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 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK HSL (nalytics) LLP ccredited to Department of 60 Whitfield Street London W1T 4EU Contact: Jan Stewart Tel: +44 (0) jan.stewart@tdlpathology.com Website: Laboratory locations: below s covered by the organisation and their relevant activities details ctivity code ddress Local contact Department 60 Whitfield Street London W1T 4EU JanStewart Molecular Urology OSCR Clinic Satellite Laboratory Foetal and Maternal ssessment Unit Elizabeth Garrett nderson Unit 235 Euston Road London, NW1 2BU JanStewart B Diabetic Clinic Satellite Laboratory First Floor Podium Diabetic Clinic K 235 Euston Road London, NW1 2BU JanStewart C Intra-operative PTH Satellite Laboratory Operating Theatres 235 Euston Road, London, NW1 2BU JanStewart D ssessment Manager: MP 1 of 8

2 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HSL (nalytics) LLP DETIL OF CCREDITTION HUMN BODY FLUIDS clinical diagnosis. Quantification of: Gas chromatography mass spectrometry using Shimadzu GC Plus with reference to: Steroid profile: SOP 334 ndrosterone (5a) etiocholanolone (5b) Dehydroepiandrosterone 11-hydroxyandrosterone 11-hydroxyaetiocholanolone 16-hydroxy-DH (Pk 1) 16-hydroxy-DH (Pk 1) Pregnanediol (Progesterone) Pregnanetriol (17-OH-Prog) ndrostenetriol Tetrahydro-11-deoxycortisol Tetrahydrocortisone llo-tetrahydrocorticosterone Tetrahydrocortisol llo-thf Cortolone Cortolone + cortol Cortol 17-hydroxypregnanolone Pk1 17-hydroxypregnanolone Pk2 11-oxo-pregnanetriol Tetrahydro-11-Deoxycortisol Hexahydro-11-deoxycortisol 1 Hexahydro-11-deoxycortisol 2 ndrostenediol Pregnenediol Pregnenetriol 16β-hydroxy-DH (16-oxo-androstenediol) and 15,16-dihydroxy-DH ssessment Manager: MP Page 2 of 8

3 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HSL (nalytics) LLP HUMN BODY FLUIDS clinical diagnosis. Quantification of: (cont d) Steroid profile: (cont d) 16,18 dihydroxy-dh (Pk 1) 16,18 dihydroxy-dh (Pk 2) 16-hydroxypregnenolone 6-hydroxy- THE 20beta-cortolone 6-hydroxy-20alphacortolone 6-hydroxy-20beta-cortolone 1-hydroxy-20beta-cortolone 15,17-dihydroxypregnanolone Oestriol 3,16, 17-trihydroxy-5- pregnane-7,20-dione 6-hydroxy-tetrahydro-11- deoxycortisol Gas chromatography mass spectrometry using Shimadzu GC Plus with reference to SOP 334 Blood / 17 Hydroxyprogesterone SOP 335 Plasma Renin activity SOP 331 by radioimmunoassay using DiaSorin GammaCoat plasma renin activity radioimmunoassay kit. Blood / plasma / Vitamin D SOPs 430 & 431 by liquid chromatography mass spectrometry using Waters cquity UPLC-TDQ and Solid Phase extraction on Tecan Freedom 100 Blood / Macroprolactin SOP 376 by electrochemiluminescent immunoassay using Roche E170 Free Cortisol SOP 385 by chemiluminescent immunoassay using Siemens Immulite XPi ssessment Manager: MP Page 3 of 8

4 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HSL (nalytics) LLP HUMN BODY FLUIDS clinical diagnosis (cont d) Sonicated Tissue from Liver Liver enzyme analysis: lanine:glyoxylate aminotransferase (GT) activity. GT immunoreactivity Glyoxylate reductase (GR) activity GR immunoreactivity SOPs 46, 244, 245 & 442 using IL ries and Kontron Spectrophotometer metabolites: (oxalate, citrate) SOPs 223 & 218 using IL ries Plasma Oxalate & bile acids SOP 442, 222,392 using IL ries Primary hyperoxaluria metabolites: U glycolate Glycolate: creatinine ratio U glycerate Glycerate:creatine ratio U hydroxyl-oxo glutarate (HOG) U HOG: creatinine ratio U dihydroxyglutarate (DHG) U DHG:creatinine ratio SOP 447 by gas chromatography mass spectrometry using Shimadzu GCMS-QP 2010S Renal stones Renal calculi SOPs 432 & 217 using Jasco FT/IR FTIR 4100 ccutrac analyser ssessment Manager: MP Page 4 of 8

5 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HSL (nalytics) LLP HUMN BODY FLUIDS clinical diagnosis (cont d) Detection of normal and abnormal protein fractions electrophoretic patterns Quantitation of Paraproteins SOP 446 by capillary zone electrophoresis using Sebia Capillarys 2 Zone electrophoresis using Sebia Hydrasys with reference to: Detection of kappa & lambda light chains (immunofixation) SOPs 341 & 342 Quantitation of Bence Jones protein (electrophoresis) SOP 344 Detection / quantification of cryoproteins SOP 150 Other Protein Biochemistry HUMN BODY FLUIDS (as stated) clinical diagnosis. Quantification of: Free light chains SOP 444 by immunoturbidimetry using Binding Site SP Plus Sweat Chloride SOP 262 by colourimetry using Wescor Total porphyrins SOP 208 by spectrophotometry using Lambda EZ01 ssessment Manager: MP Page 5 of 8

6 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HSL (nalytics) LLP Other Protein Biochemistry HUMN BODY FLUIDS (as stated) clinical diagnosis. HUMN BODY FLUIDS clinical diagnosis Faeces Occult blood SOP 203 using Beckman Haemoccult kit Reducing substances SOP 428 by colourimetry using Benedicts solution Human chorionic gonadotrophin (hcg) SOP 184 using IM Clear View hcg blood, glucose, ketones, ph, protein & urobilinogen SOP 202 using Siemens Multistix reagent strips Determination of ph SOP 543 using InoLB PH7110 ph meter ssessment Manager: MP Page 6 of 8

7 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HSL (nalytics) LLP HUMN BODY FLUIDS clinical diagnosis (cont d) Beta- Human chorionic gonadotrophin (hcg) Protein ssociated Plasma Protein- (PPP-) SOP 429 by chemiluminescent immunoassay using Perkin Elmer Delfia Xpress B Blood Hb1c SOP 427by ion-exchange high performance liquid chromatography using TOSOH G8 C / Plasma Intra-operative of Parathyroid Hormone SOP 379 by immunoassay using Future Digistat D Molecular Urology Blood / DN DN Profiling for detection of abnormal sequences for disease conditions: Documented in-house methods for DN extraction, purification, amplification and visualisation using techniques and kits in combination with manufacturers instructions: Extracted DN DN amplification using B 2720 & B Veriti thermal cyclers (SOP 440) PCR Sanger cycle sequencing using BI 310 Genetic nalyser (SOPs 317 & 319) Visualisation of PCR products by electrophoresis, interpretation and reporting (SOPs 440, 353 and 396) Primary hyperoxaluria types 1 (GXT), 2 (GRHPR) and 3 (HOG ssessment Manager: MP Page 7 of 8

8 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HSL (nalytics) LLP Molecular Urology Blood / DN DN Profiling for detection of abnormal sequences for disease conditions: (cont d) Documented in-house methods for DN extraction, purification, amplification and visualisation using techniques and kits in combination with manufacturers instructions: Congenital adrenal hyperplasia and other disorders of steroid biosynthesis: Steroid 11-hydroxylase (CYP11B1) ldosterone synthase (CYP11B2) 17-beta hydroxysteroid dehydrogenase (HSD17B3) 17-alpha hydroxylase (CYP171) 5 alpha reductase (SRD52) 3 beta hydroxysteroid dehydrogenase / isomerase (HSD3B2) Cytochrome C oxidase protein (Sco1, Sco2, surf 1) END ssessment Manager: MP Page 8 of 8

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