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References from Impact of ISO/TS 20914-based measurement uncertainty on HbA1c classification around clinical decision limits: A real-world evaluation of two analytical systems. Local targets link to admitted publications; unresolved targets remain external evidence.
2. Diagnosis and classification of diabetes: standards of care in diabetes—2026
10.2337/dc26-s002 · 2026 · External reference
Unresolved reference
2011 · External reference
Changing from glucose to HbA1c for diabetes diagnosis: predictive values of one test and importance of analytical bias and imprecision
10.1515/cclm-2013-0337 · 2014 · External reference
The long and winding road to optimal HbA1c measurement
10.1016/j.cca.2012.12.026 · 2013 · External reference
The National Glycohemoglobin Standardization Program: over 20 years of improving hemoglobin A1c measurement
10.1373/clinchem.2018.296962 · 2019 · External reference
Traceability, reference systems and result comparability
2007 · External reference
Unresolved reference
2019 · External reference
Statistical methods for monitoring the relationship between the IFCC reference measurement procedure for hemoglobin A1c and the designated comparison methods in the United States, Japan, and Sweden
10.1373/clinchem.2008.103556 · 2008 · External reference
Unresolved reference
2008 · External reference
Unresolved reference
2022 · External reference
Unresolved reference
2017 · External reference
Defining analytical performance specifications: consensus statement from the 1st strategic conference of the European Federation of Clinical Chemistry and Laboratory Medicine
10.1515/cclm-2015-0067 · 2015 · External reference
Setting analytical performance specifications using HbA1c as a model measurand
10.1016/j.cca.2021.10.016 · 2021 · External reference
Performance specifications for measurement uncertainty of common biochemical measurands according to Milan models
10.1515/cclm-2021-0170 · 2021 · External reference
The internal quality control in the traceability era
10.1515/cclm-2020-0371 · 2021 · External reference
Analytical performance specifications for combined uncertainty budget in the implementation of metrological traceability
10.1515/cclm-2023-1325 · 2024 · External reference
Evaluation of the analytical performances of the Cobas c513 analyser for HbA1c assay
10.11613/bm.2018.030708 · 2018 · External reference
Application of six sigma model to evaluate the analytical quality of four HbA1c analyzers
10.7754/clin.lab.2016.160608 · 2017 · External reference
Unresolved reference
External reference
Implementation of metrological traceability in laboratory medicine: where we are and what is missing
10.1515/cclm-2019-1128 · 2020 · External reference
The utility of measurement uncertainty in medical laboratories
10.1515/cclm-2019-1336 · 2020 · External reference
Definition and application of performance specifications for measurement uncertainty of 23 common laboratory tests: linking theory to daily practice
10.1515/cclm-2022-0806 · 2023 · External reference
More on the accuracy of the architect enzymatic assay for hemoglobin A1c and its traceability to the IFCC reference system
10.1515/cclm-2015-0550 · 2016 · External reference
A step towards optimal efficiency of HbA1c measurement as a first-line laboratory test: the TOP-HOLE (towards OPtimal glycoHemOgLobin tEsting) project
10.1515/cclm-2021-1249 · 2022 · External reference
10.1093/clinchem/hvae131
10.1093/clinchem/hvae131 · 2024 · External reference
Impact of analytical and biological variations on classification of diabetes using fasting plasma glucose, oral glucose tolerance test and HbA1c
10.1038/s41598-017-14172-8 · 2017 · External reference
The risk of clinical misinterpretation of HbA1c: modelling the impact of biological variation and analytical performance on HbA1c used for diagnosis and monitoring of diabetes
10.1016/j.cca.2023.117495 · 2023 · External reference
Regulation (EU) 2017/746 of 5 April 2017 on in vitro diagnostic medical devices and repealing directive 98/79/EC and commission decision 2010/227/EU
2017 · External reference