中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2010年
9期
814-818
,共5页
宋凌燕%吴炯%宋斌斌%邵文琦%张春燕%王蓓丽%郭玮%潘柏申
宋凌燕%吳炯%宋斌斌%邵文琦%張春燕%王蓓麗%郭瑋%潘柏申
송릉연%오형%송빈빈%소문기%장춘연%왕배려%곽위%반백신
肌钙蛋白T%参考值%诊断技术和方法%评价研究
肌鈣蛋白T%參攷值%診斷技術和方法%評價研究
기개단백T%삼고치%진단기술화방법%평개연구
Troponin T%Reference values%Diagnostic techniques and procedure%Evaluation studies
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.
目的 評價hs-cTnT的分析性能,瞭解其生物學變異,建立本實驗室參攷範圍.方法 收集AMI患者100例及錶麵健康人474名的血清,評價hs-cTnT檢測的功能靈敏度和批內、批間不精密度(以CV錶示),併與目前使用的con-cTnT進行比較,檢測錶麵健康人血清中hs-cTnT濃度,建立實驗室參攷範圍;評估hs-cTnT短期及長期生物學變異.結果 hs-cTnT的功能靈敏度為0.005 μg/L,低濃度(0.014μg/L)批內、批間CV分彆為2.97%和3.64%;高濃度(2.500 μg/L)批內、批間CV分彆為0.66%和1.01%.hs-cTnT和con-cTnT檢測結果相關性良好(R2=0.972,P＜0.01).本實驗室hs-cTnT的錶麵健康人群第99百分位值為:女性≤60歲為0.003μg/L,男性≤60歲為0.008 μg/L,女性＞60歲為0.015μg/L,男性＞60歲為0.021μg/L.22名錶麵健康誌願者hs-cTnT的短期生物學變異分彆為:CVa=3.8%、CVi=4.8%、CVg=49.9%和CVt=58.5%;長期生物學變異分彆為:CVa=5.3%、CVi=6.4%、CVg=56.6%和CVt=68.3%.天內和天間箇體指數(index of individuality)分彆為0.18和0.23.結論 hs-cTnT檢測方法的分析性能優于con-cTnT檢測方法,達到瞭導則可接受水平.試驗結果為新一代hs-cTnT檢測方法應用于AMI的臨床診斷提供依據.
목적 평개hs-cTnT적분석성능,료해기생물학변이,건립본실험실삼고범위.방법 수집AMI환자100례급표면건강인474명적혈청,평개hs-cTnT검측적공능령민도화비내、비간불정밀도(이CV표시),병여목전사용적con-cTnT진행비교,검측표면건강인혈청중hs-cTnT농도,건립실험실삼고범위;평고hs-cTnT단기급장기생물학변이.결과 hs-cTnT적공능령민도위0.005 μg/L,저농도(0.014μg/L)비내、비간CV분별위2.97%화3.64%;고농도(2.500 μg/L)비내、비간CV분별위0.66%화1.01%.hs-cTnT화con-cTnT검측결과상관성량호(R2=0.972,P＜0.01).본실험실hs-cTnT적표면건강인군제99백분위치위:녀성≤60세위0.003μg/L,남성≤60세위0.008 μg/L,녀성＞60세위0.015μg/L,남성＞60세위0.021μg/L.22명표면건강지원자hs-cTnT적단기생물학변이분별위:CVa=3.8%、CVi=4.8%、CVg=49.9%화CVt=58.5%;장기생물학변이분별위:CVa=5.3%、CVi=6.4%、CVg=56.6%화CVt=68.3%.천내화천간개체지수(index of individuality)분별위0.18화0.23.결론 hs-cTnT검측방법적분석성능우우con-cTnT검측방법,체도료도칙가접수수평.시험결과위신일대hs-cTnT검측방법응용우AMI적림상진단제공의거.
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.
