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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 Orcid Logo, Steve Luzio Orcid Logo, Rachel Churm Orcid Logo

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

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

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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
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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 &#x2212;20&#x202F;&#xB0;C for 14 and 28 days post collection.ResultsMedian (IQR) HbA1c was 60 (44.0&#x2013;71.2) mmol/mol (7.6 (6.17&#x2013;8.66) %) and 62 (45.0&#x2013;69.0) mmol/mol (7.8 (6.27&#x2013;8.46) %) for D10 and Quo-Test, respectively, with very good agreement (R2=0.969, P&lt;0.0001). Mean (range) intra- and inter-assay variation was 1.2% (0.0&#x2013;2.7%) and 1.6% (0.0&#x2013;2.7%) for the D10 and 3.5% (0.0&#x2013;6.7%) and 2.7% (0.7&#x2013;5.1%) for the Quo-Test. Mean change in HbA1c after 28 days storage at &#x2212;20&#x202F;&#xB0;C was &#x2212;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.</abstract><type>Journal Article</type><journal>Practical Laboratory Medicine</journal><volume>8</volume><paginationStart>26</paginationStart><paginationEnd>29</paginationEnd><publisher/><issnPrint>23525517</issnPrint><keywords>(POCT) Point Of Care Testing; (HPLC) High Performance Liquid Chromatography; (HbA1c) Glycated Hemoglobin;</keywords><publishedDay>31</publishedDay><publishedMonth>8</publishedMonth><publishedYear>2017</publishedYear><publishedDate>2017-08-31</publishedDate><doi>10.1016/j.plabm.2017.04.001</doi><url/><notes/><college>COLLEGE NANME</college><department>Biomedical Sciences</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>BMS</DepartmentCode><institution>Swansea University</institution><apcterm/><lastEdited>2019-06-18T09:11:23.6675716</lastEdited><Created>2019-06-06T09:27:30.5438820</Created><path><level id="1">Swansea University Medical School</level><level id="2">Medicine</level></path><authors><author><firstname>D.A.</firstname><surname>Grant</surname><order>1</order></author><author><firstname>G.J.</firstname><surname>Dunseath</surname><order>2</order></author><author><firstname>R.</firstname><surname>Churm</surname><order>3</order></author><author><firstname>S.D.</firstname><surname>Luzio</surname><order>4</order></author><author><firstname>Gareth</firstname><surname>Dunseath</surname><orcid>0000-0001-6022-862X</orcid><order>5</order></author><author><firstname>Steve</firstname><surname>Luzio</surname><orcid>0000-0002-7206-6530</orcid><order>6</order></author><author><firstname>Rachel</firstname><surname>Churm</surname><orcid>0000-0001-9855-6282</orcid><order>7</order></author></authors><documents><document><filename>0050666-18062019091036.pdf</filename><originalFilename>50666.pdf</originalFilename><uploaded>2019-06-18T09:10:36.9230000</uploaded><type>Output</type><contentLength>942839</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><embargoDate>2019-06-17T00:00:00.0000000</embargoDate><documentNotes>Released under the terms of a Creative Commons Attribution License (CC-BY).</documentNotes><copyrightCorrect>true</copyrightCorrect><language>eng</language></document></documents><OutputDurs/></rfc1807>
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 BMS 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 Biomedical Sciences COLLEGE CODE BMS Swansea University 2019-06-18T09:11:23.6675716 2019-06-06T09:27:30.5438820 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
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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 Swansea University Medical School
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hierarchy_top_id swanseauniversitymedicalschool
hierarchy_top_title Swansea University Medical School
hierarchy_parent_id swanseauniversitymedicalschool
hierarchy_parent_title Swansea University Medical School
department_str Medicine{{{_:::_}}}Swansea University Medical School{{{_:::_}}}Medicine
document_store_str 1
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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 2017-08-31T04:04:05Z
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