[1]田 原,溫冬梅,王偉佳,等.硼酸鹽親和色譜法檢測糖化血紅蛋白的分析性能評價[J].醫學信息,2020,(04):77-79.[doi:10.3969/j.issn.1006-1959.2020.04.023]
 TIAN Yuan,WEN Dong-mei,WANG Wei-jia,et al.Evaluation of Analytical Performance of Glycated Hemoglobin by Borate Affinity Chromatography[J].Medical Information,2020,(04):77-79.[doi:10.3969/j.issn.1006-1959.2020.04.023]
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硼酸鹽親和色譜法檢測糖化血紅蛋白的分析性能評價()
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醫學信息[ISSN:1006-1959/CN:61-1278/R]

卷:
期數:
2020年04期
頁碼:
77-79
欄目:
論著
出版日期:
2020-02-15

文章信息/Info

Title:
Evaluation of Analytical Performance of Glycated Hemoglobin by Borate Affinity Chromatography
文章編號:
1006-1959(2020)04-0077-03
作者:
田 原溫冬梅王偉佳
(中山大學附屬中山醫院檢驗醫學中心,廣東 中山 528403)
Author(s):
TIAN YuanWEN Dong-meiWANG Wei-jiaet al
(Laboratory Medical Center,Zhongshan Hospital Affiliated to Sun Yat-sen University,Zhongshan 528403,Guangdong,China)
關鍵詞:
糖化血紅蛋白硼酸鹽親和色譜法性能評價
Keywords:
Glycated hemoglobinBorate affinity chromatographyPerformance evaluation
分類號:
R446.6
DOI:
10.3969/j.issn.1006-1959.2020.04.023
文獻標志碼:
A
摘要:
目的 評價硼酸鹽親和色譜法(AC-HPLC)檢測糖化血紅蛋白(HbA1c)的分析性能。方法 參考美國臨床與實驗室標準化協會(CLSI)發布的方法學評價系列文件(EP文件)及相關文獻,對Premier Hb9210系統檢測HbA1c的精密度、正確度、分析測量范圍以及生物參考區間進行驗證,并與廠商聲明的性能和有關質量標準進行比較。結果 硼酸鹽親和色譜法檢測HbA1c兩個不同水平的批內精密度(CV%)分別為0.8%和0.6%;總精密度(CV%)分別為1.53%和0.9%。與離子交換高效液相色譜法(IE-HPLC)的VariantⅡ檢測系統的相對偏倚為3.26%。與來源于美國國家糖化血紅蛋白標準化計劃(NGSP)定值樣本靶值的相對偏差為2.3%~3.2%,HbA1c濃度為4.1%~16.4%,理論值與實測均值呈線性相關,回歸方程為Y=1.0018x+0.3903,r2=0.9942。隨機選擇的20名健康參考個體糖化血紅蛋白濃度均在廠商提供的參考區間內。結論 Premier Hb9210糖化血紅蛋白分析儀的主要分析性能達到了廠商聲明的性能和有關的質量要求,適用于我室檢測糖化血紅蛋白。
Abstract:
Objective To evaluate the analytical performance of glycosylated hemoglobin (HbA1c) by borate affinity chromatography (AC-HPLC). Methods Refer to the Methodological Evaluation Series Documents (EP files) and related documents issued by the American Society for Clinical and Laboratory Standardization (CLSI) to verify the precision, accuracy, analytical measurement range and biological reference interval of the Premier Hb9210 system for detecting HbA1c And compare with the manufacturer’s stated performance and relevant quality standards.Results The intra-batch precision (CV%) of two different levels of HbA1c detected by borate affinity chromatography was 0.8% and 0.6%, respectively; the total precision (CV%) was 1.53% and 0.9%. The relative bias of the Variant II detection system with ion exchange high performance liquid chromatography (IE-HPLC) was 3.26%. The relative deviation from the target value of the fixed sample from the National Glycated Hemoglobin Standardization Program (NGSP) is 2.3% ~ 3.2%, the HbA1c concentration is 4.1% ~ 16.4%, the theoretical value is linearly related to the measured mean, and the regression equation is Y=1.0018x+0.3903,r2=0.9942.Glycated hemoglobin concentrations of 20 randomly selected healthy reference individuals were within the reference interval provided by the manufacturer.Conclusion The main analytical performance of Premier Hb9210 glycated hemoglobin analyzer has reached the performance and relevant quality requirements declared by the manufacturer.

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