检验医学
檢驗醫學
검험의학
LABORATORY MEDICINE
2014年
5期
505-512
,共8页
温冬梅%张秀明%王伟佳%陈亚琼%索明环%徐全中%吴剑杨%李曼%萧金丽%阚丽娟%周甲思
溫鼕梅%張秀明%王偉佳%陳亞瓊%索明環%徐全中%吳劍楊%李曼%蕭金麗%闞麗娟%週甲思
온동매%장수명%왕위가%진아경%색명배%서전중%오검양%리만%소금려%감려연%주갑사
糖化血红蛋白A1c%免疫抑制比浊法%高效液相色谱法%相关性分析%血红蛋白E病
糖化血紅蛋白A1c%免疫抑製比濁法%高效液相色譜法%相關性分析%血紅蛋白E病
당화혈홍단백A1c%면역억제비탁법%고효액상색보법%상관성분석%혈홍단백E병
Glycosylated hemoglobin A1c%Turbidimetric inhibition immunoassay%High performance liquid chromatography%Correlation analysis%Hemoglobin E disease
目的：评价免疫抑制比浊法（TINIA）检测糖化血红蛋白（HbA1c ）的分析性能，与离子交换高效液相色谱法（IE-HPLC）检测HbA1c进行比对和偏倚评估，并评估血红蛋白（Hb）变异体E（HbE）对TINIA和IE-HPLC的影响。方法参考美国临床与实验室标准化协会（CLSI）发布的方法学评价系列文件（EP文件）及有关文献，对TINIA检测HbA1c的精密度、正确度、分析测量范围、分析干扰以及生物参考区间进行评价和验证，对TINIA与IE-HPLC检测Hb结构正常的血液样本和含HbE的血液样本进行对比分析和偏倚评估，分析患者平均血糖的相关性。结果 TINIA检测HbA1c的批内精密度＜2．08％，总不精密度＜2．94％；在HbA1c浓度为4．4％～18．3％范围内，理论值与实测均值呈线性相关（r＝0．9994）；Hb、游离胆红素（FBiL）、结合胆红素（CBiL）、乳糜（CH）浓度分别为9．9～49．6μmol/L、65．6～328．0μmol/L、65．6～328．0μmol/L和3000～12000 FTU时，差异百分比均＜5％；厂商提供的参考区间（4．8％～5．9％）适用于临床实验室。对于Hb结构正常的血液样本，TINIA和IE-HPLC的HbA1c检测结果差异无统计学意义（P＞0．05），两种方法的相关性良好（r2＝0．9992）。对于HbE浓度在5．4％～54．7％范围内的血液样本，TINIA的平均偏倚为-4．1％～1．9％，均＜5％，几乎不受HbE 的干扰， HbA1c检测结果与平均血糖的相关性较好（r＝0．9988）；当HbE＞6．4％时IE-HPLC检测HbA1c的实测值与理论值平均偏倚为5．7％～278．7％，差异百分比均＞5％，测定结果与预期理论结果有明显差异；两种方法检测结果差异有统计学意义（P＜0．01）。结论 TINIA检测HbA1c的分析性能符合临床测定的性能要求，不受HbE的干扰。当HbE＞6．4％时，IE-HPLC法检测HbA1c会受干扰，出现假性增高的情况。
目的：評價免疫抑製比濁法（TINIA）檢測糖化血紅蛋白（HbA1c ）的分析性能，與離子交換高效液相色譜法（IE-HPLC）檢測HbA1c進行比對和偏倚評估，併評估血紅蛋白（Hb）變異體E（HbE）對TINIA和IE-HPLC的影響。方法參攷美國臨床與實驗室標準化協會（CLSI）髮佈的方法學評價繫列文件（EP文件）及有關文獻，對TINIA檢測HbA1c的精密度、正確度、分析測量範圍、分析榦擾以及生物參攷區間進行評價和驗證，對TINIA與IE-HPLC檢測Hb結構正常的血液樣本和含HbE的血液樣本進行對比分析和偏倚評估，分析患者平均血糖的相關性。結果 TINIA檢測HbA1c的批內精密度＜2．08％，總不精密度＜2．94％；在HbA1c濃度為4．4％～18．3％範圍內，理論值與實測均值呈線性相關（r＝0．9994）；Hb、遊離膽紅素（FBiL）、結閤膽紅素（CBiL）、乳糜（CH）濃度分彆為9．9～49．6μmol/L、65．6～328．0μmol/L、65．6～328．0μmol/L和3000～12000 FTU時，差異百分比均＜5％；廠商提供的參攷區間（4．8％～5．9％）適用于臨床實驗室。對于Hb結構正常的血液樣本，TINIA和IE-HPLC的HbA1c檢測結果差異無統計學意義（P＞0．05），兩種方法的相關性良好（r2＝0．9992）。對于HbE濃度在5．4％～54．7％範圍內的血液樣本，TINIA的平均偏倚為-4．1％～1．9％，均＜5％，幾乎不受HbE 的榦擾， HbA1c檢測結果與平均血糖的相關性較好（r＝0．9988）；噹HbE＞6．4％時IE-HPLC檢測HbA1c的實測值與理論值平均偏倚為5．7％～278．7％，差異百分比均＞5％，測定結果與預期理論結果有明顯差異；兩種方法檢測結果差異有統計學意義（P＜0．01）。結論 TINIA檢測HbA1c的分析性能符閤臨床測定的性能要求，不受HbE的榦擾。噹HbE＞6．4％時，IE-HPLC法檢測HbA1c會受榦擾，齣現假性增高的情況。
목적：평개면역억제비탁법（TINIA）검측당화혈홍단백（HbA1c ）적분석성능，여리자교환고효액상색보법（IE-HPLC）검측HbA1c진행비대화편의평고，병평고혈홍단백（Hb）변이체E（HbE）대TINIA화IE-HPLC적영향。방법삼고미국림상여실험실표준화협회（CLSI）발포적방법학평개계렬문건（EP문건）급유관문헌，대TINIA검측HbA1c적정밀도、정학도、분석측량범위、분석간우이급생물삼고구간진행평개화험증，대TINIA여IE-HPLC검측Hb결구정상적혈액양본화함HbE적혈액양본진행대비분석화편의평고，분석환자평균혈당적상관성。결과 TINIA검측HbA1c적비내정밀도＜2．08％，총불정밀도＜2．94％；재HbA1c농도위4．4％～18．3％범위내，이론치여실측균치정선성상관（r＝0．9994）；Hb、유리담홍소（FBiL）、결합담홍소（CBiL）、유미（CH）농도분별위9．9～49．6μmol/L、65．6～328．0μmol/L、65．6～328．0μmol/L화3000～12000 FTU시，차이백분비균＜5％；엄상제공적삼고구간（4．8％～5．9％）괄용우림상실험실。대우Hb결구정상적혈액양본，TINIA화IE-HPLC적HbA1c검측결과차이무통계학의의（P＞0．05），량충방법적상관성량호（r2＝0．9992）。대우HbE농도재5．4％～54．7％범위내적혈액양본，TINIA적평균편의위-4．1％～1．9％，균＜5％，궤호불수HbE 적간우， HbA1c검측결과여평균혈당적상관성교호（r＝0．9988）；당HbE＞6．4％시IE-HPLC검측HbA1c적실측치여이론치평균편의위5．7％～278．7％，차이백분비균＞5％，측정결과여예기이론결과유명현차이；량충방법검측결과차이유통계학의의（P＜0．01）。결론 TINIA검측HbA1c적분석성능부합림상측정적성능요구，불수HbE적간우。당HbE＞6．4％시，IE-HPLC법검측HbA1c회수간우，출현가성증고적정황。
Objective To evaluate the analysis performance of glycosylated hemoglobin A1c (HbA1c )detection by turbidimetric inhibition immunoassay (TINIA),to compare and evaluate the bias with ion exchange high performance liquid chromatography (IE-HPLC)for detecting HbA1c ,and to evaluate the influence of hemoglobin (Hb)E (HbE)on TINIA and IE-HPLC.Methods According to the methodology evaluation document (EP document)and relevant literatures from the Clinical and Laboratory Standards Institute (CLSI ),the precision,accuracy,detection range, analysis interference and biological reference interval analysis of HbA1c detection by TINIA were evaluated and verified. The comparison analysis and bias evaluation of TINIA and IE-HPLC for blood samples with normal Hb structure and blood samples in HbE patients were performed.The correlation with average blood glucose was analyzed.Results The within-run precision by TINIA was <2.08%,the total imprecision was <2.94%,and the theoretical value with detection mean value was linearly correlated in the concentration range of 4.4%-18.3%(r=0.9994).When Hb,free bilirubin(FBiL),conjugated bilirubin (CBiL)and chyle (CH)concentrations were 9.9-49.6 μmol/L,65.6-328.0 μmol/L,65.6-328.0 μmol/L and 3 000-12 000 FTU,the difference percentage was <5%.The manufacturers provided reference interval (4.8%-5.9%)being suitable for clinical laboratories.For the blood samples with normal Hb structure,there was no statistical significance for HbA1c detection between the 2 methods (P>0.05 ),and the results of HbA1c detection by TINIA and IE-HPLC had good correlation (r2 =0.999 2).For the blood samples with HbE concentration in the range of 5.4%-54.7%,the average bias by TINIA was -4.1%-1.9%,which was <5%.The interference was almost not affected by HbE,and the correlation of HbA1c detection results with average blood glucose was good (r=0.998 8).While HbE >6.4%,the average bias of the detection value and the theoretical value for HbA1c by IE-HPLC was 5.7%-278.7%,the difference percentage was >5%,and the expected theoretical results with the detection value had significant differences,and there was statistical significance between the 2 methods (P <0.01).Conclusions The performance of HbA1c detection by TINIA meets the performance requirements of clinical determination,and has a good correlation with that by IE-HPLC without interference by HbE.When HbE>6.4%,IE-HPLC for the detection of HbA1c has interference,and there will be false increasing.
