Analytical Performance Requirements for Systems for Self-Monitoring of Blood Glucose With Focus on System Accuracy

Abstract

In the European Union (EU), the ISO (International Organization for Standardization) 15197 standard is applicable for the evaluation of systems for self-monitoring of blood glucose (SMBG) before the market approval. In 2013, a revised version of this standard was published. Relevant revisions in the analytical performance requirements are the inclusion of the evaluation of influence quantities, for example, hematocrit, and some changes in the testing procedures for measurement precision and system accuracy evaluation, for example, number of test strip lots. Regarding system accuracy evaluation, the most important change is the inclusion of more stringent accuracy criteria. In 2014, the Food and Drug Administration (FDA) in the United States published their own guidance document for the premarket evaluation of SMBG systems with even more stringent system accuracy criteria than stipulated by ISO 15197:2013. The establishment of strict accuracy criteria applicable for the premarket evaluation is a possible approach to further improve the measurement quality of SMBG systems. However, the system accuracy testing procedure is quite complex, and some critical aspects, for example, systematic measurement difference between the reference measurement procedure and a higher-order procedure, may potentially limit the apparent accuracy of a given system. Therefore, the implementation of a harmonized reference measurement procedure for which traceability to standards of higher order is verified through an unbroken, documented chain of calibrations is desirable. In addition, the establishment of regular and standardized post-marketing evaluations of distributed test strip lots should be considered as an approach toward an improved measurement quality of available SMBG systems.

American Association Of Clinical Endocrinologists And American College Of Endocrinology 2016 Outpatient Glucose Monitoring Consensus Statement

“…If devices are tested by trained technicians, one would expect greater accuracy than if they were tested by untrained lay-persons such as patients and family caregivers. There is a suggestion that testing performed by nontrained people under "real-world" conditions might become required (144).…”

Avaliação da acurácia de dois glicosímetros veterinários para uso em cães

“…Tais comparações constataram a acurácia pretendida pela ISO15197:2013 foram aquelas nas quais as variáveis de avaliação eram controladas de modo a manter e garantir a comparação de semelhantes para tipo de amostra (plasma vs. plasma equivalente) e enzimas do sistema de mensuração da glicemia (Hx e GOx). (13,22) . A análise pelas GAE de Parkes et al (12) é uma avaliação proposta pela ISO 15197:2013 que permite a avaliação da acurácia dos GT apesar das interferências de erros analíticos inerentes tanto ao GT quanto ao MLab usado como referência.…”

Electrochemical Glucose Biosensors for Diabetes Care

“…The minimum accuracy criteria require that at least 95% of measurements fall within AE15% and at least 99% fall within AE20% of the reference value across the entire claimed glucose measurement range. Table 2 (adapted from Table 1 in Freckmann et al [182]) compares the minimum SMBG System Accuracy Criteria from the ISO 15197 Standard (2003 and 2013) with the FDA 2014 Draft Guidance document [16,182]. The system accuracy requirements as proposed by the FDA are quite stringent, and there is considerable concern among industry and medical experts about the ability of most commercially available systems to meet the criteria.…”