accreditation · crossmatching ce iso15189 5.5, lp-btr-028 and lp-btr-028a manual method of...

INAB Registration No. 192MT

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Schedule of

Accreditation

Organisation Name

St Vincents University Hospital

INAB Reg No

192MT

Contact Name

Anne Dickinson

Address

St Vincent's Healthcare Group, Elm Park, Dublin

Contact Phone No

01 2213695

Email

[email protected]

Website

Accreditation Standard

ISO 15189

Date Initially Awarded

22/04/2008

Scope Classification Microbiology and virology

Scope Classification Blood Transfusion Science

Scope Classification Haematology

Scope Classification Immunology

Scope Classification Histopathology and cytopathology

Scope Classification Chemical pathology

Scope Classification Genetics

Services available to the public¹

Yes

¹ Refer to document on interpreting INAB Scopes of Accreditation

Sites from which accredited services are delivered

(the detail of the accredited services delivered at each site are on the Scope of Accreditation)

Name Address

1 SVPH Satellite Laboratory

St Vincent's Private Hospital, Merrion Road, Dublin 4, Dublin

2 Head Office St Vincent's Healthcare Group, Elm Park, Dublin, D4


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Scope of

Accreditation

Head Office

Blood Transfusion Science

Category: A

Medical pathology field - Test

Test/assay Specimen Type Equipment/Technique Method (CE/Non-CE/In house developed/based on standard method)

Range of measurement

Std. ref & SOP

1020 Transfusion science - .01 Blood grouping including ABO, Rh(D) and other antigens by manual methods

Blood Grouping (ABO & RhD Typing)

Whole Blood Manual Method in tubes

CE ISO15189 5.5, LP-BTR-008

Blood Grouping (ABO & RhD Typing), Blood Transfusion Service Red Blood Cells; Confirming ABO and RhD group and donor units

Whole Blood, Red Blood Cells

Manual Method in tubes

CE ISO15189 5.5, LP-BTR-008

1020 Transfusion science - .02 Blood grouping including ABO, Rh(D) and other antigens by automated methods

Blood Grouping (ABO & RhD Typing). Antibody Screening

Whole Blood IH1000 analyser, Diamed ID-Gel Station

CE ISO15189 5.5, LP-BTR-IH1000, LP-BTR-080

IH1000 analyser, Diamed ID-Gel Station


Blood Grouping (ABO & RhD Typing). Antibody Screening, Blood Transfusion Service Red Blood Cells; Confirming ABO and RhD group and donor units

Whole Blood, Red Blood Cells

Diamed ID-Gel Station, IH1000 analyser


Diamed ID-Gel Station, IH1000 analyser


1020 Transfusion science - .03 Blood group antibody screen

Antibody Screening Plasma IAT Manual Method using gel cards and tube technique

CE ISO15189 5.5, LP-BTR-018

IAT Manual Method using gel cards and tube technique

CE ISO15189 5.5, LP-BTR-018

IAT Manual Method using gel cards and

CE ISO15189 5.5, LP-BTR-018


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tube technique

IAT Manual Method using gel cards and tube technique

CE ISO15189 5.5, LP-BTR-018

1020 Transfusion science - .04 Identification of blood group antibodies

Antibody Identification

Manual method using Gel IAT and enzyme, and Tube method using IAT

CE ISO15189 5.5, LP-BTR-019

Manual method using Gel IAT and enzyme, and Tube method using IAT

CE ISO15189 5.5, LP-BTR-019

LISS Alloadsorption Antibody Adsorption CE ISO151895.5, LP-BTR-023, LP-BTR-017

1020 Transfusion science - .05 Cross match compatible donor units

Serological crossmatch testing. Compatability analysis for the release of compatible blood by electronic means

Manual method of crossmatching in tubes and gel technique, Electronic Crossmatching

CE ISO15189 5.5, LP-BTR-028 and LP-BTR-028A







1020 Transfusion science - .06 Red cell phenotyping

Antigen Typing Red Blood Cells Manual method in tubes and cards

CE ISO15189 5.5, LP-BTR-027

Manual method in tubes and cards

CE ISO15189 5.5, LP-BTR-027

1020 Transfusion science - .07 Antibody elution

Antibody Elution Testing of EDTA specimens

EDTA ISO15189 5.5, LP-BTR-024

CE ISO15189 5.5, LP-BTR-024

1020 Transfusion science - .09 Direct antiglobulin test

Direct Antiglobulin Testing

Red Blood Cells manual method with monospecific gel cards

CE ISO15189 5.5, LP-BTR-015

manual method with monospecific gel cards

CE ISO15189 5.5, LP-BTR-015

1020 Transfusion science - .99 Miscellaneous tests

Blood Transfusion Service Red Blood Cells; Confirming ABO and RhD group and donor units

Manual Method using tubes, automated method using gel cards

CE ISO15189 5.5, LP-BTR-009


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Head Office

Chemical Pathology

Category: A


Test/assay Specimen Type Technique Equipment/Range of Measurement

Method (CE/Non-CE/In house developed/based on standard method)

Std. Ref & SOP

1061 Clinical Chemistry - .01 Analytes in general use in cardiac, liver function, lipid, renal and other profiles and metabolic studies

Adjusted Calcium Serum/ Plasma Calculation Roche Cobas 8000/ APEX iLAB (Calculation)

CE ISO15189 5.5/ LP-CHEM-CALC/ LP-BIO-INTERP

Alanine Aminotransferase (ALT)

colorimetric Roche Cobas 8000

CE ISO15189 5.5/ LP-BIO-ROCHE

Alkaline Phosphatase



Amylase Serum/ Plasma/ fluid/ urine

enzymatic colorimetric Roche Cobas 8000

CE ISO15189 5.5/ LP-BIO-ROCHE/ LP-BIO-U-HP

Angiotensin Converting Enzyme (ACE)

Serum/ Plasma photometric Roche Cobas 8000


Aspartate Aminotransferase (AST)



Bilirubin - Direct Serum/ Plasma/ fluid colorimetric Roche Cobas 8000


Bilirubin - Total colorimetric Roche Cobas 8000

CE ISO15189 5.5/ LP-BIO-ROCHE/ LP-BIO-FLUIDS

C Reactive Protein Serum/ Plasma particle enhanced immunoturbidometric assay

Roche Cobas 8000


Calcium Serum/ Plasma/ Urine photometric Roche Cobas 8000


Calcium/ Creatinine Ratio

Urine Calculation Roche Cobas 8000/ APEX iLAB (Calculation

CE ISO15189 5.5/ LP-CHEM-CALC/ LP-BIO-U-HP

Carbon Dioxide Serum/ Plasma photometric Roche Cobas 8000


Chloride Serum/ Plasma/ Urine / Fluid

ISE Roche Cobas 8000


Chloride Direct ISE Serum/ Plasma direct ISE Roche Cobas 8000

CE ISO15189 5.5/ LP-CHEM-ROCHEIMM

Cholesterol Serum/ Plasma/ Fluid enzymatic colorimetric assay

Roche Cobas 8000


CKD-EPI GFR Serum/ Plasma Calculation Roche Cobas 8000/ APEX iLAB

CRCE ISO15189 5.5/ LP-CHEM-


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(Calculation) CALC/ LP-BIO-INTERP

Cortisol competitive immunoassay using electrochemiluminescence

Roche Cobas 8000


Creatine Kinase photometric Roche Cobas 8000


Creatinine (Enzymatic)

enzymatic method measured photometrically

Roche Cobas 8000


eGFR calculated calculated Roche Cobas 8000


Serum/ Plasma Calculation Roche Cobas 8000/ APEX iLAB (Calculation)


Free T3 competitive immunoassay using electrochemiluminescence

Roche Cobas 8000

CE ISO15189 5.5/ LP-CHEM-ROCHEIMM/ LP-BIO-INTERP

FT4 competitive immunoassay using electrochemiluminescence

Roche Cobas 8000


Gamma Glutamyl Transferase

enzymatic colorimetric assay

Roche Cobas 8000


Glucose Serum/ Plasma/ Fluid/ CSF

photometric Roche Cobas 8000

CE ISO15189 5.5/ LP-BIO-ROCHE/ LP-BIO-CSF

HDL and LDL Cholesterol

Serum/ Plasma homogeneous enzymatic colorimetric test

Roche Cobas 8000


Homocysteine EDTA Plasma enzymatic Roche Cobas 8000


Ionised Calcium Serum/ Plasma Potentiometry Radiometer Blood Gas Analyser

CE ISO15189 5.5/ LP-SCHEM-CALI

Iron colorimetric Roche Cobas 8000


Lactate Dehydrogenase

Serum/ Plasma/ Fluid enzymatic assay Roche Cobas 8000


Magnesium Serum/ Plasma/ Urine colorimetric end point assay

Roche Cobas 8000


NT-Pro-BNP Serum Electrochemiluminescent sandwich Immunoassay

Roche Cobas 8000


Phosphate Serum/ Plasma/ Urine photometric Roche Cobas 8000


Potassium Serum/ Plasma/ Urine / Fluid



Potassium Direct ISE Serum/ Plasma direct ISE Roche Cobas 8000


Potentiometry using a calcium ion specific electrode (0.48-2.56 mmol/l)

Potentiometry Radiometer Blood Gas Analyser

CE ISO15189 5.5/ LP-SCHEM-ABL800

Serum/ Urine/ Fluid Osmolality Freezing Point Depression (50-850mOsm/kg)

Serum/ Urine Freezing Point Depression Advanced Micro-Osmometer

CE ISO15189 5.5/ LP-SCHEM-OSM/ LP-SCHEM-OSM3320


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Sodium Serum/ Plasma/ Urine/ Fluid


CE ISO15189 5.5/ LP-BIO-ROCHE/ LP-BIO-U-HP/ LP-BIO-FLUIDS

Sodium Direct ISE Serum/ Plasma direct ISE Roche Cobas 8000


T3 competitive immunoassay using electrochemiluminescence

Roche Cobas 8000


Triglycerides Serum/ Plasma/ Fluid enzymatic colorimetric assay

Roche Cobas 8000


Troponin T High Sensitivity

Serum/ Plasma Electrochemiluminescent Immunoassay

Roche Cobas 8000


Electrochemiluminescent Immunoassay

Roche Cobas 8000


TSH electrochemiluminescent sandwich Immunoassay

Roche Cobas 8000


Urea Serum/ Plasma/ Urine/ Fluid

photometric Roche Cobas 8000


Urea/ Creatinine Ratio

Urine Calculation Roche Cobas 8000/ APEX iLAB (Calculation)

CE ISO15189 5.5/ LP-CHEM-CALC/ LP-BIO-U-HP

Uric Acid Serum/ Plasma/ Urine/ Fluid

enymatic colorimetric Roche Cobas 8000

CE ISO15189 5.5/ LP-BIO-ROCHE/ LP-BIO-U-HP/ LP-BIO-FLUIDS

1061 Clinical Chemistry - .02 Proteins, quantitative analysis

Albumin Serum/Plasma/Urine Colourimetric Roche Cobas 8000

CE ISO151895.5/LP-BIO-ROCHE/LP-BIO-U-HP

Beta 2 Microglobulin Serum immunoturbidometric Roche Cobas 8000


Caeruloplasmin Immunoturbidimetric Roche Cobas 8000

CE ISO151895.5/LP-BIO-ROCHE

Calculated Globulin Serum/ Plasma Calculation Roche Cobas 8000/ APEX iLAB (Calculation)


Complement C3 Serum Immunoturbidimetric Roche Cobas 8000


Complement C4 Immunoturbidimetric Roche Cobas 8000


CSF Total Protein CSF turbidometric Roche Cobas 8000

CE ISO15189 5.5/ LP-BIO-CSF

Immunoglobulin A Serum Immunoturbidimetric Roche Cobas 8000


Immunoglobulin E Immunoturbidimetric Roche Cobas 8000


Immunoglobulin G Immunoturbidimetric Roche Cobas 8000


Immunoglobulin M Immunoturbidimetric Roche Cobas 8000



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Osteocalcin Electrochemiluminescent Immunoassay

Roche Cobas 8000


Total Protein Serum/Plasma/Urine/CSF Colourimetric Roche Cobas 8000

CE ISO151895.5/LP-BIO-ROCHE/LP-BIO-U-HP/LP-BIO-CSF

1061 Clinical Chemistry - .03 Proteins, qualitative and semiquantitative analysis

Protein Electrophoresis

Serum/ Urine Electrophoresis Sebia Hydrasys CE ISO15189 5.5/ LP-BIO-SPE

1061 Clinical Chemistry - .05 CO-oximetry

Carboxyhaemoglobin Blood absorption spectrophotometry

Radiometer Blood Gas Analyser

CE ISO15189 5.5/ LP-BIO-COHB-800

Co-oximetry GEM5000 Blood Gas Analyser

CE ISO15189 5.5/ LP-CHEM-ABG

Methaemoglobin absorption spectrophotometry


CE ISO15189 5.5/ LP-BIO-COHB-800



1061 Clinical Chemistry - .06 Blood pH and gas tensions

Base Excess calculation GEM5000 Blood Gas Analyser


calculation Radiometer Blood Gas Analyser

CE ISO15189 5.5/ LP-BIO-BE-800

HCO3 actual calculation GEM5000 Blood Gas Analyser


HCO3 Std calculation GEM5000 Blood Gas Analyser


O2 Saturation absorption spectrophotometry


CE ISO15189 5.5/ LP-BIO-O2SAT-800



pCO2 ISE Radiometer Blood Gas Analyser

CE ISO15189 5.5/ LP-BIO-PCO2-800

Potentiometry GEM5000 Blood Gas Analyser


Ph ISE Radiometer Blood Gas Analyser

CE ISO15189 5.5/ LP-BIO-PH-800



pO2 ISE Radiometer Blood Gas Analyser

CE ISO15189 5.5/ LP-BIO-PO2-800



1061 Clinical Chemistry - .07 Other analytes performed on a blood gas analyser

Chloride Serum/ Plasma Potentiometry GEM5000 Blood Gas Analyser


Glucose Blood Amperometry GEM5000 Blood Gas Analyser


Ionised Calcium Serum/ Plasma Potentiometry GEM5000 Blood Gas Analyser



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Lactate Blood Amperometry GEM5000 Blood Gas Analyser


lactate electrode Radiometer Blood Gas Analyser

CE ISO15189 5.5/ LP-BIO-LACT-800

Potassium Serum/ Plasma Potentiometry GEM5000 Blood Gas Analyser


Sodium Potentiometry GEM5000 Blood Gas Analyser


1061 Clinical Chemistry - .10 Drugs for therapeutic monitoring

Amikacin Serum immunoassay using absorbance

Roche Cobas 8000


Carbamazepine homogeneous microparticle agglutination immunoassay

Roche Cobas 8000


Digoxin Electrochemiluminescent Immunoassay

Roche Cobas 8000


Gentamicin kinetic interaction of microparticles in solution (KIMS)

Roche Cobas 8000


Lithium colorimetric Roche Cobas 8000


Phenytoin KIMS Roche Cobas 8000


Theophyline KIMS Roche Cobas 8000


Tobramycin enzyme immunoassay Roche Cobas 8000


Vancomycin homogeneous enzyme immunoassay

Roche Cobas 8000


1061 Clinical Chemistry - .14 Alcohol for non-legal purposes

Ethanol Plasma enzymatic Roche Cobas 8000


1061 Clinical Chemistry - .15 Drugs for toxicological purposes

Paracetamol Serum Enzymatic Roche Cobas 8000


Salicylate photometric Roche Cobas 8000


1061 Clinical Chemistry - .20 Hormones

ACTH, clinically relevant levels

EDTA Plasma Electrochemiluminescent Immunoassay

Roche Cobas 8000


Androstenedione Serum/ Plasma RIA Wallac Wizard Gamma Counter

CE ISO15189 5.5/ LP-SCHEM-ANDRO/ LP-SCHEM-GAMMAOP

Chromogranin A Plasma RIA Wallac Wizard Gamma Counter

CE ISO15189 5.5/ LP-SCHEM-CGA/ LP-SCHEM-GAMMAOP

DHEAS, clinically relevant levels


Roche Cobas 8000



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FSH, clinically relevant levels


Roche Cobas 8000


Insulin Like Growth Factor 1 (IGF1)

Serum IRMA Wallac Wizard Gamma Counter

CE ISO15189 5.5/ LP-SCHEM-IGF/ LP-SCHEM-GAMMAOP

Insulin, clinically relevant levels


Roche Cobas 8000


LH, clinically relevant levels


Roche Cobas 8000


Oestradiol, clinically relevant levels


Roche Cobas 8000


Parathyroid Hormone


Roche Cobas 8000


Progesterone, clinically relevant levels


Roche Cobas 8000


Prolactin, clinically relevant levels


Roche Cobas 8000


SHBG, clinically relevant levels


Roche Cobas 8000


Testosterone, clinically relevant levels


Roche Cobas 8000


Vitamin D Electrochemiluminescent Immunoassay

Roche Cobas 8000


1061 Clinical Chemistry - .40 Iron studies

Ferritin Electrochemiluminescent Immunoassay

Roche Cobas 8000


Iron colorimetric Roche Cobas 8000


Transferrin immunoturbidometric assay using electrochemiluminescence

Roche Cobas 8000


Transferrin Saturation

Calculation Roche Cobas 8000/ APEX iLAB (Calculation)


Calculation Roche Cobas 8000/ APEX iLAB (calculation)

CE ISO15189 5.5/ LP-CHEM-CALC-LP-BIO-INTERP

1061 Clinical Chemistry - .45 Vitamin B12 and folate

Folate Electrochemiluminescent Immunoassay

Roche Cobas 8000


Vitamin B12 Electrochemiluminescent Immunoassay

Roche Cobas 8000


1061 Clinical Chemistry - .50 Protein and peptide tumour markers

AFP Electrochemiluminescent Immunoassay

Roche Cobas 8000



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CA125 Electrochemiluminescent Immunoassay

Roche Cobas 8000


CA15-3 Electrochemiluminescent Immunoassay

Roche Cobas 8000



Roche Cobas 8000


CEA Electrochemiluminescent Immunoassay

Roche Cobas 8000


HCG Electrochemiluminescent Immunoassay

Roche Cobas 8000


PSA Electrochemiluminescent Immunoassay

Roche Cobas 8000


Thyroglobulin, clinically relevant levels


Roche Cobas 8000

CE ISO15189 5.5/ LP-SCHEM-ROCHE

1061 Clinical Chemistry - .60 Glycohaemoglobins

HbA1c, clinically relevant levels

Blood HPLC Menarini 8180 CE ISO15189 5.5/ LP-SCHEM-HbA1c

1061 Clinical Chemistry - .99 Miscellaneous tests

Bone Alkaline Phosphatase

Serum/ Plasma monoclonal antibody immunoenzymatic assay

Grifols Triturus CE ISO15189 5.5/ LP-SCHEM-BAP

C-Terminal Propeptide of Type 1 Collagen


Roche Cobas 8000


Procollagen Type 1 amino-terminal propeptide


Roche Cobas 8000


Urine N-Terminal Telopeptide of Type 1 Collagen

Urine competitive-inhibition enzyme-linked immunosorbent assay

Grifols Triturus CE ISO15189 5.5/ LP-SCHEM-NTX


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Head Office

Genetics

Category: A


Test/assay Specimen Type Technique Equipment Method (CE/Non-CE/In house developed/based on standard method)

Std. Ref & SOP

1075 Molecular genetics - .06 Assay for identified pathogenic variant(s)

Clinical Chemistry: Hereditary Haemochromatosis HFE gene mutations (C282Y, H63D, S65C)

Blood testing in genomic DNA purified from peripheral blood

Roche Magna Pure Compact automated DNA extractor and Roche Lightcycler 480 11 Real Time PCR analyser

CE ISO15189 5.5/ LP-BIO-MOL-HFE1

1076 Molecular pathology - .01 Assay for somatic variants in DNA sequence(s)

Histology: Assays for somatic variants in DNA sequences: Semi-automated BRAF/ NRAS mutation testing

Human Tissue and cytology cell blocks

semiautomated BRAF/ NRAS mutation testing

Roche Lightcycler 480 11 Real Time PCR analyser

CE ISO15189 5.5/ LP-HIS-MICRODIS/ LP-HIS-DNACOBAS/ LP-HIS-NRASBRAFTEST

Histology: Assays for somatic variants in DNA sequences: Semi-automated EGFR mutation testing

semiautomated EGFR mutation testing


CE ISO15189 5.5/ LP-HIS-MICRODIS/ LP-HIS-DNACOBAS/ LP-HIS-EGFRTEST

Histology: Assays for somatic variants in DNA sequences: Semi-automated KRAS mutation testing

semiautomated KRAS mutation testing


CE ISO15189 5.5/ LP-HIS-MICRODIS/ LP-HIS-DNACOBAS/ LP-HIS-KRASTEST


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Head Office

Haematology

Category: A


Test/Assay Specimen Type Technique Range of Measurement/Equipment


Std. Ref & SOP

1030 Haematology - .01 Blood counts

Full Blood Count including WCC, HB, Platelet Count, RCC, HCT, MCV, MCH, RDW

Blood Cell counting and Flow Cytometric

Sysmex XE5000 CE ISO15189 5.5/ LP-HAE-SYSMEX/ LP-HAE-APXAUTH-H/ LP-HAE-FBC-AUTOC

1030 Haematology - .02 Visual examination of blood films

Blood Films to investigate abnormal white cells, red cells and platelets. This includes manual WCC differentials (neutrophils, lymphocytes, basophils, eosinophils)

Microscopy Microscope CE ISO15189 5.5/ LP-HAE-BLDFLMREP/ LP-HAE-BLDFLMMAK/ LP-HAE-SXSP100-M/ LP-HAE-SLDSTN

1030 Haematology - .03 Erthrocyte sedimentation rate

ESR Sedimentation & Aggregation

Alifax Test 1 THL ESR Analyser

CE ISO15189 5.5/ LP-HAE-ESR

1030 Haematology - .05 Automated differential leucocyte counts

Five Part Differential

Flow Cytometric Sysmex XE5000 CE ISO15189 5.5/ LP-HAE-SYSMEX

1030 Haematology - .06 Automated reticulocyte counts

Reticulocyte Counts

Flow Cytometric Sysmex XE5000 CE ISO15189 5.5/ LP-HAE-SYSMEX

1030 Haematology - .09 Examination of malarial parasites

Malaria Testing using Antigen and Antibody kits; Thick and thin blood films

Microscopy Microscope CE ISO15189 5.5/ LP-HAE-M-DIAG

1030 Haematology - .20 Bone marrow examination

Bone marrow staining and examination

Bone Marrow Microscopy Microscope CE ISO15189 5.5/ LP-HAE-BMLABEL

1030 Haematology - .40 Limited haemostasis related tests

Anti Xa Assay Blood Optical IL ACL TOP 500 Coagulation analyser

CE ISO15189 5.5/ LP-HAE-ANTIXA

Anti-Cardiolipin Antibodies (IgM and IgG)

Optical Indirect solid phase immunometric assay, Triturus analyser

CE ISO15189 5.5/ LP-HAE-ACA

Optical Indirect solid phase immunometric assay, Triturus analyser

CE ISO15189 5.5/ LP-HAE-ACA

Factor Assays (FII, FV, FVII, FVIII, FIX, FX, FXI, FXII)

Optical IL ACL TOP 500 Coagulation analyser

CE ISO15189 5.5/ LP-HAE-FA

Lupus Screen (DRVVT, Silica


CE ISO15189 5.5/ LP-HAE-LUPUS


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Clotting Time)

Thrombin Time Optical IL ACL TOP 500 Coagulation Analyser

CE ISO15189 5.5/ LP-HAE-TT

Thrombophilia Screen (Protein C, Protein S, Anti-Thrombin, Activated Protein C resistance)


CE ISO15189 5.5/ LP-HAE-SAMPREPTS/ LP-HAE-STOREC/ LP-HAE-THROMBOPHILIA

1030 Haematology - .41 General haemostasis related tests

Activated Partial Thromboplastin Time (APTT)


CE ISO15189 5.5/ LP-HAE-COAG

D-dimers Latex Immunoassay

IL ACL TOP 500 Coagulation analyser


Fibrinogen Optical IL ACL TOP 500 Coagulation analyser


International Normalised Ratio (INR)



Prothrombin Time (PT)



1030 Haematology - .55 Iron studies

Haemosiderin Urine Cytochemistry N/A CE ISO15189 5.5/ LP-HAE-IRONSTN

Iron Stain for Bone Marrow

Bone Marrow Cytochemistry N/A CE ISO15189 5.5/ LP-HAE-IRONSTN

1030 Haematology - .99 Miscellaneous tests

Sickle Cell Screen Blood Turbimetric N/A CE ISO15189 5.5/ LP-HAE-SCT


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Head Office

Histopathology and Cytopathology

Category: A


Test/assay Specimen Type

Equipment/Technique Method (CE/Non-CE/In house developed/based on standard method)


Std. ref & SOP

1051 Histopathology - .01 Processing fixed specimens for Histopathological testing

Cut Up; Tissue Porcessing; Embedding; Microtomy; Automated and Manual Haematoxylin and Eosin Staining; Coverslipping

Human Tissue

Sakura VIP5 Tissue Processors

Based on standard method

ISO15189 5.5/ LP-HIS-TISSPROC/ LP-HIS-VIP/ LP-HIS-EMBED/ LP-HIS-DICBX/ SVUH Histopathology Manual

Cut Up; Tissue Processing; Embedding; Microtomy; Automated and Manual Haematoxylin and Eosin Staining; Coverslipping

Sakura VIP5 Tissue Processors


ISO15189 5.5/ SVUH Histopathology Manual/ LP-HIS_SPREQMIN/ LP-HIS-SPECREC/ LP-HIS-FRESHINF/ LP-HIS-SPDISSECT/ LP-HIS-FRESHBRE/ LP-HIS-FRESHKID/ LP-HIS-FRESHLN/ LP-HIS-FRESHBMX/ LP-HIS-FRESHNER/ LP-HIS-FRESHSKX/ LP-HIS-FAXITRON/ LP-HIS-DIGFAXITRON/ LP-HIS-GROSPHOTO/ LP-HIS-CLINMCON/ LP-HIS-BMX/ LP-HIS-DECAL/ LP-HIS-BRCHECK/ LP-HIS-POC/ LP-HIS-RADIOACT/ LP-HIS-BIOPAN/ LP-HIS-AMPPROC/ LP-HIS-LIQINT/ LP-HIS-MCLASS1/ LP-HIS-PRFORMAL

1051 Histopathology - .02 Processing fresh specimens for frozen section examination

Cut Up; Frozen Section cryotomy and staining

Leica CM1900 cryostat Based on standard method

ISO15189 5.5/ LP-HIS-FRESHFS/ LP-HIS-LIQNIT/ LP-HIS-MCLASS1

1051 Histopathology - .03 Histochemistry

Automated H&E Prisma automated slide stainer and G2 coverslipper


ISO15189 5.5/ LP-HIS-INTQC/ LP-HIS-AXPSREQ/ LP-HIS-SECTW/ LP-HIS-PRISMA/ LP-HIS-G2COVER

Prisma automated slide stainer and G2 coverslipper


ISO15189 5.5/ LP-HIS-INTQC/ LP-HIS-AXPSREQ/ LP-HIS-SECTW/ LP-HIS-PRISMA/ LP-HIS-G2COVER

Automated special stains using the ARTISAN: PAS,

Dako Artisan Link Pro Special Stainer

CE ISO15189 5.5/ LP-HIS-ARTISANPRO/ LP-HIS-EQASP


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PASD, Perls, Trichromw, Reticulin, Jones' Methenamine Silver, Grocotts (fungi & pneumocystis), Congo Red, Ziehl Neelson

Dako Artisan Link Pro Special Stainer

CE ISO15189 5.5/ LP-HIS-ARTISANPRO/ LP-HIS-EQASP

H&E, Shikata, Haemotoxylin Shikata, Gram, Van Gieson, AB/PAS, Millers Elastin, Alcian Blue, Rubeanic Acid, MSB, Oil Red O

Manual Based on standard method

ISO15189 5.5/ LP-HIS-H&EMAN/ LP-HIS-SHIKO/ LP-HIS-GRAM/ LP-HIS-VANG/ LP-HIS-AB/PAS/ LP-HIS-MILLER/ LP-HIS-AB/ LP-HIS-RUB/ LP-HIS-MSB/ LP-HIS-ORO

1051 Histopathology - .04 Histological interpretation-medical renal pathology

1051.04.41 Medical Renal Pathology and 1051.04.42 Breast Screening. Diagnostic Interpretation and reporting of human tissue specimens. Specialist areas EXCLUDED: Paediatric Pathology, Perinatal Pathology, Neuropathology. Specicalist Areas INCLUDED: Medical Renal Pathology, Breast Screening Pathology

Consultant Microscope ISO15189 5.5/ LP-HIS-REPHER-2/ LP-HIS-REPOR/PR

1051 Histopathology - .09 Immunohistochemistry

Automated and Semi-Automated Immunohistochemistry: AE1/3, AFP, ALK1, Amyloid A, Basal Cell Cocktail, Beta-Catenin, BCl2, BCl6, Per-EP4, CA125, Cam5.2, Calponin, Calretinin, Calcitonin, CD10, CD117, CD138, CD15, CD20, CD23, CD3, CD30, CD31, CD34, CD4, CD45, CD5, CD56, CD68, CD79A, CD8, CDX2, CEA-Monoclonal, CEA-polyclonal, Chromogranin, CK20, CK5/6, CK7, CK903, C-myc, CMV, Cyclin D1, D2-40, Desmin, DOG1, Double Stain Breast (p63-AE1/3),Double Stain Lung Adeno (TTF-1 - Napsin A), Double Stain Lung Squamous (p63-Ker5/6),Double StainLymphatic Invasion (AE1/3 - D2-40), EBV (In situ

Bond Immunostainer ,Ventana Benchmark XTs & Benchmark Ultra

All CE marked except SSR2A, SSR5, IgG4, Glutamine Synthetase, HbsAg & c-myc

ISO15189 5.5/ LP-HIS-VENTBENCHMARKXT/ Ventana User Manual/ LP-HIS-BOND/ Leica BondMax User Manual/ LP-HIS-BENCHMARKULTRA/ LP-HIS-REPOR/PR/ LP-HIS-REPHER2/ LF-HIS-IMMUNOWBK


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hybridisation, ISH), E-Cadherin, EMA, GCDFP-15, Glutamine Synthetase, Glypican 3, Her2Neu, HCG, HbcAg, HbsAg, H. Pylori, Hepar, HSV1, HSV2, HMB45, IgG4, Ki67, Kappa (ISH), Lambda (ISH), Mammaglobin, Melan A, MLH1, MSH2, MSH6,Mum-1, Myeloperoxidase, Napsin A, Neurofilament, OR, P5045/ Racemase, p-16, P53, P63, PAX8, PLAP, PMS2, PR, PSA, RCC, S100, SMA, SSR2A, SSR5, Synaptophysin, TdT (Terminal Deoxynucleotidyl Transferase), Thyrpoglobulin, TTF-1, Vimentin, WT-1

Bond Immunostainer ,Ventana Benchmark XTs & Benchmark Ultra

All CE marked except SSR2A, SSR5, IgG4, Glutamine Synthetase, HbsAg & c-myc

ISO15189 5.5/ LP-HIS-VENTBENCHMARKXT/ Ventana User Manual/ LP-HIS-BOND/ Leica BondMax User Manual/ LP-HIS-BENCHMARKULTRA/ LP-HIS-REPOR/PR/ LP-HIS-REPHER2/ LF-HIS-IMMUNOWBK

Pax 5, Androgen Receptor, Muc 4, Stat 6, PD-L1, GATA-3

Human tissue/ slide

Leica Bond Max, Ventana BenchMark XT, Ventana Ultra / Immunohistochemistry

CE marked LP-HIS-VENTBENCHMARKXT LP-HIS-BOND LP-HIS-BENCHMARKULTRA

1051 Histopathology - .10 Fluorescence in situ hybridisation

Semi-Automated FISH for HER2 Neu

Human Tissue

Bond Max Immunostainer HER2/ CEP17 ratio

CE ISO15189 5.5/ LP-HIS-FISH, LP-HIS-BOND/ LP-HIS-FISHIMAGE

1052 Cytopathology - .02 Non gynaecological cytology

Exfoliative and FNA cytology

Urinary Cytology Serous fluid Cytology Respiratory Cytology and FNAs

Thin Prep 2000, Leica ST5020

ISO15189 5.5/ LP-HIS-CYT/ LP-HIS-EBUS/ LP-HIS-PRCTFNA/ LP-HIS-TISSUE/ LP-HIS-PAPAUTO/ LP-HIS-PAPMAN/ LP-HIS-CMGG

Thin Prep 2000, Leica ST5020

ISO15189 5.5/ LP-HIS-CYT/ LP-HIS-EBUS/ LP-HIS-PRCTFNA/ LP-HIS-TISSUE/ LP-HIS-PAPAUTO/ LP-HIS-PAPMAN/ LP-HIS-CMGG

1052 Cytopathology - .05 Immunocytochemistry

Automated and semi Automated Immunocytochemistry using the Ventana Benchmark XTs,

Bond Immunostainer , Ventana Benchmark XTs & Benchmark Ultra

All CE marked except SSR2A, SSR5, IgG4, Glutamine Synthetase,

ISO15189 5.5/ LP-HIS-VENTBENCHMARKXT/ LP-HIS-BOND


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Benchmark Ultra and the Bond Immunostainers. Panels covering malignancies arising from the above

HbsAg & c-myc


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Head Office

Immunology

Category: A


Test/Assay Specimen Type Equipment/Technique Method (CE/Non-CE/In house developed/based on standard method)


Std. Ref & SOP

1040 Immunology - .04 Allergen - specific lgE

Allergen Specific IgE as follows: e1 cat dander; e5 dog dander; d1 house dust mite f1 egg white; f2 milk; f4 wheat; f13 peanut; f14 soyabean; f256 walnut m3 aspergillus; k82 latex; c1 Peniciloyl G; c2 Penicilloyl V fx1 nut mix; fx2 fish/ shellfish mix; fx7 food mix; fx13 vegetable mix; fx15 fruit mix; fx20 grain mix; fx23 meat mix gx1 grass pollen mix; tx8 tree pollen mix; wx8 weed pollen mix; mx2 mould mix

Serum Allergen – specific IgE: Specific IgE to a range of allergens are measured on the Phadia250

CE 0.1-100kUA/L ISO15189 5.5/ LP-IMM-PHADIA

1040 Immunology - .10 Rheumatoid factor - quantitative assays

Rheumatoid Factor (RF)

IgM RF measured by immunoassay on the Phadia250

CE 0.4-200 IU/ml ISO15189 5.5/ LP-IMM-PHADIA

1040 Immunology - .12 Detection of autoantibodies in body fluids and biopsy material

Anti GBM antibodies

Detected by immunoassay on the Phadia250


Anti-CCP antibodies


CE 0.4-340 U/ml ISO15189 5.5/ LP-IMM-PHADIA

Anti-dsDNA antibodies



Screen at 1/20 by IIF on C. luciliae using the Quantalyser 160

CE ISO15189 5.5/ LP-IMM-QUANTA

Anti-ENA antibodies


CE 0.03-32 (ratio) ISO15189 5.5/ LP-IMM-PHADIA

Anti-ENA Profile including: Anti-Ro, Anti-La, Anti-Sm, Anti-U1RNP, Anti-Scl-70, Anti-Jo-1


CE Measuring Ranges: Anti-Ro: 0.3 - >/= 240U/ml, Anti-La: 0.3 - >/= 320U/ml, Anti-Sm: 0.1 - >/= 120U/ml, Anti-U1RNP: 0.3 -

ISO15189 5.5, LP-IMM-PHADIA


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>/= 240U/ml, Anti-Scl-70: 0.4 - >/= 320U/ml, Anti-Jo-1: 0.3 - >/= 240U/ml

Anti-LKM antibodies Screen at 1/40 by IIF on composite block of liver, kidney, stomach using the Quantalyser 160


Anti-mitochondrial antibodies

Screen at 1/40 by IIF on composite block of liver, kidney, stomach using the Quantalyser 160


Anti-MPO antibodies



Anti-neutrophil cytoplasmic antibodies (ANCA )

Screen at 1/20 by indirect immunofluorescence (IIF)on ethanol fixed neutrophils using the Quantalyser 160


Anti-Nuclar Antibody (ANA)

Screen at 1/80 by IIF on HEp2 using the Quantalyser 160


Anti-Parietal Cell antibodies



Anti-PR3 antibodies Detected by immunoassay on the Phadia250


Anti-smooth muscle antibodies



Anti-tissue transglutaminase (Anti-tTG) antibodies


CE 0.1-128 U/ml ISO15189 5.5/ LP-IMM-PHADIA

1040 Immunology - .99 Miscellaneous tests

Cyclosporin Whole blood (EDTA)

CMIA on Abbott Architect

CE 30-1500 ng/ml ISO15189 5.5/ LP-IMM-ARCHITECT

Screening test for infectious mononucleosis

Serum Screening test for infectious mononucleosis: IgM heterophile antibodies detected by POC kit

CE ISO15189 5.5/ LP-IMM-IM

Tacrolimus Whole blood (EDTA)

CMIA on Abbott Architect

CE 1.5-30 ng/ml ISO15189 5.5/ LP-IMM-ARCHITECT


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Head Office

Microbiology and Virology

Category: A


Test/assay Specimen Type

Equipment/Technique Method (CE/Non-CE/In house developed/based on standard method)


Std. ref & SOP

1012 Preparation of films on glass slides followed by microscopic examination with or without fixation and staining with dyes as required - .01 Microscopic examination for general bacteriology purposes (including enumeration and description of human cells)

Preparation of films; Gram stains Microscopic Examination of clinical specimens; Cell Counts and Gram stains

Gram stains: Wound swabs (of specific type), body fluids, tissues, sputum, BAL, isolates from culture plats, genital swabs. Cell Counts: CSF, body fluids, urine.

standard method ISO15189 5.5/ LP-MIC-GRAM LP-MIC-CSF/ LP-MIC-BOFYFL/ LP-MIC-URINE/ LP-MIC-SPUT/ LP-MIC-BAL

1012 Preparation of films on glass slides followed by microscopic examination with or without fixation and staining with dyes as required - .03 Microscopic examination for fungi

Wet preparation and KOH preparation for fungal hyphae

Skin, hair, nail, BAL, AWO, sputum, HVS, ear swab, throat swab, tissue

standard method ISO15189 5.5/ LP-MIC-DERM (dermatology samples)/ LP-MIC-GEN (HVS)/ LP-MIC-BAL (BAL, B wash)/ LP-MIC-Sinus (AWO)/ LP-MIC-THROAT/ LP-MIC-EAR/ LP-MIC-SPUT/LP-MIC-TISSUE/LP-MIC-MYCOL

1012 Preparation of films on glass slides followed by microscopic examination with or without fixation and staining with dyes as required - .04 Microscopic examination for mycobacteria

Auromine-Rhodamine stain for AFB on Clinical Specimens

Sputum, BAL, Body fluids, CSF, Tissue

standard method ISO15189/ LP-MIC-STAIN/ LP-MIC-TB/ LP-MIC-AFB STAIN

1013 Culture of organisms in liquid or agar based culture media with visual or instrument monitoring for growth - .01 Culture of general bacteria

CRE/ ESBL screens Rectal Swab N/A ISO15189 5.5 LP-MIC-CRE/ESBL

Culture of General Bacteria on agar based culture media

Urine, faeces, sputum, BAL, AWO, bone marrow, CSF, body fluids, wound swabs,

standard method ISO15189 5.5/ LP-MIC-URINE/ LP-MIC-SVRE/ LP-MIC-FAEC/ LP-


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tissue, ulcers, genital swabs, throat, eyes, ears, IV tips, MRSA and VRE screens

MIC-TISS/ LP-MIC-BILE/ LP-MIC-SPUT/ LP-MIC-CAPD/ LP-MIC-BAL/ LP-MIC-CORNEA/ LP-MIC-SINUS/ LP-MIC-HPGA/ LP-MIC-GEN/ LP-MIC-MRSA/ LP-MIC-THROAT/ LP-MIC-IVA/ LP-MIC-SKIN/ LP-MIC-BODYFL/ LP-MIC-PUS/ LP-MIC-CSF/ LP-MIC-MOUTH/ LP-MIC-ULCER/ LP-MIC-EAR/ LP-MIC-NOSE/ LP-MIC-EYE/ LP-MIC-PSORE

1013 Culture of organisms in liquid or agar based culture media with visual or instrument monitoring for growth - .02 Culture of fungi

Culture of fungi on agar based culture media

Dermatology, BAL, AWO, tissues, ears, devices, mouth, HVS, sputum, throat, urine

ISO15189 5.5/ LP-MIC-DERM (dermatology)/ LP-MIC-BAL/ LP-MIC-SINUS (AWO)/ LP-MIC-GEN (HVS)/ LP-MIC-THROAT/ LP-MIC-EAR/ LP-MIC-MOUTH/ LP-MIC-TISS (tissue/ devices)/ LP-MIC-SPUT/ LP-MIC-URINE

1013 Culture of organisms in liquid or agar based culture media with visual or instrument monitoring for growth - .03 Culture of mycobacteria

Culture of mycobacterium using liquid based and agar based media

Sputum, BAL, Body fluids, CSF, Tissue

Automated liquid culture using Biomerieux MBACT. Manual TB culture using LJ slopes/ BCSA plates

Liquid Culture: CE marked. Solid Culture: Standard method

ISO15189 5.5/ LP-MIC-TB

1014 Detection of bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques - .02 Particle agglutination

Latex Tests: For Staph aureus and for BHS Lancefield grouping (as identification or partial identification of cultured bacteria)

BioRad Pastorex Strep and BioRad Pastorex Staph Plus

CE marked kits ISO15189

1014 Detection of bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques -

MecA testing Alere PBP2a SA Culture colony Test

CE marked N/A ISO15189 5.5/LP-MIC-AST


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.04 Immunochromatographic methods,

Pneumococcal and Legionella urinary antigen

Urine BinaxNOW Legionella Urinary Antigen and BinaxNOW Pneumococcal Urinary Antigen

CE marked kits ISO15189 5.5/ LP-MIC-LEGUAG/ LP-MIC-PNEUAG

Resist-4 O.K.N.V. Detection of Carbapenemase in bacterial culture

RESIST-4 O.K.N.V. CE marked N/A ISO15189 5.5/LP-MIC-AST

1015 Detection and/or identification of bacterial, parasite, fungal and viral nucleic acids - .03 Nucleic acid amplification tests, CE marked commercial systems

CRE Screening in rectal swabs

Cepheid GeneXpert CE marked ISO15189 5.5/LP-MIC-AST LP-MIC-AST LP-MIC-GENEXPERT

Detection of Influenza A, B and RSV

Cepheid GeneXpert CE marked N/A ISO15189 5.5/ LP-MIC-FLU LP-MIC-GENEXPERT

Molecular detection of faeces bacterial (and parasitic Cryptosporidium and Giardia) enteric pathogens including C. difficile

Faeces EntericBio Gastro Panel 2 and EntericBio C. difficile

CE marked kits ISO15189 5.5/ LP-MIC-FAEC/ LP-MIC-FCD

1016 Identification of cultured bacteria and fungi using non-nucleic acid based techniques - .01 Biochemical methods , CE marked commercial systems

Automated Identification of Gram positive and Gram negative bacteria on Biomerieux Vitek 2 (automated system)

Biomerieux Vitek 2 CE marked ISO15189 5.5/ LP-MIC-AST/ LP-MIC-VITEK2

1016 Identification of cultured bacteria and fungi using non-nucleic acid based techniques - .03 Identification of fungi by microscopic morphology

Microscopic identification of significant moulds

Morphology and Microsopic examination (lactphenol blue)

standard method ISO15189 5.5/ LP-MIC-DERM/ LP-MIC-STAIN

1016 Identification of cultured bacteria and fungi using non-nucleic acid based techniques - .04 Identification using MALDI-TOF Spectroscopy

Automated identification of organisms (bacteria and yeast) using Biomerieux Vitek MS

Biomerieux VitekMS CE marked ISO15189 5.5/ LP-MIC-ID/ LP-MIC-VITEK2/ LP-MIC-AST

1017 Measurement of antimicrobial activity and application of clinical interpretive criteria to general bacteria (rapidly growing aerobes) - .01 Anaerobes

Anerobic bacteria: Gradient MIC strips using EUCAST guidelines

Manual susceptibility testing by MIC strips using Eucast guidelines

standard method ISO15189 5.5/ LP-MIC-AST

ESBL Screening in rectal swabs

Biomerieux Vitek 2 CE marked N/A ISO15189 5.5/ LP-MIC-AST

General aerobic/CO2/microareophilic bacteria: Automated susceptibility testing, manual susceptibility testing

Automated susceptibility testing using Vitek 2. Manual sensitivities standard method using Eucast

Vitek 2: CE marked

ISO15189 5.5/ LP-MIC-AST/ LP-MIC-VITEK2


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by disks and MIC strips using EUCAST guidelines

Guidelines

1017 Measurement of antimicrobial activity and application of clinical interpretive criteria to general bacteria (rapidly growing aerobes) - .03 Yeasts

Yeasts: Automated susceptibility testing using CLSI guidelines

Automated susceptibility testing for Candida using Vitek 2

Vitek 2: CE marked

ISO15189 5.5/ LP-MIC-AST


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SVPH Satellite Laboratory

Chemical Pathology

Category: A


Test/assay Specimen Type Technique Equipment/Range of Measurement


Std. Ref & SOP

1061 Clinical Chemistry - .01 Analytes in general use in cardiac, liver function, lipid, renal and other profiles and metabolic studies

Alanine Aminotransferase (ALT)

Serum Colourimetric Roche Cobas 6000

CE ISO15189 5.5/ LP-SAT-ROCHE

Alkaline Phosphatase

Colourimetric Roche Cobas 6000


Amylase Enzymatic Colourimetric Roche Cobas 6000


Aspartate Aminotransferase (AST)

Colourimetric Roche Cobas 6000

CE ISO15189 5.5, LP-SAT-ROCHE

Bilirubin - Total Colourimetric Roche Cobas 6000


C Reactive Protein particle enhanced immunoturbidometric assay

Roche Cobas 6000


Calcium Photometric Roche Cobas 6000


Carbon Dioxide Photometric Roche Cobas 6000


Chloride ISE Roche Cobas 6000


Cholesterol Enzymatic Colourimetric Assay

Roche Cobas 6000


Creatine Kinase Photometric Roche Cobas 6000


Creatinine (Enzymatic)

enzymatic method measured photometrically

Roche Cobas 6000


eGFR Calculated Roche Cobas 6000



Roche Cobas 6000



Roche Cobas 6000


Gamma Glutamyl Enzymatic colourimetric Roche Cobas CE ISO15189


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Transferase (GGT) assay 6000 5.5/ LP-SAT-ROCHE

Glucose Photometric Roche Cobas 6000


HDL and LDL Cholesterol

Homogeneous enzymatic colourimetric test

Roche Cobas 6000


Iron Colourimetric Roche Cobas 6000


Lactate Dehydrogenase

Enzymatic assay Roche Cobas 6000


Magnesium Colourimetric end point assay

Roche Cobas 6000


NT-Pro-BNP Electrochemiluminescent sandwich Immunoassay

Roche Cobas 6000


Phosphate Photometric Roche Cobas 6000


Potassium ISE Roche Cobas 6000


Sodium ISE Roche Cobas 6000


Total T3 competitive immunoassay using electrochemiluminescence

Roche Cobas 6000


Triglycerides Enzymatic Colourimetric assay

Roche Cobas 6000


Troponin T high sensitivity


Roche Cobas 6000


TSH electrochemiluminescent sandwich Immunoassay

Roche Cobas 6000


Urea Photometric Roche Cobas 6000


Uric Acid Enzymatic Colourimetric Roche Cobas 6000


1061 Clinical Chemistry - .02 Proteins, quantitative analysis

IgA immunoturbidometric assay using electrochemiluminescence

Roche Cobas 6000


IgE sandwich immunoassay Roche Cobas 6000


IgG immunoturbidometric assay using electrochemiluminescence

Roche Cobas 6000


IgM immunoturbidometric assay using electrochemiluminescence

Roche Cobas 6000


Total Protein immunoturbidometric Roche Cobas CE ISO15189


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assay using electrochemiluminescence

6000 5.5/ LP-SAT-ROCHE

1061 Clinical Chemistry - .10 Drugs for therapeutic monitoring

Gentamycin kinetic interaction of microparticles in solution (KIMS)

Roche Cobas 6000


Vancomycin homogeneous enzyme immunoassay

Roche Cobas 6000


1061 Clinical Chemistry - .40 Iron studies

Ferritin Electrochemiluminescent Immunoassay

Roche Cobas 6000


Transferrin immunoturbidometric assay using electrochemiluminescence

Roche Cobas 6000


Immunoturbidometric assay using electrochemiluminescence

Roche Cobas 6000


1061 Clinical Chemistry - .45 Vitamin B12 and folate

Folate Electrochemiluminescent Immunoassay

Roche Cobas 6000


Vitamin B12 Electrochemiluminescent Immunoassay

Roche Cobas 6000


1061 Clinical Chemistry - .50 Protein and peptide tumour markers

AFP Electrochemiluminescent Immunoassay

Roche Cobas 6000


CA125 Electrochemiluminescent Immunoassay

Roche Cobas 6000



Roche Cobas 6000



Roche Cobas 6000


CEA Electrochemiluminescent Immunoassay

Roche Cobas 6000


HCG Electrochemiluminescent Immunoassay

Roche Cobas 6000


PSA Electrochemiluminescent Immunoassay

Roche Cobas 6000


1061 Clinical Chemistry - .60 Glycohaemoglobins

HbA1c Blood Turbidimetric Inhibition Immunoassay with TTAB Haemolyzer

Roche Cobas 6000


accreditation · crossmatching ce iso15189 5.5, lp-btr-028 and lp-btr-028a manual method of...

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