Abstract
SARS-CoV-2 viral antigen detection may be an interesting alternative to RT-PCR for the diagnosis of SARS-CoV-2 infection as a less laborious or expensive method but requires validation. This study aimed to compare the performance of the DiaSorin™ LiaisonXL automated quantitative antigen test (QAT) and the AAZ™ rapid antigen test (RAT) to the DiaSorin™ MDX RT-PCR assay. A total of 242 nasopharyngeal samples were tested at La Pitié-Salpêtrière University Hospital (Paris, France). Performances for the detection of variants of SARS-CoV-2 were further investigated. RATs were visually read for qualitative results and band intensity was determined. Overall sensitivity was 63.2% for QAT and 58.6% for RAT. For RT-PCR Ct value 25, sensitivity was 89.8% for both tests. Both tests showed comparable sensitivity for detection of variants. There was a strong relationship between antigen concentration and band positivity. On the same set of samples these tests share similar performances.
Highlights
Academic Editor: Anna BaraniakCoronavirus disease 2019 (COVID-19) has led to more than 5.3 million deaths worldwide since December 2019 (WHO Coronavirus COVID-19 Dashboard, update 20th December 2021) [1]
N antigen testing assays compared with the real time RT-PCR for SARS-CoV-2 detection: quantitative antigen test (QAT) vs. RT-PCR and rapid antigen test (RAT) vs. RT-PCR
WHO recommended criteria of 80% sensitivity and 97% specificity for validating the suitability of an antigen assay compared to an approved nucleic acid amplification test (NAAT) (WHO SARSCoV-2 antigen-detecting rapid diagnostic tests: An implementation guide) [5]
Summary
Academic Editor: Anna BaraniakCoronavirus disease 2019 (COVID-19) has led to more than 5.3 million deaths worldwide since December 2019 (WHO Coronavirus COVID-19 Dashboard, update 20th December 2021) [1]. Viral RNA detection in nasopharyngeal samples (NPS) through real-time RT-PCR is considered as the gold standard method for the diagnosis of SARS-CoV-2 infection, it is not always applicable for mass detection. Viral nucleocapsid (N) protein is a highly conserved 46 kDa protein composed of 422 amino acids which participate in viral RNA packaging and forms the ribonucleoprotein core. It is an essential component of betacoronavirus and the most abundantly produced viral protein during SARS-CoV-2 infection [2,3]. This study aimed to compare the detection performance of SARS-CoV-2 N protein in NPS samples using the automated quantitative antigen test (QAT) LIAISON® SARS-CoV-2 Ag assay (DiaSorin, Saluggia, Italy) and the rapid antigen test (RAT) COVID-VIRO® (AAZ, Boulogne-Billancourt, France) compare to the SimplexaTM
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