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1.
Ter Arkh ; 96(3): 312-314, 2024 Apr 16.
Artículo en Ruso | MEDLINE | ID: mdl-38713050

RESUMEN

In the article "Point-of-care blood glucose testing: post-market performance assessment of the Accu-Chek Inform II hospital-use glucose meter," published in the Terapevticheskii Arkhiv journal, Vol. 95, No.12, 2023 (DOI: 10.26442/00403660.2023.12.202522), errors were made: the term "measurements at the place of treatment" was changed, as well as the section "Conflict of interest." At the request of the authors' team, errors in the conflict of interest and the wording of the term have been corrected, and the section "Information about the authors" has been updated. The publisher replaced the original version of the published article with the corrected one; the information on the website was also corrected. Correct text of the section "Conflict of interest": Conflict of interest. All authors are not employees or consultants of Roche Diagnostics and have not received any compensation from Roche Diagnostics. Correct wording of the term in Russian: "измерения по месту лечения". Changes were made to the title of the article in Russian: "Измерения глюкозы по месту лечения: пострегистрационное испытание госпитального глюкометра Акку-Чек Информ II", the text of the abstract, keywords, citation, in the text of the article, and abbreviations. Information of the place of work has been updated: Center for Laboratory Diagnostics of the Russian Children Clinical Hospital, a Branch of the Pirogov Russian National Research Medical University. The publisher apologizes to readers and authors for the errors and is confident that the correction of errors will ensure the correct perception and interpretation of the results of the study described in the text.


Asunto(s)
Glucemia , Humanos , Glucemia/análisis , Sistemas de Atención de Punto , Automonitorización de la Glucosa Sanguínea/instrumentación , Automonitorización de la Glucosa Sanguínea/métodos , Pruebas en el Punto de Atención , Vigilancia de Productos Comercializados/métodos , Federación de Rusia
2.
Ter Arkh ; 95(12): 1151-1163, 2023 Dec 28.
Artículo en Ruso | MEDLINE | ID: mdl-38785055

RESUMEN

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 CGL measurements with the meter and reference laboratory analyzer in capillary blood samples. Overall, 99 parallel CGL measurements were made in 45 samples. Accuracy was evaluated according to the ISO 15197-2013 and POCT12-A3 criteria. 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.


Asunto(s)
Automonitorización de la Glucosa Sanguínea , Glucemia , Sistemas de Atención de Punto , Humanos , Glucemia/análisis , Automonitorización de la Glucosa Sanguínea/instrumentación , Automonitorización de la Glucosa Sanguínea/métodos , Automonitorización de la Glucosa Sanguínea/normas , Federación de Rusia , Sistemas de Atención de Punto/normas , Pruebas en el Punto de Atención/normas , Reproducibilidad de los Resultados , Diabetes Mellitus/sangre , Diabetes Mellitus/diagnóstico
3.
Klin Lab Diagn ; 61(1): 39-45, 2016 Jan.
Artículo en Ruso | MEDLINE | ID: mdl-27183728

RESUMEN

The individual portable systems of control of glucose level in blood commonly known as glucometers permit to patients with diabetes mellitus to independently correct pharmaceutical therapy. The effectiveness of this correction depends on accuracy of control of glucose level. The evaluation was implemented concerning minimal admissible accuracy and clinical accuracy of control of glucose level of devices Contour TC, Satellite Express and One Touch Select according standards expounded in GOST 15197-2011 and international standard ISO 15197-2013. It is demonstrated that Contour TC and One Touch Select meet the requirements of these standards in part of accuracy while Satellite Express does not.


Asunto(s)
Automonitorización de la Glucosa Sanguínea/normas , Glucemia/análisis , Diabetes Mellitus/sangre , Automonitorización de la Glucosa Sanguínea/instrumentación , Diabetes Mellitus/diagnóstico , Humanos , Reproducibilidad de los Resultados , Sensibilidad y Especificidad
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