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 Issue No: 003 Issue date: 25 January 2019 Blood Sciences (Biochemistry) Pathology Building Queen Alexandra Hospital Portsmouth PO6 3LY United Kingdom Contact: Mr Alex Walster Quality, Risk & Governance Manager Tel: +44 (0) Website: ology.htm Testing performed at the above address only DETAIL OF ACCREDITATION TISSUES diagnosis Serum unless otherwise stated Biochemistry Automation plus specific methods listed below: Alanine Aminotransferase (ALT) Albumin Alcohol Alkaline Phosphatase (ALP) Alpha-1-Antitrypsin (AAT) Alpha fetoprotein (AFP) IFCC P5P-Activated Methodology BCG Methodology Kinetic UV method IFCC AMP-Buffer Methodology Immunoturbidometric method Amylase IFCC- EPS Methodology EDTA Plasma Ammonia Enzymatic colorimetric assay Aspartate Aminotransferase (AST) Routine Chemistry: IFCC P5P activated Methodology Assessment Manager: BD Page 1 of 20

2 Biochemistry Automation (cont d) Serum unless otherwise stated B2M Latex Particle immunoturbidimetric method BHCG Bicarbonate (CO2) Bile acids Routine Chemistry: PEPC Methodology Enzymatic colorimetric assay Paediatric serum sample Bilirubin REICHERT UNISTAT Bilirubinometer, LPR-BSL-AB- BILIRUBINOMETER Direct photometry at 460nm and 550nm CA 15-3 CA 19-9 CA125 Calcium Carbamazepine Chemiluminescent Chemiluminescent Routine Chemistry: Arsenazo III method Therapeutic Drug Monitoring: CEDIA B Galactosidase Assay Assessment Manager: BD Page 2 of 20

3 Biochemistry Automation (cont d) Serum unless otherwise stated Caeruloplasmin Specific Proteins: Immunoturbidimetric method Carcinoembryonic antigen (CEA) Cholesterol CK Complement C3 Complement C4 Routine Chemistry: CHE enzymatic method IFCC NAC-Activated Methodology Specific proteins: Goat anti-c3, PEG 6000 Immunoturbidimetric method Specific proteins: Goat anti-c4, PEG 6000 Immunoturbidimetric method Conjugated bilirubin Routine Chemistry: 3,5 Dichlorophenyl diazonium tetrafluoroborate (DPD) Methodology Cortisol C-Reactive Protein Specific proteins: Latex Particle immunoturbidimetric method Assessment Manager: BD Page 3 of 20

4 Biochemistry Automation (cont d) Serum unless otherwise stated Creatinine Routine Chemistry: Kinetic Jaffe (compensated) Methodology Dehydroepiandrosterone (DHEA) Digoxin Erythropoietin (EPO) Therapeutic Drug Monitoring: Immunoturbidometric assay Ferritin Chemiluminescent Free-T3 Free-T4 FSH Gamma-Glutamyl Transferase (GGT) Gentamicin Chemiluminescent Chemiluminescent Chemiluminescent Routine Chemistry: IFCC Glutamylcarboxy-p-nitroanilide Methodology CEDIA B Galactosidase Assay Assessment Manager: BD Page 4 of 20

5 Biochemistry Automation (cont d) Serum & fluoride oxalate plasma Glucose Hexokinase Methodology Serum unless otherwise stated Growth Hormone Chemiluminescent Haptoglobin HCG HDL Cholesterol IgA IgG IgM Intact-PTH PTH Iron Specific Proteins: Immunoturbidimetric method Routine Chemistry: Enzymatic colorimetric Immunoturbidimetric method Immunoturbidimetric method Immunoturbidimetric method Beckman Access 2: LPR-BSL-S- Access2 Chemiluminescent Fast PTH assay Routine Chemistry: TPTZ colorimetric method Assessment Manager: BD Page 5 of 20

6 Biochemistry Automation (cont d) Serum unless otherwise stated Lactate Lactate Oxidase Enzyme assay Serum & Cerebrospinal Fluid Lactate Dehydrogenase (LDH) IFCC Lactate to Pyruvate Methodology LH Lithium Magnesium Therapeutic Drug Monitoring: Spectrophotmetric, Thermo Infinity method Xylidyl blue Methodology Phenobarbitone Phenytoin Phosphate Potassium Progesterone Prolactin Prostate Specific Antigen (PSA) Beckman AU 5800/680 CEDIA B Galactosidase Assay CEDIA B Galactosidase Assay Phospho-Molybdate Methodology Indirect ISE-Crown ether membrane Assessment Manager: BD Page 6 of 20

7 Biochemistry Automation (cont d) Serum unless otherwise stated Salicylate Routine Chemistry: Enzyme assay Chloride Folate Glucose Sex Hormone Binding Globulin Sodium Testosterone Theophylline Routine Chemistry: Indirect ISE- Oriented PVC membrane Routine Chemistry: Hexokinase Methodology Routine Chemistry: Indirect ISE- Crown ether membrane Therapeutic Drug Monitoring: CEDIA B Galactosidase Assay Assessment Manager: BD Page 7 of 20

8 Biochemistry Automation (cont d) Serum unless otherwise stated Thyroglobulin Total Bilirubin Total Protein 3,5-dichlorophenyldiazonium tetrafluoroborate (DPD) Methodology Biuret Methodology Transferrin Triglyceride Troponin I TSH Urate Specific Proteins: Immunoturbidimetric method Enzymatic/GPO Methodology Routine Chemistry: Uricase Enzymatic Trinder Methodology Assessment Manager: BD Page 8 of 20

9 Biochemistry Automation (cont d) Serum unless otherwise stated Urea GLDH/Kinetic Methodology Valproate CEDIA B Galactosidase Assay Vancomycin Vitamin B12 Vitamin D Calcium (adjusted) Calcium Creatinine Ratio Particle-enhanced turbidimetric immunoassay Calculated Calculated Urine CAPD Creatinine (Correct) Calculated Creat/Clear Estimated GFR (Females) Estimated GFR (Males) Lo.Dens.Lip (LDL) Calculated Calculated Calculated Calculated Urine Protein Creatinine Ratio Calculated Free Testosterone Free Androgen Index Total Chol / HDL Chol Ratio Calculated Calculated Calculated Assessment Manager: BD Page 9 of 20

10 Biochemistry Automation (cont d) Urine Amylase IFCC-EPS Methodology Urine Albumin Immunoturbidimetric method Urine Calcium Arsenazo III method Urine Chloride Indirect ISE-Oriented PVC membrane Urine Creatinine Kinetic Jaffe (compensated) Urine Glucose Hexokinase Methodology Urine Magnesium Xylidyl blue Methodology Urine Phosphate Phospho-Molybdate Methodology Urine Potassium Indirect ISE-Crown ether membrane Urine Protein Pyrogallol Red method Urine Sodium Indirect ISE-Crown ether membrane Urine Urate Uricase Enzymatic Trinder Methodology Urine Urea GLDH/Kinetic Methodology Cerebrospinal Fluid Albumin BCG Methodology Cerebrospinal Fluid Lactate Lactate Oxidase Enzyme assay Cerebrospinal Fluid Total Protein Pyrogallol Red method Assessment Manager: BD Page 10 of 20

11 Biochemistry Automation (cont d) Cerebrospinal Fluid Glucose Hexokinase Methodology Antenatal Screening Serum Serum BHCG PAPP-A UE3 Delfia Xpress analyser LPR-BSL-S- XPRESS Serum AFP Serum Inhibin Beckman Access2 LPR-BSL-S- Access2 EDTA whole blood Sickledex screening Solubility test LPR-BSL-S-SICCHK Neonatal Screening Bloodspots TSH Autodelfia analyser, LPR-BSL-S-TSH (DELFIA) IRT Haemoglobin variants (new-born screening) Phenylalanine Carnitines C8 & C10 BioRad HPLC VNBS, SOP: LPR- BSL-S-VNBS HPLC Tandem Mass spectrometer LPR-BSL-S-TQD LC-MSMS Tyrosine Leucine Methionine C5 / C5DC Assessment Manager: BD Page 11 of 20

12 EDTA whole blood Haemoglobin variants (antenatal screening) Manual Biochemistry TOSOH G8 HPLC, SOP; LPR-BSL- S-TosG8Thal HPLC Serum/Urine Osmolality Advanced Instruments Osmometer BSL-AB-PR-OSM3320 Freezing point depression Whole blood (EDTA) HbA1c TOSOH G8 LPR-BSL-M-HBAIC HLPC Whole blood (EDTA) Ciclosporin Waters TMS LPR-BSL-M- IMMUNOSUPPRESSANT Tandem Mass Spectrometry Whole blood (EDTA) Tacrolimus Waters TMS LPR-BSL-M- IMMUNOSUPPRESSANT Tandem Mass Spectrometry Urine Urine Bilirubin and Urobilinogen Roche Combur 9 urine dipsticks LPR-BSL-M-UBIL Roche Combur 9 urine dipsticks Urine Oxalate Trinity Biotech Kit with UV Spectrophotometer LPR-M-BSL- OXALATES Enzymatic, Colorimetric, Endpoint Cerebrospinal Fluid Xanthochromia UV/Vis Spectrophotometer LPR- BSL-M-XANTHOCHROMIA Scanning UV/Vis spectrophotometer Assessment Manager: BD Page 12 of 20

13 Sweat Chloride UV/Vis Spectrophotometer LPR- BSL-M-SWEAT CHLORIDE Inhouse colorimetric method (mercuric thiocyanate and ferric nitrate) Serum SST unless otherwise stated B-2 Microglobulin Beckman AU 5800/680 LI-BSL-AB-AU5800 & LI-BSL-AB- AU680 turbidometric Serum free light chains C1 esterase inhibitor Spa Plus LPR-BSL-I-SFLC Immunonephelometry Spa Plus LPR-BS-P-CINH Immunonephelometry Urine Bence-Jones Protein Sebia Hydrasys 2 LPR-BSL-I-HSYS, LPR-BSL-I- DENSIT, LPR-BSL-I-UPE Protein electrophoresis Urine Urine Immunofixation Sebia Hydrasys 2 LPR-BSL-I-HSYS, LPR-BSL-I- UIFE Protein electrophoresis with immunofixation Whole blood Haemoglobin Electrophoresis Sebia Hydrasys 2 LPR-BSL-I-HSYS, LPR-BSL-I-HB ELECT Electrophoresis (Acid and Alkali) Protein Electrophoresis Capillarys 2 LPR-BSL-I-CAPILLARYS Capillary zone electrophoresis Immunotyping Capillarys 2 LPR-BSL-I-CAPILLARYS Capillary zone electrophoresis Assessment Manager: BD Page 13 of 20

14 Proteins Section Serum SST unless otherwise stated Serum Immunofixation Sebia Hydrasys 2 LPR-BSL-I-HSYS, LPR-BSL-I-SIFE Protein electrophoresis with immunofixation BNP Vidas 3 LPR-BSL-P-VIDAS3BNP enzymelinked fluorescent assay Immunology examination activities diagnosis ANA Titre Anti Adrenal Gland Antibody Inova tissue slides LPR-BSL-I-IIF Indirect Immunoflourescence ASP-1200 & manual preparation Anti Cardiac Muscle Anti Double Stranded DNA Anti Endomysium IgA Anti Endomysium IgG Anti Jo-1 Anti La (SSB) Dynex DS 2 & Organtec Kit LPR- BSL-I-DNAD Automated ELISA Inova tissue slides LPR-BSL-I-IIF Indirect Immunofluorescence ASP-1200 & manual preparation Dynex DS 2 & Organtec Kit LPR- BSL-I-ENAP Automated ELISA Anti myeloperoxidase Anti Proteinase 3 Anti Ribonucleoprotein Anti Ro (SSA) Assessment Manager: BD Page 14 of 20

15 Serum SST unless otherwise stated Immunology examination activities Anti SCL-70 Anti Skeletal Muscle Anti Sm Anti-Nuclear Ab. Screen Cardiolipin Abs. IgG Cardiolipin Abs. IgM Cytoplasmic ANCA ENA Profile (Recombinant) Gastric Parietal cell ab. Glomerular B-M ab. (Screen) Glomerular B-M ab. (Titre) Inova tissue slides LPR-BSL-I-IIF Indirect Immunofluorescence ASP-1200 & manual preparation Dynex DS 2 & Organtec Kit LPR- BSL-I-ENAP Automated ELISA Dynex DS 2 & Organtec Kit LPR- BSL-I-ENAP Automated ELISA Dynex DS 2 & Organtec Kit LPR- BSL-I-CARDIOLIPIN Automated ELISA Dynex DS 2 & Organtec Kit LPR- BSL-I-CARDIOLIPIN Automated ELISA Inova tissue slides LPR-BSL-I-IIF Indirect Immunofluorescence ASP-1200 & manual preparation Euroline ANA profile 3 Kit LPR- BSL-I-INNO Manual Immunoblot Inova tissue slides LPR-BSL-I-IIF Indirect Immunofluorescence ASP-1200 & manual preparation GBM Quick card: Biodiagnostics LPR-BSL-I-GBM GBM Quick card Phadia UniCap 250 LPR-BSL-I- ELIA CAP/ELiA immunoassay Assessment Manager: BD Page 15 of 20

16 Immunology examination activities Serum SST unless otherwise stated HEp-2 cell ANA pattern Inova tissue slides LPR-BSL-I-IIF Indirect Immunofluorescence ASP-1200 & manual preparation Autoimmune Liver Panel (Smooth muscle/mitochondrial/lkm/ana) Autoimmune Liver Titre Dynex DS 2 & Organtec Kit LPR- BSL-I-IIF Indirect Immunofluorescence ASP-1200 & manual preparation Pancreatic Islet cell abs. Perinuclear ANCA Skin Autoantibodies IgA Phadia UniCap 250 LPR-BSL-I- IC250, LPR-BSL-I-SIGE CAP/ELiA immunoassay Skin Autoantibodies IgG Thyroid peroxidase antibodies Thyroglobulin Antibody Assay Tissue transglutaminase ab. Cyclic citrullinated peptide CCP (Titre) Dynex DS 2 & Organtec Kit LPR- BSL-I-TPO Automated ELISA Biomerieux kit on the Vidas Dynex DS 2 & Organtec Kit LPR- BSL-I-TTG Automated ELISA Phadia UniCap 250 LPR-BSL-I- CCP CAP/ELiA immunoassay Allergy Testing IgE to Almonds IgE to Amoxicilloyl Phadia UniCap 250 LPR-BSL-I- IC250, LPR-BSL-I-SIGE CAP/ELiA immunoassay IgE to Apple Assessment Manager: BD Page 16 of 20

17 Immunology examination activities Allergy Testing (cont d) Serum SST unless otherwise stated IgE to Aspergillus Phadia UniCap 250 LPR-BSL-I- IC250, LPR-BSL-I-SIGE CAP/ELiA immunoassay IgE to Banana IgE to Barley IgE to Bee venom IgE to Beef IgE to Brazil nut IgE to Cage Birds IgE to Carrot IgE to Cashew IgE to cat epithelium IgE to Chicken Meat IgE to Cladosporium IgE to Coconut IgE to Codfish IgE to Crab IgE to Chocolate/Cocoa IgE to Cherry IgE to Cheddar type Cheese IgE to Dog dander IgE to Egg Assessment Manager: BD Page 17 of 20

18 Immunology examination activities Allergy Testing (cont d) Serum SST unless otherwise stated IgE to Gluten Phadia UniCap 250 LPR-BSL-I- IC250, LPR-BSL-I-SIGE CAP/ELiA immunoassay IgE to Grape IgE to Grass pollen (gx1) IgE to Hamster IgE to Hazelnut IgE to horse dander IgE to House Dust Mite IgE to Kiwi Fruit IgE to Latex IgE to Lentil IgE to Milk IgE to Oats IgE to Onion IgE to Oranges IgE to Pea IgE to Peach IgE to peanut IgE to Ara h2 IgE to Ara h8 Assessment Manager: BD Page 18 of 20

19 Immunology examination activities Allergy Testing (cont d) Serum SST unless otherwise stated IgE to Bet v1 Phadia UniCap 250 LPR-BSL-I- IC250, LPR-BSL-I-SIGE CAP/ELiA immunoassay IgE to Pear IgE to Pecan Nuts IgE to Penicillin G IgE to Penicillin V IgE to Pineapple IgE to Pine Nut IgE to Pistachio IgE to Pityrosporum IgE to Potato IgE to Rice IgE to Rodent mixture IgE to Rye IgE to Salmon IgE to Sesame Seed IgE to Shrimp IgE to Soyabean IgE to Strawberries Assessment Manager: BD Page 19 of 20

20 Immunology examination activities Allergy Testing (cont d) Serum SST unless otherwise stated IgE to Tomato Phadia UniCap 250 LPR-BSL-I- IC250, LPR-BSL-I-SIGE CAP/ELiA immunoassay IgE to Tree mixture (tx8) IgE to Tuna IgE to Walnut IgE to Wasp Venom IgE to wheat IgE to Yeast Total IGE IgG to Aspergillus Fumigatus IgG to Budgerigar IgG to Micropolyspora faeni END Assessment Manager: BD Page 20 of 20