Tweet
Virol J
. 2022 Sep 1;19(1):140.
doi: 10.1186/s12985-022-01871-6.
Performance evaluation of antigen detection rapid diagnostic test (Ag-RDT) for COVID-19 diagnosis in a primary healthcare center during the Shanghai COVID-19 quarantine period
Lan Dong # 1 , Wen-Fang Li # 1 , Ying Jiang # 2 3
Affiliations
- PMID: 36050725
- DOI: 10.1186/s12985-022-01871-6
Abstract
Background: Rapid and accurate detection of SARS-CoV-2 infection is the cornerstone of prompt patient care. However, the reliability of the antigen rapid diagnostic test (Ag-RDT) in the diagnosis of SARS-CoV-2 infection remains inconclusive.
Methods: We conducted a field evaluation of Ag-RDT performance during the Shanghai Coronavirus disease 2019 (COVID-19) quarantine and screened 7225 individuals visiting our Emergency Department. 83 asymptomatic SARS-CoV-2 (+) individuals were enrolled in the current study. Simultaneously, Ag-RDT was performed to evaluate its testing performance.
Results: For the Ag-RDT(-) cases, the average cycle threshold (Ct) values of the N gene were 27.26 ± 4.59, which were significantly higher than the Ct value (21.9 ± 4.73) of the Ag-RDT(+) individuals (p < 0.0001). The overall sensitivity of Ag-RDT versus that of RT-PCR was 43.37%. The Ag-RDT(+) individuals regarding the N gene's Ct value were 16 cases in the < 20 range, 12 in 20-25, 5 in 25-30, and 3 in 30-35. The corresponding sensitivity was 84.21%, 52.17%, 21.74% and 16.67%, respectively. Meanwhile, sampling had a straight specificity of 100% regardless of the Ct value.
Conclusions: The Ag-RDT were extremely sensitive in asymptomatic COVID-19 individuals with a Ct value < 20.
Keywords: Antigen rapid diagnostic test (Ag-RDT); COVID-19; N gene; ORF1ab gene; SARS-CoV-2; Sensitivity.