| Autor: |
Lihong Liu, Kathrine Meyers, Lawrence J. Purpura, Nadia Nguyen, Hiroshi Mohri, Jennifer Y. Chang, Medini K. Annavajhala, Leo Lopez, III, Sang Won Lee, Jayesh Shah, Benjamin Lane, Anyelina Cantos, Sade A. Tukuru, Yicheng Guo, Kenra Ford, Yueh-Ting Chiu, Zizhang Sheng, Tenzin Choesang, Delivette Castor, Maple Wang, Christina Pili, Michael N. Van Hoy, Andrew Wallach, Jamie Horton, Zhiqiang Chen, Susan Rosenthal, Son McLaren, Baowei Jiang, Frank Wang, Helen H. Lu, Anne-Catrin Uhlemann, David D. Ho, Michael T. Yin |
| Jazyk: |
angličtina |
| Rok vydání: |
2022 |
| Předmět: |
|
| Zdroj: |
Journal of Clinical Virology Plus, Vol 2, Iss 3, Pp 100080- (2022) |
| Druh dokumentu: |
article |
| ISSN: |
2667-0380 |
| DOI: |
10.1016/j.jcvp.2022.100080 |
| Popis: |
Background: SARS-CoV-2 antigen-based tests are well-calibrated to infectiousness and have a critical role to play in the COVID-19 public health response. We report the development and performance of a unique lateral flow immunoassay (LFA). Methods: Combinations of several monoclonal antibodies targeting multiple antigenic sites on the SARS-CoV-2 nucleocapsid protein (NP) were isolated, evaluated, and chosen for the development of a LFA termed CoV-SCAN (BioMedomics, Inc.). Clinical point-of-care studies in symptomatic and asymptomatic individuals were conducted to evaluate positive predictive agreement (PPA) and negative predictive agreement (NPA) with RT-PCR as comparator. Results: In laboratory testing, CoV-SCAN detected 14 recombinant N-proteins of SARS-CoV-2 variants with sensitivity in the range of 0.2–3.2 ng/mL, and 10 authentic SARS-CoV-2 variants with sensitivity in the range of 1.6–12.5 TCID50/swab. No cross reactivity was observed with other human coronaviruses or other respiratory pathogens. In clinical point-of-care testing on 148 individuals over age 2 with symptoms of ≤5 days, PPA was 87.2% (CI 95: 78.3–94.8%) and NPA was 100% (CI 95: 94.2–100%). In another 884 asymptomatic individuals, PPA was 85.7% (CI 95: 42.1–99.6%) and 99.7% (99.0–99.9%). Overall, CoV-SCAN detected over 97.2% of specimens with CT values |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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