Aims/hypothesis The use of HbA 1c for the diagnosis of diabetes is now widely advocated despite caveats to its use.
Background A major objective of the IFCC Task Force on implementation of HbA1c standardization is to develop a model to define quality targets for HbA1c. Methods Two generic models, the Biological Variation and Sigma-metrics model, are investigated. Variables in the models were selected for HbA1c and data of EQA/PT programs were used to evaluate the suitability of the models to set and evaluate quality targets within and between laboratories. Results In the biological variation model 48% of individual laboratories and none of the 26 instrument groups met the minimum performance criterion. In the Sigma-metrics model, with a total allowable error (TAE) set at 5 mmol/mol (0.46% NGSP) 77% of the individual laboratories and 12 of 26 instrument groups met the 2 sigma criterion. Conclusion The Biological Variation and Sigma-metrics model were demonstrated to be suitable for setting and evaluating quality targets within and between laboratories. The Sigma-metrics model is more flexible as both the TAE and the risk of failure can be adjusted to requirements related to e.g. use for diagnosis/monitoring or requirements of (inter)national authorities. With the aim of reaching international consensus on advice regarding quality targets for HbA1c, the Task Force suggests the Sigma-metrics model as the model of choice with default values of 5 mmol/mol (0.46%) for TAE, and risk levels of 2 and 4 sigma for routine laboratories and laboratories performing clinical trials, respectively. These goals should serve as a starting point for discussion with international stakeholders in the field of diabetes.
Background: Point-of-care (POC) devices could be used to measure hemoglobin A 1c (HbA 1c ) in the doctors' office, allowing immediate feedback of results to patients. Reports have raised concerns about the analytical performance of some of these devices. We carried out a systematic review and meta-analysis using a novel approach to compare the accuracy and precision of POC HbA 1c devices. Methods: Medline, Embase and Web of Science databases were searched in June 2015 for published reports comparing POC HbA 1c devices with laboratory methods. Two reviewers screened articles and extracted data on bias, precision and diagnostic accuracy. Mean bias and variability between the POC and laboratory test were combined in a meta-analysis. Study quality was assessed using the QUADAS2 tool. Results: Two researchers independently reviewed 1739 records for eligibility. Sixty-one studies were included in the meta-analysis of mean bias. Devices evaluated were A1cgear, A1cNow, Afinion, B-analyst, Clover, Cobas b101, DCA 2000/Vantage, HemoCue, Innovastar, Nycocard,
Novelty StatementThis review is the first to systematically evaluate the evidence for a link between HbA1c and cancer risk. It outlines the relationships between HbA1c and the incidence and mortality of all and site-specific cancers. Furthering our understanding of the relationship between HbA1c and cancer is of great clinical and academic interest. This review goes some way to outlining these associations and highlighting areas where more research is needed. 2 AbstractAims Cancer is a major public health problem accounting for 8.2 million deaths worldwide in 2012. Glycated Haemoglobin (HbA1c) is associated with the risk of developing certain cancers, though the existing evidence is conflicting. The aim of this systematic review is to identify the relationship between HbA1c and cancers in people with or without diabetes.Methods Embase, Medline, Cinahl and Cochrane Library were searched. Eligible articles included randomised-controlled trials, cohort studies, case-control studies, systematic reviews and meta-analyses. Participants of either sex, with or without type 1 or 2 diabetes, were included. The studies were assessed using the Scottish Intercollegiate Guidelines Network (SIGN) criteria by two independent assessors. No meta-analysis was performed due to heterogeneity of results.Results Nineteen studies from 1006 met the inclusion criteria. Fourteen were cohort studies and five nested case control studies. Eight studies investigated outcomes for all cancer sites.Four of these studies reported that higher HbA1c levels were associated with increased incidence and/or mortality risk for all cancers. One study observed a U-shape relationship between HbA1c and cancer incidence and mortality. Increasing HbA1c levels were associated with increased risk of developing colorectal, pancreatic, respiratory and female genital tract cancers. No increased risk was observed for breast cancer, gastrointestinal or urological malignancies.Conclusion HbA1c appears to be associated with cancer incidence and/or cancer mortality.However, further studies are needed to fully understand the complex relationship between HbA1c and cancer.3
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