高血脂高胆红素对IE-H PLC法检测糖化血红蛋白干扰的评价

摘要

目的：探讨高血脂和高胆红素对离子交换高效液相色谱法（IE‐HPLC）检测糖化血红蛋白的干扰。方法将收集的新鲜EDTA‐K2抗凝全血标本分成4组：对照组（HbA1c＜6．2％）、糖尿病组（HbA1c≥6．2％）、高血脂组（TG 3～20 mmol／L）、高胆红素组（TBIL 21～549μmol／L）。分别用硼酸盐亲和层析高效液相色谱法（AC‐HPLC）和IE‐HPLC检测 HbA1c。结果当HbA1c≤18．7％时IE‐HPLC检测 HbA1c相关系数 r＝0．993；95％置信区间（95％ CI）为－0．71～0．89；偏差（％）为－5．8％～6．8％；差异无统计学意义（P＝0．198）。当 HbA1c＜16．3％时IE‐HPLC检测 HbA1c相关系数 r＝0．997；95％ CI为－0．31～0．67；偏差（％）为－5．8％～4．3％；差异有统计学意义（P＝0．000），结果无显著干扰；当％ HbA1c为16．3～18．7时结果出现正偏倚。当TG≤20．78 mmol／L时IE‐HPLC检测 HbA1c结果相关系数 r＝0．995；95％ CI为－0．26～0．50；偏差（％）为－5．5％～5．8％；差异有统计学意义（P＝0．000）结果无显著干扰；当 TBIL≤549．3μmol／L对IE‐HPLC检测 HbA1c相关系数 r＝0．990；95％ CI为－0．08～0．63；偏差（％）为－14％～4．1％；差异有统计学意义（P＝0．000）；当TBIL≤342．1μmol／L对IE‐HPLC检测HbA1c相关系数 r＝0．994；95％ CI为－0．09～0．50；偏差（％）为―5．5％～4．1％，结果无显著干扰；当 TBIL为380．7～549．3μmol／L时结果出现负偏倚。结论实验数据表明 IE‐HPLC检测 HbA1c有良好的抗脂血能力；当 TBIL ≤342．1μmol／L和HbA1c＜16．3％对检测HbA1c无明显干扰能满足一般临床检测需求；当 HbA1c标本的 TG≥20．78 mmol／L、TBIL ≥342．1μmol／L、HbA1c≥16．3％临床工作者应结合患者本身情况选择更合适检测HbA1c的方法。%Objective To investigate the interference of hyperlipidemia and hyperbilirubinaemia to HbA1c measurements by ion‐exchange high‐performance liquid chromatography(IE‐HPLC) method .Methods Fresh whole‐blood samples collected with EDTA‐K2 anticoagulant tubes were divided into four groups :control group(HbA1c<6 .2% ) ,diabetes group(HbA1c≥6 .2% ) ,hyperlipi‐demia group(TG 3 -20 mmol/L);hyperbilirubinaemis group (TBIL 21 -549 μmol/L) .HbA1c of these samples were measured with affinity chromatography(AC‐HPLC) and IE‐HPLC respectively .Results When HbA1c≤18 .7% ,r=0 .993 ;95% confidence interval(CI) of HbA1c results by using IE‐HPLC method was -0 .71 -0 .89 ;coefficient of variation was -5 .8% -6 .8% ;P=0 .198 and the difference was not statistically significant .When HbA1c< 16 .3% ,r= 0 .997;95% CI of HbA1c results with IE‐HPLC method is -0 .31-0 .67;coefficient of variation was -5 .8% -4 .3% .P=0 .000 and the difference was statistically signifi‐cant .No interference was detectded with the results ;When HbA1c was 16 .3% -18 .7% ,positive bias was observed with the re‐sults .When TG≤20 .78 mmol/L ,r=0 .995;95% CI of HbA1c results with IE‐HPLC method was -0 .26-0 .50 ;coefficient of var‐iation was -5 .5% -5 .8% .P=0 .000 and the difference was statistically significant .No interference was detectded with the re‐sults;When TBIL≤549 .3 μmol/L ,r=0 .990 ;95% CI of HbA1c results with IE‐HPLC method was -0 .08 -0 .63;coefficient of variation was -14% -4 .1% .P=0 .000 and the difference was statistically significant .When TBIL≤342 .1 μmol/L ,r= 0 .994 ;95% CI of HbA1c results with IE‐HPLC method was -0 .09-0 .50;coefficient of variation was -5 .5% -4 .1% .No interference was detectded with the results .When TBIL was 380 .7-549 .3 μmol/L ,negative bias was observed with the results .Conclusion Our data indicated that HbA1c measurement with IE‐HPLC method could resist the interference of hyperlipidemia;When TBIL≤380 .7 μmol/L and HbA1c<16 .3% ,the results could meet the needs of general clinical detection .Clinical staff should choose more specific HbA1c measurement method according to the patient's condition .