高敏感方法检测心肌肌钙蛋白T的分析性能评价

The analytical performance assessment of high-sensitivity cardiac troponin T reference intervals investigation

目的 评价hs-cTnT的分析性能,了解其生物学变异,建立本实验室参考范围.方法 收集AMI患者100例及表面健康人474名的血清,评价hs-cTnT检测的功能灵敏度和批内、批间不精密度（以CV表示）,并与目前使用的con-cTnT进行比较,检测表面健康人血清中hs-cTnT浓度,建立实验室参考范围 评估hs-cTnT短期及长期生物学变异.结果 hs-cTnT的功能灵敏度为0.005 μg/L,低浓度（0.014μg/L）批内、批间CV分别为2.97%和3.64% 高浓度（2.500 μg/L）批内、批间CV分别为0.66%和1.01%.hs-cTnT和con-cTnT检测结果相关性良好（R2=0.972,P＜0.01）.本实验室hs-cTnT的表面健康人群第99百分位值为：女性≤60岁为0.003μg/L,男性≤60岁为0.008 μg/L,女性＞60岁为0.015μg/L,男性＞60岁为0.021μg/L.22名表面健康志愿者hs-cTnT的短期生物学变异分别为：CVa=3.8%、CVi=4.8%、CVg=49.9%和CVt=58.5% 长期生物学变异分别为：CVa=5.3%、CVi=6.4%、CVg=56.6%和CVt=68.3%.天内和天间个体指数（index of individuality）分别为0.18和0.23.结论 hs-cTnT检测方法的分析性能优于con-cTnT检测方法,达到了导则可接受水平.试验结果为新一代hs-cTnT检测方法应用于AMI的临床诊断提供依据.

Objective To assess the analytical performance of hs-cTnT and biological variations in healthy population as well as establish hs-cTnT reference intervals. Methods The serum samples from 100 acute myocardial infraction patients and 474 apparently healthy subjects were collected. The functional sensitivity,within- and between-run imprecision were determined. The hs-cTnT assay and con-cTnT assay were evaluated. The serum hs-cTnT levels were detected in apparently healthy subjects to establish reference intervals. Moreover,the long-term and short-term biological variations for hs-cTnT in healthy volunteers were assessed. Results The functional sensitivity of hs-cTnT was 0. 005 μg/L. The within- and between-run precision for lower level control（0. 014 μg/L） and higher level control（2. 500 μg/L） was 2. 97% vs 3. 64%and 0. 66% vs 1.01% ,respectively. The correlation between hs-cTnT assay and con-cTnT assay was good （ R2 =0. 972 ,P 〈0. 01 ）. The 99th percentile in apparently healthy subjects was 0. 003 μg/L for women less than60 years, 0.008 μg/L for men less than 60 years, 0.015 μg/L for women above 60 years and 0. 021 μg/L for men above 60 years. The CVa, CVi, CVg and CVt of short-term biological variations in detecting hs-cTnT from 22 apparently healthy subjects were 3.8%, 4. 8%, 49.9% and 58.5%,respectively. The CVa,CVi ,CVg and CVt of long-term biological variations were 5. 3% ,6. 4% ,56. 6% and 68. 3% respectively. Conclusions The analytical performance of the hs-cTnT is better than con-cTnT assay,achieving acceptable level according to guideline. Our experimental result could provide the basis for the new high sensitivity cTnT assay in the diagnosis of acute myocardial infarction.