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Rapid antigen test for SARS-CoV-2: results of validation and use in real life
Irena Grmek Kosnik1, Urska Dermota1, Andrej Golle1
1National Laboratory for Health, Environment & Food, Prvomajska 2, 2000, Maribor, Slovenia.
Abstract:
Aim: To verify a SARS-CoV-2 rapid antigen test (RAT) compared with PCR. Materials & methods: Validation of RAT included 2295 subjects. Next matching of RAT with the PCR was checked in 13,852 subjects referred to PCR after being positive in RAT. Results: Sensitivity and specificity of RAT were 77.38 and 99.10%, respectively. A 74.60% of RAT positive results were confirmed with PCR. Conclusion: The test met WHO susceptibility criteria in a group of symptomatic subjects. In terms of specificity, it met requirements in all subjects. The concordance of RAT with PCR in real life was in line with our verification data.
