摘要
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.
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2010年第9期814-818,共5页
Chinese Journal of Laboratory Medicine
基金
基金项目:上海市科委科研计划项目(08411960400)
关键词
肌钙蛋白T
参考值
诊断技术和方法
评价研究
Troponin T Reference values Diagnostic techniques and procedure Evaluation studies