621-P: The Inaccuracy of Commercial Home Hemoglobin A1c Tests

Abstract

The COVID-19 pandemic and rapid expansion of telemedicine has increased the need for accurate and reliable capillary A1c testing. Nevertheless, validation studies of commercially available kits have been in short supply. As such, capillary and venous A1c samples were assessed using 3 commercial home kits (Home Access, CoreMedica, A1cNow) and 2 non-commercial kits from academic centers (U of MN Advanced Research and Diagnostic Lab [ARDL] and Children’s Mercy Hospital [CMH]). Samples were collected either with study staff guidance (non-commercial) or hands-on assistance (commercial) and sent by USPS for processing except for the immediate response A1cNow+ kit. Differences in A1c between commercial kits and reference values were appreciable (Table). Notably, none of the commercially tested kits reached the National Glycohemoglobin Standardization Program target of more than 90% of values within 5% of DCCT venous reference values although the Home Access kit performed much better than the other two. In contrast, evaluation of kits from ARDL and CMH showed 97.4% of values within the 5% standard. Ease of use and discomfort with sample collection varied between kits. While the accuracy of the commercial kits analyzed was limited, participants’ response was positive overall. Telemedicine is likely to persist as a mainstay of diabetes care well after the COVID-19 era. As such, accurate home A1c testing represents an urgent need for the diabetes community.View largeDownload slideView largeDownload slide DisclosureL. M. Jacobsen: None. L. E. Bocchino: Other Relationship; Self; Leona M. and Harry B. Helmsley Charitable Trust, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health. J. Adams: None. J. W. Lum: None. M. J. Haller: Board Member; Self; SAB Biotherapeutics, Inc., Consultant; Self; MannKind Corporation, Other Relationship; Self; Janssen Pharmaceuticals, Inc., Sanofi. R. Beck: Consultant; Self; Bigfoot Biomedical, Inc., Diasome Pharmaceuticals, Inc., Insulet Corporation, Lilly Diabetes, vTv Therapeutics, Research Support; Self; Beta Bionics, Inc., Dexcom, Inc., Medtronic, Novo Nordisk, Tandem Diabetes Care.