Division of Pediatric Endocrinology, University of Florida, Gainesville, Florida, USA.
Jaeb Center for Health Research, Tampa, Florida, USA.
Diabetes Technol Ther. 2022 Nov;24(11):789-796. doi: 10.1089/dia.2022.0187.
The COVID-19 pandemic and the rapid expansion of telemedicine have increased the need for accurate and reliable capillary hemoglobin A1c (HbA1c) testing. Nevertheless, validation studies of commercially available products suitable for home use have been in short supply. Three commercial home-use capillary blood sample HbA1c tests (Home Access, CoreMedica, and A1cNow+) were evaluated in 219 participants with type 1 or type 2 diabetes (4-80 years years of age, HbA1c 5.1%-13.4% [32-123 mmol/mol]) at four clinical sites. Comparisons were made between HbA1c measurements from the commercial tests and paired venous samples for which HbA1c was measured at two central reference laboratories. The primary outcome was percentage of commercial HbA1c values within 5% of the corresponding reference values. HbA1c values were within 5% (relative difference) of paired reference values for 82% of Home Access samples, 29% of CoreMedica samples, and 46% of A1cNow+ samples. Absolute differences were within 0.3% of the reference value for 75% of Home Access samples, 28% of CoreMedica samples, and 44% of A1cNow+ samples and exceeded 0.5% for 8%, 55%, and 37%, respectively. None of the commercial home-use HbA1c tests produced the National Glycohemoglobin Standardization Program goal of ≥90% measurements within 5% of a DCCT venous reference. However, the Home Access product performed substantially better than the CoreMedica or A1cNow+ products. Telemedicine is likely to persist as a mainstay of diabetes care well after the COVID-19 era. As such, accurate home-based HbA1c assessment represents an urgent need for the diabetes community.
COVID-19 大流行和远程医疗的快速扩张增加了对准确可靠的毛细血管血红蛋白 A1c（HbA1c）检测的需求。然而，适合家庭使用的商业产品的验证研究一直供不应求。在四个临床地点，对 219 名 1 型或 2 型糖尿病患者（年龄 4-80 岁，HbA1c 5.1%-13.4%[32-123mmol/mol]）使用三种商业家用毛细血管血样 HbA1c 检测（Home Access、CoreMedica 和 A1cNow+）进行了评估。将商业检测的 HbA1c 测量值与在两个中心参考实验室测量的配对静脉样本进行比较。主要结局是商业 HbA1c 值与相应参考值的百分比在 5%以内。对于 82%的 Home Access 样本、29%的 CoreMedica 样本和 46%的 A1cNow+样本，HbA1c 值与配对参考值相差 5%（相对差值）以内。对于 75%的 Home Access 样本、28%的 CoreMedica 样本和 44%的 A1cNow+样本，绝对差值在参考值的 0.3%以内，而分别有 8%、55%和 37%的样本超过 0.5%。没有一种商业家用 HbA1c 检测达到国家糖化血红蛋白标准化计划的目标，即≥90%的测量值在 DCCT 静脉参考值的 5%以内。然而，Home Access 产品的性能明显优于 CoreMedica 或 A1cNow+产品。远程医疗很可能在 COVID-19 时代之后仍然是糖尿病护理的主要手段。因此，准确的基于家庭的 HbA1c 评估是糖尿病患者群体的迫切需求。
