Ricós Carmen, Fernández-Calle Pilar, Gonzalez-Lao Elisabet, Simón Margarida, Díaz-Garzón Jorge, Boned Beatriz, Marqués-García Fernando, Minchinela Joana, Perich Maria Carmen, Tejedor-Ganduxé Xavier, Corte Zoraida, Aarsand Aasne K, Aslan Berna, Carobene Anna, Coskun Abdurrahman, Sandberg Sverre
Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain.
Padilla, 323, Barcelona 08035, Spain.
Adv Lab Med. 2020 May 19;1(3):20200029. doi: 10.1515/almed-2020-0029. eCollection 2020 Oct.
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, including recently published high-quality studies such as the European Biological Variation study (EuBIVAS).
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. 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.
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=1.4% (1.2-2.1) and CV=5.7% (4.7-10.6), whereas estimates for HbA, CV=1.2% (0.3-2.5), CV=5.4% (3.3-7.3), and glucose, CV=5.0% (4.1-12.0), CV=8.1% (2.7-10.8) did not differ from previously published global estimates.
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.
多年来已开展了大量生物变异（BV）研究，但这些研究的质量参差不齐。本研究的目的是对糖化白蛋白的BV研究进行系统评价和批判性评估，并给出葡萄糖和糖化血红蛋白（HbA）的最新BV估计值，包括最近发表的高质量研究，如欧洲生物变异研究（EuBIVAS）。
进行系统的文献检索以识别BV研究。识别出9篇先前综述未纳入的出版物；4篇关于糖化白蛋白，3篇关于葡萄糖，3篇关于HbA。相关研究通过生物变异数据批判性评估清单（BIVAC）进行评估。全球BV估计值通过对具有相似研究设计的健康受试者中符合BIVAC标准的研究进行荟萃分析得出。
1项研究获得BIVAC A级，2项B级和6项C级。在大多数情况下，C级与统计分析缺陷有关。糖化白蛋白的BV估计值为：变异系数（CV）=1.4%（1.2 - 2.1）和CV = 5.7%（4.7 - 10.6），而HbA的估计值，CV = 1.2%（0.3 - 2.5），CV = 5.4%（3.3 - 7.3），以及葡萄糖的估计值，CV = 5.0%（4.1 - 12.0），CV = 8.1%（2.7 - 10.8）与先前发表的全球估计值无差异。
根据方法学质量对BV研究进行批判性评估和评级，随后进行荟萃分析，可得出稳健且可靠的BV估计值。本研究给出了糖化白蛋白、葡萄糖和HbA的最新且基于证据的BV估计值。
