Evaluation of two fluorescence immunoassays for the rapid detection of SARS-CoV-2 antigen-new tool to detect infective COVID-19 patients

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dc.contributor.authorPorte, Lorena
dc.contributor.authorLegarraga, Paulette
dc.contributor.authorIruretagoyena, Mirentxu
dc.contributor.authorVollrath, Valeska
dc.contributor.authorPizarro, Gabriel
dc.contributor.authorMunita, José
dc.contributor.authorAraos, Rafael
dc.contributor.authorWeitzel, Thomas
dc.date.accessioned2022-01-12T15:13:58Z
dc.date.available2022-01-12T15:13:58Z
dc.date.issued2021
dc.description.abstractBackground 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. Methods 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. Results 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. Conclusion 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 ~106 copies/mL (Ct values ≤ 25), the estimated threshold of contagiousness, suggests that the assays might serve to rapidly identify infective individuals.es
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dc.identifier.citationPorte L, Legarraga P, Iruretagoyena M, Vollrath V, Pizarro G, Munita J, Araos R, Weitzel T. Evaluation of two fluorescence immunoassays for the rapid detection of SARS-CoV-2 antigen-new tool to detect infective COVID-19 patients. PeerJ. 2021 Jan 21;9:e10801. doi: 10.7717/peerj.10801es
dc.identifier.urihttps://doi.org/10.7717/peerj.10801es
dc.identifier.urihttp://hdl.handle.net/11447/5432
dc.language.isoenes
dc.subjectSARS-CoV-2es
dc.subjectCovid-19es
dc.subjectDiagnosises
dc.subjectRapid diagnostic testes
dc.subjectAntigen detectiones
dc.titleEvaluation of two fluorescence immunoassays for the rapid detection of SARS-CoV-2 antigen-new tool to detect infective COVID-19 patientses
dc.typeArticlees
dcterms.sourcePeerJ – the Journal of Life & Environmental Scienceses

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