Little Randie R, Rohlfing Curt L, Tennill Alethea L, Connolly Shawn, Hanson Steve
Department of Pathology, University of Missouri School of Medicine, Columbia, Missouri 65212, USA.
Diabetes Technol Ther. 2007 Feb;9(1):36-42. doi: 10.1089/dia.2006.0055.
Glycated hemoglobin, reported as hemoglobin A1c (HbA1c), is widely used as a measure of long-term glycemic control in patients with diabetes. The accuracy of measurements depends in part on proper storage of the sample prior to analysis.
Three whole blood (WB) samples at three HbA1c levels were collected and stored at -70 degrees C, -20 degrees C, 4 degrees C, room temperature (17-23 degrees C), and 37 degrees C. One aliquot from each temperature was analyzed by each method on days 1, 2, 3, 6, 7, 10, 14, 21, 28, and 57.
The Primus CLC (385 and 330) (Primus Corp., Kansas City, MO) showed stability of WB at -20 degrees C and 4 degrees C for 57 days, room temperature for 14 days, and 37 degrees C for 1 day. The Tosoh 2.2 Plus (Tosoh Bioscience, Inc., South San Francisco, CA) showed stability at -20 degrees C for 3 days, 4 degrees C for 14 days, room temperature for 3 days, and 37 degrees C for less than 24 h. With the Tosoh G7, results were acceptable at -20 degrees C for 10 days, 4 degrees C for 57 days, room temperature for 7 days, and 37 degrees C for less than 24 h. The Bio-Rad Variant (Bio-Rad Laboratories, Hercules, CA) showed stability at -20 degrees C for 6 days, 4 degrees C for 14 days, room temperature for 3 days, and 37 degrees C for less than 24 h. The Bio-Rad Variant II showed stability at -20 degrees C for 28 days, 4 degrees C for 57 days, room temperature for 7 days, and 37 degrees C for less than 24 h.
All methods either met or exceeded manufacturers' claims for stability. The CLC 385/330, Tosoh G7, and Bio-Rad Variant II high performance liquid chromatography methods showed better stability than the Tosoh 2.2 Plus and Bio-Rad Variant.
糖化血红蛋白，报告为糖化血红蛋白A1c（HbA1c），被广泛用作糖尿病患者长期血糖控制的指标。测量的准确性部分取决于分析前样本的妥善保存。
收集三个不同HbA1c水平的全血（WB）样本，并分别储存在-70℃、-20℃、4℃、室温（17 - 23℃）和37℃。在第1、2、3、6、7、10、14、21、28和57天，对每个温度下的一份样本用每种方法进行分析。
Primus CLC（385和330）（Primus公司，密苏里州堪萨斯城）显示全血在-20℃和4℃下可稳定保存57天，在室温下可稳定保存14天，在37℃下可稳定保存1天。Tosoh 2.2 Plus（Tosoh生物科学公司，加利福尼亚州南旧金山）在-20℃下可稳定保存3天，在4℃下可稳定保存14天，在室温下可稳定保存3天，在37℃下稳定时间少于24小时。使用Tosoh G7，在-20℃下10天内结果可接受，在4℃下57天内可接受，在室温下7天内可接受，在37℃下稳定时间少于24小时。Bio-Rad Variant（Bio-Rad实验室，加利福尼亚州赫拉克勒斯）在-20℃下可稳定保存6天，在4℃下可稳定保存14天，在室温下可稳定保存3天，在37℃下稳定时间少于24小时。Bio-Rad Variant II在-20℃下可稳定保存28天，在4℃下可稳定保存57天，在室温下可稳定保存7天，在37℃下稳定时间少于24小时。
所有方法均达到或超过了制造商所宣称的稳定性。CLC 385/330、Tosoh G7和Bio-Rad Variant II高效液相色谱法显示出比Tosoh 2.2 Plus和Bio-Rad Variant更好的稳定性。
