PORTE TORRE, LORENA ISABELLORENA ISABELPORTE TORRELEGARRAGA RADDATZ, PAULETTEPAULETTELEGARRAGA RADDATZIRURETAGOYENA BRUCE, MIRENTXU INESMIRENTXU INESIRURETAGOYENA BRUCEValeska VollrathGabriel PizarroMUNITA SEPULVEDA, JOSE MANUELJOSE MANUELMUNITA SEPULVEDAARAOS BRALIC, RAFAEL IGNACIORAFAEL IGNACIOARAOS BRALICWEITZEL, THOMASTHOMASWEITZEL2023-02-032023-02-032021Porte, L., Legarraga, P., Iruretagoyena, M., Vollrath, V., Pizarro, G., Munita, J., Araos, R., & Weitzel, T. (2021). Evaluation of two fluorescence immunoassays for the rapid detection of SARS-CoV-2 antigen—New tool to detect infective COVID-19 patients. PeerJ, 9, e10801. https://doi.org/10.7717/peerj.10801http://hdl.handle.net/11447/5432https://investigadores.udd.cl/handle/123456789/576510.7717/peerj.108012-s2.0-85099961703WOS:000609257700005<jats:sec> <jats:title>Background</jats:title> <jats:p>Real-Time Reverse-Transcription Polymerase Chain Reaction (RT-PCR) is currently the only recommended diagnostic method for SARS-CoV-2. However, rapid immunoassays for SARS-CoV-2 antigen could significantly reduce the COVID-19 burden currently weighing on laboratories around the world.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>We evaluated the performance of two rapid fluorescence immunoassays (FIAs), SOFIA SARS Antigen FIA (Quidel Corporation, San Diego, CA, USA) and STANDARD F COVID-19 Ag FIA (SD Biosensor Inc., Gyeonggi-do, Republic of Korea), which use an automated reader. The study used 64 RT-PCR characterized clinical samples (32 positive; 32 negative), which consisted of nasopharyngeal swabs in universal transport medium.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>Of the 32 positive specimens, all from patients within 5 days of symptom onset, the Quidel and SD Biosensor assays detected 30 (93.8%) and 29 (90.6%) samples, respectively. Among the 27 samples with high viral loads (Ct ≤ 25), the two tests had a sensitivity of 100%. Specificity was 96.9% for both kits.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusion</jats:title> <jats:p>The high performance of the evaluated FIAs indicates a potential use as rapid and PCR-independent tools for COVID-19 diagnosis in early stages of infection. The excellent sensitivity to detect cases with viral loads above ~10<jats:sup>6</jats:sup> copies/mL (Ct values ≤ 25), the estimated threshold of contagiousness, suggests that the assays might serve to rapidly identify infective individuals.</jats:p> </jats:sec>Resource Types::text::journal::journal article