Multicenter assessment of a hemoglobin A1c point-of-care device for diagnosis of diabetes mellitus

Philip M. Sobolesky; Breland E. Smith; Amy K. Saenger; Karen Schulz; Fred S. Apple; Mitchell G. Scott; Alan H.B. Wu; Randie R. Little; Robert L. Fitzgerald

doi:10.1016/j.clinbiochem.2018.09.007

Multicenter assessment of a hemoglobin A1c point-of-care device for diagnosis of diabetes mellitus

Philip M. Sobolesky, Breland E. Smith, Amy K. Saenger, Karen Schulz, Fred S. Apple, Mitchell G. Scott, Alan H.B. Wu, Randie R. Little, Robert L. Fitzgerald

Laboratory Medicine and Pathology

Research output: Contribution to journal › Article › peer-review

10 Scopus citations

Abstract

Objective: A multisite investigation compared the analytical performance of a point-of-care (POC) HbA1c device with multiple commonly used HbA1c laboratory methods and an NGSP (National Glycohemoglobin Standardization Program) reference method. Research Design and Methods: The Afinion AS100 POC device analyzed HbA1c using 618 EDTA whole blood excess patient specimens with clinically indicated HbA1c testing. Results were compared to measurements across five clinical laboratories and the NGSP reference method. Precision was evaluated over 8–10 consecutive days for low-, mid-, and high-range HbA1c specimens at all five sites. Results: Over a wide range of HbA1c values (4.0%–15% HbA1c), 97.1% of the POC results and 94.5% of routine laboratory results fell within the target value of ±6% of the NGSP reference method results. The POC HbA1c results at 6.5% exhibited a total relative bias of −0.6% (−0.04% HbA1c) compared to the reference method while the aggregate of laboratory methods displayed a relative bias of −0.9% (−0.06% HbA1c). The total imprecision of the POC results ranged from 0.74–2.13% CV across the analytic measurement range compared to 0.81–3.23% CV for the routine laboratory methods. Conclusions: The accuracy and precision of the Afinion POC HbA1c method was comparable to the laboratory HbA1c methods supporting the FDA's recent approval of the Afinion HbA1c Dx device for use in the diagnosis of diabetes.

Original language	English (US)
Pages (from-to)	18-22
Number of pages	5
Journal	Clinical Biochemistry
Volume	61
DOIs	https://doi.org/10.1016/j.clinbiochem.2018.09.007
State	Published - Nov 2018

Bibliographical note

Funding Information:
The authors acknowledge the contribution of Alere Inc. in designing the multisite investigation, providing the Afinion AS100 point-of-care instruments to each laboratory participating in this study, and performing statistical analysis of the study results. No conflicts of interest relevant to this article were reported. B.E.S. and P.M.S. conducted and oversaw the study at the University of California, San Diego Center for Advanced Laboratory Medicine under the guidance of R.L.F. A.K.S., K.S., F.S.A., M.G.S., and A.H.B.W. were responsible for conducting and overseeing the study at their respective laboratories. R.R.L. was responsible for overseeing the reference method at the DDL. B.E.S. and P.M.S. drafted the manuscript, and R.L.F., A.K.S., K.S., F.S.A., M.G.S., A.H.B.W., and R.R.L. edited and made significant contributions to the final draft of the manuscript.

Publisher Copyright:
© 2018

Keywords

Diabetes
HbA1c
NGSP
Point-of-care

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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title = "Multicenter assessment of a hemoglobin A1c point-of-care device for diagnosis of diabetes mellitus",

abstract = "Objective: A multisite investigation compared the analytical performance of a point-of-care (POC) HbA1c device with multiple commonly used HbA1c laboratory methods and an NGSP (National Glycohemoglobin Standardization Program) reference method. Research Design and Methods: The Afinion AS100 POC device analyzed HbA1c using 618 EDTA whole blood excess patient specimens with clinically indicated HbA1c testing. Results were compared to measurements across five clinical laboratories and the NGSP reference method. Precision was evaluated over 8–10 consecutive days for low-, mid-, and high-range HbA1c specimens at all five sites. Results: Over a wide range of HbA1c values (4.0%–15% HbA1c), 97.1% of the POC results and 94.5% of routine laboratory results fell within the target value of ±6% of the NGSP reference method results. The POC HbA1c results at 6.5% exhibited a total relative bias of −0.6% (−0.04% HbA1c) compared to the reference method while the aggregate of laboratory methods displayed a relative bias of −0.9% (−0.06% HbA1c). The total imprecision of the POC results ranged from 0.74–2.13% CV across the analytic measurement range compared to 0.81–3.23% CV for the routine laboratory methods. Conclusions: The accuracy and precision of the Afinion POC HbA1c method was comparable to the laboratory HbA1c methods supporting the FDA's recent approval of the Afinion HbA1c Dx device for use in the diagnosis of diabetes.",

keywords = "Diabetes, HbA1c, NGSP, Point-of-care",

author = "Sobolesky, {Philip M.} and Smith, {Breland E.} and Saenger, {Amy K.} and Karen Schulz and Apple, {Fred S.} and Scott, {Mitchell G.} and Wu, {Alan H.B.} and Little, {Randie R.} and Fitzgerald, {Robert L.}",

note = "Funding Information: The authors acknowledge the contribution of Alere Inc. in designing the multisite investigation, providing the Afinion AS100 point-of-care instruments to each laboratory participating in this study, and performing statistical analysis of the study results. No conflicts of interest relevant to this article were reported. B.E.S. and P.M.S. conducted and oversaw the study at the University of California, San Diego Center for Advanced Laboratory Medicine under the guidance of R.L.F. A.K.S., K.S., F.S.A., M.G.S., and A.H.B.W. were responsible for conducting and overseeing the study at their respective laboratories. R.R.L. was responsible for overseeing the reference method at the DDL. B.E.S. and P.M.S. drafted the manuscript, and R.L.F., A.K.S., K.S., F.S.A., M.G.S., A.H.B.W., and R.R.L. edited and made significant contributions to the final draft of the manuscript. Publisher Copyright: {\textcopyright} 2018",

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doi = "10.1016/j.clinbiochem.2018.09.007",

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AU - Sobolesky, Philip M.

AU - Smith, Breland E.

AU - Saenger, Amy K.

AU - Schulz, Karen

AU - Apple, Fred S.

AU - Scott, Mitchell G.

AU - Wu, Alan H.B.

AU - Little, Randie R.

AU - Fitzgerald, Robert L.

N1 - Funding Information: The authors acknowledge the contribution of Alere Inc. in designing the multisite investigation, providing the Afinion AS100 point-of-care instruments to each laboratory participating in this study, and performing statistical analysis of the study results. No conflicts of interest relevant to this article were reported. B.E.S. and P.M.S. conducted and oversaw the study at the University of California, San Diego Center for Advanced Laboratory Medicine under the guidance of R.L.F. A.K.S., K.S., F.S.A., M.G.S., and A.H.B.W. were responsible for conducting and overseeing the study at their respective laboratories. R.R.L. was responsible for overseeing the reference method at the DDL. B.E.S. and P.M.S. drafted the manuscript, and R.L.F., A.K.S., K.S., F.S.A., M.G.S., A.H.B.W., and R.R.L. edited and made significant contributions to the final draft of the manuscript. Publisher Copyright: © 2018

PY - 2018/11

Y1 - 2018/11

N2 - Objective: A multisite investigation compared the analytical performance of a point-of-care (POC) HbA1c device with multiple commonly used HbA1c laboratory methods and an NGSP (National Glycohemoglobin Standardization Program) reference method. Research Design and Methods: The Afinion AS100 POC device analyzed HbA1c using 618 EDTA whole blood excess patient specimens with clinically indicated HbA1c testing. Results were compared to measurements across five clinical laboratories and the NGSP reference method. Precision was evaluated over 8–10 consecutive days for low-, mid-, and high-range HbA1c specimens at all five sites. Results: Over a wide range of HbA1c values (4.0%–15% HbA1c), 97.1% of the POC results and 94.5% of routine laboratory results fell within the target value of ±6% of the NGSP reference method results. The POC HbA1c results at 6.5% exhibited a total relative bias of −0.6% (−0.04% HbA1c) compared to the reference method while the aggregate of laboratory methods displayed a relative bias of −0.9% (−0.06% HbA1c). The total imprecision of the POC results ranged from 0.74–2.13% CV across the analytic measurement range compared to 0.81–3.23% CV for the routine laboratory methods. Conclusions: The accuracy and precision of the Afinion POC HbA1c method was comparable to the laboratory HbA1c methods supporting the FDA's recent approval of the Afinion HbA1c Dx device for use in the diagnosis of diabetes.

AB - Objective: A multisite investigation compared the analytical performance of a point-of-care (POC) HbA1c device with multiple commonly used HbA1c laboratory methods and an NGSP (National Glycohemoglobin Standardization Program) reference method. Research Design and Methods: The Afinion AS100 POC device analyzed HbA1c using 618 EDTA whole blood excess patient specimens with clinically indicated HbA1c testing. Results were compared to measurements across five clinical laboratories and the NGSP reference method. Precision was evaluated over 8–10 consecutive days for low-, mid-, and high-range HbA1c specimens at all five sites. Results: Over a wide range of HbA1c values (4.0%–15% HbA1c), 97.1% of the POC results and 94.5% of routine laboratory results fell within the target value of ±6% of the NGSP reference method results. The POC HbA1c results at 6.5% exhibited a total relative bias of −0.6% (−0.04% HbA1c) compared to the reference method while the aggregate of laboratory methods displayed a relative bias of −0.9% (−0.06% HbA1c). The total imprecision of the POC results ranged from 0.74–2.13% CV across the analytic measurement range compared to 0.81–3.23% CV for the routine laboratory methods. Conclusions: The accuracy and precision of the Afinion POC HbA1c method was comparable to the laboratory HbA1c methods supporting the FDA's recent approval of the Afinion HbA1c Dx device for use in the diagnosis of diabetes.

KW - Diabetes

KW - HbA1c

KW - NGSP

KW - Point-of-care

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Multicenter assessment of a hemoglobin A1c point-of-care device for diagnosis of diabetes mellitus

Abstract

Bibliographical note

Keywords

UN SDGs

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