CAJ | 학술논문

目的：建立时间分辨荧光免疫分析检测心肌肌钙蛋白Ⅰ的方法并应用于临床。方法：采用时间分辨荧光免疫分析及双抗体夹心法，对检测体系的标准曲线、最低检测量、稳定性、精密度和交叉反应等相关性能指标进行评价，通过检测健康体检人员及临床急性心肌梗死患者血清标本并与目前应用于临床的微粒子发光法进行比对，评价TRFIA方法的临床应用可行性。结果：该方法检测肌钙蛋白I的标准曲线Y＝7485.878＋1400.924 X，相关系数为0.999，最低检测限为0.052 ng/ml。批内、批间精密度均＜10％。该方法的正常参考范围为＜0.14μg/L，ROC曲线的AUC为0.971，敏感度96.45％，特异性91.43％，准确度95.69％，阳性预示值98.45％，阴性预示值82.05％。该方法与微粒子发光法具有很强的相关性（ r＝0.993），与ECG、cTnT、CK-MB没有明显的统计学差异（ P＞0.05）。急性心肌梗死患者治疗前后的检测结果具有明显的统计学差异（ P＜0.001）。结论：时间分辨荧光免疫分析法检测肌钙蛋白Ⅰ符合临床诊断的相关要求，可应用于临床急性心肌梗死患者的诊断及疾病检测。
목적：건립시간분변형광면역분석검측심기기개단백Ⅰ적방법병응용우림상。방법：채용시간분변형광면역분석급쌍항체협심법，대검측체계적표준곡선、최저검측량、은정성、정밀도화교차반응등상관성능지표진행평개，통과검측건강체검인원급림상급성심기경사환자혈청표본병여목전응용우림상적미입자발광법진행비대，평개TRFIA방법적림상응용가행성。결과：해방법검측기개단백I적표준곡선Y＝7485.878＋1400.924 X，상관계수위0.999，최저검측한위0.052 ng/ml。비내、비간정밀도균＜10％。해방법적정상삼고범위위＜0.14μg/L，ROC곡선적AUC위0.971，민감도96.45％，특이성91.43％，준학도95.69％，양성예시치98.45％，음성예시치82.05％。해방법여미입자발광법구유흔강적상관성（ r＝0.993），여ECG、cTnT、CK-MB몰유명현적통계학차이（ P＞0.05）。급성심기경사환자치료전후적검측결과구유명현적통계학차이（ P＜0.001）。결론：시간분변형광면역분석법검측기개단백Ⅰ부합림상진단적상관요구，가응용우림상급성심기경사환자적진단급질병검측。
To establish a method to detect cardiac troponin I by using time-resolved fluoroimmunoassay ( TRFIA) and apply to the clinic.Methods:The assay were measured by TRIFA and double antibody sandwich method .Standard protocols were evaluated with the standard curve , the limit of detection , stability, precision and cross reaction .Healthy reference populations and clinical serum specimens were measured to established the reference interval and evaluated the perspective of the clinical application . Results:The standard curve was Y=7485 .878+1400.924 X with a correlation coefficient of 0.999.The limit of detection was 0.052 ng/ml.The intra-and inter-assay coefficients of variation ( CV) were all <10%.Reference values was <0.14 μg/L.The AUC of ROC curve was 0.971 while the sensitivity was 96.45%,the specificity was 91.43% and the accuracy was 95.69%, with 98.45% of positive predictive value and 82.05%of negative predictive value.The correlation coefficient was 0.993 between our proposed method and the commercially available CLIA kits.There was no significant difference in statistics compared with ECG , CK-MB and cTnT ( P>0.05 ).There was significant difference in statistics compared before and after treatment with AMI ( P<0.001 ) .Conclusion: The TRFIA method for detecting cTnI achieves clinical application standards and may be used for the diagnosis and serosurveillance of acute myocardial infarction patients.