issued by united kingdom accreditation service...manual microscopy (unstained) or automated cell...
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Assessment Manager: DE Page 1 of 29
Schedule of Accreditation issued by
United Kingdom Accreditation Service
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
8659
Accredited to
ISO 15189:2012
Imperial College Healthcare NHS Trust Operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Department of Infection & Immunity Sciences
(Microbiology, I&I and H&I laboratories) Acrow East
St Mary's Hospital
Praed Street
London
W2 1NY
Contact: Emer Fahy
Tel: +44 (0)20 331 15175
E-Mail: [email protected]
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: Microbiology Laboratory Charing Cross Hospital Fulham Palace Road London W6 8RF
Local contact: Emer Fahy
Microbiology CXH
Address Infection & Immunity Laboratory 9th Floor Laboratory Block Charing Cross Hospital Fulham Palace Road London W6 8RF
Local contact Emer Fahy
Immunology Microbiology Serology Molecular Virology
CXH
Address Histocompatability & Immunogenetics Laboratory G Block Hammersmith Hospital Du Cane Road London W12 0HS
Local contact Emer Fahy
Histocompatibility & Immunogenetics HH
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Che r t sey Lane , S ta ines -upon -Thames , TW18 3HR, UK
Imperial College Healthcare NHS Trust Operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 2 of 29
Site activities performed away from the locations listed above:
Location details Activity Location code
8th floor Specialist Chemistry laboratory Charing Cross Hospital Fulham Palace Road London W6 8RF
Local contact: Emer Fahy
Serology in support of clinical diagnosis
CXH (C)
I&I Laboratory 8th floor Specialist Chemistry laboratory Charing Cross Hospital Fulham Palace Road London W6 8RF
Local contact: Emer Fahy
Serology in support of clinical diagnosis
CXH (I&C)
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 3 of 29
DETAIL OF ACCREDITATION
Materials/Products tested
Type of test/Properties measured/Range of
measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES
Microbiology examination activities for the purpose of clinical diagnosis
In House documented methods based on current Public Health England (PHE) Standards for Microbiology Investigations’ (SMIs)’
CXH
Blood, Bone Bronchio-alveolar lavages (BAL) / washings, CPAP fluid Contact lens and fluid Corneal scrape material CSF Drain fluid, dressings, bile Expressed breast milk Faeces Fluids, Aspirates, antral washouts Lymph node aspirates (including ultra sound guided EBUS) Pleural effusions / fluid Prostheses, heart valves, Intra uterine devices Semen Skin, hair, nails Sputum Swabs, pus Tips and lines Tissue, biopsies, brushes Urines, suprapubic aspirates, nephrostomy, ileal conduits, void bladder urines.
General isolation for characterisation of microorganisms for the purpose of diagnosis
Manual or automated inoculation, incubation and image capture of culture media using: CSF SOP (MIC-LP-006-X) Cross Infection (MIC-LP-003-X) ENT SOP (MIC-LP-008-X) Faeces MC&S SOP (MIC-LP-009-X) Faeces C.difficile culture (MIC-LP-005-X) Female genital SOP (MIC-LP-140-X) GUM Bench SOP (MIC-LP-141-X) Fungal Culture SOP (MIC-LP-159-X) Superficial Mycoses (MIC-LP-073-X) H.pylori Culture SOP (MIC-LP-011-X) Peritoneal Dialysis Fluid SOP (MIC-LP-012-X) Sterile fluids SOP (MIC-LP-013-X) Sterility Testing (MIC-LP-084-X) Respiratory SOP (MIC-LP-018-X) Tissue and Bone SOP (MIC-LP-014-X) Wounds & General Set Up Bench SOP (MIC-LP-137-IMP) Wounds and General bench reading SOP (MIC-LP-136-IMP) Kiestra SOP MIC-LP-163-X
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 4 of 29
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Microbiology examination activities for the purpose of clinical diagnosis (cont’d)
In House documented methods based on current Public Health England (PHE) Standards for Microbiology Investigations’ (SMIs)’
CXH
Blood, body fluids, bone marrow harvests,
Fluorescent detection of CO2 levels to detect microorganisms using BACTEC FX: Blood culture FX (MIC-LP-021-X) Mycobacterial methods (MIC-LP-017-X)
Sputum Bronchio-alveolar lavages (BAL) / washings, Pleural fluid / effusions CSF, Fluids Early Morning Urine Gastric washings Lymph node aspirates (including ultra sound guided EBUS), Pus, Tissues, biopsies, brushes, skin biopsies, Blood, bone marrow
Fluorescent Detection of O2 levels to detect Mycobacteria using Mycobacteria Growth Indicator Tube (MGIT), manual culture using Kirschner liquid medium Mycobacterial methods (MIC-LP-017-X)
Stem cells Sterility for Human products
Fluorescent detection of CO2 levels to detect microorganisms using BACTEC FX Stem Cell SOP (MIC-LP-139-X) Blood culture FX (MIC-LP-021-X)
Swabs, Urine
Screening for Methiicillin resistant Staphylococcus aureus (MRSA )
Manual or automated inoculation, incubation and image capture of culture media using: Cross Infection (MIC-LP-003-X)
Bacteria, Fungi
Antimicrobial susceptibility testing of clinically significant bacteria and fungi
Manual disc diffusion using the latest EUCAST methodology. Manual reading or automated digital imaging by Kiestra using: MIC and EUCAST sensitivity testing (MIC-LP-044-X) Fungal Susceptibility Testing (MIC-LP-076-X) Kiestra SOP MIC-LP-163-X
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 5 of 29
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Microbiology examination activities for the purpose of clinical diagnosis (cont’d)
In House documented methods based on current Public Health England (PHE) Standards for Microbiology Investigations’ (SMIs)’
CXH
Urine Semi-quantification of white
blood cells, red blood cells, squamous epithelial cells, bacteria, yeast, casts, spermatazoa
Manual microscopy (unstained) or automated cell counting by digital imaging using Sedimax ConTrust: Urine SOP Misys (MIC-LP-058-X) Menarini Sedimax SOP (MIC-LP-133-IMP), Urine SOP Misys (MIC-LP-058-X)
CSF, peritoneal dialysis fluid, ascitic fluid, Prosthetic joint fluid
Quantification of white blood cells and red blood cells
Manual count: CSF SOP MIC-LP-006-X, Peritoneal dialysis fluid SOP MIC-LP-012-X, Sterile fluids MIC-LP-013-X
Cultured isolates Automated identification of
bacteria, yeasts
Identification using Bruker Matrix Assisted Laser Desorption Ionization Time-of-Flight (MALDI-TOF): MALDI-TOF SOP (MIC-LP-134-X)
Cultured isolates
Identification of bacteria, yeasts and fungi
Identification and staining methods MIC-LP-047-IMP using the following manual techniques: Gram stain, Manual biochemical test assays.
Cultured isolates
Serological typing of Salmonella sp. PSO, PSH, Vi, Shigella sp., E. coli O157, V. cholera O1
Using manual slide agglutination technique Faeces MC&S SOP MIC-LP-009-X
Culture positive liquid media Identification of M.
tuberculosis complex isolates Using BD MGIT MTBc identification card: Mycobacterial methods SOP MIC-LP-017-X
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 6 of 29
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Microbiology examination activities for the purpose of clinical diagnosis (cont’d)
In House documented methods based on current Public Health England (PHE) Standards for Microbiology Investigations’ (SMIs)’
CXH
Blood, Bone marrow, stem cell material, Bone Bronchio-alveolar lavages (BAL) / washings, Pleural effusions / fluid Contact lens and fluid Corneal scrape material CSF , Fluids, Aspirates, antral washouts, drain fluids Lymph node aspirates (including ultra sound guided EBUS) Pus, Sputum, Swabs Prostheses, heart valves Tissue, biopsies, brushes Urine
Microscopic examination in order to detect and differentiate microorganisms and cellular elements for the purpose of diagnosis
Light microscopy (stained) using Gram stain, Diff-Quick Differential stain and Lactophenol cotton blue, lactofuschin Microbiology Identification & Staining Methods (MIC-LP-047-IMP) Kiestra SOP MIC-LP-163-X CSF SOP (MIC-LP-006-X) Cross Infection (MIC-LP-003-X) ENT SOP (MIC-LP-008-X) Faeces MC&S SOP (MIC-LP-009-X) Faeces C.difficile culture (MIC-LP-005-X) Female genital SOP (MIC-LP-140-X) GUM Bench SOP (MIC-LP-141-X) Fungal Culture SOP (MIC-LP-159-X) Superficial Mycoses (MIC-LP-073-X) H.pylori Culture SOP (MIC-LP-011-X) Peritoneal Dialysis Fluid SOP (MIC-LP-012-X) Sterile fluids SOP (MIC-LP-013-X) Sterility Testing (MIC-LP-084-X) Respiratory SOP (MIC-LP-018-X) Tissue and Bone SOP (MIC-LP-014-X) Wounds & General Set Up Bench SOP (MIC-LP-137-IMP) Wounds and General bench reading SOP (MIC-LP-136-IMP)
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 7 of 29
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Microbiology examination activities for the purpose of clinical diagnosis (cont’d)
In House documented methods based on current Public Health England (PHE) Standards for Microbiology Investigations (SMI)
CXH
Sputum, Bronchio-alveolar lavages (BAL) Pleural fluid / effusions CSF, Fluids, Pus Gastric washings Lymph node aspirates (including ultra sound guided EBUS), Tissues, biopsies, brushes, skin biopsies, Blood, bone marrow
Immunofluorescent microscopy using Auramine staining and Light microscopy using Ziehl–Neelsen staining: Mycobacterial methods (MIC-LP-017-X)
Skin , Hair, Nails Sputum, Bronchio-alveolar lavages (BAL) / washings, Pleural fluids / effusions Blood, bone marrow CSF, Fluids, Pus Tissues, biopsies
Microscopic examination in order to detect and differentiate microorganisms and cellular elements for the purpose of diagnosis
Immunofluorescent microscopy using Calcoflor and Light Microscopy (unstained Superficial Mycoses (MIC-LP-073-X), Long term (Systemic) Mycoses (MIC-LP-074-X), Short Term Fungal Culture (MIC-LP-075-X)
Faeces, Sellotape slides, parasitic material
Microscopic examination in order to detect the presence of parasites (ova, cysts, trophozoites, worms)
Manual microscopy (unstained) Faeces OCP SOP (MIC-LP-010-X)
Urine Microscopic examination in
order to detect the presence of Schistosomes.
Manual microscopy (unstained): Urine SOP MIC-LP-058-X
Faeces Microscopic examination in
order to detect the presence of Cryptosporidium sp.
Immunofluorescent microscopy using auramine staining: Faeces OCP SOP (MIC-LP-010-X)
Using the Dynex DS2 Automated
ELISA System:
Faeces Detection of Helicobacter sp.
antigen Helicobacter Antigen SOP MIC-LP-028-X)
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 8 of 29
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Microbiology examination activities for the purpose of clinical diagnosis (cont’d)
In House documented methods based on current Public Health England (PHE) Standards for Microbiology Investigations (SMI)
CXH
Using the Dynex DS2 Automated
ELISA System:
Faeces Detection of GDH and
Clostridium difficile toxins A and B
Using rapid membrane enzyme immunoassay: C. Diff Quik Chek Complete C.difficile Rapid (MIC-LP-004-X)
Detection of viral antigens Using Manual Immunochromato-
graphic lateral-flow:
Faeces Rota/Adenovirus antigen
detection RIDA® Quick Rotavirus/Adenovirus Combi (N1002) MIC-LP-148-IMP
Norovirus antigen detection RIDA® Norovirus N1402 MIC-
LP-149-X
Serum Rapid Detection of HIV-1/2
Antigen/Antibody Using Determine™ HIV-1/2 Antigen/Antibody Combo: HIV-1/2 Antigen/Antibody Combo MIC-LP-161-X
Serum, CSF
Cryptococcal Antigen
Using IMMY Lateral Flow Assay Cryptococcal Antigen Detection SOP (MIC-LP-153-X)
Urine Pneumococcal Urinary
Antigen Binax NOW Streptococcus pneumonia urinary antigen card: Pneumococcal Urinary Antigen (MIC-LP-022-X)
Urine Legionella Urinary Antigen Binax NOW Legionella urinary
antigen card: Legionella Urinary Antigen (MIC-LP-023-X)
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 9 of 29
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Molecular examination activities for the purpose of clinical diagnosis
In house documented procedures based on equipment manuals and standard methods:
CXH
Sputum, Bronchio-alveolar lavages (BAL) / washings, ultra sound guided EBUS)
Mycobacteria tuberculosis complex and rifampicin resistance detection
Real Time PCR using GeneXpert and Ultra-10 kit’ TB GeneXpert SOP (MIC-LP-129-X) Cepheid GeneXpert SOP MIC-LP-166-X
Swabs MRSA and SA detection to
identify mecA, mecC and SCCmec subtype’
Real Time PCR using GeneXpert and Nasal (NxG) kit: Cepheid GeneXpert SOP MIC-LP-166-X MRSA GeneXpert SOP MIC-LP-151-X
Cultered Isolates Detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP-1 gene sequences associated with carbapenem-non-susceptibility in Gram-negative bacteria
Real Time PCR using Cepheid GeneXpert and Carba-R Assay: Cepheid GeneXpert SOP MIC-LP-166-X Xpert Carba Cepheid Complete MIC-LP-160-X
Cultured isolates
Clostridium dificile ribotyping Using G-Storm GS1 thermocycler, Electrophoresis gel tank: Clostridium difficile PCR ribotyping (MIC-LP-138-X)
Urethral, vaginal, vulvo-vaginal self-taken, rectal, throat, eye swabs, urine
Chlamydia detection GC and Chlamydia DNA screen by PCR
Using Becton Dickinson (BD) Viper™ , Chlamydia / GC SDA Viper SOP (MIC-LP-020-X)
Urethral, vaginal, vulvo-vaginal self-taken, rectal, throat, eye swabs, urine
Detection of Chlamydia trachomatis LGV strains
Using Roche Magnapure Compact 24 (Nucleic Acid Extraction system) and Lightcycler 96 (Nucleic acid amplification). Detection of Chlamydia trachomatis LGV strains (MIC-LP-157-IMP)
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 10 of 29
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Molecular examination activities for the purpose of clinical diagnosis (cont’d)
In house documented procedures based on equipment manuals and standard methods:
CXH
Urethral, vaginal, vulvo-vaginal self-taken, rectal, throat swabs, urine
Neisseria gonorrhoeae confirmation by PCR
Using the BD MAXTM GC rt PCR kit on the BD MAXTM analyser, SOP BDmax GC NAAT confirmations MIC-LP-165-X
Feaces
Detection of: Salmonella enterica Shigella spp Enteroinvasive E.coli, Campylobacter jejuni/coli/lari, Shiga toxin producing E.coli (STEC), Cryptosporidium parvum / hominis Giardia lamblia
EntericBio Gastro Panel 2 by Real Time PCR Serosep autosampler and Roche light cycler 480 using MIC-LP-168-X
Immunology examination
activities for the purpose of clinical diagnosis
Allergy and Immune Serology Fluoro Enzyme Immuno Assay
(FEIA) by Phadia250:
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
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 11 of 29
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Immunology examination activities for the purpose of clinical diagnosis
In house documented procedures based on equipment manuals and standard methods:
CXH
Allergy and Immune Serology
(cont’d) Fluoro Enzyme Immuno Assay (FEIA) by Phadia250:
Serum (cont’d) Specific IgE for the following INI-LP-00199-X
Cashew Nut Cat Cefaclor Cheese Cheddar Chick Pea Chicken Meat Chilli Pepper Chocolate Cockroach Coconut
Cod Fish Coffee Corn Cows Milk Crab Cray Fish 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
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 12 of 29
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Immunology examination activities for the purpose of clinical diagnosis
In house documented procedures based on equipment manuals and standard methods:
CXH
Allergy and Immune Serology
(cont’d) Fluoro Enzyme Immuno Assay (FEIA) by Phadia250:
Serum (cont’d) Specific IgE for the following INI-LP-00199-X Macadamia Nut Mackerel Mould Mix Mango Mixed Tree Morphine Mustard Mushroom Oats Omega-5-Gliadin Onion Orange Oyster Pea 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
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 13 of 29
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Immunology examination activities for the purpose of clinical diagnosis
In house documented procedures based on equipment manuals and standard methods:
CXH
Serum (cont’d) Allergy and Immune Serology
(cont’d) Fluoro Enzyme Immuno Assay (FEIA) by Phadia250:
Specific IgE for the following INI-LP-00199-X Tomato Tuna Fish White Bean Walnut Wasp Venom Weed Mix Wheat Yeast Total IgE Tryptase INI-LP-00204-X
Enzyme Linked Immunosorbent Assay (ELISA) Best 2000
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
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 14 of 29
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Immunology examination activities for the purposes of clinical diagnosis (cont’d):
Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
CXH
Serum Enzyme Linked Immunosorbent
Assay (ELISA) DS2
Anti Cardiolipin total antibody
screen (IgG/IgM) INI-LP-0027-X
Enzyme Linked Immunosorbent Assay (ELISA) DS2: INI-LP-0027-X
Anti cardiolipin antibody IgM Anti cardiolipin antibody IgG Anti β2 glycoprotein 1 IgG
antibody
Anti β2 glycoprotein 1 IgG /
IgM antibody
Anti β2 glycoprotein 1 IgM
antibody
Enzyme Linked Immunosorbent
Assay (ELISA) Manual method:
Glutamate Decarboxylase
Antibody INI-LP-00195-X
Thyroid stimulating hormone
receptor (TSHR) antibodies INI-LP-0018-X
PLA2R antibodies INI-LP-00201-X Anti-IA2 IgG INI-LP-00233-X
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 15 of 29
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Immunology examination activities for the purposes of clinical diagnosis (cont’d):
Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
CXH
Enzyme Linked Immunosorbent
Assay (ELISA) Manual method:
Serum Antibodies to Tumour Necrosis
Factor (TNF) Adalimumab (Humira®), Etanercept (Enbrel®) and Infliximab (Remicade®
INI-LP-00209-X
Vedolizumab Ab INI-LP-00234-X Three Anti-TNF neutralising
antibodies for ( Adalimumab (Humira®), Etanercept (Enbrel®) and Infliximab (Remicade®)
Bioassay for IDX,ADA or ETA INI-LP-00210-X
Indirect Immunofluorescence by /ASP-1200/
Anti Nuclear antibody INI-LP-0037-X Anti Neutrophil cytoplasmic
antibody INI-LP-0034-X
Indirect Immunofluorescence by manual method
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 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
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 16 of 29
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Immunology examination activities for the purposes of clinical diagnosis (cont’d):
Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
CXH
Indirect Immunofluorescence by
manual method
Serum 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
Fluoro Enzyme Immuno Assay (FEIA) by Phadia250
Serum Glomerular Basement
Membrane Ab INI-LP-00190-X
ANCA: MPO antibodies INI-LP-00190-X Fluoro Enzyme Immuno Assay
(FEIA) by Phadia250
ANCA : PR3 antibodies INI-LP-00190-X Anti-Nuclear antibody (ANA)
screen INI-LP-00221-X
MPO , PR3 and GBM antibody
confirmations Immunoblot by D-Tek Dot blot: INI-LP-0025-X
Liver autoantibody
confirmation (AMA-M2, 3E (BPO), Sp100, PML, gp210, LKM-1, LC-1, SLA/LP, Ro52)”
Immunoblot by Euroblot One / manual technique: INI-LP-0052-X, INI-LP-0047-X
Immunoblot by Euroblot One ENA Characterisation. INI-LP-0047-X Myositis immunoblot INI-LP-0047-X
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 17 of 29
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Immunology 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 Serum, CSF Neuronal autoantibody
confirmation (Amphiphysin, CV2, PNMA2(MA2), Ri, Hu, YO)
INI-LP-0047-X CXH
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
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 18 of 29
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Immunology examination activities for the purposes of clinical diagnosis (cont’d):
Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
CXH
Whole blood Immunophenotyping of the
following markers/antigens to diagnose and monitor primary and secondary immunodeficiency :
Flow Cytometry by Beckman Coulter Navios
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
Quantiferon TB Assay INI-LP-0028-X
TB Elispot INI-LP-00110-X Immunodeficiency and
Complement Turbidimetry by Binding Site SPA Plus:
Serum IgG Subclasses INI-LP-00193-X Serum, plasma C1-Esterase inhibitor INI-LP-00193-X
Enzyme Linked Immunosorbent Assay(ELISA) Manual:
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
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 19 of 29
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS (cont’d):
Immunology examination activities for the purposes of clinical diagnosis (cont’d):
Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
CXH
Enzyme Linked Immunosorbent
Assay(ELISA) Best 2000
Serum Pneumococcal antibodies INI-LP-00205-X Manual immunofixation: C3-Nephritic factor (antibody
to c3-convertase) INI-LP-00185-X
Manual Photometric Analysis: Functional C1 inhibitor INI-LP-0023-X Manual Radial Immunodiffusion: Complement Factor H INI-LP-0042-X Complement Factor I INI-LP-0042-X Complement Genetics Manual extraction using Qiagen
DNA QIAamp Minikit
DNA extracted from peripheral blood mononuclear cells (PBMC)
INI-LP-0017-X DNA extraction from Whole Blood – Qiagen mini-columns
PCR amplification using
Thermocycler Biorad C1000 / AC196 Alpha Cycle
Manual extraction using Qiagen
DNA QIAamp Minikit
Extracted DNA
Sequencing reaction by Thermocycler Biorad C1000 / AC196 Alpha Cycle
Sequence fragment resolution by AB 3130XL
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 20 of 29
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
Documented In-house Methods and Manufacturer’s instructions for analyser with specific reference to:
CXH
Extracted DNA 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
Manual extraction using Qiagen
DNA QIAamp Minikit
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
Membrane Cofactor Protein
(MCP)/ CD46 INI-LP-00224-X
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 21 of 29
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:
Microbiology & Serology Manual Latex agglutination test
using RHEUMAJET ASO CXH
Anti-Streptolysin O titre INI-LP-0057-X Manual Indirect Latex
Agglutination Test by microtitration (MAST TOXOREAGENT)
CXH
Toxoplasma Screen INI-LP-0066-X Manual Flocculation test using
Biokit RPR Reditest CXH
Rapid Plasma Reagin (RPR) INI-LP-0062-X Passive particle agglutination
using SERODIA TPPA CXH
Treponema pallidum particle
agglutination test (TPPA) INI-LP-0067-X
Chemiluminescent Magnetic
Immunoassay (CMIA) by Abbott Architect:
CXH
Serum Hepatitis C virus Antigen INI-LP-00119-X Chemiluminescent
Immunoassay by Diasorin Liaison CXH (C)
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 22 of 29
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:
Serum VZV (Varicella Zoster virus )
IgG antibody INI-LP-00235-X, CHM-LP-579-IMP
CXH
Enzyme Linked Immunosorbent
Assay (ELISA) by DS2:
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
Measles Virus IgG INI-LP-00177-X
IgG Hepatitis E virus INI-LP-00232-X IgM Hepatitis E virus INI-LP-00232-X Chemiluminescence
immunoassay (CLIA) by Diasorin Liaison XL
Hepatitis B Surface Antigen
confirmation INI-LP-00251-X
Hepatitis B Core Total
Antibody INI-LP-00250-X
Mumps IgG INI-LP-00252-X
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 23 of 29
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:
CXH
HIV1/2 antibody/antigen confirmation
Multiplex Flow Immunoassay by Bio-Rad Bioplex 2200 using HIV Confirmation Bio-Rad Bioplex INI-LP-00248-X) INI-LP-0078-X
Enzyme Linked Fluoresence
Assay (ELFA) by Biomerieux VIDAS:
Serum HIV p24 Antigen EIA INI-LP-00142-X
Lyme IgG antibodies INI-LP-00131-X Lyme IgM antibodies INI-LP-00131-X Rubella virus IgM by EIA INI-LP0075-X Immunochromographic technique
using Biorad Geenius HIV I/II Confirmatory Assay
HIV Antibody Typing Assay INI-LP-00215-X
Plasma Molecular Virology Real time PCR Roche AmpliPrep96
Quantitative CMV viral load INI-LP-00140-X
Quantitative Hepatitis B Virus viral load
INI-LP-00139-X
Quantitative Hepatitis C Virus viral load
INI-LP-00107-X
Real time PCR Roche AmpliPrep96
Quantitative HIV-1 viral load INI-LP-00138-X
Qiagen extraction and Real time
PCR on Roche TaqMan48
Plasma/CSF/Sperm Wash Quantitative HIV-1 viral load
(ROCHE AMPLICOR) INI-LP-00108-X
Roche Cobas 6800
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 24 of 29
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:
CXH
Plasma Quantitative Hepatitis C Virus
viral load INI-LP-00228-X
Quantitative Hepatitis B Virus
viral load INI-LP-00228-X
Quantitative HIV-1 viral load INI-LP-00228-X Roche MagnaPure extraction and
RotorGene Real Time PCR
Whole blood Epstein-Barr virus (EBV) DNA
by real-time quant PCR INI-LP-00125-X
Plasma Quantitative Adenovirus viral
load INI-LP-00208-X
Multiplex nested Real time with
melt curve analysis PCR using High-Plex 24 system Aus Diagnostics
NPA/BAL/ETA/ swabs Respiratory pathogens
molecular detection (Influenza A, Influenza B. RSV, Parainfluenza 1, 2, 3, 4 Adenovirus, Rhinovirus Enterovirus, HMPV, Mycoplasma pneumoniae Bordetella sp, Bordetella pertussis
INI-LP-00237-X
Qiagen instrumentation:
Rotorgene Q and EZ1 Advance PCR by melt curve analysis:
Swabs Herpes simplex virus detection INI-LP-0069-X Plasma, DNA extracted from peripheral blood mononuclear cells (PBMC)
Manual extraction using Qiagen RNA or DNA QIAamp Minikit
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 25 of 29
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:
CXH
Extracted DNA, RNA 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 /AC196 Alpha Cycle
Sequencing reaction using Thermocycler Biorad C1000 /AC196 Alpha Cycle
Plasma, DNA extracted from peripheral blood mononuclear cells (PBMC)
Manual extraction using Qiagen RNA or DNA QIAamp Minikit
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)
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 26 of 29
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:
CXH
Plasma DNA HIV-1 V3 Loop (Tropism) INI-LP-00198-X Sequencing using AB 3130XL /
Thermocycler Biorad C1000 /AC196 Alpha Cycle / Abbott Viroseq HIV-1 Genotyping system
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)
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 27 of 29
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 /AC196 Alpha Cycle / Abbott Viroseq HIV-1 Genotyping system: INI-LP-00200-X
CXH
Plasma HIV-1 Drug Resistance to the
following drugs and genotyping of the protease and -reverse transcriptase : fosamprenavir/r (FPV/r) indinavir/r (IDV/r) lopinavir/r (LPV/r)
HIV-1 Drug Resistance to the
following drugs and genotyping of the protease and -reverse transcriptase :
Protease and Reverse
Transcriptase Protease Inhibitors: nelfinavir (NFV) saquinavir/r (SQV/r) tipranavir/r (TPV/r) HIV-1 Drug Resistance to the following drugs and genotyping of the protease and -reverse transcriptase :
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)
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 28 of 29
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:
HH
H&I Tissue Typing Blood DNA Extraction Semi-automated method using
EZ1 DNA Extraction kit IMM-LP-050-H, IMM-LP-270-H
DNA quantification using the
Nanodrop PCR- Sequence Specific Oligo Typing (SSO) Thermal cycler S1000,PTC200, or Veriti, Luminex:
Blood (DNA) HLA B27 IMM-LP-266-H HLA B57 IMM-LP-266-H HLA Class I & II Typing IMM-LP-266-H
DNA quantification using the Nanodrop, PCR-Sequence Specific Primer (SSP)Thermal cycler S1000 or PTC200, or Veriti ,Luminex:
HLA Class I & II Typing IMM-LP-206-H, IMM-LP-055-H,
IMM-LP-066-H
DNA quantification using the Nanodrop, PCR-Sequence Specific Primer (SSP)Thermal cycler S1000, PTC200 or Veriti and Quantstudio6 Flex
HLA Class I & II Typing IMM-LP-206-H, IMM-LP-055-H, IMM-LP-066-H , IMM-LP-272-H,
8659
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service Bu i ld ing Two , P ine Trees , Che r tsey Lane, S ta ines , M idd lesex , TW18 3HR, UK
Imperial College Healthcare NHS Trust operating as North West London Pathology
Issue No: 010 Issue date: 10 August 2020
Testing performed by the Organisation at the locations specified
Assessment Manager: DE Page 29 of 29
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:
HH
DNA quantification using the
Nanodrop Sequence Based Typing (SBT)by Thermal cycler S1000 or PTC200, ABI 3130XL Genetic Analyser:
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:
Serum CDC direct crossmatch IMM-LP-090-H, IMM-LP-091-H
Beckman Coulter FC500 cytometer:
Flow cytometric direct
crossmatch IMM-LP-216-H
HLA Antibody Screen I And II Luminex using OneLambda
Labscreen IMM-LP-127-H, IMM-LP-267-H
HLA Antibody Characterisation Class I & II
Luminex using OneLambda Labscreen Single Antigen and Lifecodes Single Antigen tests: IMM-LP-265-H; IMM-LP-129-H
END