Evaluation of FAST COVID-19 SARS-CoV-2 Antigen Rapid Test Kit for Detection of SARS-CoV-2 in Respiratory Samples from Mildly Symptomatic or Asymptomatic Patients.

ABSTRACT

Molecular tests are the gold standard to diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection but are associated with a diagnostic delay, while antigen detection tests can generate results within 20 min even outside a laboratory. In order to evaluate the accuracy and reliability of the FAST COVID-19 SARS-CoV-2 Antigen Rapid Test Kit (Ag-RDT), two respiratory swabs were collected simultaneously from 501 patients, with mild or no coronavirus disease 2019 (COVID-19)-related symptoms, and analyzed with both the Reverse Transcriptase-quantitative Polymerase Chain Reaction (RT-qPCR) and the FAST COVID-19 SARS-CoV-2 Antigen Rapid Test. Results were then compared to determine clinical performance in a screening setting. We measured a precision of 97.41% (95% CI 92.42-99.15%) and a recall of 98.26% (95% CI 93.88-99.25%), with a specificity of 99.22% (95% CI 97.74-99.74%), a negative predictive value of 99.48% (95% CI 97.98-99.87%), and an overall accuracy of 99.00% (95% CI 97.69-99.68%). Concordance was described by a Kappa coefficient of 0.971 (95% CI 0.947-0.996). Considering short lead times, low cost, and opportunities for decentralized testing, the Ag-RDT test can enhance the efforts to control SARS-CoV-2 spread in several settings.