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 Department of Immunology Southampton General Hospital Tremona Road Southampton SO16 6YD United Kingdom Contact: Dr Efem Eren Tel: +44 (0) Testing performed at the above address only Website: atoryservices.aspx HUMAN BODY FLUIDS DETAIL OF ACCREDITATION for the purposes of clinical diagnosis Autoimmunity & Allergy specific IgE to: Almond Amoxicilloyl Ampicilloyl Animal mix - Cat dander, Horse dander, Cow dander, Dog dander Aspergillus fumigatus Avocado Banana Barley Brazil nut Cacao Caged bird mix - Budgerigar feathers, Canary bird feathers, Parakeet feathers, Parrot feathers, Finch feathers Cashew nut Cat dander Cefaclor Cereal mix - Wheat, Oat, Maize, Sesame seed, Buckwheat Cheese, cheddar type Chicken Chickpea Chlorhexidine Coconut Cod fish Common silver birch Common wasp (Yellow jacket). Thermofisher Immunocap 250 analyser (fluorescence solid phase immunoassay) SOP IIC 1.26 Assessment Manager: PW Page 1 of 11

2 Autoimmunity & Allergy specific IgE to : Dog dander Egg Egg white Egg yolk Ethylene oxide Feather mix - Goose feathers, Chicken feathers, Duck feathers, Turkey feathers Fish mix - Fish, Shrimp, Blue mussel, Tuna, Salmon Gal-alpha-1,3-Gal thyroglobulin Bovine Gelatin bovine General food mix - Egg white, Milk, Fish, Wheat, Peanut, Soybean Gluten Grape Grass mix - Dactylis glomerata, Festuca elatior, Lolium perenne, Phleum pratense, Poa pratensis Hazel nut Honey bee Horse dander House dust mite (Dermatophagoides pteronyssinus) Kiwi Latex Lemon Lupin seed Maize/Corn Mast cell tryptase Milk Milk, boiled Morphine Mould mix - Penicillium chrysogenum, Cladosporium herbarum, Aspergillus fumigatus, Alternaria alternate Thermofisher Immunocap 250 analyser (fluorescence solid phase immunoassay) SOP IIC 1.26 (Cont d) Assessment Manager: PW Page 2 of 11

3 Autoimmunity & Allergy specific IgE to : ngal d 1 Ovomucoid, Egg Nut mix - Peanut, Hazel nut, Brazil nut, Almond, Coconut Oat Orange Peanut Pecan nut Penicilloyl G Penicilloyl V Pholcodine Pistachio Pityrosporum orbiculare Rabbit epithelium, rara h 2 Peanut rara h 8 PR-10, Peanut rcor a 1 PR-10, Hazel nut rcor a 14, Hazel nut rcor a 8 LTP, Hazel nut rpru p 3 LTP, Peach rtri a 19 Omega-5 Gliadin, Wheat Rye Salmon Sesame seed Shrimp Soybean Staphylococcal enterotoxin B Strawberry Suxamethonium (succinylcholine) Timothy grass Tomato Tree mix - Acer negundo, Betula verrucosa, Fagus grandifolia, Quercus alba, Juglans californica Walnut Wheat Thermofisher Immunocap 250 analyser (fluorescence solid phase immunoassay) Cont d SOP IIC 1.26 Assessment Manager: PW Page 3 of 11

4 Urine Urine Immunoglobulins: IgG, IgA and IgM serum proteins IgG, IgA, IgM plus Kappa and Lambda light chains (standard mask) Monoclonal component Immunoglobulins: IgG IgA IgM Kappa light chains Lambda light chains Detection of urine monoclonal proteins Detection of: IgG IgA IgM Kappa light chains Lambda light chains (free and bound) Sebia Capillarys2 system Capillary zone electrophoresis SOP IIC 1.5 Immunofixation SOP IIC 1.5 Scanning densitometry SOP IIC 1.5 Sebia Hydrasys 2 system Immunofixation SOP IIC 1.2 Urine protein electrophoresis SOP IIC 1.29 SOP IIC 1.30 Immunofixation SOP IIC 1.4 Assessment Manager: PW Page 4 of 11

5 Serum/Plasma/CSF Serum/Plasma/Urine Serum/Plasma/CSF Immunoglobulins and specific proteins: Immunoglobulin G Immunoglobulin A Immunoglobulin M Immunoglobulin E Complement C3 Complement C4 Beta-2 microglobulin Haptoglobin Rheumatoid factor Immunoglobulins and specific proteins: Immunoglobulin G Immunoglobulin A Immunoglobulin M Immunoglobulin E Complement C3 Complement C4 Beta-2 microglobulin Albumin Rheumatoid factor Freelite Lambda light chain Freelite Kappa light chain Immunoglobulins: Beckman AU5800 Immunoassay SOP AUM54 SOP AUM53 SOP AUM55 SOP AUM56 SOP AUM58 SOP AUM59 SOP AUM57 SOP AUM61 SOP AUM62 Beckman Coulter Immage Nephelometer SOP IIC 1.23 Iso Electric Focussing using inhouse gels and GE EPS 3501 XL Serum/Plasma/CSF Oligoclonal band detection SOP IIC 1.20 SOP IIC 1.21 Assessment Manager: PW Page 5 of 11

6 Detection of autoantibodies: Fluorescence solid phase immunoassay on the Thermofisher Immunocap 250 analyser Anti M2 antibody SOP IAI 2.0 & 2.8 Anti-Tissue transglutaminase (IgA) SOP IAI 2.0 & 2.12 Anti-Myeloperoxidase SOP IAI 2.0 & 2.1 Anti-proteinase 3 SOP IAI 2.0 & 2.1 Anti-Glomerular basement SOP IAI 2.0 & 2.2 membrane Anti-double DNA SOP IAI 2.0 & 2.4 Anti Ro (SSA) antibody SOP IAI 2.0 & 2.6 Anti La (SSB) antibody SOP IAI 2.0 & 2.6 Anti RNP antibody SOP IAI 2.0 & 2.6 Anti Scl-70 antibody SOP IAI 2.0 & 2.6 Anti Jo-1 antibody SOP IAI 2.0 & 2.6 Anti CCP antibody SOP IAI 2.0 & 2.7 Anti-tissue transglutaminase (IgG) SOP IAI 2.0 &2.11 Anti Tryptase SOP IAI 2.0 & 3.0 Anti A.fumigatus (IgG) SOP IAI 2.0 & 3.1 Anti M. faeni/ A.thermophylae mix SOP IAI 2.0 & 3.1 (IgG) Anti-Pigeon serum proteins (IgG) SOP IAI 2.0 & 3.1 CTD screen containing: dsdna SSA/Ro SSB/La Sm, RNP SCL-70 Jo1 PMScl Centromere B Fibrillarin RNA pol III Rib. P Mi2 SOP IAI 2.0 & 2.3 Faecal extract B2GP1 SOP IAI 2.0 & 2.9 Extractable nuclear antigen screen SOP IAI 2.0 & 2.5 Calprotectin SOP IAI 2.0, 2.13a & 2.13b Assessment Manager: PW Page 6 of 11

7 Detection of autoantibodies: Immunochromatographic assay Anti-Glomerular basement membrane antibody Biodiagnostics Ltd anti-gbm Quickcard SOP IAI 5.4 Detection of autoantibodies: Indirect Immunofluorescence using the Eurostar UV microscope and Werfen ASP slide processor or Manual IIF preparation Auto Immune liver screen (ANA, SOP IAI 4.0, 4.1 & 4.3 SMA, GPC, MITO, LKM) ANCA screen SOP IAI 4.0, 4.1 & 4.2 Adrenal auto antibody SOP IAI 4.0, 4.1 & 4.5 Bullous auto antibody SOP IAI 4.0, 4.1 & 4.5 Centromere auto antibody SOP IAI 4.0, 4.1 & 4.4 Endomysial auto antibody SOP IAI 4.0, 4.1 & 4.5 Islet cell auto antibody SOP IAI 4.0, 4.1 & 4.5 Neuronal auto antibody SOP IAI 4.0, 4.1 & 4.5 Salivary gland auto antibody SOP IAI 4.0 & 4.5 Ovarian auto antibody SOP IAI 4.0, 4.1 & 4.5 Skeletal muscle auto antibody SOP IAI 4.0 & 4.5 Cardiac muscle autoantibody SOP IAI 4.0 & 4.5 Hep2 auto antibody screen SOP IAI 4.0, 4.1 & 4.4. Crithidia lucilliae dsdna screen SOP IAI 4.0, 4.1 & 4.5 Gastric parietal cell auto antibody SOP IAI 4.0, 4.1 & 4.5 Detection of autoantibodies: Manual Immunoblot SOP IAI 5.0 Extended ENA screen Myositis. Consists of: PL7 PL12 EJ SRP Mi2 MDA-5 TIF1-gamma HMGCR Ro52 Blue Dot reagent Assessment Manager: PW Page 7 of 11

8 Serum/ CSF Extended ENA screen Scleroderma. Consists of: Centromere-A Centromere-B PM-Scl 100 PM-Scl 75 Ku RNA-polymerase 3 Paraneoplastic antibody screen for: Anti Hu Anti Yo Anti Ri Anti CV2 Anti Amphiphysin Anti Ma1 Anti Ma2 Ganglioside blot for: Anti GM1 Anti GM2 Anti GM3 Anti GM4 Anti GD1a Anti GD1b Anti CD2 Anti CD3 Anti GT1a Anti GT1b Anti GQ1b Manual Immunoblot Blue Dot reagent Manual Immunoblot using Ravo Diagnostics reagents SOP IAI 5.1 Manual Immunoblot using Generic Assays reagent SOP IAI 5.2 Detection of autoantibodies: ELISA detection and quantification using Molecular Devices VMax plate reader Nucleosomes Histones Anti Glutamic acid decarboxylase Generic Assays reagent (manual process) SOP IAI 6.0 Organtec reagent (manual process) SOP IAI 6.0 RSR reagent (manual process) SOP IIC 1.37 Assessment Manager: PW Page 8 of 11

9 Detection of autoantibodies: ELISA detection and quantification using Molecular Devices VMax plate reader Anti Acetyl Choline receptor antibody RSR reagent (manual process) SOP IIC 1.39 Detection of autoantibodies: ELISA detection and quantification using Dynex DS2 automatic plate processor Anti-Cardiolipin IgG Anti-Cardiolipin IgM Intrinsic factor antibodies Anti-Thyroid peroxidise Detection and semi-quantification of autoantibodies: Functional antibodies against Tetanus toxoid Functional antibodies against S.pneumoniae Functional antibodies against H. influenza C1 Esterase (functional) Organtec reagent SOP IAI 1.1 & 1.3 Organtec reagent SOP IAI 1.1 & 1.3 Organtec reagent SOP IAI 1.1 & 1.4 Organtec reagent SOP IAI 1.1 & 1.2 ELISA detection and quantification using Molecular Devices VMax plate reader Binding site reagent (manual process) SOP IIC 1.8 Binding site reagent (manual process SOP IIC 1.9 Binding site reagent (manual process) SOP IIC1.7 Quidel reagent (manual process) SOP IIC 1.34 Assessment Manager: PW Page 9 of 11

10 CH50 Complement function test Binding site reagent (manual process) SOP IIC 1.3 Detection and semi-quantification of autoantibodies: Immunoglobulin A (low concentration) Immunoglobulin subclasses IgG1-4 C1 Esterase AP5 Radial Immunodiffusion (RID) Manual RID Binding site reagent SOP IIC 1.12 Manual RID Binding site reagent SOP IIC 1.19 Manual RID Binding site reagent SOP IIC 1.28 Manual RID Binding site reagent SOP IIC 1.31 Blood/ CSF/ Bone marrow Flow Cytometry Flow Cytometry using BD Bioscience FACSCanto II Flow cytometer CD4 Count for Monitoring: CD3,8,45 and 4 mix SOP FLOW030 HLA-B27 Lymphocyte Subsets: CD3, CD4, CD8, CD16/CD56, CD45 and CD19 Memory B cell Subsets: CD19, IgM and CD27 Paroxysmal Nocturnal Haemoglobinuria (PNH): CD235a, CD55/CD59 tandem mix, CD45, CD24, CD15 and FLAER VH Bio (B27) and DB (CD3) SOP FLOW031 SOP FLOW032 SOP FLOW033 SOP FLOW034 Assessment Manager: PW Page 10 of 11

11 Blood/ CSF/ Bone marrow Flow Cytometry Flow Cytometry using BD Bioscience FACSCanto II Flow cytometer. Neutrophil Oxidative Burst: Percentage of phagocytic cells which produce reactive oxidants (conversion of DHR 123 to R 123) and their enzymatic activity (amount of R 123 per cell) Estimation of Fetomaternal Haemorrhage (FMH) Memory T cell Subsets: CD45A, CD27, CD3 and CD8 Leukaemia and Lymphoma Immunophenotyping Acute screen: CD34, CD7,CD71, CD45,CD5, CD10, CD19, CD20, CD15, CD117, CD34, DR, CD33, CD3, CD2,CD13, CD14, CD64, CD41a, GPA, CD61, TDT and MPO B Cell abnormality: BD CD5, CD10, CD19, CD38, CD103, CD22, CD20, CD79b, FMC7, CD23, CD25, CD11C, Kappa/Lambda, CD38, CD56, CD138 and TDT T Cell abnormality: BD CD3, CD25, DR, CD69, CD45A, CD27, CD8, CD26, CD7 and CD4 BD Glycotope Biotechnology kit (Phagoburst) SOP FLOW035 NBTS reagent (BRAD3 and AEVZ) SOP FLOW040 SOP FLOW044 Flow Cytometry using BD Bioscience FACSCanto II Flow cytometer SOP FLOW039 SOP FLOW039 SOP FLOW039 SOP FLOW039 END Assessment Manager: PW Page 11 of 11

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