Schedule of Accreditation United Kingdom Accreditation Service · Coulter Navios CXH Whole blood Lymphocyte Subsets INI-LP-00146-X Neutrophil Function Tests (Phagoburst) INI-LP-00152-X

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


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


Testing performed by the Organisation at the locations specified


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













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













Location

Code


Examination activities for the purposes of clinical diagnosis (cont’d)




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













Location

Code






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













Location

Code





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


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













Location

Code




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













Location

Code




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













Location

Code




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













Location

Code




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


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













Location

Code




Manual extraction using Qiagen


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)


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)


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













Location

Code




Manual extraction using Qiagen


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













Location

Code




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


Hepatitis B Virus core IgM


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













Location

Code





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


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


HIV1/2 antibody/antigen

confirmation INI-LP-0078-X

HIV p24 Antigen EIA INI-LP-00142-X

8756

Accredited to

ISO 15189:2012













Location

Code




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













Location

Code




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













Location

Code




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













Location

Code




Sequencing using AB 3130XL /


CXH

Plasma HIV-1 Drug Resistance to the


INI-LP-00200-X

fosamprenavir/r (FPV/r) indinavir/r (IDV/r) lopinavir/r (LPV/r) Sequencing using AB 3130XL /


CXH

Plasma, HIV-1 Drug Resistance to the


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













Location

Code



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













Location

Code


Examination activities for the purposes of clinical diagnosis (cont)


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

Documents

Schedule of Accreditation United Kingdom Accreditation Service · Coulter Navios CXH Whole blood Lymphocyte Subsets INI-LP-00146-X Neutrophil Function Tests (Phagoburst) INI-LP-00152-X