Wu Ho-Sheng, Chiu Shu-Chun, Tseng Tsan-Chang, Lin Szu-Fong, Lin Jih-Hui, Hsu Yu-Hen, Wang Mei-Ching, Lin Tsuey-Li, Yang Wen-Zieh, Ferng Tian-Lin, Huang Kai-Hung, Hsu Li-Ching, Lee Li-Li, Yang Jyh-Yuan, Chen Hour-Young, Su Shun-Pi, Yang Shih-Yan, Lin Shih-Yan, Lin Ting-Hsiang, Su Ih-Sen
Center for Disease Control, Department of Health, Taiwan, Republic of China.
Emerg Infect Dis. 2004 Feb;10(2):304-10. doi: 10.3201/eid1002.030731.
Severe acute respiratory syndrome (SARS) has raised a global alert since March 2003. After its causative agent, SARS-associated coronavirus (SARS-CoV), was confirmed, laboratory methods, including virus isolation, reverse transcriptase-polymerase chain reaction (RT-PCR), and serologic methods, have been quickly developed. In this study, we evaluated four serologic tests ( neutralization test, enzyme-linked immunosorbent assay [ELISA], immunofluorescent assay [IFA], and immunochromatographic test [ICT]) for detecting antibodies to SARS-CoV in sera of 537 probable SARS case-patients with correlation to the RT-PCR. With the neutralization test as a reference method, the sensitivity, specificity, positive predictive value, and negative predictive value were 98.2%, 98.7%, 98.7%, and 98.4% for ELISA; 99.1%, 87.8%, 88.1% and 99.1% for IFA; 33.6%, 98.2%, 95.7%, and 56.1% for ICT, respectively. We also compared the recombinant-based western blot with the whole virus-based IFA and ELISA; the data showed a high correlation between these methods, with an overall agreement of >90%. Our results provide a systematic analysis of serologic and molecular methods for evaluating SARS-CoV infection.
自2003年3月以来,严重急性呼吸综合征(SARS)已拉响全球警报。在其病原体——严重急性呼吸综合征相关冠状病毒(SARS-CoV)被确认后,包括病毒分离、逆转录聚合酶链反应(RT-PCR)在内的实验室方法以及血清学方法迅速得到开发。在本研究中,我们评估了四种血清学检测方法(中和试验、酶联免疫吸附测定[ELISA]、免疫荧光测定[IFA]和免疫层析试验[ICT]),用于检测537例疑似SARS病例患者血清中针对SARS-CoV的抗体,并与RT-PCR结果进行相关性分析。以中和试验作为参考方法,ELISA的敏感性、特异性、阳性预测值和阴性预测值分别为98.2%、98.7%、98.7%和98.4%;IFA分别为99.1%、87.8%、88.1%和99.1%;ICT分别为33.6%、98.2%、95.7%和56.1%。我们还比较了基于重组蛋白的免疫印迹法与基于全病毒的IFA和ELISA;数据显示这些方法之间具有高度相关性,总体一致性>90%。我们的结果为评估SARS-CoV感染的血清学和分子方法提供了系统分析。