新研究揭示不同儲存條件對糖化血紅蛋白測量的影響,評估五種高效液相色譜法

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研究比較了五種高效液相色譜法在不同溫度下對糖化血紅蛋白(HbA1c)測量的影響。結果顯示,Primus CLC 385/330和Tosoh G7具有較佳的樣本穩定性,能在低溫和室溫下保持較長時間的穩定。這項研究有助於改善糖尿病患者的長期血糖控制評估。

Effects of sample storage conditions on glycated hemoglobin measurement: evaluation of five different high performance liquid chromatography methods

樣本儲存條件對糖化血紅蛋白測量的影響:五種不同高效液相色譜法的評估

Little RR, Rohlfing CL, Tennill AL, Connolly S, Hanson S. Effects of sample storage conditions on glycated hemoglobin measurement: evaluation of five different high performance liquid chromatography methods. Diabetes Technol Ther. 2007;9(1):36-42. doi:10.1089/dia.2006.0055

https://pubmed.ncbi.nlm.nih.gov/17316096/

Abstract

Background

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.

Methods

 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.

Results

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.

Conclusions

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.

摘要

背景

糖化血紅蛋白,以 HbA1c 報告,廣泛用於評估糖尿病患者的長期血糖控制。測量的準確性部分取決於分析前樣本的正確儲存。

方法

收集三個 HbA1c 水平的三個全血 (WB) 樣本,並儲存在 -70°C、-20°C、4°C、室溫 (17-23°C) 和 37°C。每個溫度下的樣本分別在第 1、2、3、6、7、10、14、21、28 和 57 天使用每種方法進行分析。

結果

Primus CLC (385 和 330) (Primus Corp., Kansas City, MO) 顯示全血在 -20°C 和 4°C 下穩定 57 天,在室溫下穩定 14 天,在 37°C 下穩定 1 天。Tosoh 2.2 Plus (Tosoh Bioscience, Inc., South San Francisco, CA) 顯示在 -20°C 下穩定 3 天,4°C 下穩定 14 天,室溫下穩定 3 天,37°C 下穩定不超過 24 小時。使用 Tosoh G7,在 -20°C 下結果在 10 天內可接受,4°C 下 57 天,室溫下 7 天,37°C 下不超過 24 小時。Bio-Rad Variant (Bio-Rad Laboratories, Hercules, CA) 在 -20°C 下穩定 6 天,4°C 下穩定 14 天,室溫下穩定 3 天,37°C 下穩定不超過 24 小時。Bio-Rad Variant II 在 -20°C 下穩定 28 天,4°C 下穩定 57 天,室溫下穩定 7 天,37°C 下穩定不超過 24 小時。

結論

所有方法均達到或超過製造商的穩定性要求。CLC 385/330、Tosoh G7 和 Bio-Rad Variant II 高效液相色譜法的穩定性優於 Tosoh 2.2 Plus 和 Bio-Rad Variant。