Abstract
We assessed the performance of the Panbio rapid antigen detection (RAD) test for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and we compared it with the routine reverse transcriptase-polymerase chain reaction (RT-PCR)-based molecular test in a population of 4167 unselected patients admitted to IRCCS Sacro Cuore Don Calabria Hospital. Analysis stratified by cycling threshold (C t ) value of SARS-CoV-2 gene targets indicated that antigen (Ag)-positive C t values were significantly lower compared to Ag-negative values (p < 0.0001). Overall, we found discordance in 140, tested negative by RAD and positive by RT-PCR, and in 4 resulted positive by RAD and negative by RT-PCR. RAD test achieved a sensitivity and specificity of 66.82% and 99.89%, respectively. The positive predictive value was shown to be 97.87% while the negative predictive value was shown to be 97.62%. In our context, the RAD test showed a reliable diagnostic response in subjects that displayed high C t values, corresponding to high viral load, while low ability was displayed to identify positive cases with medium-low C t values, thus presenting low viral load and where confirmatory RT-PCR was needed. Our finding supports the use of the RAD test in real-life settings where a high volume of swabs is being processed but with caution when interpreting a positive test result in a low prevalence setting.
Keywords: Panbio™ COVID-19; RAD; RT-PCR; SARS-CoV-2.
【저자키워드】 RT-PCR, SARS-CoV-2., Panbio™ COVID-19, RAD, 【초록키워드】 SARS-CoV-2, coronavirus, Infection, diagnostic, severe acute respiratory syndrome Coronavirus, RT-PCR, Predictive value, Antigen, Prevalence, polymerase chain reaction, Positive predictive value, Sensitivity and specificity, Viral load, swabs, Patient, Swab, threshold, antigen detection, Negative predictive value, reverse transcriptase, test result, Chain Reaction, Support, Volume, acute respiratory syndrome, Discordance, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, subject, caution, high viral load, Positive test, positive test result, positive, PanBio, molecular test, IRCCS, significantly lower, Cycling, gene target, shown, tested, identify, indicated, presenting, processed, stratified, Calabria, 【제목키워드】 SARS-CoV-2, hospital, Italy, Patient,