David Sacks (United States of America)
NIH
Laboratory Medicine
David Sacks is Senior Investigator and Chief of Clinical Chemistry at the National Institutes of Health, Adjunct Professor of Medicine at Georgetown University, Clinical Professor of Pathology at George Washington University and Honorary Professor of Clinical Laboratory Sciences at the University of Cape Town. He received his medical training at the University of Cape Town. He completed residencies in Internal Medicine at Georgetown University-affiliated hospitals in Washington, D.C. and in Clinical Pathology at Washington University, St. Louis., He spent 21 years in the Department of Pathology at Harvard Medical School. Dr. Sacks’s primary clinical focus is on diabetes mellitus, with an emphasis on the interface between the clinical laboratory and patient care. Dr. Sacks has published more than 245 articles in peer reviewed scientific journals. He is an Associate Editor for Clinical Chemistry and serves on the editorial boards of other journals. His awards include the American Association for Clinical Chemistry (AACC) Award for Outstanding Contributions in a Selected Area of Research (2005), the NACB Distinguished Scientist Award (2009), the AACC Outstanding Contributions in Education (2012) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Distinguished Award for Laboratory Medicine and Patient Care (2020).

Moderator of 1 Session

 Conference Calendar

PARALLEL SESSION - METHODS AND REGULATORY ISSUES IN DIABETES

Session Type
Parallel Session
Date
Fri, 29.04.2022
Session Time
09:00 - 10:00
Room
Hall 114
Chair(s)

Presenter of 1 Presentation

 Conference Calendar

Is POC HbA1c Adequate?

Session Name
0430 - PARALLEL SESSION - METHODS AND REGULATORY ISSUES IN DIABETES (ID 27)
Session Type
Parallel Session
Date
Fri, 29.04.2022
Session Time
09:00 - 10:00
Room
Hall 114
Presenter
Lecture Time
09:00 - 09:20

Abstract

Abstract Body

Hemoglobin A1c (HbA1c) is used very widely both to monitor patients with diabetes mellitus and to diagnose diabetes. An International Expert Committee recommended that HbA1c ≥6.5% rather than fasting glucose be used to diagnose diabetes (Diabetes Care 2009; 32:1327). Since 2010 when HbA1c was advocated by the American Diabetes Association (ADA) for both screening and diagnosis of diabetes (and endorsed in 2011 by the World Health Organization), there has been a dramatic increase in the use of HbA1c for diagnosis. Initially HbA1c was measured only in central laboratories, but subsequently smaller point-of-care testing (POCT) devices became commercially available to analyze HbA1c in doctors’ offices and clinics. At present, the ADA cautions that POCT devices for HbA1c should not be used for diagnosis. Although several point-of-care HbA1c assays are NGSP-certified, the test is waived in the USA and proficiency testing is not necessary. Therefore, no objective information is available concerning their performance in the hands of those who measure HbA1c in patient samples. Nevertheless, some advocate for use of POCT HbA1c devices for diagnosis and the topic remains highly contentious. Numerous publications have evaluated performance of HbA1c POCT devices, with many shown to have inadequate analytic performance (eg, Clin Chem 2010; 56:44; Clin Chem 2014; 60:1062). The use of HbA1c POCT in diabetes diagnosis has also been addressed in both the clinical and laboratory published literature (eg, Clin Chem 2013; 59:1790; Prim Care Diabetes. 2017;11:248; Ann Fam Med. 2017;15:162; JAMA 2019; 322:1404). This talk will provide a current perspective on these issues.

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