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

Viapath Analytics LLP

Issue No: 007 Issue date: 11 May 2021

Department of Haematological Contact: Nura Ibrahim Medicine Tel: +44 (0) 203 299 7685 Ground Floor Bessemer Wing E-Mail: [email protected] King's College Hospital 9092 Website: www.viapath.co.uk Denmark Hill

Accredited to London ISO 15189:2012 SE5 9RS United Kingdom Testing performed at the above address only

Site activities performed away from the locations listed above:

Location details Activity

King’s College Hospital (Denmark Hill): Storage & issue of blood & blood products only • Emergency Department • Liver Theatre • Neuro Theatre • Main Theatres • Nightingale Birth Centre (NBC) • Liver Unit ITU (LITU) • Centenary Wing • Harris Birthright (Windsor Walk)

King’s College Hospital (Orpington Site): • Orthopaedic Theatres

Assessment Manager: MS2 Page 1 of 22

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

Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012

Testing performed at main address only

DETAIL OF ACCREDITATION

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN TISSUES AND FLUIDS Cytogenetic analysis for the In house documented methods purpose of clinical diagnosis incorporating manufacturers’ instructions as required

Bone Marrow Detection of diagnostically and Culturing of human tissues/cells Peripheral Blood prognostically relevant cytogenetic using: Smears abnormalities defined in the WHO LP-HAE-CYT-Booking In CSF Classification of Tumours of LP-HAE-CYT-SYSMEXAUTO Ascitic fluid Haematopoietic and Lymphoid LP-HAE-CYT-Set Up Pleural Effusion Tissues (2008 & 2016 revisions) Preparation of cultured cells by Karyotyping manual harvest and G-banding for chromosome analysis using: LP-HAE-CYT-HRVST LP-HAE-CYT-Slide Prep LP-HAE-CYT-GBAND LP-HAE-CYT-MSLOAD

Cell separation of CD138+ cells from Multiple Myeloma referrals using: LP-HAE-CYT-PCD

Fluorescence In-situ Hybridisation (FISH) using commercial probes and: LP-HAE-CYT-FISH

G-banded metaphase analysis using: LP-HAE-CYT-ANALYSIS

Fluorescent In-Situ Hybridisation (FISH) analysis using: LP-HAE-CYT-ANALYSIS LP-HAE-CYT-FISHCAP

Peripheral Blood Constitutional analysis to confirm G-banded metaphase analysis & karyotyping findings FISH analysis using: LP-HAE-CYT-ANALYSIS

Assessment Manager: MS2 Page 2 of 22

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

Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN TISSUES AND FLUIDS Molecular haematology In house documented methods (cont’d) examinations for the purpose of incorporating manufacturers’ clinical diagnosis instructions as required

Amniotic Fluid DNA Extraction, manual methods Chorionic Villus Sample and automated using: Cultured Amniocytes Dried Blood Spot QIAsymphony (blood) Foetal Blood LP-HAE-PND105 Formalin-Fixed Paraffin-Embedded (FFPE) samples Qiagen EZ1 Plasma LP-HAE-PND076 (foetal samples) Saliva LP-HAE-PND116 (saliva) Serum Whole blood

Genomic DNA extracted in house PCR amplification using any of from whole blood (unless stated (unless stated otherwise for otherwise for specified tests) or specified tests): received as primary sample type Applied Biosystems Veriti™ Thermal Cycler and: Veriti™ Thermal Cycler User Guide (PN 4375799) Rotor-Gene 600 and: Rotor-Gene 600 Operator manual 1.7.87 Eppendorf Mastercycler Nexus and: Eppendorf Mastercycler Nexus operating manual (2012)

and DNA extracted from Saliva Thrombophilia genetic analysis: Detection of three genetic variants RT PCR Allelic discrimination affecting thrombophilia: TaqMan assay Factor V Leiden LP-HAE-PND110 Prothrombin C Methylene Tetrahydrofolate Reductase

Hereditary Haemochromatosis genetic analysis: Detection of the two common RT PCR Allelic discrimination genetic variants in the HFE gene TaqMan assay associated with hereditary LP-HAE-PND104 haemochromatosis: HFE p.C282Y HFE p.H63D

Assessment Manager: MS2 Page 3 of 22

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

Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN TISSUES AND FLUIDS Molecular haematology In house documented methods (cont’d) examinations for the purpose of incorporating manufacturers’ clinical diagnosis (cont’d) instructions as required Genomic DNA extracted in house from whole blood (unless stated otherwise for specified tests) or received as primary sample type

Detection of large deletions and Multiplex ligation-dependent probe duplications in the HFE gene amplification (MLPA) by PCR using: Eppendorf Mastercycler Nexus or Applied Biosystems Veriti™ Applied Biosystems 3130xl Genetic Analyser LP-HAE-PND117

Alpha-1-antitrypsin deficiency genotyping: Detection of two genetic variants in RT PCR machine allelic the SERPINA1 gene which are discrimination TaqMan assay known to cause Alpha-1-antitrypsin LP-HAE-PND111 deficiency: Z and S mutations

Gilbert’s syndrome genetic analysis: Homozygosity for the 7 repeat Applied Biosystems 3130xl allele of the dinucleotide repeat Genetic Analyser region in the promoter of the LP-HAE-PND071 UGT1A gene

and DNA extracted from Saliva Variegate and Acute Intermittent Porphyria genetic analysis: Detection of the most common RT PCR allelic discrimination PPOX gene mutation known to TaqMan assay using: cause Variegate Porphyria: Rotor-Gene 600 R59W LP-HAE-PND122

Detection of other single base Sanger Sequencing using: changes and microlesions in the Applied Biosystems 3130xl PPOX gene that cause Variegate Genetic Analyser Porphyria LP-HAE-PND125

Detection of single base changes Sanger Sequencing using: and microlesions in the HMBS Applied Biosystems 3130xl gene that cause Acute Intermittent Genetic Analyser Porphyria LP-HAE-PND121

Assessment Manager: MS2 Page 4 of 22

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

Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN TISSUES AND FLUIDS Molecular haematology In house documented methods (cont’d) examinations for the purpose of incorporating manufacturers’ clinical diagnosis (cont’d) instructions as required Genomic DNA extracted in house from whole blood (unless stated otherwise for specified tests) or received as primary sample type

and DNA extracted from CVS Pyruvate Kinase deficiency genetic analysis: Detection of single base changes Sanger Sequencing using: and microlesions in the PKLR Applied Biosystems 3130xl gene Genetic Analyser LP-HAE-PND126

Detection of large deletions and MLPA by PCR using: duplications in the PKLR gene Eppendorf Mastercycler Nexus or Applied Biosystems Veriti™ Thermal Cycler- Veriti™ Applied Biosystems 3130xl Genetic Analyser LP-HAE-PND117

Glucose-6-phosphate dehydrogenase (G6PD) deficiency: Detection of the most common RT PCR Allelic discrimination African G6PD mutations: TaqMan assay using: V68M Rotor-Gene 600 N126D LP-HAE-PND046

Detection of the common Restriction fragment length Mediterranean G6PD mutation: polymorphism (RFLP) assay by S188F PCR and agarose gel electrophoresis LP-HAE-PND013

and DNA extracted from: Saliva Haemoglobin variant genetic Dried Blood Spot analysis: Amniotic Fluid Detect of the most common HBB RT PCR Allelic discrimination CVS gene mutation known to cause TaqMan assay using: Cultured Amniocytes Sickle cell disease: HbS Rotor-Gene 600 Foetal Blood and the haemoglobin variant: HbC LP-HAE-PND039

Assessment Manager: MS2 Page 5 of 22

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

Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN TISSUES AND FLUIDS Molecular haematology In house documented methods (cont’d) examinations for the purpose of incorporating manufacturers’ clinical diagnosis (cont’d) instructions as required Genomic DNA extracted in house from whole blood (unless stated otherwise for specified tests) or received as primary sample type

Confirmation of HbS and HbC Restriction fragment length variants polymorphism (RFLP) assay by PCR using: Eppendorf Mastercycler Nexus or Applied Biosystems Veriti™ and Agarose gel electrophoresis LP-HAE-PND013

Confirmation of HbC variants Amplification refractory mutation system (ARMS) assay by PCR using: Eppendorf Mastercycler Nexus or Applied Biosystems Veriti™ Thermal Cycler and Agarose gel electrophoresis LP-HAE-PND014

Confirmation of the HbS mutation Sanger Sequencing using: Applied Biosystems 3130xl Genetic Analyser LP-HAE-PND039

Detection of single base changes Sanger Sequencing using: and microlesions in the HBB, HBA1, Applied Biosystems 3130xl Genetic HBA2 and HBD genes Analyser LP-HAE-PND118

Detection of large deletions and MLPA by PCR and: duplications in the HBB, HBA1 and Applied Biosystems 3130xl HBA2 genes Genetic Analyser LP-HAE-PND117

Assessment Manager: MS2 Page 6 of 22

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

Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN TISSUES AND FLUIDS Molecular haematology In house documented methods (cont’d) examinations for the purpose of incorporating manufacturers’ clinical diagnosis (cont’d) instructions as required Genomic DNA extracted in house from whole blood (unless stated otherwise for specified tests) or received as primary sample type

and DNA extracted from: Thalassaemia syndromes genetic Saliva analysis: Dried blood spots Detection of common deletions in Gap PCR using: Amniotic fluid the HBA1 and HBA2 genes known Eppendorf Mastercycler Nexus or CVS to cause Alpha Thalassaemia Applied Biosystems Veriti™ Cultured amniocytes Thermal Cycler and Agarose gel Fetal blood electrophoresis LP-HAE-PND052

Detection of single base changes Sanger Sequencing using: and microlesions in the HBB, HBA1 Applied Biosystems 3130xl Genetic and HBA2 genes that cause Analyser Thalassaemia syndromes LP-HAE-PND118

Detection of large deletions and MLPA by PCR using: duplications in the alpha globin loci Eppendorf Mastercycler Nexus or on chromosome 16 and the beta Applied Biosystems Veriti™ globin loci on chromosome 11 Thermal Cycler Applied Biosystems 3130xl Genetic Analyser LP-HAE-PND117

Confirmation of Haemoglobin ARMS assay by PCR using: variants Eppendorf Mastercycler Nexus or Applied Biosystems Veriti™ Thermal Cycler and Agarose gel electrophoresis LP-HAE-PND014

and DNA extracted from: Hereditary persistence of fetal Whole blood haemoglobin (HPFH) genetic Saliva analysis: Dried Blood Spot Detection of the most common MLPA by PCR using: deletional forms of HPFH caused by Eppendorf Mastercycler Nexus or large deletions in the beta globin Applied Biosystems Veriti™ loci Thermal Cycler Applied Biosystems 3130xl Genetic Analyser LP-HAE-PND072

Assessment Manager: MS2 Page 7 of 22

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

Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN TISSUES AND FLUIDS Molecular haematology In house documented methods (cont’d) examinations for the purpose of incorporating manufacturers’ clinical diagnosis (cont’d) instructions as required Genomic DNA extracted in house from whole blood (unless stated otherwise for specified tests) or received as primary sample type

Confirmation of the deletional forms Gap PCR Eppendorf Mastercycler of HPFH Nexus or Applied Biosystems Veriti™ Thermal Cycler and Agarose gel electrophoresis LP-HAE-PND072

Detection of single base changes Sanger Sequencing using: and microlesions in the promoter Applied Biosystems 3130xl Genetic regions of the A gamma (HBG1) Analyser and the G gamma (HBG2) globin LP-HAE-PND118 genes to that cause non-deletional HPFH

and DNA extracted from: Whole blood Amniotic Fluid CVS Cultured Amniocytes Dried Blood Spot Maternal cell contamination: Fetal Blood Analysis of repeat length of 16 ABI AmpFLSTR kit multiplexed Formalin-Fixed Paraffin-Embedded microsatellite markers PCR reaction. Products analysed (FFPE) samples using Applied Biosystems 3130xl Plasma Genetic Analyser Serum LP-HAE-PND067

Assessment Manager: MS2 Page 8 of 22

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

Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN TISSUES AND FLUIDS Molecular haematology In house documented methods (cont’d) examinations for the purpose of incorporating manufacturers’ clinical diagnosis (cont’d) instructions as required Genomic DNA extracted in house from whole blood (unless stated otherwise for specified tests) or received as primary sample type

Red blood cell disorders and Beckman Coulter FXP robot to mutations: construct sequencing libraries Membranopathy followed by hybridisation to probe Red Cell Enzyme targets and amplification. Haemoglobinopathies Amplified library sequenced by Next Congenital Erythrocytosis Generation Sequencing (NGS) on Diamond-Blackfan Anaeimia Illumina MiSeq. Bone Marrow Failure Data analysed using a NIPY Thrombocytopenia pipeline Neutropenia LP-HAE-PND132 Porphyria Siderblastic Anaemia Iron Regulation HLH Lymphedema Single Genes (HP, Serpina1, UGTA1) Sex Chromosome Markers

Validation of variants from NGS Sanger Sequencing using: Applied Biosystems 3130xl Genetic Analyser LP-HAE-PND131

Assessment Manager: MS2 Page 9 of 22

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

Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN BODY FLUIDS Haematology/Immunophenotyping In house documented methods examinations for the purpose of incorporating manufacturers’ clinical diagnosis instructions as required

Immunophenotyping for Chronic T and B lymphoproliferative disorders: Blood LST Tube: Becton Dickinson FACS Canto II Bone Marrow CD19 Flow Cytometry of fluorescent CD20 labelled cells CD45 LP-HAE-IM1030 Kappa LP-HAE-IM1006 Lambda LP-HAE-IM1053 CD38 CD5 CD4 CD8 CD3 CD56

B-cell follow on:

Tube 1: CD19 CD81 CD23 CD79b CD10 CD200 CD43 CD45

Tube 2: CD19 CD103 CD123 CD11c CD25 ROR1 CD45

Assessment Manager: MS2 Page 10 of 22

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

Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN BODY FLUIDS (cont’d) Haematology/Immunophenotyping In house documented methods examinations for the purpose of incorporating manufacturers’ clinical diagnosis (cont’d) instructions as required

Blood T-cell follow on: Becton Dickinson FACS Canto II Bone Marrow Flow Cytometry of fluorescent Tube 1: labelled cells CD57 LP-HAE-IM1030 CD2 LP-HAE-IM1006 CD16 LP-HAE-IM1053 CD7 CD25 CD3 HLADR CD45

Tube 2: TCR Alpha/Beta CD30 CD10 TCR Gamma/Delta CD3 CD4 CD45

Immunophenotyping for diagnosis of acute leukemia: Blood Acute “Screen”: Becton Dickinson FACS Canto II Bone Marrow CD8 Flow Cytometry of fluorescent Lambda labelled cells CD13 LP-HAE-IM1030 Kappa LP-HAE-IM1006 CD34 CD33 CD3 HLADR CD117 CD4 CD19 CD45

Assessment Manager: MS2 Page 11 of 22

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

Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN BODY FLUIDS (cont’d) Haematology/Immunophenotyping In house documented methods examinations for the purpose of incorporating manufacturers’ clinical diagnosis (cont’d) instructions as required

Blood Acute Leukemia Orientation Tube: Becton Dickinson FACS Canto II Bone Marrow MPO Flow Cytometry of fluorescent CD79a labelled cells CD34 LP-HAE-IM1030 CD19 LP-HAE-IM1006 CD7 CD3 cytCD3 CD45AML 4 Antigen Backbone: CD34 CD117 HLADR CD45

Tube 1: CD16 CD13 CD10 CD11b

Tube 2: CD14 CD300e CD64

Tube 3: CD38, CD56, CD15, CD19

Tube 4: CD36 CD105 CD33 CD71

Tube 5: CD61/CD42 CD123 CD7 CD4

Assessment Manager: MS2 Page 12 of 22

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

Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN BODY FLUIDS (cont’d) Haematology/Immunophenotyping In house documented methods examinations for the purpose of incorporating manufacturers’ clinical diagnosis (cont’d) instructions as required

Blood B-ALL: Becton Dickinson FACS Canto II Bone Marrow Flow Cytometry of fluorescent Tube 1: labelled cells CD58 LP-HAE-IM1030 CD66c LP-HAE-IM1006 CD34 CD10 CD38 CD20 CD45 CD19

Tube 2: TDT NG2 CD34 CD13 CD19 HLADR CD123 CD45

T-ALL

Tube 1 TDT CD1A CD5 CD10 CD8 CD3 CD4 CD45

Tube 2: CD2 CD99 CD5 CD7 TCR gamma delta CD3 CD123 CD45

Assessment Manager: MS2 Page 13 of 22

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

Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN BODY FLUIDS (cont’d) Haematology/Immunophenotyping In house documented methods examinations for the purpose of incorporating manufacturers’ clinical diagnosis (cont’d) instructions as required

Minimal Residual Disease (MRD) assessment of: Blood B-acute lymphoblastic leukaemia: Becton Dickinson FACS Canto II Bone Marrow CD58 Flow Cytometry of fluorescent CD66c labelled cells CD34 LP- HAE-IM1123 CD10 LP-HAE-IM1122 CD38 CD20 CD45 CD19

Chronic lymphocytic leukaemia: CD81 CD79b CD5 ROR 1 CD19 CD20 CD43 CD45

Acute myeloid leukaemia: LP-HAE-IM-1125 CD34 CD117 CD45 HLADR CD13 CD33 CD11b CD2 CD5 CD38 CD123 CD19 CD36 CD56 CD7 CD64

Assessment Manager: MS2 Page 14 of 22

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

Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN BODY FLUIDS (cont’d) Haematology/Immunophenotyping In house documented methods examinations for the purpose of incorporating manufacturers’ clinical diagnosis (cont’d) instructions as required

Immunophenotyping for the diagnosis of Plasma cell disorders: Blood CD27 Becton Dickinson FACS Canto II Bone Marrow CD56 Flow Cytometry of fluorescent CD5 labelled cells CD138 LP-HAE-IM1108 CD38 CD20 CD45 CD19

Cyt Kappa / Cyt Lambda CD117 CD138 CD38 CD45 CD19

Testing for Paroxysmal Nocturnal Haemoglobinuria (PNH): Blood WBC: Becton Dickinson FACS Canto II Bone Marrow CD157 Flow Cytometry of fluorescent FLAER labelled cells CD64 LP-HAE-IM1030 CD15 LP-HAE-IM1006 CD45

RBC: CD59 CD235a

Assessment Manager: MS2 Page 15 of 22

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

Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN BODY FLUIDS (cont’d) Haematology/Immunophenotyping In house documented methods examinations for the purpose of incorporating manufacturers’ clinical diagnosis (cont’d) instructions as required

Immunophenotyping for Myelodisplastic Syndrome (MDS) assessmenty Blood CD34 Becton Dickinson FACS Canto II Bone Marrow CD117 Flow Cytometry of fluorescent CD45 labelled cells HLADR LP-HAE-IM1126 CD16 CD10 CD11b CD13 CD14 CD64 IREM2 CD38 CD19 CD56 CD15 CD71 CD36 CD33 CD7 CD123 CD4

Assessment Manager: MS2 Page 16 of 22

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

Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN BODY FLUIDS (cont’d) Haematology examinations for the In house documented methods purpose of clinical diagnosis incorporating manufacturers’ instructions as required

Blood Full Blood Count (FBC): Sysmex XN-9100 series – XN10 WBC Optical Analysis (Flow Cytometry) RBC LP-BS-HA001 HGB PCV(HCT) MCV MCH MCHC RDW-CV PLT MPV #NEUT #LYMP #MONO #EOS #BASO #NRBC Metamylelocyte count Mylelocyte count Promyelocyte count Blasts Blast Flag Immature Granulocyte Flag Platelet Clump Flag Atypical Lymphocyte Flag

Blood Reticulocytes: Sysmex XN-9100 series – XN10 Retic absolute Optical Analysis (Flow Cytometry) Retic Percentage LP-BS-HA001 LFR MFR HFR Retic RBC IRF %HYPO Ret-He

Assessment Manager: MS2 Page 17 of 22

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

Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN BODY FLUIDS (cont’d) Haematology examinations for the In house documented methods purpose of clinical diagnosis incorporating manufacturers’ (cont’d) instructions as required

Blood Detection and speciation of Malaria Wright-Giemsa & Giemsa R66 parasites: staining followed by Light Plasmodium falciparum, P. vivax, P. Microscopy ovale, P. malariae, P. knowlesi, ML008, ML009 trypanosomes, microfilariae, Leishmania spp.

P. falciparum-specific HRPII antigen BINAX NOW ICT Pan-malarial antigen of: Immunochromatographic assay P. falciparum, P. vivax, ML009 P. ovale, P. malariae

Blood (Thin blood films) Detection of Plasmodium spp. Pathway Diagnostics Quantitative Buffy Coat (QBC) kit & Fluorescence microscopy ML009

Blood Morphological analysis & differential Light Microscopy cell count ML007, ML018

Blood Erythrocyte Sedimentation Rate Sysmex Starrsed Interrliner XN FRL (ESR) Westergren method LP-BS-HA002

Blood Infectious Mononucleosis screen: Accusay Mono Solid-phase Detection of the heterophile immunoassay antibody and: ML003

Assessment Manager: MS2 Page 18 of 22

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

Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN BODY FLUIDS (cont’d) Haematology examinations for the In house documented methods purpose of clinical diagnosis incorporating manufacturers’ (cont’d) instructions as required

Blood Prothrombin/ INR Sysmex CS-5100 Activated partial thromboplastin Clot method time/APTT LP-BS-HT001 Clauss Fibrinogen Thrombin Time Factor Assays: FII FV FVII FVIII FIX FX FXI FXII

Blood Reptilase Time Sysmex CS-5100 DRVV Snake Venom Assays Activated Protein C Resistance LP-HAE-HT004, HT070, HT073

Blood DDimer Sysmex CS-5100 VWF Antigen Latex bead Immunoturbidimetric Free Protein S Assay LP-HAE-HT077, HT087, HT025

Blood Anti-Xa: Sysmex CS-5100 Heparin Chromogenic method Rivaroxaban LP-HAE-HT075, HT072 Apixaban Edoxaban Antithrombin Activity Protein C Activity

Blood Ecarin Time - Dabigatran Sysmex CS-5100 Chromogenic Ecarin Time LP-HAE- HT096

Assessment Manager: MS2 Page 19 of 22

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

Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN BODY FLUIDS (cont’d) Haematology examinations for the In house documented methods purpose of clinical diagnosis incorporating manufacturers’ (cont’d) instructions as required

Documented in-house methods to meet the requirements of the Sickle Cell and Thalassaemia screening programme(s) as defined in the July 2018 ‘Sickle Cell and Thalassaemia screening: laboratory QA evidence requirements’

Blood Haemoglobinopathy Screening (inc. Bio-Rad Variant II HPLC Antenatal, Pre-anaesthetic, Sickle LP-HAE-RC-HB003 Cell and Thalassaemia Screening by detection of haemoglobin Helena Acid Agarose Gel variants: Electrophoresis Haemoglobins S, C, D, E, O-Arab, LP-HAE-RC-HB005 Lepore Perkin Elmer Iso-Electric focussing system LP-HAE-RC-NNS012

Blood Sickle cell solubility Microgen Sickle solubility test LP-HAE-RC-HB002

Dry Blood Spot Newborn Screening confirmation of Manual DBS punching and haemoglobin variants: Perkin Elmer Iso-Electric focussing Haemoglobins S, C, D, E, O-Arab system LP-HAE-RC-NNS012

Blood Haemoglobin H bodies identification Supra-vital staining with brilliant Cresyl blue and microscopic examination LP-HAE-RC-HB009

Blood Haemoglobin S and Haemoglobin F Bio-Rad Variant II HPLC analyser quantification LP-HAE-RC-HB003

Blood Investigation for Hereditary EMA dye binding to red blood cells Spherocytosis and flow cytometry analysis on Becton Dickinson FACS Canto II LP-HAE-RC-NEH-007

Assessment Manager: MS2 Page 20 of 22

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

Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN BODY FLUIDS (cont’d) Haematology examinations for the In house documented methods purpose of clinical diagnosis incorporating manufacturers’ (cont’d) instructions as required

Blood Analysis of prepared red cell lysate by spectrophotometric measurement of rate of reduction of NADP or oxidation of NADH Red Cell Enzymes: using Glock and McLean method

Glucose-6-Phosphate Dehydrogenase (G6PD) LP-HAE-RC-MET013 Pyruvate Kinase LP-HAE-RC-MET015 Hexokinase LP-HAE-RC-MET014 Glucose Phosphate Isomerase LP-HAE-RC-MET017 Phospho-glycerate Kinase LP-HAE-RC-MET019 Triose-phosphate Isomerase LP-HAE-RC-MET020 Aldolase LP-HAE-RC-MET016 Glutathione Reductase LP-HAE-RC-MET022 Methaemoglobin Reductase LP-HAE-RC-MET021

Blood Glucose-6-Phosphate BinaxNOW G6PD kit Dehydrogenase deficiency screen LP-HAE-RC-MET023

Bone marrow Morphological analysis May-Grunwald and Giemsa staining followed by microscopy LP-HAE-IM1005

Blood transfusion examinations for In house documented methods the purpose of clinical diagnosis incorporating manufacturers’ instructions as required

Blood ABO / RhD Blood Group antigens: Automated using: A, B & D Biorad IH1000 Biorad Gelstation LP-HAE-BT2-001, BT-3-A

Blood Antibody Screen for: Automated using: D, C, Cw, E, c, e, K, Fya, Fyb, Jka, Biorad IH1000 Jkb, S, s, Lea, Leb, M,N & Lua Biorad Gelstation LP-HAE-BT2-001, BT3-A

Assessment Manager: MS2 Page 21 of 22

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

Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN BODY FLUIDS (cont’d) Blood transfusion examinations for In house documented methods the purpose of clinical diagnosis incorporating manufacturers’ instructions as required

Blood DAT (polyspecific, monospecific) Automated using: Biorad IH1000 Biorad Gelstation LP-HAE-BT2-001, BT2-05, BT3-D

Blood RHK phenotype antigens: Automated using: D,C,c, E, e, K Biorad IH1000 Biorad Gelstation LP-HAE-BT2-001, BT2-003

Blood Non-RHK phenotype antigens: Automated (except Fya/Fyb) using: Jka, Jkb, Lea, Leb, S, s, M/N, Fya, Biorad Gelstation, ID- Incubator 37 Fyb SI, ID-Centrifuge 12 S, DiaCent-12 LP-HAE-BT2-003, BT3-008

Blood Antibody Titres of: Manual using: Anti-A BioRad cards/gels, ID-Centrifuge Anti-B 12, ID-Incubator 37I LP-HAE-BT5-033

Blood Foetal maternal haemorrhage Kleihauer acid elution test using Microscopy LP-HAE-BT3-J

Blood Antibody identification of: Automated or manual using: D, C, Cw, E, c, e, K, Fya, Fyb, Jka, Biorad Gelstation, ID-Incubator 37 Jkb, S, s, Lea, Leb, M, N & Lua SI, ID-Centrifuge 12 S LP-HAE-BT2-002, BT3-B

Blood Baby ABO / RhD Blood Group Automated using: antigens: Biorad IH1000 A, B, AB & D Biorad Gelstation LP-HAE-BT3-A, BT2-001

Blood ABO / RhD Blood Group antigens: Manual using: A, B & D BioRad cards/gels, DiaCent 12 Centrifuge LP-HAE-BT4-008

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Assessment Manager: MS2 Page 22 of 22