Validation of a Rapid Antigen Test as a Screening Tool for SARS-CoV-2 Infection in Asymptomatic Populations. Sensitivity, Specificity and Predictive Values

Background: Early diagnosis of SARS-CoV-2 infection is essential to reduce disease spread. Rapid antigen tests have not been sufficiently evaluated in asymptomatic patients be used as massive population screening tools. Methods: Head-to-head evaluation Roche rapid test a tool adults from semi-closed community. Sensitivity, specificity and predictive values were calculated using RT-PCR reference method . Findings: Roche-rapid was performed on 2542 community with incidence 1.93%. It showed sensitivity 71.43% (IC 95%: 56.74 – 83.42) 99.68% 99.37 - 99.86). Positive Predictive Value 81.4 (IC95% 66.6 91.61) Negative 99.44 95% 99.06 99.69). Test related viral load, higher Ct under 25 (93.75%, IC 71.96 98.93), that dropped 29.41% 10.31- 55.96) above 25.  Interpretation: This study demonstrates are less effective population, therefore useful for widespread testing, due the potential false-negative results their consequences. Funding: research received no external funding. Diagnostics S.L. provided required study. Declaration Interest: None declare. Ethical Approval: Approved by University Navarra Ethics committee