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Evaluation of a rapid diagnostic test for detection of SARS-CoV-2 antigen in nasopharyngeal swabs

, Jari Intra, Daniela Riggio, Simona Sabella, Lorenza Rondelli, Simone Barbieri, Valerio Leoni, Maria Luisa Biondi
Published: 6 May 2021

Abstract: Background and aims: Rapid and accurate diagnosis is essential to limit the spread of SARS-CoV-2 and for patient’s management. Currently, real-time reverse transcription polymerase chain reaction (RT-PCR) is the recommended laboratory test to detect SARS-CoV-2. However, the requirement of special instruments and skilled personnel have limited the use of this technique. Recently, several rapid antigen detection tests have been developed and used as frontline. The aim of this work was to assess the performances of STANDARD F COVID-19 Ag FIA Kit, a rapid fluorescence immunoassay for the detection of SARS-CoV-2 nucleoprotein antigens, in comparison to RT-PCR.Materials and methods: Twenty-three nasopharyngeal swabs were collected and tested. Results: Among the 20 positive RT-PCR samples, 9 were detected by the immunofluorescence assay, reporting an overall sensitivity of 45%. The sensitivity increased to 64% in the case of a high viral load, where all three target genes, RdRp, N, and E, were detected by RT-PCR. Conclusions: A better antigen detection rate is associated with low Cycle threshold values which are inversely related to the viral load. STANDARD F COVID-19 Ag test cannot be considered as the frontline assay for COVID-19 diagnosis, but it might be used in association with clinical signs of patients to reduce the number of RT-PCR testing.
Keywords: PCR / viral load / antigen / nasopharyngeal / frontline / SARS CoV

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