Abstract
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.
Highlights
The proportion of Rapid antigen tests (RAT) confirmed results by nucleic acid amplification test (NAAT) was well within the 95% CI of the expected proportion, on the basis of the PPV calculated for 1% prevalence [14]
The analysis of the semi-quantitative data from the tools employed in this study was performed on a sub-set (n = 603) of samples from subjects tested positive by RAT with
We evaluated the results of the SARS-CoV-2 testing strategy at points of entry (PoE) in COVID-19 Ag Fluorescence ImmunoAssay (FIA) (SD Biosensor, Suwon, Korea), characterized by 30 min until results and
Summary
Rapid antigen tests (RAT) represent a good option for mass testing and for rapidly capturing individuals that are potentially more infectious, especially in decentralized settings, or in those scenarios where molecular testing is not feasible or accessible Despite their lower sensitivity, they are able to identify current infections during the most contagious phase and are faster, simpler-to-use, and less expensive than NAAT [7,8]. Overall, these tests can help to relieve the pressure on healthcare systems and support public health strategies to control virus spread. The global request for ‘test, test, test’ has increased the attention and expectations directed toward these tools
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