Clinical Need for Point-of-Care Testing for Diabetes in Clinical and Laboratory Improvement Amendments-Waived Settings

Pamela R Kushner; Vivian Fonseca; James H Nichols; Jay H Shubrook; Eden Miller; Eugene Wright; Christopher DeFilippi; Joseph A Vassalotti

doi:10.2337/cd24-0071

Clinical Need for Point-of-Care Testing for Diabetes in Clinical and Laboratory Improvement Amendments-Waived Settings

Clin Diabetes. 2024 Oct 30;43(2):227-239. doi: 10.2337/cd24-0071. eCollection 2025 Spring.

Authors

Pamela R Kushner¹, Vivian Fonseca², James H Nichols³, Jay H Shubrook⁴, Eden Miller⁵, Eugene Wright⁶, Christopher DeFilippi⁷, Joseph A Vassalotti^{8

9}

Affiliations

¹ University of California, Irvine, Irvine, CA.
² Tulane University Health Sciences Center, New Orleans, LA.
³ Department of Pathology, Microbiology, and Immunology, Vanderbilt University Medical Center, Nashville, TN.
⁴ Department of Clinical Sciences and Community Health, Touro University California College of Osteopathic Medicine, Vallejo, CA.
⁵ Diabetes and Obesity Care, Bend, OR.
⁶ Department of Medicine, Duke University Medical Center, Durham, NC.
⁷ Inova Heart and Vascular Institute, Baltimore City County, MD.
⁸ National Kidney Foundation, New York, NY.
⁹ Icahn School of Medicine at Mount Sinai, New York, NY.

Abstract

Point-of-care testing (POCT) has been used in multiple care settings for acute disease and, to a lesser extent, chronic disease testing. All POCT is regulated under the Clinical and Laboratory Improvement Amendments of 1988 (CLIA). CLIA-waived POCT requires no proficiency testing and can be carried out by nonlaboratory personnel. This review describes the benefits and limitations of POCT for cardiometabolic diseases and related conditions. It also explores the current U.S. regulatory environment for CLIA-waived POCT, highlighting the need for increased access.