Year: 2013
Type: article
Abstract: BACKGROUND: A new version of international standard (ISO 15197) and CLSI Guideline (POCT12) with more stringent accuracy criteria are near publication. We evaluated the glucose test performance of the FreeStyle Precision Pro system, a new blood glucose monitoring system (BGMS) designed to enhance accuracy for point-of-care testing (POCT). METHODS: Precision, interference and system accuracy with 503 blood samples from capillary, venous and arterial sources were evaluated in a multicenter study. Study results were analyzed and presented in accordance with the specifications and recommendations of the final draft ISO 15197 and the new POCT12. RESULTS: The FreeStyle Precision Pro system demonstrated acceptable precision (CV <5%), no interference across a hematocrit range of 15-65%, and, except for xylose, no interference from 24 of 25 potentially interfering substances. It also met all accuracy criteria specified in the final draft ISO 15197 and POCT12, with 97.3-98.9% of the individual results of various blood sample types agreeing within ±12 mg/dl of the laboratory analyzer values at glucose concentrations <100mg/dl and within ±12.5% of the laboratory analyzer values at glucose concentrations ≥100 mg/dl. CONCLUSIONS: The FreeStyle Precision Pro system met the tighter accuracy requirements, providing a means for enhancing accuracy for point-of-care blood glucose monitoring.
Source: Clinica Chimica Acta
Authors: Ronald Brazg, Kristen Hughes, Pamela Martin, Julie Coard, John Toffaletti, Elizabeth McDonnell, Elizabeth Taylor, Lausanne Farrell, Mona Patel, Jeanne Ward, Ting Chen, Shridhara Alva, Ronald Ng
Language: English
Subfield: Medical Laboratory Technology
Field: Health Professions
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,550
Funder: Abbott Diabetes Care
OpenAlex ID: W1993948348