Comparison of RT-PCR test results from nasopharyngeal swabs and the Wantai SARS-CoV-2 Diagnostics antigen test and viability test results
Aim of the study
The aim of the study is to compare the Wantai SARS-CoV-2 Diagnostics diagnostic antigen test (AT) for the detection of SARS-CoV-2 in clinical samples, to determine the sensitivity and specificity of antigen tests. The RT-PCR method from nasopharyngeal swab samples will be used as a reference method. For different RT-PCR and AT results, a virus viability test will be performed.
480 individuals of the tested individuals were included in the study, the testing took place from 8 February to 21 February 2021. Based on the RT-PCR and viability test, 28.5% of SARS-CoV-2 positive was evaluated. The UK mutation was diagnosed in 61% of positive samples.
The sensitivity of Wantai AT reached 91.1% (85.2-95.4%).
The specificity of Wantai AT 98.5% (95% IS 96.4-99.5%).
Of the entire cohort, 51.8% reported clinical symptoms. This incidence was 79.6% for the positive and 39.8% for the negative ones.
In individuals with clinical symptoms the sensitivity reached the value of 93.3%, in individuals without clinical symptoms it was lower than 81.5%. The specificity remained high at 99.2% or 98.0%, respectively.
According to Commission Recommendation (EU) 2020/1743), EU Member States should endeavour to use rapid antigen tests with an acceptable functional competence, i.e. sensitivity≥80% and specificity≥97% in order to avoid false negative and false positive test results as much as possible. Based on the ECDC recommendation, the sensitivity should be higher≥90%.
Based on the performed study, the WANTAI antigen test complied with the recommendations.
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