临床应用重组SARS病毒双抗原夹心诊断试剂盒的检测效果评价

严重急性呼吸综合征(severe acute respiralory syndrome,SARS)的临床表现为非典型性肺炎.继加拿大首次完成SARS病毒株Tor2的全基因组测序后1],世界卫生组织(WTO)宣布一种新型的冠状病毒(coronavirus)是引发SARS的病原体2,3].由于SARS具有极强的传染性和较高的病死率(5%～15%),且早期疾病体征较难与某些非SARS病毒引起的非典型肺炎相区分4],由此导致大量疑似病例无法确诊,以及因误诊引起的交叉感染给人们造成巨大的心理压力和社会恐慌.所以,建立快速、准确的早期诊断方法显得尤为重要.目前的实验室诊断方法中,主要有基于病毒抗体检测的免疫荧光法和酶联免疫吸附试验(ELISA),以及基于基因检测的多聚酶链式反应(PCR)和基因芯片法.其中ELISA主要是使用病毒裂解抗原,检测病毒IgG及IgM抗体的间接ELISA.由于病毒裂解抗原的复杂性,以及间接ELISA中二抗带来的假阳性结果,间接ELISA试剂在正常人群中有1.5%～2%的阳性结果.

Evaluation of the Clinical Detection Results Using Recombinant SARS Antigen-Capturing ELISA Diagnostic Kit

It is necessary to establish a rapid and accurate diagnostic method for controlling the epidemic of severe acute respiratory syndrome (SARS). Cooperating with Henan Bioengineering Research Center, we developed a new diagnostic kit for antibodies to SARS virus based on antigen-capturing ELISA. Here we report the clinical detection results obtained from several hospitals which used this diagnostic kit for SARS diagnosing. Comparing with other detection kits now used, the antigen-capturing ELISA has stronger specificity and higher sensitivity, and more fits for rapid confirming and diagnosing of SARS cases, SARS epidemiological investigation and SARS epidemic source research.