issued by United Kingdom Accreditation Service...Manual microscopy (unstained) or automated cell counting by digital imaging using Sedimax ConTrust: Urine SOP Misys (MIC-LP-058-X)

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


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


Testing performed by the Organisation at the locations specified


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


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


Serology in support of clinical diagnosis

CXH (I&C)

8659

Accredited to

ISO 15189:2012


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




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








Type of test/Properties

measured/Range of measurement



Location

Code

HUMAN BODY FLUIDS AND TISSUES (cont’d)

Microbiology examination activities for the purpose of clinical diagnosis (cont’d)


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












Location

Code




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












Location

Code




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












Location

Code



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












Location

Code



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












Location

Code


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












Location

Code


Molecular examination activities for the purpose of clinical diagnosis (cont’d)


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












Location

Code


Immunology examination activities for the purpose of clinical diagnosis


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












Location

Code




CXH

Allergy and Immune Serology


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












Location

Code




CXH

Serum (cont’d) Allergy and Immune Serology


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












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

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ISO 15189:2012












Location

Code




CXH


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

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ISO 15189:2012












Location

Code




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

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ISO 15189:2012












Location

Code




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

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ISO 15189:2012












Location

Code




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

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ISO 15189:2012












Location

Code




CXH


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

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ISO 15189:2012












Location

Code


Examination activities for the purposes of clinical diagnosis


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)


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)


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

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ISO 15189:2012












Location

Code


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


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)

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ISO 15189:2012












Location

Code




Serum VZV (Varicella Zoster virus )

IgG antibody INI-LP-00235-X, CHM-LP-579-IMP

CXH


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


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

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ISO 15189:2012












Location

Code




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

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ISO 15189:2012












Location

Code




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

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ISO 15189:2012












Location

Code




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












Location

Code




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












Location

Code



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












Location

Code


Examination activities for the purposes of clinical diagnosis (cont)


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












Location

Code


Examination activities for the purposes of clinical diagnosis (cont)


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

Documents

issued by United Kingdom Accreditation Service...Manual microscopy (unstained) or automated cell counting by digital imaging using Sedimax ConTrust: Urine SOP Misys (MIC-LP-058-X)