即时检测糖化血红蛋白：基于证据的分析。
Point-of-Care Hemoglobin A1c Testing: An Evidence-Based Analysis.
出版信息
Ont Health Technol Assess Ser. 2014 Jul 1;14(8):1-30. eCollection 2014.
BACKGROUND
The increasing prevalence of diabetes in Ontario means that there will be growing demand for hemoglobin A1c (HbA1c) testing to monitor glycemic control for the management of this chronic disease. Testing HbA1c where patients receive their diabetes care may improve system efficiency if the results from point-of-care HbA1c testing are comparable to those from laboratory HbA1c measurements.
OBJECTIVES
To review the correlation between point-of-care HbA1c testing and laboratory HbA1c measurement in patients with diabetes in clinical settings.
DATA SOURCES
The literature search included studies published between January 2003 and June 2013. Search terms included glycohemoglobin, hemoglobin A1c, point of care, and diabetes.
REVIEW METHODS
Studies were included if participants had diabetes; if they compared point-of-care HbA1c devices (licensed by Health Canada and available in Canada) with laboratory HbA1c measurement (reference method); if they performed point-of-care HbA1c testing using capillary blood samples (finger pricks) and laboratory HbA1c measurement using venous blood samples within 7 days; and if they reported a correlation coefficient between point-of-care HbA1c and laboratory HbA1c results.
RESULTS
Three point-of-care HbA1c devices were reviewed in this analysis: Bayer's A1cNow+, Bio-Rad's In2it, and Siemens' DCA Vantage. Five observational studies met the inclusion criteria. The pooled results showed a positive correlation between point-of-care HbA1c testing and laboratory HbA1c measurement (correlation coefficient, 0.967; 95% confidence interval, 0.960-0.973).
LIMITATIONS
Outcomes were limited to the correlation coefficient, as this was a commonly reported measure of analytical performance in the literature. Results should be interpreted with caution due to risk of bias related to selection of participants, reference standards, and the multiple steps involved in POC HbA1c testing.
CONCLUSIONS
Moderate quality evidence showed a positive correlation between point-of-care HbA1c testing and laboratory HbA1c measurement. Five observational studies compared 3 point-of-care HbA1c devices with laboratory HbA1c assays, and all reported strong correlation between the 2 tests.
背景
安大略省糖尿病患病率不断上升，这意味着用于监测该慢性病血糖控制情况的糖化血红蛋白（HbA1c）检测需求也将不断增加。如果即时检测糖化血红蛋白（HbA1c）的结果与实验室糖化血红蛋白（HbA1c）测量结果具有可比性，那么在患者接受糖尿病治疗的地方进行HbA1c检测可能会提高系统效率。
目的
回顾临床环境中糖尿病患者即时检测糖化血红蛋白（HbA1c）与实验室糖化血红蛋白（HbA1c）测量之间的相关性。
数据来源
文献检索纳入了2003年1月至2013年6月发表的研究。检索词包括糖化血红蛋白、血红蛋白A1c、即时检测和糖尿病。
综述方法
纳入的研究需满足以下条件：参与者患有糖尿病；将即时检测糖化血红蛋白（HbA1c）设备（获得加拿大卫生部许可且在加拿大可用）与实验室糖化血红蛋白（HbA1c）测量（参考方法）进行比较；在7天内使用毛细血管血样本（手指针刺）进行即时检测糖化血红蛋白（HbA1c），并使用静脉血样本进行实验室糖化血红蛋白（HbA1c）测量；报告即时检测糖化血红蛋白（HbA1c）与实验室糖化血红蛋白（HbA1c）结果之间的相关系数。
结果
本分析中评估了三种即时检测糖化血红蛋白（HbA1c）设备：拜耳的A1cNow +、伯乐的In2it和西门子的DCA Vantage。五项观察性研究符合纳入标准。汇总结果显示即时检测糖化血红蛋白（HbA1c）与实验室糖化血红蛋白（HbA1c）测量之间呈正相关（相关系数为0.967；95%置信区间为0.960 - 0.973）。
局限性
由于这是文献中通常报道的分析性能指标，因此结果仅限于相关系数。由于存在与参与者选择、参考标准以及即时检测糖化血红蛋白（HbA1c）测试所涉及的多个步骤相关的偏倚风险，结果应谨慎解释。
结论
中等质量证据表明即时检测糖化血红蛋白（HbA1c）与实验室糖化血红蛋白（HbA1c）测量之间呈正相关。五项观察性研究将三种即时检测糖化血红蛋白（HbA1c）设备与实验室糖化血红蛋白（HbA1c）检测进行了比较，所有研究均报告这两种检测之间具有强相关性。
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