中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2014年
12期
921-927
,共7页
温冬梅%张秀明%张德才%庞嘉琳%吴剑杨%李曼%徐全中%索明环%萧金丽
溫鼕梅%張秀明%張德纔%龐嘉琳%吳劍楊%李曼%徐全中%索明環%蕭金麗
온동매%장수명%장덕재%방가림%오검양%리만%서전중%색명배%소금려
血红蛋白E%血红蛋白类,异常%血红蛋白A,糖基化
血紅蛋白E%血紅蛋白類,異常%血紅蛋白A,糖基化
혈홍단백E%혈홍단백류,이상%혈홍단백A,당기화
Hemoglobin E%Hemoglobins,abnormal%Hemogbobin A,glycosylated
目的 评价血红蛋白变异体E(HbE)对5种糖化血红蛋白(HbA1c)检测系统测定结果的干扰.其中离子交换高效液相色谱(IE-HPLC)法2种、硼酸盐亲和层析高效液相色谱法(AC-HPLC)、免疫抑制比浊法(TINIA)和酶法(EM)各1种.方法 观察性研究.收集2012年5月至2013年10月来自中山大学附属中山医院的60份全血样本,分为健康对照组(20份)、糖尿病组(20份)和HbE变异体组(20份),分别用5种检测系统检测全血HbA1c浓度,依据美国国家糖化血红蛋白标准化计划(NGSP)的判定标准,对不同组别5种检测系统的检测结果进行比对分析和偏倚评估,对HbE变异体组各检测系统HbA1c检测结果计算得出的估计平均血糖值(eAG)与空腹血糖(FPG)水平差异进行统计学分析,对检测结果进行Deming回归分析,确定HbE对HbA1c检测结果是否具有显著临床影响,将6％与9％ HbA1c±10％相对偏差作为评价范围.采用配对t检验进行统计学分析.结果 正常对照组和糖尿病组4种检测系统与通过NGSP Ⅰ级实验室认证的比较系统差值的95％置信区间(95％CI)差异均在比较系统的±0.7％ HbA1c以内、偏差％均小于6％,测定结果差异无统计学意义(P＞0.05).HbE变异体组AC-HPLC法、Variant Ⅱ IE-HPLC法和TINIA法3种检测系统HbA1c结果计算得出的eAG和FPG水平差异无统计学意义(P＞0.05),而Variant Ⅱ Turbo IE-HPLC和酶法2个检测系统结果计算得出的eAG水平与FPG水平差异均具有统计学意义(P＜0.01).Biorad Variant Ⅱ IE-HPLC法、TINIA法与比较系统AC-HPLC法测定结果差值的95％ CI差异落在比较系统的±0.7％ HbA1c以内、偏差％分别为-2.0％ ～5.6％和-5.8％ ～4.0％,测定结果差异无统计学意义(P＞0.05),且6％与9％ HbA1c浓度时,检测方法及比较系统样本的平均差异均小于临床可接受范围,结果显示这2种方法不受HbE的干扰.而Biorad Variant Ⅱ Turbo IE-HPLC法和酶法2种检测系统与比较系统AC-HPLC法测定结果的95％ CI差异均落在比较系统的±0.7％ HbA1c以外、偏差％分别为13.9％ ～40.1％和-34.1％ ～-1.3％,均大于6％,测定结果差异均具有显著统计学意义(P＜0.01).Biorad Variant Ⅱ Turbor IE-HPLC法与比较系统相比呈正偏差,酶法与比较系统相比呈负偏差.且6％与9％ HbA1c浓度时,检测方法及比较系统样本的平均差异均大于临床可接受范围,HbE对这2种方法具有显著临床干扰.结论 Hb E对不同HbA1c检测系统的干扰程度不同,临床实验室在进行HbA1c检测时,应注意识别Hb变异成分,选用合适的方法进行HbA1c测定或替代指标以防止干扰的发生.
目的 評價血紅蛋白變異體E(HbE)對5種糖化血紅蛋白(HbA1c)檢測繫統測定結果的榦擾.其中離子交換高效液相色譜(IE-HPLC)法2種、硼痠鹽親和層析高效液相色譜法(AC-HPLC)、免疫抑製比濁法(TINIA)和酶法(EM)各1種.方法 觀察性研究.收集2012年5月至2013年10月來自中山大學附屬中山醫院的60份全血樣本,分為健康對照組(20份)、糖尿病組(20份)和HbE變異體組(20份),分彆用5種檢測繫統檢測全血HbA1c濃度,依據美國國傢糖化血紅蛋白標準化計劃(NGSP)的判定標準,對不同組彆5種檢測繫統的檢測結果進行比對分析和偏倚評估,對HbE變異體組各檢測繫統HbA1c檢測結果計算得齣的估計平均血糖值(eAG)與空腹血糖(FPG)水平差異進行統計學分析,對檢測結果進行Deming迴歸分析,確定HbE對HbA1c檢測結果是否具有顯著臨床影響,將6％與9％ HbA1c±10％相對偏差作為評價範圍.採用配對t檢驗進行統計學分析.結果 正常對照組和糖尿病組4種檢測繫統與通過NGSP Ⅰ級實驗室認證的比較繫統差值的95％置信區間(95％CI)差異均在比較繫統的±0.7％ HbA1c以內、偏差％均小于6％,測定結果差異無統計學意義(P＞0.05).HbE變異體組AC-HPLC法、Variant Ⅱ IE-HPLC法和TINIA法3種檢測繫統HbA1c結果計算得齣的eAG和FPG水平差異無統計學意義(P＞0.05),而Variant Ⅱ Turbo IE-HPLC和酶法2箇檢測繫統結果計算得齣的eAG水平與FPG水平差異均具有統計學意義(P＜0.01).Biorad Variant Ⅱ IE-HPLC法、TINIA法與比較繫統AC-HPLC法測定結果差值的95％ CI差異落在比較繫統的±0.7％ HbA1c以內、偏差％分彆為-2.0％ ～5.6％和-5.8％ ～4.0％,測定結果差異無統計學意義(P＞0.05),且6％與9％ HbA1c濃度時,檢測方法及比較繫統樣本的平均差異均小于臨床可接受範圍,結果顯示這2種方法不受HbE的榦擾.而Biorad Variant Ⅱ Turbo IE-HPLC法和酶法2種檢測繫統與比較繫統AC-HPLC法測定結果的95％ CI差異均落在比較繫統的±0.7％ HbA1c以外、偏差％分彆為13.9％ ～40.1％和-34.1％ ～-1.3％,均大于6％,測定結果差異均具有顯著統計學意義(P＜0.01).Biorad Variant Ⅱ Turbor IE-HPLC法與比較繫統相比呈正偏差,酶法與比較繫統相比呈負偏差.且6％與9％ HbA1c濃度時,檢測方法及比較繫統樣本的平均差異均大于臨床可接受範圍,HbE對這2種方法具有顯著臨床榦擾.結論 Hb E對不同HbA1c檢測繫統的榦擾程度不同,臨床實驗室在進行HbA1c檢測時,應註意識彆Hb變異成分,選用閤適的方法進行HbA1c測定或替代指標以防止榦擾的髮生.
목적 평개혈홍단백변이체E(HbE)대5충당화혈홍단백(HbA1c)검측계통측정결과적간우.기중리자교환고효액상색보(IE-HPLC)법2충、붕산염친화층석고효액상색보법(AC-HPLC)、면역억제비탁법(TINIA)화매법(EM)각1충.방법 관찰성연구.수집2012년5월지2013년10월래자중산대학부속중산의원적60빈전혈양본,분위건강대조조(20빈)、당뇨병조(20빈)화HbE변이체조(20빈),분별용5충검측계통검측전혈HbA1c농도,의거미국국가당화혈홍단백표준화계화(NGSP)적판정표준,대불동조별5충검측계통적검측결과진행비대분석화편의평고,대HbE변이체조각검측계통HbA1c검측결과계산득출적고계평균혈당치(eAG)여공복혈당(FPG)수평차이진행통계학분석,대검측결과진행Deming회귀분석,학정HbE대HbA1c검측결과시부구유현저림상영향,장6％여9％ HbA1c±10％상대편차작위평개범위.채용배대t검험진행통계학분석.결과 정상대조조화당뇨병조4충검측계통여통과NGSP Ⅰ급실험실인증적비교계통차치적95％치신구간(95％CI)차이균재비교계통적±0.7％ HbA1c이내、편차％균소우6％,측정결과차이무통계학의의(P＞0.05).HbE변이체조AC-HPLC법、Variant Ⅱ IE-HPLC법화TINIA법3충검측계통HbA1c결과계산득출적eAG화FPG수평차이무통계학의의(P＞0.05),이Variant Ⅱ Turbo IE-HPLC화매법2개검측계통결과계산득출적eAG수평여FPG수평차이균구유통계학의의(P＜0.01).Biorad Variant Ⅱ IE-HPLC법、TINIA법여비교계통AC-HPLC법측정결과차치적95％ CI차이락재비교계통적±0.7％ HbA1c이내、편차％분별위-2.0％ ～5.6％화-5.8％ ～4.0％,측정결과차이무통계학의의(P＞0.05),차6％여9％ HbA1c농도시,검측방법급비교계통양본적평균차이균소우림상가접수범위,결과현시저2충방법불수HbE적간우.이Biorad Variant Ⅱ Turbo IE-HPLC법화매법2충검측계통여비교계통AC-HPLC법측정결과적95％ CI차이균락재비교계통적±0.7％ HbA1c이외、편차％분별위13.9％ ～40.1％화-34.1％ ～-1.3％,균대우6％,측정결과차이균구유현저통계학의의(P＜0.01).Biorad Variant Ⅱ Turbor IE-HPLC법여비교계통상비정정편차,매법여비교계통상비정부편차.차6％여9％ HbA1c농도시,검측방법급비교계통양본적평균차이균대우림상가접수범위,HbE대저2충방법구유현저림상간우.결론 Hb E대불동HbA1c검측계통적간우정도불동,림상실험실재진행HbA1c검측시,응주의식별Hb변이성분,선용합괄적방법진행HbA1c측정혹체대지표이방지간우적발생.
Objective To evaluate the interference of hemoglobin variant E (HbE) on five kinds of glycosylated hemoglobin (HbA1c) system.Two of them were ion-exchange high performance liquid chromatography (IE-HPLC) methods,one was affinity chromatography high performance liquid chromatography (AC-HPLC) method,one was turbidimetric inhibition immunoassay method (TINIA),one was enzyme (EM) method.Methods All 60 blood samples from May 2012 to October 2013 were collected from Zhongshan Hospital of Yat-sen University,and then divided into normal control group (20 cases),diabetic group (20 cases) and HbE group (20 cases).Variants were used to detect the whole blood concentration of HbA1c by five detection systems.Based on the judgment standards of National Glycohemoglobin Standardization Program (NGSP),comparison analysis and bias evaluation results for different groups of 5 kinds of detection systems were estimated.The statistical difference of mean blood glucose (eAG) and fasting blood glucose (FPG) was calculated using the estimation of HbE variant group detection system HbA1c results.The test results were analyzed by Deming regression analysis,to determine whether HbE has significant clinical effect on the results of HbA1c,using 6％ HbA1c and 9％ ± 10％ relative error as the evaluation scope.Results The 95％ confidence interval (95％ CI) of the 4 kinds of detection system in normal control group and diabetic group were within ± 0.7％ HbA1c deviation,which was less than 6％,comparing to NGSP Ⅰ laboratory certification,indicating no significant difference of determination results(P ＞ 0.05).There were no significant difference between eAG and FPG levels in HbE group using AC-HPLC,Variant HbE variant Ⅱ IE-HPLC method and TINIA method(P ＞0.05).While the difference between eAG level and FPG level of Variant Ⅱ Turbo IE-HPLC and enzymatic method was statistically significant (P ＜ 0.01).Bio-rad Variant Ⅱ IE-HPLC method,TINIA method and AC-HPLC method for the determination of the difference of control system 95％ CI difference fall in the control system of ±0.7％ HbA1c,and deviations were-2.0％-7.0％ and-7.1％-4.0％,indicating no significant difference of determination results (P ＞ 0.05).Also when in the 6％ and 9％ HbA1c concentrations,detection method and average differences between control samples were less than the clinically acceptable range,indicating that the interference of these 2 methods was not affected by HbE.The difference of 95％ CIof Bio-Rad Variant Ⅱ Turbo IE-HPLC method and enzyme method were located outside the ± 0.7％ HbA1c,comparing to AC-HPLC method.The determinations of the deviation were 13.9％-40.1％ and -34.1％--1.3％ respectively,which were greater than 6％.The difference was of statistically significance(P ＜ 0.01).Comparing to the control system,Bio-rad Variant Ⅱ Turbor IE-HPLC held the positive deviation,while the enzyme method held the negative deviation.Also when in the 6％ and 9％ HbA1c concentrations,the mean differences of samples under detection method and control method were both greater than the clinically acceptable range,indicating that HbE has significant clinical interference in these 2 kinds of methods.Conclusion HbE had different interference effects in clinical laboratory for HbA1c test,so one should pay attention to this kind of Hb variance in daily practice.Appropriate method should be selected to prevent the occurrence of interference to the determination or to find a surrogate marker of HbA1c.
