中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2015年
7期
461-465
,共5页
李永姝%梁海青%韩雪晶%石萍%贾克刚
李永姝%樑海青%韓雪晶%石萍%賈剋剛
리영주%량해청%한설정%석평%가극강
肌钙蛋白I%心肌梗死%发光%免疫测定%敏感性与特异性
肌鈣蛋白I%心肌梗死%髮光%免疫測定%敏感性與特異性
기개단백I%심기경사%발광%면역측정%민감성여특이성
Troponin I%Myocardial infarction%Luminescence%Immunoassay%Sensitivity and specificity
目的：评价VITROS ECIQ增强型化学发光法检测高敏心肌肌钙蛋白I（ cTnI）的效果。方法方法学评价，参照美国临床实验室标准化协会（ CLSI） EP－17A、EP－6A、EP－15A文件和相关文献，采用VITROS ECIQ增强型化学发光法对cTnI的检出限、功能灵敏度、精密度、线性范围进行了验证同时建立了表观健康人群第99百分位值。收集2013年1至11月于泰达国际心血管病医院急诊因胸痛就诊的共652例患者相关资料，其中323例急性ST段抬高型心肌梗死（ STEMI ）及非ST段抬高型心肌梗死（ NSTEMI）患者为病例组，排除其他诊断329例，选取303例表观正常人群为对照组，应用ROC曲线分析cTnI在STEMI、NSTEMI诊断中的灵敏度和特异性。非正态分布的定量资料比较采用非参数检验Mann－Whitney U。结果 VITROS检测cTnI的空白限（ LoB）为0．0065 ng／ml、检出限（LoD）为0．0155 ng／ml、功能灵敏度（FS）为0．01676 ng／ml；重复性精密度CV为1．73％～2．33％，中间精密度CV为4．93％～9．96％，均满足试剂盒声明的不精密度；线性范围为0．0155～78．4 ng／ml （R2＝0．9999），表观健康人群第99百分位值为0．017 ng／ml。 ROC曲线分析发现，cTnI的曲线下面积（ AUC）为0．986，95％CI 0．973～0．994，以0．017ng／ml为诊断截点时，其在急性心肌梗死诊断中的敏感性和特异性分别为90．09％、99．34％。胸痛入院即刻STEMI、NSTEMI两组间cTnI水平差异无统计学意义（Z＝－0．485，P＞0．05），STEMI组与对照组cTnI水平差异有统计学意义（Z＝－19．567， P＜0．001），NSTEMI 组与对照组 cTnI 水平差异有统计学意义（Z＝－14．598，P ＜0．001）。结论VITROS ECIQ增强型化学发光法检测cTnI具有良好的灵敏度、精密度、线性范围，可满足临床检测要求。（中华检验医学杂志，2015，38：461－465）
目的：評價VITROS ECIQ增彊型化學髮光法檢測高敏心肌肌鈣蛋白I（ cTnI）的效果。方法方法學評價，參照美國臨床實驗室標準化協會（ CLSI） EP－17A、EP－6A、EP－15A文件和相關文獻，採用VITROS ECIQ增彊型化學髮光法對cTnI的檢齣限、功能靈敏度、精密度、線性範圍進行瞭驗證同時建立瞭錶觀健康人群第99百分位值。收集2013年1至11月于泰達國際心血管病醫院急診因胸痛就診的共652例患者相關資料，其中323例急性ST段抬高型心肌梗死（ STEMI ）及非ST段抬高型心肌梗死（ NSTEMI）患者為病例組，排除其他診斷329例，選取303例錶觀正常人群為對照組，應用ROC麯線分析cTnI在STEMI、NSTEMI診斷中的靈敏度和特異性。非正態分佈的定量資料比較採用非參數檢驗Mann－Whitney U。結果 VITROS檢測cTnI的空白限（ LoB）為0．0065 ng／ml、檢齣限（LoD）為0．0155 ng／ml、功能靈敏度（FS）為0．01676 ng／ml；重複性精密度CV為1．73％～2．33％，中間精密度CV為4．93％～9．96％，均滿足試劑盒聲明的不精密度；線性範圍為0．0155～78．4 ng／ml （R2＝0．9999），錶觀健康人群第99百分位值為0．017 ng／ml。 ROC麯線分析髮現，cTnI的麯線下麵積（ AUC）為0．986，95％CI 0．973～0．994，以0．017ng／ml為診斷截點時，其在急性心肌梗死診斷中的敏感性和特異性分彆為90．09％、99．34％。胸痛入院即刻STEMI、NSTEMI兩組間cTnI水平差異無統計學意義（Z＝－0．485，P＞0．05），STEMI組與對照組cTnI水平差異有統計學意義（Z＝－19．567， P＜0．001），NSTEMI 組與對照組 cTnI 水平差異有統計學意義（Z＝－14．598，P ＜0．001）。結論VITROS ECIQ增彊型化學髮光法檢測cTnI具有良好的靈敏度、精密度、線性範圍，可滿足臨床檢測要求。（中華檢驗醫學雜誌，2015，38：461－465）
목적：평개VITROS ECIQ증강형화학발광법검측고민심기기개단백I（ cTnI）적효과。방법방법학평개，삼조미국림상실험실표준화협회（ CLSI） EP－17A、EP－6A、EP－15A문건화상관문헌，채용VITROS ECIQ증강형화학발광법대cTnI적검출한、공능령민도、정밀도、선성범위진행료험증동시건립료표관건강인군제99백분위치。수집2013년1지11월우태체국제심혈관병의원급진인흉통취진적공652례환자상관자료，기중323례급성ST단태고형심기경사（ STEMI ）급비ST단태고형심기경사（ NSTEMI）환자위병례조，배제기타진단329례，선취303례표관정상인군위대조조，응용ROC곡선분석cTnI재STEMI、NSTEMI진단중적령민도화특이성。비정태분포적정량자료비교채용비삼수검험Mann－Whitney U。결과 VITROS검측cTnI적공백한（ LoB）위0．0065 ng／ml、검출한（LoD）위0．0155 ng／ml、공능령민도（FS）위0．01676 ng／ml；중복성정밀도CV위1．73％～2．33％，중간정밀도CV위4．93％～9．96％，균만족시제합성명적불정밀도；선성범위위0．0155～78．4 ng／ml （R2＝0．9999），표관건강인군제99백분위치위0．017 ng／ml。 ROC곡선분석발현，cTnI적곡선하면적（ AUC）위0．986，95％CI 0．973～0．994，이0．017ng／ml위진단절점시，기재급성심기경사진단중적민감성화특이성분별위90．09％、99．34％。흉통입원즉각STEMI、NSTEMI량조간cTnI수평차이무통계학의의（Z＝－0．485，P＞0．05），STEMI조여대조조cTnI수평차이유통계학의의（Z＝－19．567， P＜0．001），NSTEMI 조여대조조 cTnI 수평차이유통계학의의（Z＝－14．598，P ＜0．001）。결론VITROS ECIQ증강형화학발광법검측cTnI구유량호적령민도、정밀도、선성범위，가만족림상검측요구。（중화검험의학잡지，2015，38：461－465）
Objective To evaluate the performances of high-sensitivity cardiac troponin I ( cTnI ) on VITRO ECIQ with enhanced chemiluminescence method .Methods This verification study validated the limited of detection,function sensitivity,imprecision,linearity of the high-sensitivity cardic troponin used VITROS ECIQ according to the document EP-17A, EP-6A,EP-15A published by Clinical and Laboratory Standards Institute (CLSI) and determined 99th percentiles.All 652 patients with chest pain on immediate admission in TEDA International Cardiovascular Hospital during January to November 2013 were enrolled in this study.Including 323 cases of acute ST segment elevation myocardial infarction and non ST segment elevation myocardial infarction patients as the case group , exclude 329 cases of other diagnosis ,303 cases of apparent normal people as control group .The receiver operating characteristic curve was used to evaluated the sensitivity and the specificity of cTnI . Non-normal distribution of quantitative data were used nonparametric test Mann-Whitney U, With P<0.05 for the difference was statistically significant .Results The LoB was 0.006 5 ng/ml and the LoD was 0.015 5 ng/ml;the FS was 0.016 76 ng/ml;repeatability CV <br> was 1.73 % -2.33 %, reproducibility CV was 4.93% -9.96%.The imprecision were lower than that declared by assay producer.The linearity was 0.015 5-78.4 ng/ml(R2 =0.999 9); the 99th percentile reference value was 0.017 ng/ml.The area under the curve ( AUC) of cTnI was 0.986,95%CI 0.973 -0.994,with the cut-off value as 0.017 ng/ml, the diagnostic sensitivity and specificity in CIN were 90.09%and 99.34%.Compared between STEMI and NSTEMI groups after admission , the levels of cTnI had no significantly difference , Z were -0.485, P >0.05;compared between STEMI and control groups after admission, the levels of cTnI had significantly difference , Z were -19.567,P<0.001;compared between NSTEMI and control groups after admission , the levels of cTnI had significantly difference , Z were-14.598,P<0.001.Conclusions High-sensitivity cardiac troponin I detection by VITROS ECIQ with enhanced chemiluminescence method has good performances of sensitivity , linearity, specificity, which meet the clinical needs.
