 83

25 Microbiology Laboratory Irish Mycobacteria Reference Laboratory 1015 Myco- Bacteriology.99 Molecular epidemiology typing of M. tuberculosis complex isolates using 24 locus MIRU-VNTR typing kit (GenoScreen) Positive Isolates Amplification and detection of target DNA ABI 3130 Genetic Analyser LM-IMRL-0010 LP-IMRL-0048 LP-IMRL-0005 Edition 7, 19/10/ MT Page 25 of 83

26 Haematology Laboratory Test / Assay Name Specimen Type Method 1030 Haematology Full Blood Count (FBC) including, WBC, reticulocyte and nucleated RBC quantitation Blood Film examination EDTA Blood EDTA Blood Electrical impedance cell counting and sizing, Fluorescent Flow Cytometry & Spectrophotometry Blood film staining Sysmex XN 10 and 20 Automated Blood Cell Counters SP 10 blood film stainer Haem-RH- LM-0026 Haem - RH LP Erythrocyte Sedimentation rate (ESR) EDTA Blood Manual blood film examination by microscopy. Sysmex DI 60 Automated digital morphology system with operator reclassification and result validation. Screening test for.57 Infectious Mononucleosis.09 Malaria Screen EDTA Blood Manual microscopy Immunochromatographic test Microscopes Sysmex DI 60 Starrsed Interrliner Automated ESR analyser EDTA Blood Immunoassay Manual Test Microscopy & manual Test Haem-LP-RH-0015 Haem-LM-RH Haem-LP-RH-0017 Haem-LP- RH-0016 Haem-LM-RH Haem-LM-RH Haem-LM-RH Edition 7, 19/10/ MT Page 26 of 83

27 Haematology Laboratory 1030 Haematology.55 Ferritin Serum.58 Vitamin B12 Serum Serum Folate / Folic Acid IF (Intrinsic Factor) Antibody (Ab.) Homocysteine (Hcy.) Erythropoietin (EpO) Serum Transferrin Receptor (stfr) Cyclosporine A Serum Serum EDTA Blood Serum Serum EDTA Blood Chemiluminescent immunometric assay Chemiluminescent immunometric assay Chemiluminescent immunometric assay Chemiluminescent immunometric assay Chemiluminescent immunometric assay Chemiluminescent immunometric assay Chemiluminescent immunometric assay Chemiluminescent immunometric assay Siemens Advia Centaur XP Siemens Advia Centaur XP Siemens Advia Centaur XP Beckman- Coulter Access 2 Siemens Advia Centaur XP Beckman- Coulter Access 2 Beckman- Coulter Access 2 Siemens Advia Centaur XP HAEM-LM-NA HAEM-LM-NA HAEM-LM-NA HAEM-LM-NA HAEM-LM-NA HAEM-LM-NA HAEM-LM-NA HAEM-LM-NA Tacrolimus (FK 506) EDTA Blood Chemiluminescent immunometric assay Abbott Architect HAEM-LM-NA Edition 7, 19/10/ MT Page 27 of 83

28 Haematology Laboratory 1030 Haematology.20 MGG stain for Bone Marrow aspirates Bone marrow Iron Stain Bone Marrow Cytochemical stain IUL polystainer Bone Marrow Cytochemical stain Manual Test HAEM-LM-SH HAEM-LM-SH Plasma Viscosity Dapsone Screen (Heinz Body Screen) Haemoglobinopathy Screen Tests for Haemoglobin variants and Thalassemia EDTA Blood/Serum Viscometery Benson Viscometer EDTA Blood Supra vital stain Manual Test EDTA Blood EDTA Blood HPLC Capillary Electrophoresis Biorad Variant Sebia Capillarys 2 flex piercing analyser HAEM-LP-SH HAEM-LM-SH HAEM-LP-SH HAEM-LP-SH IEF of Hb EDTA Blood Isoelectric focussing Multiphor Electrophoresis Hb H inclusions EDTA Blood Supra vital stain Manual Test Sickle screen EDTA Blood Solubility test Manual Test Membrane Screen EDTA Blood Flow Cytometry BD Facs Canto II PNH Screen EDTA Blood Flow Cytometry BD Facs Canto II Urinary Haemosiderin Urine Cytochemical stain Manual Test HAEM-LM-SH HAEM-LM-SH HAEM-LP-SH HAEM-LM-SH HAEM-LM-SH HAEM-LM-SH Haptoglobin EDTA Blood Radial Immuno diffusion Manual Test HAEM-LM-SH Edition 7, 19/10/ MT Page 28 of 83

29 Haematology Laboratory 1030 Haematology.36 Glucose-6- phosphate - Dehydrogenase (G6PD) screen EDTA Blood.37 G6PD Assay EDTA Blood Fluorescent spot test Spectrophotometric assay Manual Test Thermospectronic Helios Gamma HAEM-LM-SH- 0069A HAEM-LM-SH- 0069B Edition 7, 19/10/ MT Page 29 of 83

30 Haematology Laboratory Test / Assay Name Specimen Type Method 1030 Haematology.70 Immunophenotyping (breakdown below): Bone Marrow in RPMI or EDTA Blood Flow Cytometry BD Facs Canto II Chronic Lymphoproliferative Panels: Antigens Tested. B cell panel: CD19, CD5, CD3, CD45, surface Kappa, Surface Lambda, CD38, CD43, CD200, Surface IgM, FMC7, CD20, CD10, CD22, CD23, CD103, CD11c, CD25 and CD79b. T cell panel: CD5, CD3, CD19, CD45, CD7, CD5, CD2, CD4, CD8, CD26 TCRab, TCRgd, CD16, CD56. Bone Marrow in RPMI or EDTA Blood Flow Cytometry BD Facs Canto II HAEM-LM-SH-0103 HAEM-LM-SH-0110 Edition 7, 19/10/ MT Page 30 of 83

31 Haematology Laboratory 1030 Haematology.70 Acute Leukaemia Panel: Antigens Tested: CD45, CD19, CD117, CD34, CD14, CD64, CD33, CD7, CD13, HLA-DR, CD2, CD10, CD20, CD38, CD56, CD34, cyt MPO, cyt CD3, cyt CD79a, nuc TdT, CD68, cyt IgM, Surface IgM, CD15, CD36, CD11b, CD4, GLY-A, CD41, CD1a, CD123, CD5, CD8, CD9, CD99, CD65, CD138 and NG2. Bone Marrow in RPMI or EDTA Blood Flow Cytometry BD Facs Canto II HAEM-LM-SH-0103 HAEM-LM-SH-0110 HAEM-LM-SH-0104 Edition 7, 19/10/ MT Page 31 of 83

32 Haematology Laboratory 1030 Haematology.70 Minimal Residual Disease (MRD) B-CLL Assay: Antigens tested: CD 19, CD3, CD56, CD45, CD5, Surface Ig Light chains Kappa and Lambda, CD38, CD20, CD22, CD81, CD43, CD79b. T Cell Enumeration: Antigen tested CD3, CD19 and CD45 Bone Marrow in RPMI or EDTA Blood Bone Marrow in RPMI or EDTA Blood Flow Cytometry Flow Cytometry BD Facs Canto II BD Facs Canto II HAEM-LM-SH HAEM-LM-SH CSF Immunophenotyping; Antigens tested: CD19, CD3, CD10, CD45, CD4, CD8, CD20, CD14, CD34, CD5, CD7 and CD117 CSF Flow Cytometry BD Facs Canto II HAEM-LM-SH Edition 7, 19/10/ MT Page 32 of 83

33 Haematology Laboratory 1030 Haematology.41 PT APTT D-Dimer Fibrinogen Fibrinogen Fibrinogen Reptilase Time Thrombin Time Sodium Citrate Sodium Citrate Sodium Citrate Sodium Citrate Sodium Citrate Sodium Citrate Sodium Citrate Sodium Citrate Photo-optical detection Photo-optical detection Enzyme Linked Fluorescent Assay Photo-optical detection Mechanical detection Radial Immuodiffusion Mechanical detection Mechanical detection ACL TOP ACL TOP MINI VIDAS ACL TOP Thrombotrack Select 2 Immuno- Viewer Plate Reader Thrombotrack Select 2 Thrombotrack Select 2 HAEM-LM- COAG-0077 HAEM-LM- COAG-0077 HAEM-LM- COAG-0012 HAEM-LM- COAG-0084 HAEM-LM- COAG-0008 HAEM-LM- COAG-0046 HAEM-LM- COAG-0114 HAEM-LM- COAG-0010 Anticoagulant drug monitoring Warfarin, Heparin Sodium Citrate Photo-optical detection ACL TOP HAEM-LM- COAG-0077 HAEM-LM- COAG-0112 Edition 7, 19/10/ MT Page 33 of 83

34 Haematology Laboratory Test / Assay Name Specimen Type Method 1030 Haematology.40 Anticoagulant drug monitoring Rivaroxaban/ Dabigatran/Argatroban /Apixaban Correction Tests Factor II:C assay Factor V:C assay Factor VII:C assay Factor X:C assay Factor VIII:C assay Factor IX:C assay Factor XI:C assay Factor XII:C assay Factor VIII Inhibitor assay Factor IX Inhibitor assay FVIII chromogenic assay Factor XIII assay VWF:Ag assay VWF Multimer analysis VWF:RCo assay Sodium Citrate Sodium Citrate Sodium Citrate Sodium Citrate Sodium Citrate Sodium Citrate Sodium Citrate Sodium Citrate Sodium Citrate Sodium Citrate Sodium Citrate Sodium Citrate Sodium Citrate Sodium Citrate Sodium Citrate Sodium Citrate Sodium Citrate Photo-optical detection Photo-optical detection Photo-optical detection Photo-optical detection Photo-optical detection Photo-optical detection Photo-optical detection Photo-optical detection Photo-optical detection Photo-optical detection Photo-optical detection Photo-optical detection Photo-optical detection ACL TOP ACL TOP ACL TOP ACL TOP ACL TOP ACL TOP ACL TOP ACL TOP ACL TOP ACL TOP ACL TOP ACL TOP ACL TOP HAEM-LM-COAG-0101 HAEM-LM-COAG-0102 HAEM-LM-COAG-0110 HAEM-LM-COAG-0113 HAEM-LM-COAG-0021 HAEM-LM-COAG-0105 HAEM-LM-COAG-0106 HAEM-LM-COAG-0107 HAEM-LM-COAG-0108 HAEM-LM-COAG-0095 HAEM-LM-COAG-0104 HAEM-LM-COAG-0096 HAEM-LM-COAG-0097 HAEM-LM-COAG-0115 HAEM-LM-COAG-0030 HAEM-LM-COAG-0118 Latex immunoassay ACL TOP HAEM-LM-COAG-0087 Latex immunoassay ACL TOP HAEM-LM-COAG-0099 Plasma Immunoelectrophor esis Photo-optical detection Sub-Cell GT Agarose Gel Electrophore sis System Sysmex CS2100i HAEM-LM-COAG-0073 HAEM-LM-COAG-0100 Edition 7, 19/10/ MT Page 34 of 83

35 Haematology Laboratory 1030 Haematology.40 VWF:CB assay VWF:FVIII Binding analysis Antithrombin assay Protein C assay Protein S assay (Free antigen) APCR assay Lupus Anticoagulant screen Heparin Induced Thrombocytopenia Screen: Heparin PF4 Antibody Screening Test Sodium Citrate Sodium Citrate Sodium Citrate Sodium Citrate Enzyme Linked ImmunoSorbent Assay Enzyme Linked ImmunoSorbent Assay Photo-optical detection Photo-optical detection Labsystems Multiskan RC Plate reader Labsystems Multiskan RC Plate reader ACL TOP ACL TOP Sodium Citrate Latex immunoassay ACL Elite Pro Sodium Citrate Sodium Citrate Serum Photo-optical detection Photo-optical detection Particle gel immunoassay ACL TOP ACL TOP Diamed ID- Centrifuge HAEM-LM- COAG-0065 HAEM-LM- COAG-0103 HAEM-LM- COAG-0089 HAEM-LM- COAG-0091 HAEM-LM- COAG-0078 HAEM-LM- COAG-0092 HAEM-LM- COAG-0090 HAEM-LM- COAG-0058 Heparin Induced Thrombocytopenia Screen: IgG ELISA Serum Enzyme Linked ImmunoSorbent Assay Memert Hot Air Oven and Labsystems Multiskan RC Plate reader HAEM-LM- COAG-0085 Edition 7, 19/10/ MT Page 35 of 83

36 Haematology Laboratory 1030 Haematology.45 Platelet Function Tests.45 Quantitation of platelet adenine nucleotides using firefly luminescence.80 Prothrombin G20210A mutation analysis Factor V Leiden analysis Sodium Citrate Photo-optical detection Helena BioSciences AggRAM (Aggregation Remote Analyser Module) CTAD Luminescence Promega Glomax 20/20 Luminometer EDTA Blood EDTA Blood Point mutation genotyping Point mutation genotyping Roche MagNapure Compact and Lightcycler 2.0 Roche MagNapure Compact and Lightcycler 2.0 HAEM-LM- COAG-0032 HAEM-LM- COAG-0083 HAEM-LM- COAG-0064 HAEM-LM- COAG-0072 Edition 7, 19/10/ MT Page 36 of 83

37 F8 gene mutation screen EDTA Blood PCR amplification, dideoxyresequencing, F8 intron 22 Inversion F8 intron 1 MagNaPure Compact, Applied Biosystems 2720 Thermal cycler, ABI GeneAmp PCR system 2700 Eppendorf 5810R centrifuge, EC 105 Electrophoresis Powerpack, Electophoresis tank 1-3, Microwave, Vortex mixers, UVTec gel documentation system and Applied Biosystems ABI 3130 Genetic Analyser. HAEM-LM-HMD HAEM-LM-HMB Edition 7, 19/10/ MT Page 37 of 83

38 Haematology Laboratory 1030 Haematology.80 F9 gene mutation screen EDTA Blood PCR amplification, dideoxy-resequencing, MagNaPure Compact, Applied Biosystems 2720 Thermal cycler, ABI GeneAmp PCR system 2700, Eppendorf 5810R centrifuge, EC 105 Electrophoresis Powerpack, Electophoresis tank 1-3, Microwave, Vortex mixers, UVTec gel documentation system and Applied Biosystems ABI 3130 Genetic Analyser. HAEM-LM-HMD HEM-LP-HMD Edition 7, 19/10/ MT Page 38 of 83

39 VWF gene mutation screen EDTA Blood PCR amplification, dideoxy-resequencing MagNaPure Compact, Applied Biosystems 2720 Thermal cycler, ABI GeneAmp PCR system 2700 ABI 3130, Eppendorf 5810R centrifuge, EC 105 Electrophoresis Powerpack, Electophoresis tank 1-3, Microwave, Vortex mixers, UVTec gel documentation system and Applied Biosystems ABI 3130 Genetic Analyser HAEM-LM-HMD Edition 7, 19/10/ MT Page 39 of 83

40 Haematology Laboratory 1030 Haematology.80 SERPINC1 gene mutation screen EDTA Blood PCR amplification, dideoxy-resequencing MagNaPure Compact, Applied Biosystems 2720 Thermal cycler, ABI GeneAmp PCR system 2700 Eppendorf 5810R centrifuge, EC 105 Electrophoresis Powerpack, Electophoresis tank 1-3, Microwave, Vortex mixers, UVTec gel documentation system and Applied Biosystems ABI 3130 Genetic Analyser. HAEM-LP-HMB- 027 HAEM-LP-HMB- 017 HAEM-LM-HMB Edition 7, 19/10/ MT Page 40 of 83

41 Carrier analysis, known mutation analysis EDTA Blood PCR amplification, dideoxy-resequencing MagNaPure Compact, Applied Biosystems 2720 Thermal cycler, ABI GeneAmp PCR system 2700 ABI 3130, Eppendorf 5810R centrifuge, EC 105 Electrophoresis Powerpack, Electophoresis tank 1-3, Microwave, Vortex mixers, UVTec gel documentation system and Applied Biosystems ABI 3130 Genetic Analyser. HAEM-LM-HMD HEM-LP-HMD , HAEM-LP-HMD -005, HAEM-LP-HMD -006, Edition 7, 19/10/ MT Page 41 of 83

42 Haematology Laboratory 1030 Haematology.80 MPLA of the Factor VIII Gene Mutation screen of the fibrinogen genes (FGA, FGB, FGG) EDTA Blood EDTA Blood Multiplex Ligation dependent Probe Amplification MagNaPure Compact,Nanodrop Spectrophotometer, Applied Biosystems 2720 Thermal cycler, ABI GeneAmp PCR system 2700 Applied Biosystems ABI 3130 Genetic Analyser. MagNaPure Compact, Applied Biosystems 2720 Thermal cycler, ABI GeneAmp PCR system 2700 Eppendorf 5810R centrifuge, EC 105 Electrophoresis Powerpack, Electophoresis tank 1-3, Microwave, Vortex mixers, UVTec gel documentation system and Applied Biosystems ABI 3130 Genetic Analyser. 028 HAEM-LM-HMD HAEM-LM-HMD- 002 PCR amplification, dideoxyresequencing HAEM-LM-HMD Edition 7, 19/10/ MT Page 42 of 83

43 MYH9 gene mutation screen EDTA Blood MagNaPure Compact, Applied Biosystems 2720 Thermal cycler, ABI GeneAmp PCR system 2700, Eppendorf 5810R centrifuge, EC 105 Electrophoresis Powerpack, Electophoresis tank 1-3, Microwave, Vortex mixers, UVTec gel documentation system and Applied Biosystems ABI 3130 Genetic Analyser. PCR amplification, dideoxyresequencing HAEM-LM-HMD Edition 7, 19/10/ MT Page 43 of 83

44 Immunology Laboratory 1040 Immunology -.03 Total IgE Quantitative investigation of Total IgE in Serum Serum Enzyme Immunoassay Phadia Immunocap 250 analyser LM-IMM Immunology -.04 Allergen Specific IgE 1040 Immunology.06 Investigation of Complement Quantitative investigation of Serum samples for Allergen specific IgE & specific IgG Quantitative investigation of C3 and C4 complement components Serum Serum Enzyme Immunoassay Turbidimetry Phadia Immunocap 250 analyser Roche COBAS 6000 system LM-IMM-0036 LM-IMM-0035 LM-IMM-0051 Evaluation of blood haemolytic complement activity by the classical and alternative pathways Serum ELISA WeissLab ELISA KITS: DYNEX DS2 ANALYSER LM-IMM-0063 Quantitative measurement of C1 inhibitor level Serum Turbidimetry Binding Site SPA PLUS LM-IMM-0056 Determination of C1 esterase inhibitor function Serum ELISA Technoclone ELISA Kit LM-IMM-0008 Edition 7, 19/10/ MT Page 44 of 83

45 Immunology Laboratory.08 CSF Neurodegeneration Quantitative determination of ß-amyloid (1-42) / Total Tau (htau CSF Enzyme Immunoassay Innogenetics Innotest ELISA LM-IMM-0057 Biomarker assay Ag) and Phospho Tau (181P) in human cerebrospinal fluid (CSF)..10 Rheumatoid Factor Quantitative assays Quantitative investigation of rheumatoid factor in serum Serum Turbidimetry Roche COBAS 6000 system LM-IMM-0051 Edition 7, 19/10/ MT Page 45 of 83

46 Immunology Laboratory 1040 Immunology.12 Detection of Autoantibodies Investigation of serum samples for autoantibodies: dsdna Serum Enzyme- Immunoassay Phadia Immunocap 250 analyser LM-IMM-0052 B2 Glycoprotein Cardiolipin IgG Myeloperoxidase Proteinase 3 ttg (IgA) CCP ENA Symphony ENA Profile (RNP, Sm, Ro, LA, Scl- 70, Jo-1) GBM TPO PDH Serum Enzyme Immunoassay EURO-diagnostika ELISA KIT LM-IMM-0031 GAD Serum Enzyme Immunoassay Euroimmune ELISA kit LM-IMM-0047 Myositis specific antibodies Neuronal Antibodies Serum Serum Immunoblot Immunoblot EUROLine Immunoblot test kit LM-IMM-0062 LM-IMM-0067 Edition 7, 19/10/ MT Page 46 of 83

47 Immunology Laboratory 1040 Immunology.13 Cryoglobulins Identification of the presence of cryoglobulins Serum Immunofixation Sebia Hydrasis system LM-IMM B2- Microglobulin Quantitative measurement of B2-microglobulin Serum Turbidimetry Roche COBAS 6000 system LM-IMM Tests of Cellular Immunity quantitation of lymphocytes Enumeration of lymphocyte subsets EDTA whole blood Flow cytometry Becton Dickinson FacsCanto cytometer LM-IMM Assessment of neutrophils and monocytes in vitro functional tests Functional analysis of neutrophils EDTA whole blood Flow cytometry Becton Dickinson FacsCanto cytometer LM-IMM Cell Markers - Measurement of Surface Receptors on Lymphocytes by Flow Cytometry Measurement of Naïve, Memory and Effector T and B cell subsets, T cell receptor (TCR) double negative and activation markers (HLA-DR, CD25, CD38). EDTA whole blood Flow cytometry.54 - Tryptase Tryptase Serum Enzyme- Immunoassay Becton Dickinson FacsCanto cytometer Phadia Immunocap 250 analyser LM-IMM-0055 LM-IMM-0037 Edition 7, 19/10/ MT Page 47 of 83

48 Immunology Laboratory 1040 Immunology 0.55 Detection of immune complexes in body fluids and biopsy material Detection of autoantibodies on skin biopsies Punch skin biopsy Direct Immunofluorescence Bright Starlet Cryostat LM-IMM Simple slide tests for Immunology Investigations of autoantibodies: Serum Indirect immunofluorescence ANA dsdna ANCA LKS Screen EMA BP PV NMDA Neuronal Antibodies (CSF also for NMDA) INOVA IF slides INOVA QUANTA-lyser 240 LM-IMM-0039 LM-IMM-0014 LM-IMM-0004 LM-IMM-0005 LM-IMM-0017 LM-IMM-0020 LM-IMM-0053 LM-IMM-0065 LM-IMM-0066 Edition 7, 19/10/ MT Page 48 of 83

49 Immunology Laboratory Test / Assay Name Specimen Type Method Immunology 1061 Clinical Chemistry.02 Proteins Quantitative analysis Quantitative analysis of proteins in human serum/csf/urine: CSF Albumin CSF IgG Urinary total protein CSF Urine Serum Turbidimetry Roche COBAS 6000 system LM-IMM-0051 Serum total protein Albumin A1 antitrypsin Caeruloplasmin Transferrin TPO IgG1, IgG2, IgG3, IgG4 Free kappa/lambda light chains Serum Turbidimetry Binding Site SPAPLUS LM-IMM-0058 Edition 7, 19/10/ MT Page 49 of 83

50 Immunology Laboratory Test / Assay Name Specimen Type Method Immunology.81 Qualitative investigation of immunoglobuli n G, A, M in bodily fluids Investigation of monoclonal gammopathies in urine and serum Detection of Oligoclonal IgG in CSF Serum Urine Serum CSF Electrophoresis and Immunotyping/ Immunofixation Isoelectric focusing Sebia Capillarys 3 and Sebia Hydrasis system Sebia Hydrasis system LM-IMM-0007 LM-IMM-0026 LM-IMM-0064 LM-IMM-0001 Edition 7, 19/10/ MT Page 50 of 83

51 Immunology Laboratory Test / Assay Name Specimen Type Method Immunology 0.99 Miscellaneous tests Investigation and identification of urinary casts Urine Microscopy Leitz DMLB Microscope LM-IMM-0038 Measurement of specific antibodies to microbial antigens: Pneumococcus Tetanus Haemophilus influenza type B Serum ELISA Binding Site Anti-PCP IgG & IgG2, anti- Tetanus Toxoid IgG and Haemophilus influenzae ELISA kit LM-IMM-0023 LM-IMM-0025 Interferon Gamma Release Assay (IGRA) Serum ELISA QuantiFERON- TB Gold ELISA Kits LM-IMM-0061 Edition 7, 19/10/ MT Page 51 of 83

52 Histopathology Laboratory Test / Assay Name Specimen Type Method 1051 Histopathology.01 Processing fixed samples for Histopathological testing Specimen reception Fixation & Decalcification Cut-up Tissue processing Tissue embedding Microtomy Automated & Manual H&E Staining Coverslipping Human Tissue Cassette printer Leica IPC Tissue processor VIP150 Tissue processor VIP5 Tissue processor Pathos Delta Embedding Centre TEC5 Microtome Micron HM325 Microtome Micron HM355S Microtome Leica RM2255 Macropath D Specimen Camera Sakura Prisma Stainer Coverslipper Tissue-tek G2 Olympus BX40 microscope Olympus BX50 microscope LM-HIST-0002 LM-HIST-0003 LM-HIST-0004 LM-HIST-0005 LM-HIST-0006 LM-HIST-0009 LM-HIST-0011 LP-HIST-0001 LP-HIST-0002 LP-HIST-0004 LP-HIST-0005 LP-HIST-0006 LP-HIST-0007 LP-HIST-0050 LP-HIST-0056 LP-HIST-0068 LP-HIST-0083 LP-HIST-0099 LP-HIST-0101 LP-HIST-0119 LP-HIST-0124 LP-HIST-0125 LP-HIST-0127 LP-HIST-0135 LP-HIST-0142 LP-HIST-0143 LP-HIST-0153 Edition 7, 19/10/ MT Page 52 of 83

53 Histopathology Laboratory Test / Assay Name Specimen Type Method 1051 Histopathology.02 Immediate frozen section diagnosis Frozen Section cryotomy and staining Assisting at Moh s surgery Human Tissue Cryostat CM1900 Cryostat BM/FAS Safety cabinet Microflow Bio-Optica trimming station Linistain stainer Olympus BX50 microscope LM-HIST-0001 LP-HIST-0017 LP-HIST-0051 LP-HIST-0076 LP-HIST-0091 LP-HIST-0092 LP-HIST-0097 LP-HIST-0101 Edition 7, 19/10/ MT Page 53 of 83

54 Histopathology Laboratory Test / Assay Name Specimen Type Method 1051 Histopathology.03 Histochemistry (Special stains) Manual: Alcian blue Congo Red Elastic Haemaoxylin & Eosin Elastic Van Gieson Giemsa Gram Twort Martius scarlet blue Masson Fontana Oil Red O Rapid Romanowsky stain Shikata Orcein Sirius Red Southgate's Mucicarmine Von Kossa technique Wade Fite Human Tissue Microtome Micron HM325 Microtome Leica RM2255 Microtome Micron HM355S Dako Artisan Stainer Coverslipper Tissue-tek G2 Olympus BX40 microscope LM-HIST-0007 LP-HIST-0050 LP-HIST-0068 LP-HIST-0098 LP-HIST-0125 LP-HIST-0142 LP-HIST-0153 Automated: Periodic acid schiff D-Periodic acid schiff Perl's Prussian blue Reticulin stain Warthin Starry Ziehl Neelson Gomorri's Trichrome Grocott Hexamine Silver.04 Histological Interpretation Specialist Areas Excluded: Medical Renal Pathology Paediatric Pathology Perinatal Pathology Neuropath ology Human Tissue Olympus BX50 microscope LP-HIST-0003 LP-HIST-0101 Specialist Areas Included: Breast Pathology Edition 7, 19/10/ MT Page 54 of 83

55 Histopathology Laboratory Test / Assay Name Specimen Type Method 1051 Histopathology.05 Immunochemistry Automated immunocytochemistry Antibody panel Androgen receptor Actin Smooth Muscle AFP Alk Protein Alk-NSCLC Alpha Synuclein Alpha-1-antitrypsin Bcl-2 Bcl-6 Ber/EP4 Beta-A4 BOB-1 CA125 Calcitonin Caldesmin Calponin Calretinin CD10 CD11C CD123 CD15 CD1a CD2 CD20 CD21 CD23 CD25 Human Tissue Microtome Micron HM325 Microtome Leica RM2255 Microtome Micron HM355S Immunostainer Ventana XT Immunostainers Benchmark Ultra Coverslipper Tissue-tek G2 Olympus BX40 microscope LM-HIST-0020 LP-HIST-0050 LP-HIST-0068 LP-HIST-0129 LP-HIST-0125 LP-HIST-0142 LP HIST-0148 LP-HIST-0149 LP-HIST-0153 Edition 7, 19/10/ MT Page 55 of 83

56 Histopathology Laboratory Test / Assay Name Specimen Type Method 1051 Histopathology.05 Immunochemistry CD3 CD30 CD31 CD34 CD38 CD4 CD43 CD45 CD5 CD56 CD68 CD7 CD72 CD79a CD8 CDX2 CEA Chromogranin C-kit (CD117) CMV Cmyc Coll IV Cyclin D1 D2-40 Desmin Desmin/AE1AE3 DOG-1 EBV (LMP) E-Cadherin EMA Factor 8 Gata 3 Human Tissue Microtome Micron HM325 Microtome Leica RM2255 Microtome Micron HM355S Immunostainers Benchmark Ultra Immunostainer Ventana XT Coverslipper Tissue-tek G2 Olympus BX40 microscope LM-HIST-0020 LP-HIST-0050 LP-HIST-0068 LP-HIST-0129 LP-HIST-0125 LP-HIST-0142 LP-HIST-0148 LP-HIST-0149 LP-HIST-0153 Edition 7, 19/10/ MT Page 56 of 83

57 Histopathology Laboratory Test / Assay Name Specimen Type Method 1051 Histopathology.05 Immunochemistry GFAP Glycophorin A Glypican 3 Granzyme B HBc Ag HBs Ag HCG Helicobactor Pylori Hep Par. Her2 (4B5) Herpes HHV8 HMB45 HMBE-1 IGA IGD IGG IgG4 IGM Inhibin KerAE1AE3 Keratin 19 Keratin 20 Keratin 5/6 Keratin 7 Keratin 903 Keratin Cam 5.2 Keratin MNF Lysozyme Mammaglobin Human Tissue Microtome Micron HM325 Microtome Leica RM2255 Microtome Micron HM355S Immunostainers Benchmark Ultra Immunostainer Ventana XT Coverslipper Tissue-tek G2 Olympus BX40 microscope LM-HIST-0020 LP-HIST-0050 LP-HIST-0068 LP-HIST-0129 LP-HIST-0125 LP-HIST-0142 Lp-HIST-0148 LP-HIST-0149 LP-HIST-0153 Edition 7, 19/10/ MT Page 57 of 83

58 Histopathology Laboratory Test / Assay Name Specimen Type Method 1051 Histopathology.05 Immunochemistry Melan-A Mib-1 Mic-2 (CD99) MLH-1 MSH-2 MSH-6 MUC-4 MUM-1 Myeloperoxidase Myf-4 Neurofilament NSE OCT-2 OCT-4 Oestrogen Receptor P16 P504s P53 P63 P63/AE1AE3 P63/P504 Pax-5 Pax-8 PD-1 Perforin PLAP PMS2 Progesterone Receptor PSA S100 SM Myosin SOX-11 Synaptophysin Syphilis Tau Human Tissue Microtome Micron HM325 Microtome Leica RM2255 Microtome Micron HM355S Immunostainers Benchmark Ultra Immunostainer Ventana XT Coverslipper Tissue-tek G2 Olympus BX40 microscope LM-HIST-0020 LP-HIST-0050 LP-HIST-0068 LP-HIST-0129 LP-HIST-0125 LP-HIST-0142 LP-HIST-0148 LP-HIST-0149 LP-HIST-0153 Edition 7, 19/10/ MT Page 58 of 83

59 Histopathology Laboratory Test / Assay Name Specimen Type Method 1051 Histopathology.05 Immunochemistry TdT Thyroglobulin TIA-1 Toxoplasma Tryptase TTF Ubitiquin Vimentin VS38 WT1 Human Tissue Microtome Micron HM325 Microtome Leica RM2255 Microtome Micron HM355S Immunostainers Benchmark Ultra Immunostainer Ventana XT Coverslipper Tissue-tek G2 Olympus BX40 microscope LM-HIST-0020 LP-HIST-0050 LP-HIST-0068 LP-HIST-0129 LP-HIST-0125 LP-HIST-0142 LP-HIST-0148 LP-HIST-0149 LP-HIST-0153 Edition 7, 19/10/ MT Page 59 of 83

60 Histopathology Laboratory Test / Assay Name Specimen Type Method 1051 Histopathology.06 Fluorescence In Situ Hybridisation HER2 FISH ALK FISH breakapart. MYC breakapart. Bcl2 breakapart. Bcl6 breakapart. MALT-1 t(8:14)(q24;q32) fusion t(14:18)(q32;q21) fusion t(11:14)(q13;q11) fusion ROS-1 FISH Human Tissue VP2000 processor Tissue section Hybridizer Olympus BX51 & BX61 Fluorescent Microscopes LP-HIST-0079 LP-HIST 0115 LP-HIST-0129 LP-HIST-0132 LP-HIST-0133 LP-HIST-0134 LP-HIST-0139 LP-HIST-0140 LP-HIST Chromogenic / Brightfield In Situ Hybridisation Automated EBV ISH Automated Kappa ISH Automated Lambda ISH Human Tissue Olympus BX40 microscope Immunostainer Ventana XT LP-HIST-0068 LP-HIST-0079 LP-HIST-0132 LP-HIST-0139 Edition 7, 19/10/ MT Page 60 of 83

61 Histopathology Laboratory Test / Assay Name Specimen Type Method 1052 Cytopathology.02 Non- Gynaecological cytology Specimen reception Staining Coverslipping Processing Preparation of Specimens for Flow Cytometry. Processing of Cell Clots and Thrombin Clots. Processing of Samples and Thin Prep Vials for ICC and Special Stains. Human Tissue Cytocentrifuge IV Safety cabinet Microflow Thin Prep 2000 Dako Medimachine Stainer DRS2000 Medite coverslipper Olympus BX40 microscope LM-CYT-0003 LM-CYT-0004 LM-CYT-0005 LM-CYT-0006 LM-CYT-0007 LM-CYT-0008 LM-CYT-0009 LM-CYT-0010 LM-CYT-0011 LM-CYT-0013 LM-CYT-0015 LM-CYT-0016 LM-CYT-0017 LM-CYT-0018 LM-CYT-0019 LP-CYT-0001 LP-CYT-0020 LP-CYT-0024 LP-CYT-0025 LP-CYT-0029 LP-CYT-0030 LP-CYT-0031 LP-CYT Diagnostic Interpretation & Reporting Diagnostic Reporting & Interpretation of Non- Gynae Cytology Human Tissue Olympus BX50 microscope LP-CYT-0003 LP-HIST-0101 Edition 7, 19/10/ MT Page 61 of 83