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Objectives Numerous biological variation (BV) studies have been performed over the years, but the quality of these studies vary. The objectives of this study were to perform a systematic review and critical appraisal of BV studies on glycosylated albumin and to deliver updated BV estimates for glucose and HbA 1c , including recently published high-quality studies such as the European Biological Variation study (EuBIVAS). Methods Systematic literature searches were performed to identify BV studies. Nine publications not included in a previous review were identified; four for glycosylated albumin, three for glucose, and three for HbA 1c . Relevant studies were appraised by the Biological Variation Data Critical Appraisal Checklist (BIVAC). Global BV estimates were derived by meta-analysis of BIVAC-compliant studies in healthy subjects with similar study design. Results One study received BIVAC grade A, 2B, and 6C. In most cases, the C-grade was associated with deficiencies in statistical analysis. BV estimates for glycosylated albumin were: CV I =1.4% (1.2–2.1) and CV G =5.7% (4.7–10.6), whereas estimates for HbA 1c , CV I =1.2% (0.3–2.5), CV G =5.4% (3.3–7.3), and glucose, CV I =5.0% (4.1–12.0), CV G =8.1% (2.7–10.8) did not differ from previously published global estimates. Conclusions The critical appraisal and rating of BV studies according to their methodological quality, followed by a meta-analysis, generate robust, and reliable BV estimates. This study delivers updated and evidence-based BV estimates for glycosylated albumin, glucose and HbA 1c .

Critical appraisal and meta-analysis of biological variation studies on glycosylated albumin, glucose and HbA 1c