National Institute for Infectious Diseases, "Lazzaro Spallanzani" IRCCS, 00149 Rome, Italy.
Lazio Regional Health Service, 00145 Rome, Italy.
Biomolecules. 2021 Mar 13;11(3):425. doi: 10.3390/biom11030425.
COVID-19 pandemic is a dramatic health, social and economic global challenge. There is urgent need to maximize testing capacity. Rapid Antigen Tests (RAT) represent good candidates for point-of-care and mass surveillance testing to rapidly identify SARS-CoV-2-infected people, counterbalancing lower sensitivity vs. gold standard molecular tests with fast results and possible recurrent testing. We describe the results obtained with the testing algorithm implemented at points of entry (airports and ports) in the Lazio Region (Italy), using the STANDARD F COVID-19 Antigen Fluorescence ImmunoAssay (FIA), followed by molecular confirmation of FIA-positive samples. From mid-August to mid-October 2020, 73,643 RAT were reported to the Regional Surveillance Information System for travelers at points of entry in Lazio Region. Of these, 1176 (1.6%) were FIA-positive, and the proportion of RT-PCR-confirmed samples was 40.5%. Our data show that the probability of confirmation was directly dependent from the semi-quantitative FIA results. In addition, the molecularly confirmed samples were those with high levels of virus and that were actually harboring infectious virus. These results support public health strategies based on early mass screening campaigns by RAT in settings where molecular testing is not feasible or easily accessible, such as points of entry. This approach would contribute to promptly controlling viral spread through travel, which is now of particular concern due to the spread of SARS-CoV-2 variants.
新冠疫情是一场全球性的、严重的健康、社会和经济挑战。目前急需最大限度地提高检测能力。快速抗原检测(RAT)是一种很好的即时护理和大规模监测检测候选方法,可以快速识别 SARS-CoV-2 感染人群,平衡了相对于金标准分子检测的较低敏感性,结果快速且可能进行多次检测。我们描述了在意大利拉齐奥地区入境点(机场和港口)实施的检测算法所获得的结果,使用的是 STANDARD F COVID-19 抗原荧光免疫分析(FIA),随后对 FIA 阳性样本进行分子确认。2020 年 8 月中旬至 10 月中旬,拉齐奥地区入境点向区域监测信息系统报告了 73643 次 RAT 检测。其中,1176 次(1.6%)为 FIA 阳性,经 RT-PCR 确认的样本比例为 40.5%。我们的数据表明,确认的概率与 FIA 的半定量结果直接相关。此外,经分子确认的样本是病毒载量高、实际上携带传染性病毒的样本。这些结果支持基于 RAT 的早期大规模筛查活动的公共卫生策略,在无法或难以进行分子检测的环境中,如入境点,这种方法有助于通过旅行迅速控制病毒传播,由于 SARS-CoV-2 变异的传播,目前这一点尤其令人关注。