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

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.