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Assessment Manager: DE Page 1 of 20
Schedule of Accreditation issued by
United Kingdom Accreditation Service
Building Two, Pine Trees, Chertsey Lane, Staines, Middlesex, TW18 3HR, UK
8756
Accredited to
ISO 15189:2012
Imperial College Healthcare NHS Trust Operating as North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Infection & Immunity and Histocompatability & Immunogenetics Laboratories
Acrow East
St Mary's Hospital
Praed Street
London
W2 1NY
Contact: Dr. Peter Kelleher
Tel: +44 (0)20 331 10130
E-Mail: [email protected]
Website: http://pathology.imperial.nhs.uk/
Testing performed by the Organisation at the locations specified below
Locations covered by the organisation and their relevant activities
Laboratory locations:
Location details Activity Location code
Address Infection & Immunity Laboratory 9th Floor Laboratory Block Charing Cross Hospital Fulham Palace Road London W6 8RF
Local contact Dr. Peter Kelleher
Immunology Microbiology Serology Molecular Virology
CXH
Address Histocompatability & Immunogenetics Laboratory G Block Hammersmith hospital Du Cane Road London W12 0HS
Local contact Dr. Paul Brookes
Histocompatibility & Immunogenetics HH
Site activities performed away from the locations listed above:
Location details Activity Location code
1st Floor Blood Sciences Autolaboratory Charing Cross Hospital Fulham Palace Road London W6 8RF
Local contact: Dr. Peter Kelleher
Serology in support of clinical diagnosis
CXH (C )
I&I Laboratory 1st Floor Blood Sciences Autolaboratory Charing Cross Hospital Fulham Palace Road London W6 8RF
Local contact: Dr. Peter Kelleher
Serology in support of clinical diagnosis
CXH (I&C)
8756
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bui ld i ng Two, P ine Trees , Cher t sey Lane, S ta i nes , M idd les ex, TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as
North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 2 of 20
DETAIL OF ACCREDITATION
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS Examination activities for the
purposes of clinical diagnosis Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
Immunology
Allergy and Immune Serology Fluoro Enzyme Immuno Assay (FEIA) by Phadia250:
CXH
Serum Specific IgE for the following INI-LP-00199-X Almond Alternaria Alternata Amoxycillin Ampicillin Apple Aspergillus Avocado Banana Barley Beef Blue Mussel Brazil Nut Carrot Casein Cladosporium Candida Albicans Cashew Nut Cat Cefaclor Cheese Cheddar Chick Pea Chicken Meat Chilli Pepper Chocolate Cockroach Coconut Cod Fish Coffee Corn Cows Milk Crab Cray Fish
8756
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bui ld i ng Two, P ine Trees , Cher t sey Lane, S ta i nes , M idd les ex, TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as
North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 3 of 20
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Examination activities for the purposes of clinical diagnosis (cont’d):
Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
IMMUNOLOGY (cont’d) Allergy and Immune Serology
(cont’d) Fluoro Enzyme Immuno Assay (FEIA) by Phadia250:
CXH
Serum (cont’d) Specific IgE for the following INI-LP-00199-X Dog Egg White Egg Yolk Garlic Gluten Grape Grass Mix Green Bean House Dust Mite Halibut Hazelnut Honey Honey Bee Venom Horse Kiwi Lamb Latex Lemon Lentil Lobster Lupine Seed Macadamia Nut Mackerel Mould Mix Mango Mixed Tree Morphine Mustard Mushroom Oats Omega-5-Gliadin Onion Orange Oyster Pea
8756
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bui ld i ng Two, P ine Trees , Cher t sey Lane, S ta i nes , M idd les ex, TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as
North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 4 of 20
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Examination activities for the purposes of clinical diagnosis (cont’d)
Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
IMMUNOLOGY (cont’d) Allergy and Immune Serology
(cont’d) Fluoro Enzyme Immuno Assay (FEIA) by Phadia250:
CXH
Serum (cont’d) Specific IgE for the following INI-LP-00199-X Peach Peanut Pear Peacn Nut Penicillin G Penicillin V Pine Nut Pistachio Nut Pork Potato Rabbit Epithelium Red Kidney Bean Rice Salmon Sardine Scallop Sesame Seed Shrimp Silver Birch Soya Bean Squid Strawberry Sunflower Seed Suxamethonium Tomato Tuna Fish White Bean Walnut Wasp Venom Weed Mix Wheat Yeast
8756
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bui ld i ng Two, P ine Trees , Cher t sey Lane, S ta i nes , M idd les ex, TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as
North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 5 of 20
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Examination activities for the purposes of clinical diagnosis (cont’d):
Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
IMMUNOLOGY (cont’d) Allergy and Immune Serology
(cont’d) Fluoro Enzyme Immuno Assay (FEIA) by Phadia250:
CXH
Serum Total IgE INI-LP-00199-X Tryptase INI-LP-00204-X
Enzyme Linked Immunosorbent Assay (ELISA) Best 2000
CXH
Serum Coeliac Screen INI-LP-006-X ANTI-dsDNA Quantitative
assay INI-LP-00166-X
Anti-Extractable Nuclear
Antigen Antibody screen INI-LP-0024-X
Intrinsic factor antibody INI-LP-00179-X IgA anti-tissue
transglutaminase antibodies INI-LP-006-X
IgG anti-tissue
transglutaminase antibodies INI-LP-006-X
Enzyme Linked Immunosorbent
Assay (ELISA) DS2 CXH
Serum Anti Cardiolipin total antibody
screen (IgG/IgM) INI-LP-0027-X
Anti cardiolipin antibody IgM INI-LP-0027-X Anti cardiolipin antibody IgG INI-LP-0027-X ANTI β2 glycoprotein 1 IgG
antibody INI-LP-0027-X
Thyroid peroxidase antibodies INI-LP-0038-X
8756
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bui ld i ng Two, P ine Trees , Cher t sey Lane, S ta i nes , M idd les ex, TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as
North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 6 of 20
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Examination activities for the purposes of clinical diagnosis (cont’d):
Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
Enzyme Linked Immunosorbent
Assay (ELISA) Manual method: CXH
Serum Glutamate Decarboxylase
Antibody INI-LP-00195-X
Thyroid stimulating hormone
receptor (TSHR) antibodies INI-LP-0018-X
PLA2R antibodies INI-LP-00201-X Antibodies to Tumour Necrosis
Factor (TNF) Adalimumab (Humira®), Etanercept (Enbrel®) and Infliximab (Remicade®
INI-LP-00209-X
Bioassay for IDX,ADA or ETA CXH Serum Three Anti-TNF neutralising
antibodies for ( Adalimumab (Humira®), Etanercept (Enbrel®) and Infliximab (Remicade®)
INI-LP-00210-X
Indirect Immunofluorescence
by /ASP-1200/ CXH
Serum Anti Nuclear antibody INI-LP-0037-X Anti Neutrophil cytoplasmic
antibody INI-LP-0034-X
Indirect Immunofluorescence by manual method
CXH
Serum Adrenal Cortex Antibody INI-LP-0050-X Anti Mitochondrial Antibody INI-LP-0052-X DNA Ab(crithidia) INI-LP-008-X Endomysium Ab (IgA) INI-LP-0050-X
8756
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bui ld i ng Two, P ine Trees , Cher t sey Lane, S ta i nes , M idd les ex, TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as
North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 7 of 20
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Examination activities for the purposes of clinical diagnosis (cont’d):
Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
Indirect Immunofluorescence
by manual method CXH
Serum (cont’d) Anti-gastric parietal cells INI-LP-0052-X Islet cell antibodies INI-LP-0050-X Liver/kidney microsomal Ab INI-LP-0052-X Ovarian antibodies INI-LP-0050-X Smooth Muscle INI-LP-0052-X Smooth muscle F-actin
Smooth Muscle antibodies using Mosaic BIOCHIP Slides
INI-LP-00176-X
Serum, CSF Neuronal antibodies INI-LP-0047-X CXH
Fluoro Enzyme Immuno Assay (FEIA) by Phadia250
CXH
Serum Glomerular Basement
Membrane Ab INI-LP-00190-X
ANCA: MPO antibodies INI-LP-00190-X ANCA : PR3 antibodies INI-LP-00190-X Anti-Nuclear antibody (ANA)
screen INI-LP-00221-X
Serum Immunoblot by D-Tek Dot blot CXH MPO , PR3 and GBM antibody
confirmations INI-LP-0025-X
8756
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bui ld i ng Two, P ine Trees , Cher t sey Lane, S ta i nes , M idd les ex, TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as
North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 8 of 20
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Examination activities for the purposes of clinical diagnosis (cont’d):
Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
Immunoblot by Euroblot One /
manual technique: CXH
Serum Liver autoantibody
confirmation (AMA-M2, 3E (BPO), Sp100, PML, gp210, LKM-1, LC-1, SLA/LP, Ro52)”
INI-LP-0052-X, INI-LP-0047-X
Immunoblot by Euroblot One CXH
Serum ENA Characterisation. INI-LP-0047-X Myositis immunoblot INI-LP-0047-X Serum, CSF Neuronal autoantibody
confirmation (Amphiphysin, CV2, PNMA2(MA2), Ri, Hu, YO)
INI-LP-0047-X
Chemiluminescent Magnetic
Immunoassay (CMIA) by Abbott Architect:
CXH (C )
Serum Cyclic citrullinated peptide
Antibodies INI-LP-00165-X
Turbidimetry by Abbott Architect:
Rheumatoid factor INI-LP-00165-X COMPLEMENT C3 and C4
proteins INI-LP-00165-X
8756
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bui ld i ng Two, P ine Trees , Cher t sey Lane, S ta i nes , M idd les ex, TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as
North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 9 of 20
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Examination activities for the purposes of clinical diagnosis (cont’d):
Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
Cellular Assays
Immunophenotyping of the
following markers/antigens to diagnose and monitor primary and secondary immunodeficiency :
Flow Cytometry by Beckman Coulter Navios
CXH
Whole blood Lymphocyte Subsets INI-LP-00146-X Neutrophil Function Tests
(Phagoburst) INI-LP-00152-X
Neutrophil Function Tests
(Phagotest) INI-LP-00153-X
Neutrophil Function Tests
(Adhesion Markers) INI-LP-00154-X
B cell memory panel INI-LP-002-X T cell memory panel INI-LP-002-X Activated T cells (%) INI-LP-0012-X T Cell Subsets (CD4/CD8) INI-LP-00146-X In vitro stimulation cytokine
release ELISA, ELISpot by DS2 CXH
Whole blood Quantiferon TB Assay INI-LP-0028-X TB Elispot INI-LP-00110-X Immunodeficiency and
Complement Turbidimetry by Binding Site SPA Plus:
CXH
Serum IgG Subclasses INI-LP-00193-X Serum, plasma C1-Esterase inhibitor INI-LP-00193-X
8756
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bui ld i ng Two, P ine Trees , Cher t sey Lane, S ta i nes , M idd les ex, TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as
North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 10 of 20
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Examination activities for the purposes of clinical diagnosis (cont’d):
Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
Enzyme Linked Immunosorbent Assay(ELISA) Manual:
CXH
Serum Alternative Complement Pathway
INI-LP-00194-X
Complement C1q Antibody INI-LP-0040-X Tetanus antibodies INI-LP-0054-X Total haemolytic complement INI-LP-00194-X
Enzyme Linked Immunosorbent
Assay(ELISA) Best 2000/ CXH
Serum Pneumococcal antibodies INI-LP-00205-X Manual immunofixation: CXH Serum C3-Nephritic factor (antibody
to c3-convertase) INI-LP-00185-X
Manual Photometric Analysis: CXH Serum Functional C1 inhibitor INI-LP-0023-X Manual Radial
Immunodiffusion: CXH
Serum Complement Factor H INI-LP-0042-X Complement Factor I INI-LP-0042-X Complement Genetics Manual extraction using Qiagen
DNA QIAamp Minikit CXH
DNA extracted from peripheral blood mononuclear cells (PBMC)
Extraction & storage of DNA INI-LP-0017-X DNA extraction from Whole Blood – Qiagen mini-columns
PCR amplification using Thermocycler Biorad C1000
8756
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bui ld i ng Two, P ine Trees , Cher t sey Lane, S ta i nes , M idd les ex, TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as
North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 11 of 20
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Examination activities for the purposes of clinical diagnosis (cont’d):
Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
Manual extraction using Qiagen
DNA QIAamp Minikit CXH
Extracted DNA
Sequencing reaction by Thermocycler Biorad C1000
Sequence fragment resolution by AB 3130XL
Analysis and Reporting of the
following tests: Using Mutation Surveyor Software
Complement Factor H (CFH)
mutation screening INI-LP-00224-X
Complement Factor I (CFI)
mutation screening INI-LP-00224-X
Complement factor H-related
protein -5 (CFHR5) mutation screening
INI-LP-00224-X
Complement C3 mutation
screening INI-LP-00224-X
Analysis and Reporting of the
following tests: Using Mutation Surveyor Software
Complement Factor B (CFB)
mutation screening INI-LP-00224-X
Complement Component 1, Q
Subcomponent, A Chain (C1QA), Complement Component 1, Q Subcomponent, B Chain (C1QB), Complement Component 1, Q Subcomponent, C Chain (C1QC) mutation screening
INI-LP-00224-X
8756
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bui ld i ng Two, P ine Trees , Cher t sey Lane, S ta i nes , M idd les ex, TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as
North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 12 of 20
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Examination activities for the purposes of clinical diagnosis (cont’d):
Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
Manual extraction using Qiagen
DNA QIAamp Minikit CXH
Extracted DNA Membrane Cofactor Protein
(MCP)/ CD46 INI-LP-00224-X
Microbiology & Serology Chemiluminescent Magnetic
Immunoassay (CMIA) by Abbott Architect:
CXH (I&C)
Serum Syphilis Screen INI-LP-00130-X, INI-LP-0067-X, INI-LP-0062-X
Manual Latex agglutination test
using RHEUMAJET ASO CXH
Serum Anti-Streptolysin O titre INI-LP-0057-X Manual Indirect Latex
Agglutination Test by microtitration (MAST TOXOREAGENT)
CXH
Serum Toxoplasma Screen INI-LP-0066-X Manual Flocculation test using
Biokit RPR Reditest CXH
Serum Rapid Plasma Reagin (RPR) INI-LP-0062-X Passive particle agglutination
using SERODIA TPPA CXH
Serum Treponema pallidum particle
agglutination test (TPPA) INI-LP-0067-X
8756
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bui ld i ng Two, P ine Trees , Cher t sey Lane, S ta i nes , M idd les ex, TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as
North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 13 of 20
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Examination activities for the purposes of clinical diagnosis (cont’d):
Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
VIROLOGY
Viral Serology Chemiluminescent Magnetic Immunoassay (CMIA) by Abbott Architect:
CXH
Serum EBV VCA / EBNA IgG INI-LP-00159-X EBV VCA IgM by EIA INI-LP-00159-X EBV VCA IgG by EIA INI-LP-00159-X Hepatitis A virus IgG INI-LP-0083-X Hepatitis A virus IgM INI-LP-0083-X
Hepatitis B Virus Surface
Antibody INI-LP-00121-X
Hepatitis B Virus core IgM
antibody INI-LP-00121-X
Hepatitis B Virus core total
IgG/IgM INI-LP-00121-X/, NI-LP-LP-00141-X
Hepatitis B Virus e antibody INI-LP-00121-X Hepatitis B e antigen INI-LP-00121-X HTLV 1+2 antibodies by EIA INI-LP-00122-X Rubella virus IgG by EIA INI-LP-00127-X
Hepatitis C virus Ab by EIA INI-LP-00119-X
Hepatitis B Surface antigen INI-LP-00121-X, INI-LP-0088-X CXH (I&C)
Serum, Dried blood spot HIV 1/2 Antibody EIA INI-LP-00120-X, INI-LP0078-X CXH (I&C) Saliva HIV 1/2 Antibody EIA INI-LP-00186-X
8756
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bui ld i ng Two, P ine Trees , Cher t sey Lane, S ta i nes , M idd les ex, TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as
North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 14 of 20
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Examination activities for the purposes of clinical diagnosis (cont’d):
Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
Enzyme Linked Immunosorbent
Assay (ELISA) by DS2: CXH
Serum HSV1/2 IgG by EIA (non-typed)
INI-LP-00162-X
Measles Virus IgM INI-LP-00162-X Mumps Virus IgM INI-LP-00162-X Parvovirus B19 IgG antibodies
by EIA INI-LP-00118-X
Parvovirus B19 IgM
antibodies by EIA INI-LP-00118-X
Varicella zoster virus IgM INI-LP-00162-X
Enzyme Linked Immunosorbent
Assay (ELISA) by BEST 2000 CXH
Measles Virus IgG INI-LP-00177-X
HSV1/2 IgM by EIA (non-typed)
INI-LP-00162-X
Enzyme Linked Fluoresence
Assay (ELFA) by Biomerieux VIDAS:
CXH
Hepatitis B Surface Antigen
confirmation INI-LP-0088-X
Hepatitis B Core Total
Antibody INI-LP-00141-X
HIV1/2 antibody/antigen
confirmation INI-LP-0078-X
HIV p24 Antigen EIA INI-LP-00142-X
8756
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bui ld i ng Two, P ine Trees , Cher t sey Lane, S ta i nes , M idd les ex, TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as
North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 15 of 20
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Examination activities for the purposes of clinical diagnosis (cont’d):
Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
Enzyme Linked Fluoresence
Assay (ELFA) by Biomerieux VIDAS:
CXH
Serum Lyme IgG antibodies INI-LP-00131-X Lyme IgM antibodies INI-LP-00131-X Mumps Virus IgG INI-LP-0074-X Rubella virus IgM by EIA INI-LP0075-X Immunochromographic
technique using Biorad Geenius HIV I/II Confirmatory Assay
CXH
HIV Antibody Typing Assay INI-LP-00215-X
Plasma Molecular Virology Real time PCR Roche AmpliPrep96
CXH
CMV genome real-time quant PCR
INI-LP-00140-X
Quantitative Hepatitis B Virus DNA
INI-LP-00139-X
Hepatitis C Virus RNA Quantitative bDNA
INI-LP-00107-X
HIV-1 VIRAL LOAD(ROCHE AMPLICOR)
INI-LP-00138-X
Qiagen extraction and Real
time PCR on Roche TaqMan48 CXH
Plasma/CSF/Sperm Wash HIV-1 VIRAL LOAD(ROCHE
AMPLICOR) INI-LP-00108-X
8756
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bui ld i ng Two, P ine Trees , Cher t sey Lane, S ta i nes , M idd les ex, TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as
North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 16 of 20
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Examination activities for the purposes of clinical diagnosis (cont’d):
Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
Roche MagnaPure extraction
and RotorGene Real Time PCR CXH
Whole blood Epstein-Barr virus (EBV) DNA
by real-time quant PCR INI-LP-00125-X
Real time PCR by Rotorgene Q, EZ1 Advance and QIAgility / Qiagen extraction
CXH
NPA/BAL/ETA/ swabs Respiratory PCR screen
including Influenza A, Influenza B, parainfluenza 1, 2,3 ,4, RSV, adenovirus, rhinovirus, HMPV
INI-LP-0096-X
Plasma Adenovirus PCR INI-LP-00208-X
Qiagen instrumentation:
Rotorgene Q and EZ1 Advance PCR by melt curve analysis:
CXH
Swabs Herpes simplex virus detection INI-LP-0069-X Plasma, DNA extracted from peripheral blood mononuclear cells (PBMC)
Extraction & storage of RNA & DNA
Manual extraction using Qiagen RNA or DNA QIAamp Minikit
CXH
INI-LP-0022-X Isolation of RNA from EDTA plasma: QIAamp Protocol
INI-LP-0017-X DNA extraction from Whole Blood – Qiagen mini-columns
Reverse transcription PCR or PCR amplification using Thermocycler Biorad C1000
Extracted DNA, RNA
Sequencing reaction using Thermocycler Biorad C1000
8756
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bui ld i ng Two, P ine Trees , Cher t sey Lane, S ta i nes , M idd les ex, TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as
North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 17 of 20
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Examination activities for the purposes of clinical diagnosis (cont’d):
Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
Plasma, DNA extracted from peripheral blood mononuclear cells (PBMC)
Extraction & storage of RNA & DNA (cont’d)
Manual extraction using Qiagen RNA or DNA QIAamp Minikit
CXH
(cont’d)
Sequence fragment resolution using AB 3130XL
INI-LP-00198-X
INI-LP-00197-X
Analysis and Reporting of the following tests:
Mutation Surveyor Software or Viroseq software Stanford HIV Drug Resistance Database or Geno2Pheno [coreceptor]
Plasma HIV-1 INTEGRASE to detect resistance to the following drugs
INI-LP-00197-X
Integrase Strand Transfer
Inhibitors:
dolutegravir (DTG)
elvitegravir (EVG)
raltegravir (RAL)
Plasma DNA HIV-1 V3 Loop (Tropism) INI-LP-00198-X Sequencing using AB 3130XL /
Thermocycler Biorad C1000 / Abbott Viroseq HIV-1 Genotyping system.
CXH
Plasma HIV-1 Drug Resistance to the
following drugs and genotyping of the protease and -reverse transcriptase :
INI-LP-00200-X
Protease and Reverse
Transcriptase Protease Inhibitors:
atazanavir/r (ATV/r) darunavir/r (DRV/r)
8756
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bui ld i ng Two, P ine Trees , Cher t sey Lane, S ta i nes , M idd les ex, TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as
North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 18 of 20
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Examination activities for the purposes of clinical diagnosis (cont’d):
Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
Sequencing using AB 3130XL /
Thermocycler Biorad C1000 / Abbott Viroseq HIV-1 Genotyping system.
CXH
Plasma HIV-1 Drug Resistance to the
following drugs and genotyping of the protease and -reverse transcriptase :
INI-LP-00200-X
fosamprenavir/r (FPV/r) indinavir/r (IDV/r) lopinavir/r (LPV/r) Sequencing using AB 3130XL /
Thermocycler Biorad C1000 / Abbott Viroseq HIV-1 Genotyping system.
CXH
Plasma, HIV-1 Drug Resistance to the
following drugs and genotyping of the protease and -reverse transcriptase :
INI-LP-00200-X
Protease and Reverse
Transcriptase Protease Inhibitors:
nelfinavir (NFV) saquinavir/r (SQV/r) tipranavir/r (TPV/r)
8756
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bui ld i ng Two, P ine Trees , Cher t sey Lane, S ta i nes , M idd les ex, TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as
North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 19 of 20
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Examination activities for the purposes of clinical diagnosis (cont’d):
Sequencing using AB 3130XL / Thermocycler Biorad C1000 / Abbott Viroseq HIV-1 Genotyping system.Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
CXH
Plasma HIV-1 Drug Resistance to the following drugs and genotyping of the protease and -reverse transcriptase :
INI-LP-00200-X
Nucleoside Reverse
Transcriptase Inhibitors:
abacavir (ABC) zidovudine (AZT) stavudine (D4T) didanosine (DDI) emtricitabine (FTC) lamivudine (3TC) tenofovir (TDF)
Non-nucleoside Reverse Transcriptase Inhibitors:
efavirenz (EFV) etravirine (ETR) nevirapine (NVP) rilpivirine (RPV)
H&I TISSUE TYPING DNA quantification using the Nanodrop PCR- Sequence Specific Oligo Typing (SSO) Thermal cycler S1000 or PTC200, Luminex:
HH
Blood (DNA) HLA B27 IMM-LP-266-H HLA B57 IMM-LP-266-H HLA Class I & II Typing IMM-LP-266-H
8756
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bui ld i ng Two, P ine Trees , Cher t sey Lane, S ta i nes , M idd les ex, TW 18 3HR, UK
Imperial College Healthcare NHS Trust operating as
North West London Pathology
Issue No: 002 Issue date: 14 June 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 20 of 20
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Examination activities for the purposes of clinical diagnosis (cont)
Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
H&I TISSUE TYPING DNA quantification using the
Nanodrop, PCR-Sequence Specific Primer (SSP)Thermal cycler S1000 or PTC200, Luminex:
HH
Blood (DNA) HLA Class I & II Typing IMM-LP-206-H, IMM-LP-055-H,
IMM-LP-066-H
DNA quantification using the
Nanodrop Sequence Based Typing (SBT)by Thermal cycler S1000 or PTC200, ABI 3130XL Genetic Analyser:
HH
Blood (DNA) High Resolution Class I & II IMM-LP-213-H, IMM-LP-214-H
IMM-LP-215-H
HLA B57:01 confirmatory test IMM-LP-213-H, IMM-LP-214-H
IMM-LP-215-H
Compliment Dependent
Cytotoxicity (CDC) Inverted fluorescent microscope :
HH
Serum CDC direct crossmatch IMM-LP-090-H, IMM-LP-091-H
Beckman Coulter FC500 cytometer:
HH
Serum Flow cytometric direct
crossmatch IMM-LP-216-H
Luminex: HH Serum HLA Antibody Screen I And II IMM-LP-127-H, IMM-LP-267-H,
IMM-LP-129-H, IMM-LP-265-H
HLA Antibody Characterisation
Class I & II IMM-LP-265-H;IMM-LP-224-H
END