Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Transcription

1 National Hospital for Neurology & Neurosurgery UCLH Queen Square London WC1N 3BG United Kingdom Contact: Linda Herbert Tel: +44 (0) Website: Testing performed at the above address only DETAIL OF ACCREDITATION FLUIDS Fixed, fresh and frozen tissue; excisional and incisional biopsies and surgical resection specimens Formalin fixed tissues samples (as above) Processed tissue samples (as above) and from referral cases Paraffin waxed tissue samples (as above) purposes of diagnosis Specimen dissection Manual methods using SOP CU01 Tissue Processing SOP EQ06C in conjunction with Sekura Tissue Tek VIP processor Decalcification SOPs DE01-DE04 & DE06 in conjunction with manufacturers instructions using Sakura TDE30 decalcifier system. Tissue embedding SOPs SU06 & SU09 in conjunction with manufacturers instructions using embedding centres Tissue sectioning (microtomy) SOP SU08 using Leica & Sledge microtomes Assessment Manager:MP Page 1 of 21

2 Frozen Sections FFPE slides prepared in house ocular fluid & body fluids purposes of diagnosis (cont d) Morphological assessment and interpretation / diagnosis Routine staining purposes of diagnosis Identification of basophilic and eosinophilic structures SOPs DL26 in conjunction with Leica cryostat CM1850 MU20 and SU03 in conjunction with Leica cryostat CM1950 By microscopy with reference to: SOP RE01 (Cytology) SOP RE02 (Post-Mortems) SOP RE04 (Degenerative specimens) SOP RE05 (Muscle biopsies) SOP RE06 (Non-neurological tissue) SOP RE07 (Peripheral nerve biopsies) SOP RE08 (Smears and frozen sections) SOP RE09 (Temporal lobes) SOP RE10 (Surgical biopsies definitive specimens) SOP RE13 (Skin biopsies) Documented in-house procedures in conjunction with manufacturers instructions with reference to: SOPs SM01 and ST20 using Leica ST5020 Multistainer, Leica ST5030 Coverslipper and Haematoxylin and Eosin stains Assessment Manager: MP Page 2 of 21

3 ocular fluid & body fluids Special staining purposes of diagnosis (cont d) Acid mucins Acid and neutral mucins Amyloid Nissl substance Blood cells Protozoa Reticulin fibres Gram positive and negative bacteria Fungal elements Connective tissue Laforra bodies Myelin and Nissl substance Melanin Removal of melanin Documented in-house procedures for manual hand staining with the following stains with reference to: Alcian Blue (ph 2.5) (SOP ST02) Alcian Blue/ Periodic Acid Schiff (SOP ST04) Congo Red (SOPST10) Cresyl Fast Violet (SOP ST11) Formalin Pigment Removal (SOP ST12) Giemsa (SOP ST15A) Giemsa (SOP ST15B) Gordon and Sweets (SOP ST16) Gram Stain (SOP ST17) Grocott (SOP ST19) Haematoxylin Van Gieson (SOP ST22) Lugols Iodine (SOP ST25) Luxol Fast Blue (SOP ST26) Masson s Fontana (SOP ST27) Melanin Bleach (SOP ST28) Assessment Manager: MP Page 3 of 21

4 ocular fluid & body fluids (cont d) Special staining (cont d) purposes of diagnosis (cont d) Elastic fibres and connective tissue Fibrin Glycogen Neutral mucins, glycogen, fungi Pituitary cells Ferric iron salts Lipofuscin, melanin etc Myelin Lipofuscin Various staining of rapid smears Calcium Leprosy bacilli Lipofuscin Acid Fast Bacilli Documented in-house procedures for manual hand staining with the following stains with reference to: Miller s Elastic Van Gieson (SOP ST30) Martius Scarlet Blue (SOP ST31) Periodic Acid Schiff diastase (SOP ST33) Periodic Acid Schiff (SOPST34) Periodic Acid Schiff/Orange G (PAS/OG) (SOP ST36) Perl s Prussian Blue (SOP ST37) Schmorl Technique (SOP ST40) Solochrome Cyanin (SOP ST41) Sudan Black (SOP ST42) Toluidine Blue (SOP ST43) Von Kossa (SOP ST45) Wade Fite (SOP ST46) Ziehl Nielsen (Long) (SOP ST48) Ziehl Nielsen (SOP ST49) Assessment Manager: MP Page 4 of 21

5 ocular fluid & body fluids (cont d) Special staining (cont d) purposes of diagnosis (cont d) Acid mucins Acid and neutral mucins Amyloid Elastic fibres and connective tissue Fungal elements Neutral mucins, glycogen, fungi Glycogen removal Ferric iron salts Reticulin fibres Immunohistochemistry: SOP SM02 for automated staining using Ventana Benchmark with the following stains : Alcian Blue Alcian Blue PAS Congo Red (not nerve) EVG Grocott PAS PASD Perls Retic ocular fluid & body fluids purposes of diagnosis. Detection of: Amyloid protein Pituitary hormone adrenocorticotropin Mitochondria in muscle Alpha-1-antitrypsin Alpha-fetoprotein SOP IM17 in conjunction with Leica Immunostainer Bond Max with the following antibodies: A4, beta amyloid-n ACTH Ab3298-N Alpha-1-anti-trypsin Alpha-Fetoprotein (AFP) Assessment Manager: MP Page 5 of 21

6 ocular fluid & body fluids (cont d) Immunohistochemistry: (cont d) purposes of diagnosis. Detection of: Neuroprotein Tau-protein Classification of dementias Astrocytoma identification BCL-2 Muscular dystrophies Brachyury protein Complement CA-125 antigen Calbindin Neuromarker Myofibrillar markers in skeletal muscle SOP IM17 in conjunction with Leica Immunostainer Bond Max with the following antibodies: Alpha-synuclein AT100 AT8 (TAU) ATRX BCL-2 Oncoprotein Beta dystroglycan Brachyury C3D-Complement CA125 Calbindin Calpain 3 Low molecular weight cytokeratin CAM 5.2 Carcino embryonic antigen Muscular dystrophy lymphocytic marker CD10 antigen CD11 antigen Cd117 antigen CEA Caveolin 3 CD10 CD11c CD117 Assessment Manager: MP Page 6 of 21

7 ocular fluid & body fluids (cont d) Immunohistochemistry: (cont d) purposes of diagnosis. Detection of: Oestrogen receptor antigen Factor VIII Plasma cells Mast cells B-cell antigen Endothelial cell expression Endothelial cell expression Helper T cells Neurononal cell adhesion molecules Macrophages B-cell subset Cytotoxic T cells CDX2 antigen CGRP antigen Chromogranin granules in cells SOP IM17 in conjunction with Leica Immunostainer Bond Max with the following antibodies: Estrogen Receptor Factor VIII CD138 CD1a CD20 CD31 CD34 CD4 CD56 CD68 CD79a CD8 CDX2 CGRP Chromogranin Cytokeratin 20 expression CK 20 Cytokeratin 5 expression CK 5 Assessment Manager: MP Page 7 of 21

8 ocular fluid & body fluids (cont d) Immunohistochemistry: (cont d) purposes of diagnosis. Detection of: SOP IM17 in conjunction with Leica Immunostainer Bond Max with the following antibodies: Cytokeratin 7 expression CK 7 Cytomegalovirus Dynorphin antigen Nuclear membrane marker Epithelial Membrane Antigen Follicle Stimulating Hormone Growth hormone Glial Fibrillary Acidic Protein Herpes Simplex Virus I antigen Herpes Simplex Virus II antigen Melanoma marker Heat shock protein Human Chorionic Gonadotrophin Macrophage sub-type Gliomas IgA IgG IgG4 Cytomegalovirus Dynorphin Emerin Epithelial Membrane Antigen Follicle Stimulating Hormone GH Glial Fibrillary Acidic Protein Herpes Simplex Virus I Herpes Simplex Virus Il HMB-45 HSP70 Human Chorionic Gonadotrophin Iba1 IDH1 imm IgA IgG IgG4 Assessment Manager: MP Page 8 of 21

9 ocular fluid & body fluids (cont d) Immunohistochemistry: (cont d) purposes of diagnosis. Detection of: IgM Inhibin antigen Integrin b1 antigen Kappa light chains Cell proliferation Lanbda light chains Leucocyte common antigen Luteinising hormone antigen Mammoglobulin antigen Microtubule associated protein marker antigen Measles virus Melanoma Merosin antigen in muscle fibres Neuronal protein Mic 2 gene product Broad spectrum cytokeratin expression Neuronal cell marker SOP IM17 in conjunction with Leica Immunostainer Bond Max with the following antibodies: IgM Inhibin-α Integrin b1d Kappa Ki67 Lambda LCA / CD45 LH Mammoglobulin MAP2 Measles Melan-A Merosin NGF MIC2 MNF116 Nestin Assessment Manager: MP Page 9 of 21

10 ocular fluid & body fluids (cont d) Immunohistochemistry: (cont d) purposes of diagnosis. Detection of: Neuronal nuclear protein Nerve fibres RT97 nerve fibre sub-type Phosphorylated nerve fibres Cell growth suppressor NoGo A Neuroprotein Y SOP IM17 in conjunction with Leica Immunostainer Bond Max with the following antibodies: NeuN Neurofilament cocktail NF200 (RT97) NFP NoGo A NPY Neuronal cell neurone specific enelase NSE Oct 3/4 germ cell marker Oct 3/4 HIV ve tumour suppressor gene Dementia classification Placental alkaline phosphate antigen progesterone receptor antigen Prolactin antigen Prostate specific antigen P24 P53 P62 Placental Alkaline Phosphatase Progesterone Receptor Prolactin Prostate Specific Antigen S-100 protein antigen S-100 Protein Assessment Manager: MP Page 10 of 21

11 ocular fluid & body fluids (cont d) Immunohistochemistry: (cont d) purposes of diagnosis. Detection of: Phosphorylated neurofilaments Non-phosphorylated neurofilaments Myelin basic protein SV40 antigen Synaptophysin antigen Dementia classification Dementia classification Dementia classification Dementia classification Dementia classification Thyroglobulin antigen Thyroid Stimulating Hormone Toxoplasma Pre-albumin antigen TTF1 antigen Dementia classification Lymphocytes Vimentin antigen SOP IM17 in conjunction with Leica Immunostainer Bond Max with the following antibodies: SMI 31- phosphorylated SMI-32 non-phosphorylated SMI94 (MBP94) SV40 Synaptophysin Tau Tau RD3 Tau RD4 TDP-43 TDP43 phosphorylated Thyroglobulin Thyroid Stimulating Hormone Toxoplasma (TTR) Transthyretin TTF1 Ubiquitin UCLH1 (CD45 Ro) Vimentin Assessment Manager: MP Page 11 of 21

12 ocular fluid & body fluids (cont d) Immunohistochemistry: (cont d) purposes of diagnosis: Rare muscle disease Sarcolemmal membrane of skeletal muscle heat shock protein associated with neurodegeneration Sarcolemmal membrane of skeletal muscle Mitochondria Mitochondria Mitochondria Mitochondria Myofibrillar antigen Sarcolemmal membrane of skeletal muscle Sarcolemmal membrane of skeletal muscle Sarcolemmal membrane of skeletal muscle Sarcolemmal membrane of skeletal muscle Human leucocyte antigen Documented in-house procedure SOP IM20 in conjunction with Menarini Intellipath Immunostainer with the following antibodies: Alpha-dystroglycan Alpha-sarcoglycan Alpha-B-crystallin Spectrin Cox I Cox II Cox IV Cox IVc Desmin Dysferlin (Hamlet 1) Dystrophin 1 Dystrophin 2 Dystrophin 3 HLA Assessment Manager: MP Page 12 of 21

13 ocular fluid & body fluids (cont d) Immunohistochemistry: (cont d) purposes of diagnosis: component of type IV collagen in the extracellular matrix Documented in-house procedure SOP IM20 in conjunction with Menarini Intellipath Immunostainer with the following antibodies: Lamin A/C Laminin Alpha 2 Laminin Alpha 2 Laminin Alpha 5 Laminin Alpha 5 Laminin Beta 1 Laminin Beta 1 Laminin Gamma 1 Laminin Gamma 1 Muscle fibre sub-typing Immature muscle fibres Muscle fibre sub-typing Myofibrillar antigen Sarcolemmal membrane of skeletal muscle Sarcoplasmic of type 2 muscle fibres Sarcoplasmic of type 1 muscle fibres Inflammatory Myopathies Myosin heavy chain-fast Myosin heavy chain (neonatal) Myosin heavy chain-slow Myotilin nnos Serca-1 Serca-2 Utrophin Assessment Manager: MP Page 13 of 21

14 Sections from tissue CSF, ocular fluid & body fluids Immunohistochemistry: (cont d) Detection of β-amyloid, α- Synuclein, and PRP Proteins (prion proteins) Non-Gynaelogical Cytology SOP IM19 in conjunction with manufacturer instructions using Leica Immunostainer Bond Max with the following antibodies: KG69, ICSM35 & 12F10 Preparation of slides for staining Cerebrospinal fluid Ocular fluid and body fluids purposes of diagnosis Staining of slides for analysis Documented in-house procedures CY03A, CY04 and CY05 in conjunction with manufacturers instructions using Shandon Cytospin 4 Documented in-house procedures using Leica ST5020 Multistainer and ST503coverslipper with reference to: Fixed preparations Basic cellular components PAP (SOP CY06) Molecular Biology Giemsa (SOP CY07) Sections from tissue CSF, ocular fluid & body fluids DNA Profiling for detection of abnormal sequences for disease conditions Documented in-house methods for DNA manufacture, purification and detection using techniques and kits in combination with manufacturers instructions: Assessment Manager: MP Page 14 of 21

15 Molecular Biology (cont d) DNA Extraction SOP PC05 in conjunction with Eppendorf centrifuge and Thermomixer. NanoDrop Spectrophotometer from Labtech International SOP PC12 Automatic extraction of DNA in conjunction with using Maxwell IVD instrument Identification of IDH 1 & 2 point mutation Detection of semi-quantitative methylation rate on CpG island of MGMT RNA Extraction SOP PC05 in conjunction with Eppendorf centrifuge and Thermomixer. NanoDrop Spectrophotometer from Labtech International SOP PC13 Automatic extraction of RNA in conjunction with using Maxwell IVD instrument SOP RE17 (Reporting) SOP PC04 in conjunction with Applied Biosystems Thermocycler verity by PCR and Sanger sequencing SOP PC06 in conjunction with Eppendorf Thermomixer and Life Technologies 7900 HT Fast Real time PCR system by high resolution melting methylation assay Assessment Manager: MP Page 15 of 21

16 Slide preparations of frozen tissue sections of adult / paediatric muscle as stated Adult Molecular Biology (cont d) Identification of copy number variation on chromosome 1p, 19q, PTEN & EGFR Identification of EGFR viii mutation Identification of BRAF fusion mutations Identification of BRAF V600E point mutation Staining of slides for analysis Identification of basophilic and eosinophilic structures SOP PC02 in conjunction with manufacturers instructions for using Life Technologies 7900 HT Fast Real time PCR system using copy number assay SOP PC011 in conjunction with Applied Biosystems Thermocycler verity and Life Technologies 7900 HT Fast Real time PCR system SOP PC09 in conjunction with Applied Biosystems Thermocycler verity and Life Technologies 7900 HT Fast Real time PCR system SOP PC08 in conjunction with manufacturers instructions for using Applied Biosystems Thermocycler verity by PCR and Sanger sequencing Documented in house procedures SOP MU14 and SOP MU14a using Leica ST5020 Multistainer, Leica coverslipper ST5030, or manual hand staining Haematoxylin and Eosin (SOP MU12) Adult & Paediatric Stain-Mitochondrial complexes Modified Gomori Trichrome (SOP MU13) Adult PAS +ve substances Periodic Acid Schiff (SOP MU14) Paediatric PAS +ve substances Diastase Periodic Acid Schiff (SOP MU14a) Adult Lipids Sudan Black (SOP MU15) Adult & Paediatric Simple lipids Oil Red O (SOP MU18) Assessment Manager: MP Page 16 of 21

17 Slide preparations of frozen tissue sections of adult / paediatric muscle as stated Histochemistry purposes of diagnosis Documented in-house procedures by manual staining with reference to: Adult & Paediatric NADH SOP MU04 Adult Succinic Dehdrogenase SOP MU05 Adult & Paediatric Cytochrome Oxidase SOP MU06 Adult & Paediatric Acid phosphatase SOP MU08 Adult & Paediatric Adenylate deaminase SOP MU09 Adult Adenosine triphosphate SOP MU10 Adult & Paediatric Combined cytochrome oxidase and succinic dehydrogenase SOP MU19 Adult and paediatric Phosphorylase SOP MU07 Paediatric Phosphofructokinase SOP DL03 Paediatric Slide preparations of frozen tissue sections of paediatric muscle as stated Menadione-linked-alphaglycerophosphate dehydrogenase without substrate Immunocytochemistry purposes of diagnosis Myosin heavy chains Blood vessels and immature skeletal muscle fibres Myofibrillar markers Myofibrillar markers SOP DL04 Documented in-house procedure SOP IM21 in conjunction with manual method with Menarini Intellipath kits and the following antibodies: Myosin heavy chain Utrophin Alph-beta-crystallin BAG3 Assessment Manager: MP Page 17 of 21

18 Slide preparations of frozen tissue sections of adult / paediatric muscle as stated (cont d) Histochemistry (cont d) purposes of diagnosis (cont d) Sarcolemmal membrane Inflammatory Marker; cell lysis Documented in-house procedures by manual staining with reference to: Beta spectrin C5b-9 Myofibrillar markers Calpain 3 Sarcolemmal membrane Caveolin 3 Inflammatory Marker; T-cells (mature) Inflammatory Marker; T helper cells, monocytes and macrophages Inflammatory Marker; cytotoxic T- cells Inflammatory Marker; B-cells Myofibrillar markers CD3 CD4 CD8 CD20 Desmin Sarcolemmal membrane Dystrophin 1 Sarcolemmal membrane Dystrophin 2 Sarcolemmal membrane Dystrophin 3 Isoform of Myosin Heavy Chains in Muscle Sarcolemmal membrane Nuclear membrane marker Myofibrillar markers Myofibrillar markers Isoform of Myosin Heavy Chains in Muscle Developmental Myosin Dysferlin Emerin Fhl-1 Filamin C Foetal myosin Assessment Manager: MP Page 18 of 21

19 Slide preparations of frozen tissue sections of adult / paediatric muscle as stated (cont d) Histochemistry (cont d) purposes of diagnosis (cont d) Inflammatory Marker and Lysosomes Inflammatory Marker and blood vessels Myofibrillar markers Nerves and muscle fibres Sarcolemmal membrane Myofibrillar markers Myofibrillar markers Sarcolemmal membrane Sarcolemmal membrane Sarcolemmal membrane Sarcolemmal membrane Sarcoplasmic Reticulum of Type 2 Muscle fibres Documented in-house procedures by manual staining with reference to: Preparation of nerve biopsies for electron microscopy by the following methods: SOPs PE03 for fixation and treatment of nerve biopsies SOPs EM01 EM05 for fixation and treatment of other biopsies SOPs EM16 & EM18 for automatic processing using the Lynx processor. Lamp-2 MHC-1 Myotilin NCAM nnos Plectin P62 Alpha-sarcoglycan Beta-Sarcoglycan Delta-sarcoglycan Gamma-sarcoglycan Serca-1 Assessment Manager: MP Page 19 of 21

20 Slide preparations of frozen tissue sections of adult / paediatric muscle as stated (cont d) Peripheral nerve biopsies Histochemistry (cont d) purposes of diagnosis (cont d) Sarcoplasmic Reticulum of Type 1 Muscle fibres Isoforms of Myosin Heavy Chains Electron Microscopy purposes of diagnosis Documented in-house procedures by manual staining with reference to: Serca-2 Slow Myosin heavy chain Processing Embedding Documented in-house procedure SOP PE04 paraffin wax embedding Documented in-house procedure SOP PE05 for resin embedding Documented in-house procedure SOP PE06 for Teasing of nerve fibres for microscopic Semi-thin Sectioning SOP DL16 in conjunction with Ultramicrotome (Ultra cut S) Reichert-Jung followed by staining with Toludine blue SOP EM05 in conjunction with Ultramicrotome (Ultra cut E) Reichert-Jung Ultra-thin Sectioning using SOP DL17 and SOP EM05 Assessment Manager: MP Page 20 of 21

21 Human tissues muscle, skin, tumour and post mortem tissue Semi-thin resin sections mounted on glass slides Semi-thin resin sections mounted on glass slides Ultra-thin (~70nm) sections on support grids Electron Microscopy purposes of diagnosis To differentiate between myelin, collagen and elastin. Demonstration of tubercle bacilli. Tissue components and metrachromatic tissue elements Documented in-house procedures for staining of material using the following stains with reference to: Methylene Blue/ Azure A/ Basic fuchsin (SOP EM07) Toluidine Blue (SOP EM08) Uranyl acetate/ Lead acetate (SOP EM09 and DL18) END Assessment Manager: MP Page 21 of 21