We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Evaluation of two fluorescence immunoassays for the rapid detection of SARS-CoV-2 antigen--new tool to detect infective COVID-19 patients.
- Authors
Porte, Lorena; Legarraga, Paulette; Iruretagoyena, Mirentxu; Vollrath, Valeska; Pizarro, Gabriel; Munita, Jose; Araos, Rafael; Weitzel, Thomas
- Abstract
Background: 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.
- Subjects
KYONGGI-do (Korea); SAN Diego (Calif.); SOUTH Korea; COVID-19; SARS-CoV-2; COVID-19 testing; ANTIGENS; FLUORESCENCE; IMMUNOASSAY
- Publication
PeerJ, 2021, p1
- ISSN
2167-8359
- Publication type
Article
- DOI
10.7717/peerj.10801