突破性研究:儲存的全血樣本中糖化血紅蛋白A1c的測量可靠性確認,助力發展中國家糖尿病管理

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本研究證實,在發展中國家因設備與專業知識缺乏而難以常規進行糖化血紅蛋白A1c測試的情況下,將全血樣本儲存20天後再測量,所得結果與新鮮樣本無顯著差異。這一發現對於提高糖尿病患者的診斷和管理具有重要意義。

Glycated Haemoglobin A(1c) Measurement in Stored Whole Blood Sample is Reliable for Clinical Use

儲存全血樣本中的糖化血紅蛋白 A(1c) 測量可可靠用於臨床。

Ezenwaka CE, Seales D, Surujlal R, Mathura RP. Glycated haemoglobin A1c measurement in stored whole blood sample is reliable for clinical use. West Indian Med J. 2009;58(1):17-20.

https://pubmed.ncbi.nlm.nih.gov/19565994/

摘要與圖表

糖化血紅蛋白 A1c (HbA1c) 提供過去 2-3 個月的整體血糖濃度,其測量在糖尿病患者的管理中至關重要。然而,在許多開發中國家,由於 HbA1c 測量所需的試劑盒或試劑或專業知識並非總是可用,且測試必須在新鮮全血樣本上進行,HbA1c 測試並未成為常規。因此,本研究旨在確定全血樣本儲存所產生的降解產物是否足以影響 HbA1c 測量的診斷價值。231 份預先測定 HbA1c 值的新鮮全血樣本被儲存在 2-8 攝氏度,並使用硼酸親和免疫測定技術在儲存 20 天後對相同全血樣本進行 HbA1c 測量。結果顯示,初始 HbA1c 測量值與儲存後的測量值的平均值沒有顯著差異(7.5 +/- 2.0 vs. 7.5 +/- 2.1,p > 0.05),且無論性別皆然。此外,無論性別,儲存後的 HbA1c 值與新鮮全血樣本測量值之間有顯著相關(r = 0.83,p < 0.01)。因此,根據這些發現和其他先前的報告,儲存降解產物的影響不足以影響儲存全血樣本的 HbA1c 測試結果在臨床或研究中的使用。然而,我們建議診斷實驗室應評估其在儲存全血樣本中測定 HbA1c 的測量技術。儲存全血樣本中若存在持續的上升或下降偏差,應報告給醫生,以指導其解讀來自該實驗室和/或技術的儲存全血樣本的 HbA1c 測試結果。

Abstract and figures

Glycated haemoglobin A1c (HbA1c) gives an integrated plasma glycaemia for the previous 2-3 months and its measurement is central in the management of diabetic patients. However in many developing countries because kits/regents or expertise for HbA1c measurement are not always available and the test must be conducted on fresh whole blood samples, HbA1c tests are not routinely performed Thus, this study aimed to determine if the degradation products from whole blood sample storage are significant enough to compromise the diagnostic value of HbA1c measurements. Two hundred and thirty-one fresh whole blood samples with pre-determined HbA1c values were stored at between 2-8 degrees C and using boronate affinity immunoassay technique, HbA1c values were then measured in the same whole blood samples after 20 days of storage. The results showed that there were no significant differences in the mean values of the initial HbA1c measurement and the values obtained after storage (7.5 +/- 2.0 vs. 7.5 +/- 2.1, p > 0.05) and this was irrespective of gender. Furthermore, irrespective of gender there were significant correlations between the HbA1c values measured in fresh whole blood samples and values obtained after storage (r = 0.83, p < 0.01). Therefore, based on these findings and other previous reports, the effect of storage degradation product was not significant enough to compromise the clinical or research use of HbA1c test results from stored whole blood samples. However, we recommend that diagnostic laboratories should evaluate their HbA1c measurement techniques for HbA1c determination in stored whole blood samples. Any persistent upward or downward bias in stored whole blood samples should be reported to guide the physician in interpreting HbA1c results from stored whole blood samples from that laboratory and/or technique.