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目的探讨标本溶血时酶联免疫吸附实验(ELISA)各实验诊断效能指标的变化及对策研究。方法以时间分辨荧光免疫分析法确诊的结果为金标准,ELISA与之比较求各实验诊断效能指标。标本选择以未溶血时ELISA临界值阴性的标本75例,阳性90例,共165例未溶血标本设为对照组,将165例标本人为处理为轻,中,重度溶血,设为实验A组(试验孔校正前);同时对实验A组各标本增设试验孔,再进行实验,设为实验B组(试验孔校正后)。对各组标本的各实验诊断效能指标进行比较。结果溶血后ELISA实验的特异性下降、准确度及正确指数均下降、误诊率升高。溶血后ELISA实验经校正孔实验校正后,与校正前比较,特异性升高、准确度及正确指数均升高、误诊率下降。结论溶血对ELISA实验检测HBs Ag在特异性、准确度、正确指数及误诊率方面存在影响,通过对溶血样本增设一试验孔,能部分纠正轻、中度溶血时对HBs Ag试验结果的影响,从而减轻样本溶血时对实验特异性、准确度、正确指数及误诊率方面的影响,改善实验的诊断效能指标,值得实验室推广使用。
Objective To investigate the changes of the diagnostic indexes of various experiments in enzyme-linked immunosorbent assay (ELISA) and the countermeasures when hemolysis of specimens. Methods The results of time-resolved fluorescence immunoassay as the gold standard, ELISA and comparison of the experimental diagnostic efficacy indicators. The specimens were selected to 75 cases of non-hemolysis ELISA critical value negative, 90 cases were positive, a total of 165 cases of non-hemolysis specimens as the control group, the 165 specimens were man-made for mild, moderate and severe hemolysis, as experimental group A Test hole correction before); at the same time on the experimental group A additional specimens of each test hole, and then experiment, set to experimental group B (test hole after correction). The experimental diagnostic efficacy indicators of each group of specimens were compared. Results After hemolysis, the specificity of ELISA experiment decreased, the accuracy and correct index decreased, the misdiagnosis rate increased. After hemolysis ELISA experiment corrected by the calibration hole experiment, compared with the pre-calibration, increased specificity, accuracy and correct index were increased, the misdiagnosis rate decreased. Conclusion Hemolysis has influence on the specificity, accuracy, correct index and misdiagnosis rate of HBsAg in ELISA test. Adding a test hole to the hemolytic sample can partially correct the effect of HBs Ag on the test results of HBs Ag, Thus alleviating the influence on the experimental specificity, accuracy, correct index and misdiagnosis rate when the sample hemolysis, and improving the diagnostic performance index of the experiment, which is worth to be popularized in the laboratory.