Comparison of a point-of-care analyser for the determination of HbA1c with HPLC method

Grant, D.A.; Dunseath, G.J.; Churm, R.; Luzio, S.D.; Dunseath, Gareth; Luzio, Steve; Churm, Rachel

doi:10.1016/j.plabm.2017.04.001

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Comparison of a point-of-care analyser for the determination of HbA1c with HPLC method

D.A. Grant, G.J. Dunseath, R. Churm, S.D. Luzio, Gareth Dunseath

, Steve Luzio

, Rachel Churm

Practical Laboratory Medicine, Volume: 8, Pages: 26 - 29

Swansea University Authors: Gareth Dunseath , Steve Luzio , Rachel Churm

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DOI (Published version): 10.1016/j.plabm.2017.04.001

Abstract

As the use of Point of Care Testing (POCT) devices for measurement of glycated haemoglobin (HbA1c) increases, it is imperative to determine how their performance compares to laboratory methods. This study compared the performance of the automated Quo-Test POCT device (EKF Diagnostics), which uses bo...

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Published in:	Practical Laboratory Medicine
ISSN:	23525517
Published:	2017
Online Access:	Check full text
URI:	https://cronfa.swan.ac.uk/Record/cronfa50666

first_indexed	2019-06-06T14:58:35Z
last_indexed	2019-06-18T14:55:29Z
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spelling	2019-06-18T09:11:23.6675716 v2 50666 2019-06-06 Comparison of a point-of-care analyser for the determination of HbA1c with HPLC method fccbba9edcaee08a839a3c5cff8cbe19 0000-0001-6022-862X Gareth Dunseath Gareth Dunseath true false 01491e1cd582746a654fad9addf0de16 0000-0002-7206-6530 Steve Luzio Steve Luzio true false c6cd8267ff0b13f2ea333bbfefdae144 0000-0001-9855-6282 Rachel Churm Rachel Churm true false 2019-06-06 MEDS As the use of Point of Care Testing (POCT) devices for measurement of glycated haemoglobin (HbA1c) increases, it is imperative to determine how their performance compares to laboratory methods. This study compared the performance of the automated Quo-Test POCT device (EKF Diagnostics), which uses boronate fluorescence quenching technology, with a laboratory based High Performance Liquid Chromatography (HPLC) method (Biorad D10) for measurement of HbA1c.MethodsWhole blood EDTA samples from subjects (n=100) with and without diabetes were assayed using a BioRad D10 and a Quo-Test analyser. Intra-assay variation was determined by measuring six HbA1c samples in triplicate and inter-assay variation was determined by assaying four samples on 4 days. Stability was determined by assaying three samples stored at −20 °C for 14 and 28 days post collection.ResultsMedian (IQR) HbA1c was 60 (44.0–71.2) mmol/mol (7.6 (6.17–8.66) %) and 62 (45.0–69.0) mmol/mol (7.8 (6.27–8.46) %) for D10 and Quo-Test, respectively, with very good agreement (R2=0.969, P<0.0001). Mean (range) intra- and inter-assay variation was 1.2% (0.0–2.7%) and 1.6% (0.0–2.7%) for the D10 and 3.5% (0.0–6.7%) and 2.7% (0.7–5.1%) for the Quo-Test. Mean change in HbA1c after 28 days storage at −20 °C was −0.7% and +0.3% for D10 and Quo-Test respectively. Compared to the D10, Quo-Test showed 98% agreement for diagnosis of glucose intolerance (IGT and T2DM) and 100% for diagnosis of T2DM.ConclusionGood agreement between the D10 and Quo-Test was seen across a wide HbA1c range. The Quo-Test POCT device provided similar performance to a laboratory based HPLC method. Journal Article Practical Laboratory Medicine 8 26 29 23525517 (POCT) Point Of Care Testing; (HPLC) High Performance Liquid Chromatography; (HbA1c) Glycated Hemoglobin; 31 8 2017 2017-08-31 10.1016/j.plabm.2017.04.001 COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University 2019-06-18T09:11:23.6675716 2019-06-06T09:27:30.5438820 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine D.A. Grant 1 G.J. Dunseath 2 R. Churm 3 S.D. Luzio 4 Gareth Dunseath 0000-0001-6022-862X 5 Steve Luzio 0000-0002-7206-6530 6 Rachel Churm 0000-0001-9855-6282 7 0050666-18062019091036.pdf 50666.pdf 2019-06-18T09:10:36.9230000 Output 942839 application/pdf Version of Record true 2019-06-17T00:00:00.0000000 Released under the terms of a Creative Commons Attribution License (CC-BY). true eng
title	Comparison of a point-of-care analyser for the determination of HbA1c with HPLC method
spellingShingle	Comparison of a point-of-care analyser for the determination of HbA1c with HPLC method Gareth Dunseath Steve Luzio Rachel Churm
title_short	Comparison of a point-of-care analyser for the determination of HbA1c with HPLC method
title_full	Comparison of a point-of-care analyser for the determination of HbA1c with HPLC method
title_fullStr	Comparison of a point-of-care analyser for the determination of HbA1c with HPLC method
title_full_unstemmed	Comparison of a point-of-care analyser for the determination of HbA1c with HPLC method
title_sort	Comparison of a point-of-care analyser for the determination of HbA1c with HPLC method
author_id_str_mv	fccbba9edcaee08a839a3c5cff8cbe19 01491e1cd582746a654fad9addf0de16 c6cd8267ff0b13f2ea333bbfefdae144
author_id_fullname_str_mv	fccbba9edcaee08a839a3c5cff8cbe19_*_Gareth Dunseath 01491e1cd582746a654fad9addf0de16__Steve Luzio c6cd8267ff0b13f2ea333bbfefdae144_**_Rachel Churm
author	Gareth Dunseath Steve Luzio Rachel Churm
author2	D.A. Grant G.J. Dunseath R. Churm S.D. Luzio Gareth Dunseath Steve Luzio Rachel Churm
format	Journal article
container_title	Practical Laboratory Medicine
container_volume	8
container_start_page	26
publishDate	2017
institution	Swansea University
issn	23525517
doi_str_mv	10.1016/j.plabm.2017.04.001
college_str	Faculty of Medicine, Health and Life Sciences
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hierarchy_top_title	Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id	facultyofmedicinehealthandlifesciences
hierarchy_parent_title	Faculty of Medicine, Health and Life Sciences
department_str	Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
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description	As the use of Point of Care Testing (POCT) devices for measurement of glycated haemoglobin (HbA1c) increases, it is imperative to determine how their performance compares to laboratory methods. This study compared the performance of the automated Quo-Test POCT device (EKF Diagnostics), which uses boronate fluorescence quenching technology, with a laboratory based High Performance Liquid Chromatography (HPLC) method (Biorad D10) for measurement of HbA1c.MethodsWhole blood EDTA samples from subjects (n=100) with and without diabetes were assayed using a BioRad D10 and a Quo-Test analyser. Intra-assay variation was determined by measuring six HbA1c samples in triplicate and inter-assay variation was determined by assaying four samples on 4 days. Stability was determined by assaying three samples stored at −20 °C for 14 and 28 days post collection.ResultsMedian (IQR) HbA1c was 60 (44.0–71.2) mmol/mol (7.6 (6.17–8.66) %) and 62 (45.0–69.0) mmol/mol (7.8 (6.27–8.46) %) for D10 and Quo-Test, respectively, with very good agreement (R2=0.969, P<0.0001). Mean (range) intra- and inter-assay variation was 1.2% (0.0–2.7%) and 1.6% (0.0–2.7%) for the D10 and 3.5% (0.0–6.7%) and 2.7% (0.7–5.1%) for the Quo-Test. Mean change in HbA1c after 28 days storage at −20 °C was −0.7% and +0.3% for D10 and Quo-Test respectively. Compared to the D10, Quo-Test showed 98% agreement for diagnosis of glucose intolerance (IGT and T2DM) and 100% for diagnosis of T2DM.ConclusionGood agreement between the D10 and Quo-Test was seen across a wide HbA1c range. The Quo-Test POCT device provided similar performance to a laboratory based HPLC method.
published_date	2017-08-31T07:45:23Z
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Comparison of a point-of-care analyser for the determination of HbA1c with HPLC method

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