中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2013年
4期
343-347
,共5页
赵芳%张芳%邱玲%程歆琦%国秀芝%陈雨%齐志宏%郝英英%迟书玲
趙芳%張芳%邱玲%程歆琦%國秀芝%陳雨%齊誌宏%郝英英%遲書玲
조방%장방%구령%정흠기%국수지%진우%제지굉%학영영%지서령
血清白蛋白%临床酶试验%参考值%敏感性与特异性
血清白蛋白%臨床酶試驗%參攷值%敏感性與特異性
혈청백단백%림상매시험%삼고치%민감성여특이성
Serum albumin%Clinical enzyme tests%Reference value%Sensitivity and specificity
目的 验证酶法检测血清糖化白蛋白(GA)性能,评价临床应用价值.方法 本研究属于验证性研究.参考美国临床和实验室标准协会(CLSI) EP17-P、EP6-A、EP15-A、EP7-P方案对该项目的定量检测下限(LoQ)、线性范围、精密度、干扰因素进行验证,采用制造商提供的主校准品及3份通过高压液相色谱法(HPLC)赋值的冻干血清验证GA％正确度.使用该方法在BECKMANAU5400、ROCHE MODULAR P、HITACHI7180及BECKMAN DXC600共4种不同品牌自动生化分析仪上,检测从2012年3月份门诊患者剩余血清标本中分类随机抽样选取50份新鲜血清标本,并比对结果一致性.参考CLSI C28-A3方案,从2012年2至3月查体人群中整群随机抽样选取452名表观健康人血清,对参考区间进行验证,分析选取2012年10至12月在北京协和医院内分泌科门诊就诊的61例2型糖尿病(T2DM)患者经口服降糖药治疗30 ～ 45 d,比较患者血清中GA％与糖化血红蛋白(HbA1c)的相关性.结果 自动生化分析仪的LoQ为0.28 g/L；线性范围为0.28 ～ 36.1g/L(R2 =0.999 7)；重复性CV为0.6％ ～1.5％,实验室内再现性CV为1.3％ ～2.1％,均小于试剂盒声明不精密度；3种干扰物在试验浓度内(胆红素≤659 μmol/L、血红蛋白≤0.966 g/L及乳糜≤1530FTU)的偏差分别为-3.80％,-4.03％及-1.34％；正确度验证显示测定值与HPLC赋值偏倚为-1.2％～1.53％;4个生化检测系统GA％结果与均值的回归方程分别为Y=1.0216X-0.0449(R2=0.9991)、Y=0.9963X+0.0423(R2 =0.9990)、Y=0.9776X+0.075(R2=0.9995)、Y=1.0245X-0.0367(R2=0.9906),偏差分别为0.5％ ～3.3％、-2.4％～1.9％、-2.9％～-0.7％、-1.9％ ～5.0％；452名表观健康人血清GA％的95％置信区间为11.3％ ～15.6％；GA％与HbA1c呈显著相关(r =0.812,P＜0.01),回归方程为GA=2.345 HbA1c+1.549.结论 应用于自动化分析仪的酶法测定GA试剂盒,具有良好的灵敏度、线性范围、精密度和抗干扰能力,各检测系统间结果互通性良好；可满足临床测试要求.已报道参考范围适用于本实验室.(中华检验医学杂志,2013,36:343-347)
目的 驗證酶法檢測血清糖化白蛋白(GA)性能,評價臨床應用價值.方法 本研究屬于驗證性研究.參攷美國臨床和實驗室標準協會(CLSI) EP17-P、EP6-A、EP15-A、EP7-P方案對該項目的定量檢測下限(LoQ)、線性範圍、精密度、榦擾因素進行驗證,採用製造商提供的主校準品及3份通過高壓液相色譜法(HPLC)賦值的凍榦血清驗證GA％正確度.使用該方法在BECKMANAU5400、ROCHE MODULAR P、HITACHI7180及BECKMAN DXC600共4種不同品牌自動生化分析儀上,檢測從2012年3月份門診患者剩餘血清標本中分類隨機抽樣選取50份新鮮血清標本,併比對結果一緻性.參攷CLSI C28-A3方案,從2012年2至3月查體人群中整群隨機抽樣選取452名錶觀健康人血清,對參攷區間進行驗證,分析選取2012年10至12月在北京協和醫院內分泌科門診就診的61例2型糖尿病(T2DM)患者經口服降糖藥治療30 ～ 45 d,比較患者血清中GA％與糖化血紅蛋白(HbA1c)的相關性.結果 自動生化分析儀的LoQ為0.28 g/L；線性範圍為0.28 ～ 36.1g/L(R2 =0.999 7)；重複性CV為0.6％ ～1.5％,實驗室內再現性CV為1.3％ ～2.1％,均小于試劑盒聲明不精密度；3種榦擾物在試驗濃度內(膽紅素≤659 μmol/L、血紅蛋白≤0.966 g/L及乳糜≤1530FTU)的偏差分彆為-3.80％,-4.03％及-1.34％；正確度驗證顯示測定值與HPLC賦值偏倚為-1.2％～1.53％;4箇生化檢測繫統GA％結果與均值的迴歸方程分彆為Y=1.0216X-0.0449(R2=0.9991)、Y=0.9963X+0.0423(R2 =0.9990)、Y=0.9776X+0.075(R2=0.9995)、Y=1.0245X-0.0367(R2=0.9906),偏差分彆為0.5％ ～3.3％、-2.4％～1.9％、-2.9％～-0.7％、-1.9％ ～5.0％；452名錶觀健康人血清GA％的95％置信區間為11.3％ ～15.6％；GA％與HbA1c呈顯著相關(r =0.812,P＜0.01),迴歸方程為GA=2.345 HbA1c+1.549.結論 應用于自動化分析儀的酶法測定GA試劑盒,具有良好的靈敏度、線性範圍、精密度和抗榦擾能力,各檢測繫統間結果互通性良好；可滿足臨床測試要求.已報道參攷範圍適用于本實驗室.(中華檢驗醫學雜誌,2013,36:343-347)
목적 험증매법검측혈청당화백단백(GA)성능,평개림상응용개치.방법 본연구속우험증성연구.삼고미국림상화실험실표준협회(CLSI) EP17-P、EP6-A、EP15-A、EP7-P방안대해항목적정량검측하한(LoQ)、선성범위、정밀도、간우인소진행험증,채용제조상제공적주교준품급3빈통과고압액상색보법(HPLC)부치적동간혈청험증GA％정학도.사용해방법재BECKMANAU5400、ROCHE MODULAR P、HITACHI7180급BECKMAN DXC600공4충불동품패자동생화분석의상,검측종2012년3월빈문진환자잉여혈청표본중분류수궤추양선취50빈신선혈청표본,병비대결과일치성.삼고CLSI C28-A3방안,종2012년2지3월사체인군중정군수궤추양선취452명표관건강인혈청,대삼고구간진행험증,분석선취2012년10지12월재북경협화의원내분비과문진취진적61례2형당뇨병(T2DM)환자경구복강당약치료30 ～ 45 d,비교환자혈청중GA％여당화혈홍단백(HbA1c)적상관성.결과 자동생화분석의적LoQ위0.28 g/L；선성범위위0.28 ～ 36.1g/L(R2 =0.999 7)；중복성CV위0.6％ ～1.5％,실험실내재현성CV위1.3％ ～2.1％,균소우시제합성명불정밀도；3충간우물재시험농도내(담홍소≤659 μmol/L、혈홍단백≤0.966 g/L급유미≤1530FTU)적편차분별위-3.80％,-4.03％급-1.34％；정학도험증현시측정치여HPLC부치편의위-1.2％～1.53％;4개생화검측계통GA％결과여균치적회귀방정분별위Y=1.0216X-0.0449(R2=0.9991)、Y=0.9963X+0.0423(R2 =0.9990)、Y=0.9776X+0.075(R2=0.9995)、Y=1.0245X-0.0367(R2=0.9906),편차분별위0.5％ ～3.3％、-2.4％～1.9％、-2.9％～-0.7％、-1.9％ ～5.0％；452명표관건강인혈청GA％적95％치신구간위11.3％ ～15.6％；GA％여HbA1c정현저상관(r =0.812,P＜0.01),회귀방정위GA=2.345 HbA1c+1.549.결론 응용우자동화분석의적매법측정GA시제합,구유량호적령민도、선성범위、정밀도화항간우능력,각검측계통간결과호통성량호；가만족림상측시요구.이보도삼고범위괄용우본실험실.(중화검험의학잡지,2013,36:343-347)
Objective To verify the various performances of the enzymatic method that is used to detect the glycated albumin(GA) on automatic biochemistry analyzer and to apply it in clinic preliminary.Methods This verification study validated the limit of quantitation,linearity,imprecision,interferences (bilirubin,hemoglobin,chyle) of GA assay according to the CLSI EP17-P,EP6-A,EP15-A,EP7-P protocol.To assess the accuracy of GA assay,we used manufacturer's secondary standard material and three level freeze-dry serum that values have been assigned using HPLC method.To determine the consistency of assay,50 fresh serum samples of outpatient in Mar 2012 were tested using this kit on four automatic biochemistry analyzer (BECKMAN AU5400,ROCHE MODULAR P,HITACHI7180,BECKMAN DXC600).According to the CLSI C28-A3 protocol,the reference ranges for GA％ were validated in 452 apparently healthy individuals undertaking medical examination from Feb to Mar 2012.61 subjects with T2DM treated in the endocrinology department of PUMC Hospital from Oct.to Dec.2012 were enrolled in the study.GA％ and HbA(1c) were determined respectively after they finished their 30-45 day oral hypoglycemic agent therapy.The correlation between GA％ and HbA1c were analyzed.Results The limit of quantitation was 0.028 g/dl; the linearity was 0.028-3.61g/dl (R2 =0.9997) ; repeatability CV was 0.6％-1.5％ and reproducibility CV was 1.3％-2.1％.The imprecision were lower than that declared by assay producer.When bilirubin≤659 μmol/L,hemoglobin ≤0.966 μg/L and chyle turbidity ≤ 1530 FTU,the deviation was-3.80％,-4.03％,-1.34％ respectively.For the accuracy based tests,the bias％ of enzymatic method were-1.2％-1.53％,when compared to HPLC.The regression equations of GA％ were as follows:Y =1.0216X-0.0449 (R2 =0.9991),Y =0.9963X + 0.0423 (R2 =0.9990),Y =0.9776X +0.075 (R2 =0.9995),Y =1.0245X-0.0367 (R2 =0.9906),respectively.The bias were 0.5％-3.3％,-2.4％-1.9％,-2.9％-0.7％,-1.9％-5.0％ accordingly.The 95％ confidence interval of the 452apparently healthy subjects was 11.3％-15.6％.GA was significantly correlated with HbA1c (r =0.812,P ＜ 0.01).Linear regression analysis,produced a relationship of GA =2.345 HbA1c + 1.549.Conclusions The enzymatic method that is used to detect the glycated albumin on automatic biochemistry analyzer has good performances of sensitivity,linearity,specificity,anti-interferences,and consistency among various analyzers.Which meet the clinical needs.Reference intervals were verified for use in our lab.(Chin J Lab Med,2013,36:343-347)
