| 摘要: | 臨床檢測及定量異型血色素有兩大主要目的。第一為檢測醣化血紅素HbA1c (glycated hemoglobin A1)，由血液中的葡萄糖長時間醣化HbA形成，應用於監控糖尿病患的血糖控制。第二為定量HbA1、HbA2、HbF及特殊血紅素比例，應用於診斷血液疾病如地中海型貧血及鐮刀型血球症等。為了迅速正確的檢測HbA1、HbA1c及HbA2、HbF及特殊血紅素比例。我們評估了Bio-Rad D-10 Dual program血色素測試系統，它使用了高效能液相層析法（HPLC）的原理，可以於6.5分鐘內完成分析。在HbA1c的部分，我們將現行使用的D-10 HbA1c program與D-10 Dual program進行比較。研究結果顯示23個 HbA1c自0.0 ﹪~ 13.9 ﹪的標本顯示兩種系統並無顯著差異存在，其相關係數為Y＝0.9086X＋0.014（X＝HbA1c program，Y＝Dual program，r2=0.9907 ，p=0.498）。在HbA2、HbF及特殊血紅素比例部分，我們將現行使用的Helena’s Hemoglobin Electrophoresis(Helena’s EP)與D-10 Dual program進行比較。研究結果顯示28個HbA2自0.9 ﹪~ 6.6 ﹪的標本，在分析HbA2比例上兩種系統並無顯著差異存在，相關係數為Y＝0.6826X＋0.8369（X＝Helena’s EP，Y＝Dual program，r2=0.5021 ，p=0.922）。在HbF部分則顯示D-10 Dual program對於低值HbF( HbF ＜ 5.0 %, 15個HbF自0.0 ﹪~ 4.6 ﹪的標本實驗結果)具有較高的檢出值，平均Helena’s EP =0.17 ％，Dual program＝1.40 ％（p=0.000906）。但在高值HbF( HbF ＞ 5.0 %, 12個HbF自6.3 ﹪~ 64.3 ﹪的標本實驗結果) 在分析HbF比例上兩種系統並無顯著差異存在，相關係數為Y＝0.7617X＋9.007（X＝Helena’s EP，Y＝Dual program，r2=0.9158 ，p=0.852 ）。實驗結果顯示Bio-Rad D-10 Dual program血色素測試系統提供了精確的方法定量HbA1c、HbA2及HbF，在線性及精確度上的表現良好，與現今使用的方法比較時也具有良好的相關性。而相對於血色素電泳，D-10 Dual program還可以提供HbF較高的檢出率。採用D-10 Dual program 將可提供下列優勢：長期監控糖尿病患及早期診斷妊娠糖尿病患精確的HbA1c檢驗結果、疑似地中海型貧血及缺鐵性貧血病患HbA2及HbF的快速診斷，以及將兩種檢驗合併於同一儀器檢驗可節省的檢驗時間、存放空間及費用。
Detection and quantitation of hemoglobin (Hb) fractions is required for clinically relevant in two situations. First, the quantitation of HbA1c, the major glycated form of HbA, is an useful biomarker in the clinical management of diabetes. Second, the detection and quantitation of HbA1c, HbA2, HbF and various Hb variants is an essential method in the diagnosis of hemoglobinopathies (eg, thalassemia syndromes or sickle cell syndromes). On the analyzing HbA1c, we compared the performance of Dual program with current kit (HbA1c program) on Bio-Rad D-10 HPLC analyzer. The results obtained from 23 samples showed that there was no significant difference in the specimen throughput between the current kits and the dual kit. Coefficient was Y＝0.9086X＋0.014(X＝HbA1c program，Y＝Dual program，r2=0.9907 ，p=0.498). On the analyzing HbA2, HbF and Hb variants, we compared the performance of Bio-Rad D-10 Dual program with Helena’s Hemoglobin Electrophoresis(Helena’s EP). The HbA2 results showed that there was no significant difference between the current kits and the dual kit. Coefficient was Y＝0.6826X＋0.8369(X＝Helena’s EP，Y＝Dual program，r2=0.5021, p=0.922). But in the Low HbF group(HbF ＜ 5.0 %, results from 15 samples which HbF range is from 0.0 ﹪to 4.6 ﹪)results from the dual kit did tend to be higher as the current kit. The HbF means which on Helena’s EP is 0.17 and compared with Dual program is 1.40（p=0.000906）. On the High HbF group( HbF ＞ 5.0 %, results from 15 samples which HbF is 6.3 ﹪~ 64.3 ﹪) results showed that there was no significant difference between the current kits and the dual kit. Coefficient was Y＝0.7617X＋9.007(X＝Helena’s EP，Y＝Dual program，r2=0.9158 ，p=0.852). D-10 Dual program allowed detection and analyzing HbA1c rapidly and with good linearity and precision. It also showed good correlation with the current kits. Compared with Helena’s EP, D-10 Dual program showed higher sensitivity on analyzing HbA2, HbF and Hb variants. D-10 Dual program has several advantages: First, it provides an accurate, highly reproducible HbA1c result for patients with long-term blood sugar monitoring and gestational diabetes; Second, a rapid analysis in HbA2, HbF and Hb variants can help early diagnosis in β-thalassemia and iron deficiency anemia patient; Third, reducing cost and space through using only one instrument to analyze HbA1c, HbA2, HbF and Hb variants. |
