Hirst Jennifer A, McLellan Julie H, Price Christopher P, English Emma, Feakins Benjamin G, Stevens Richard J, Farmer Andrew J
Clin Chem Lab Med. 2017 Feb 1;55(2):167-180. doi: 10.1515/cclm-2016-0303.
Point-of-care (POC) devices could be used to measure hemoglobin A1c (HbA1c) 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 HbA1c devices.
Medline, Embase and Web of Science databases were searched in June 2015 for published reports comparing POC HbA1c 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.
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, Quo-Lab, Quo-Test and SDA1cCare. Nine devices had a negative mean bias which was significant for three devices. There was substantial variability in bias within devices. There was no difference in bias between clinical or laboratory operators in two devices.
This is the first meta-analysis to directly compare performance of POC HbA1c devices. Use of a device with a mean negative bias compared to a laboratory method may lead to higher levels of glycemia and a lower risk of hypoglycaemia. The implications of this on clinical decision-making and patient outcomes now need to be tested in a randomized trial.
即时检验（POC）设备可用于在医生办公室测量糖化血红蛋白（HbA1c），从而将检测结果立即反馈给患者。有报告对其中一些设备的分析性能提出了担忧。我们采用一种新方法进行了系统评价和荟萃分析，以比较POC HbA1c设备的准确性和精密度。
2015年6月检索了Medline、Embase和科学引文索引数据库，查找比较POC HbA1c设备与实验室检测方法的已发表报告。两名审阅者筛选文章并提取有关偏倚、精密度和诊断准确性的数据。将POC检测与实验室检测之间的平均偏倚和变异性合并进行荟萃分析。使用QUADAS2工具评估研究质量。
两名研究人员独立审查了1739条记录的入选资格。61项研究纳入了平均偏倚的荟萃分析。评估的设备有A1cgear、A1cNow、Afinion、B-analyst、Clover、Cobas b101、DCA 2000/Vantage、HemoCue、Innovastar、Nycocard、Quo-Lab、Quo-Test和SDA1cCare。9种设备的平均偏倚为负，其中3种设备的偏倚具有统计学意义。各设备的偏倚存在很大差异。两种设备在临床或实验室操作人员之间偏倚无差异。
这是首次直接比较POC HbA1c设备性能的荟萃分析。与实验室检测方法相比，使用平均偏倚为负的设备可能导致更高的血糖水平和更低的低血糖风险。现在需要通过随机试验来检验这对临床决策和患者预后的影响。
