Evaluation Clinical Application of Laboratory and Two Point-of-Care Analysers in HbA1c Measurement and Hemoglobin Variants

評估糖化血色素及變異血色素在實驗室與2台POCT儀器之臨床上應用

目的：使用大實驗室Sebia Capillarys3分析儀，與Abbort Afinion AS10和Siemens DCA Vantage分析儀在床旁檢測中的結果進行比較，以測量正常和變異的HbA1c之差異。材料和方法：使用EDTA的全血檢體去執行親和力、免疫及電泳法分析。結果：採集132檢體樣本經Sebia Capillarys3與Afinion和DCA Vantage的檢測HbA1c均顯示出良好的相關性，其數值分別為0.96（Afinion和Sebia Capillarys3）和0.95（DCA Vantage和Sebia Capillarys3）。在所有分析變異血紅素的樣本中，其包括Hb E、Hb G－新竹、Hb G－台中、α－地中海型貧血、Hb－高雄、Hb J-Meinung和HbF或其他Hb變異。在有48名變異血色素的檢體中，顯示Afinion和DCA Vantage與Sebia Capillarys3的相關性分別為0.84和0.87。最後，在Bland-Altman圖的95％信賴區間中，以Sebia Capillarys3當標準時呈現出Afinion AS100比DCA Vantage較低的偏差。結論：兩種POCT分析法對實驗室標準法有極高的相關性，因此可廣泛應用於血糖控制檢測甚至醫生的糖尿病管理中，並且減少因變異血色素可能影響HbA1c檢測數值方法以提高實驗室人員的局限性。

Aim: To use Sebia Capillarys3 analyser of the laboratory and compared the result that Abbort Afinion AS100 and Siemens DCA Vantage analysers at point-of-care testing to measure HbA_1c differences in normal hemoglobin and Hb variants. Materials and Methods: Directly tested ethylenediaminetetraacetic acid-containing venous whole blood and used the affinity, immuno-assay and electrophoresis of three analysers. Results: All 132 samples of HbA_1c measurement by Sebia Capillarys3 showed good correlation with the result of Afinion and DCA Vantage, which was 0.96 (Afinion and Sebia Capillarys3) and 0.95 (DCA Vantage and Sebia Capillarys3). In all samples contained Hb variants, they were divided into heterozygotic HbE, Hb G-Hsin Chu, Hb G-Taichung, α-thalassemia, Hb Kaohsiungth, Hb J-Meinung and HbF or other Hb variants, respectively. Among forty-eight subjects were Hb variants, indicated that the correlation of Afinion and DCA Vantage to Sebia Capillarys3 was 0.84 and 0.87, respectively. Finally, regardless of Bland-Altman plot of the range of 95% limits of agreement revealed the low bias in Afinion AS100 than DCA Vantage versus SC3. Conclusion: Both POCT analysers revealed higher relative to SC3 reference method, so it could be widely used in glycemic control even to diabetes management for doctor and reduced the impact of Hb variants that might affect the numerical method of HbA1c inspection to increase the limitations of laboratory personnel.