Clinical evaluation of the Free Style Precision Pro system

被引：11

作者：

Brazg, Ronald y ^{[2
]}

Hughes, Kristen ^{[2
]}

Martin, Pamela ^{[2
]}

Coard, Julie ^{[2
]}

Toffaletti, John ^{[3
]}

McDonnell, Elizabeth ^{[3
]}

Taylor, Elizabeth ^{[4
]}

Farrell, Lausanne ^{[1
]}

Patel, Mona ^{[1
]}

Ward, Jeanne ^{[1
]}

Chen, Ting ^{[1
]}

Alva, Shridhara ^{[1
]}

Ng, Ronald ^{[1
]}

机构：

[1] Abbott Diabet Care, Alameda, CA 94502 USA

[2] Rainier Clin Res Ctr, Renton, WA USA

[3] Duke Univ, Med Ctr, Durham, NC USA

[4] MassRes LLC, Waltham, MA USA

来源：

CLINICA CHIMICA ACTA | 2013年 / 421卷

关键词：

Point-of-care; Blood glucose monitoring system; Accuracy; Interference; ISO standard; CLSI guideline; GLUCOSE; SIMULATION;

D O I：

10.1016/j.cca.2013.03.021

中图分类号：

R446 [实验室诊断]; R-33 [实验医学、医学实验];

学科分类号：

1001 ;

摘要：

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/di of the laboratory analyzer valties at glucose concentrations <100 mg/di 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. (C) 2013 Elsevier B.V. All rights reserved.

引用

页码：243 / 250

页数：8

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