Performance Evaluation of a New Blood Glucose Monitor That Requires No Coding: The OneTouch® Vita™ System
| Autor: | John M. Ellison, Robert Marshall, Joanna K. Young |
|---|---|
| Rok vydání: | 2008 |
| Předmět: |
Blood glucose monitoring
Plasma glucose Accuracy and precision Precision testing medicine.diagnostic_test Computer science Endocrinology Diabetes and Metabolism Grid analysis Biomedical Engineering Bioengineering Original Articles computer.software_genre Lactate analyzer Test strips Internal Medicine medicine Data mining computer Biomedical engineering |
| Zdroj: | Journal of Diabetes Science and Technology. 2:814-818 |
| ISSN: | 1932-2968 |
| DOI: | 10.1177/193229680800200510 |
| Popis: | Background: Improvements to blood glucose monitoring systems aim to simplify the testing process, reduce or eliminate errors, and provide additional information for patients with diabetes. New systems must continue to demonstrate high-quality analytical performance. The new OneTouch® Vita™ System (LifeScan, Inc., Milpitas, CA) offers a no-code testing process and proven technology found in the OneTouch® Ultra® System. Comparative studies were conducted with the new and established systems to evaluate their precision and accuracy. Methods: Within-run precision in blood, total precision with controls, and system accuracy were evaluated using three lots of OneTouch Vita Test Strips and one lot of OneTouch Ultra Test Strips. Accuracy was tested across a wide glucose range (38–520 mg/dl, 2.1–28.9 mmol/liter) using fingertip blood samples from 139 subjects. Reference plasma glucose values were obtained using the YSI 2300 STAT Plus Glucose & Lactate Analyzer (YSI Inc., Yellow Springs, OH). All studies were designed in accordance with requirements published by the International Organization for Standardization (ISO 15197). Results: Precision testing (within-run and total) with both systems produced coefficients of variation (CVs) of Conclusion: The OneTouch Vita System provides a simple no-code testing process with performance comparable to the OneTouch Ultra and OneTouch Ultra2 Systems. |
| Databáze: | OpenAIRE |
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