[Point-of-Care Blood Glucose Testing: Post-Market Performance Assessment of the Accu-Chek Inform II Hospital-Use Glucose Meter].
| Autor: | Petryaykina EE; Russian Children's Clinical Hospital - Branch of Pirogov Russian National Research Medical University., Mayanskiy NA; Russian Children's Clinical Hospital - Branch of Pirogov Russian National Research Medical University., Demina ES; Russian Children's Clinical Hospital - Branch of Pirogov Russian National Research Medical University., Karamysheva IV; Russian Children's Clinical Hospital - Branch of Pirogov Russian National Research Medical University., Gorst KA; Russian Children's Clinical Hospital - Branch of Pirogov Russian National Research Medical University., Timofeev AV; Russian Children's Clinical Hospital - Branch of Pirogov Russian National Research Medical University. |
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| Jazyk: | ruština |
| Zdroj: | Terapevticheskii arkhiv [Ter Arkh] 2023 Dec 28; Vol. 95 (12), pp. 1151-1163. Date of Electronic Publication: 2023 Dec 28. |
| DOI: | 10.26442/00403660.2023.12.202522 |
| Abstrakt: | Background: A point-of-care glucose testing (POCT) is an essential component of care in patients with hyperglycemia and hypoglycemia in inpatient and outpatient settings. In Russian medical facilities (MFs), conventional glucose meters designed for self-monitoring by patients with diabetes are commonly used for POCT. These home-use meters have two serious disadvantages: the first is large measurement bias and the second - they can't be integrated into laboratory information systems, so measurement data have to be recorded into patient charts manually. Both factors may lead to medical errors. It is reasonable to use in the MFs specialized POCT glucose meters, as they are superior to conventional ones in accuracy and may be easily connected to laboratory information systems. With this in mind, physicians at the Russian Children's Clinical Hospital decided to substitute conventional meters with the Accu-Chek Inform II POCT meter, however, after preliminary performance assessment of the model. Aim: To test the Accu-Chek Inform II performance characteristics: accuracy, linearity, repeatability, and mean absolute relative difference (MARD). Materials and Methods: Performance of the Accu-Chek Inform II was tested by comparing the results of parallel C Results: The Accu-Chek Inform II meter met the requirements of ISO 15197-2013 and POCT12-A3 and demonstrated high linearity (correlation coefficient, r =1,0), good repeatability (mean coefficient of variation, CV=1,38%) and acceptable MARD (4,9%). Conclusion: The Accu-Chek Inform II POCT glucose meter may be efficiently and safely used in inpatient and outpatient MFs and particularly in pediatric clinics. |
| Databáze: | MEDLINE |
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