دورية أكاديمية
Development and performance of a point-of-care rapid antigen test for detection of SARS-COV-2 variants.
| العنوان: | Development and performance of a point-of-care rapid antigen test for detection of SARS-COV-2 variants. |
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| المؤلفون: | Liu L; Aaron Diamond AIDS Research Center, Columbia University, New York, NY, United States., Meyers K; Aaron Diamond AIDS Research Center, Columbia University, New York, NY, United States., Purpura LJ; Department of Medicine, Infectious Diseases, Columbia University, New York, NY, United States., Nguyen N; Aaron Diamond AIDS Research Center, Columbia University, New York, NY, United States., Mohri H; Aaron Diamond AIDS Research Center, Columbia University, New York, NY, United States., Chang JY; Department of Medicine, Infectious Diseases, Columbia University, New York, NY, United States., Annavajhala MK; Department of Medicine, Infectious Diseases, Columbia University, New York, NY, United States., Lopez L 3rd; NYC Health and Hospitals and NYU Grossman School of Medicine, New York, NY, United States., Lee SW; Department of Biomedical Engineering, Columbia University, New York, NY, United States., Shah J; Department of Medicine, Infectious Diseases, Columbia University, New York, NY, United States., Lane B; Aaron Diamond AIDS Research Center, Columbia University, New York, NY, United States., Cantos A; Department of Medicine, Infectious Diseases, Columbia University, New York, NY, United States., Tukuru SA; Department of Medicine, Infectious Diseases, Columbia University, New York, NY, United States., Guo Y; Aaron Diamond AIDS Research Center, Columbia University, New York, NY, United States., Ford K; NYC Health and Hospitals, New York, NY, United States., Chiu YT; Department of Biomedical Engineering, Columbia University, New York, NY, United States., Sheng Z; Aaron Diamond AIDS Research Center, Columbia University, New York, NY, United States., Choesang T; NYC Health and Hospitals, New York, NY, United States., Castor D; Department of Medicine, Infectious Diseases, Columbia University, New York, NY, United States., Wang M; Aaron Diamond AIDS Research Center, Columbia University, New York, NY, United States., Pili C; NYC Health and Hospitals, New York, NY, United States., Van Hoy MN; BioMedomics Inc, Morrisville, NC, United States., Wallach A; NYC Health and Hospitals and NYU Grossman School of Medicine, New York, NY, United States., Horton J; Economic Development Corporation, New York, NY, United States., Chen Z; BioMedomics Inc, Morrisville, NC, United States., Rosenthal S; Economic Development Corporation, New York, NY, United States., McLaren S; Department of Emergency Medicine, Columbia University, New York NY United States., Jiang B; BioMedomics Inc, Morrisville, NC, United States., Wang F; BioMedomics Inc, Morrisville, NC, United States., Lu HH; Department of Biomedical Engineering, Columbia University, New York, NY, United States., Uhlemann AC; Department of Medicine, Infectious Diseases, Columbia University, New York, NY, United States., Ho DD; Aaron Diamond AIDS Research Center, Columbia University, New York, NY, United States., Yin MT; Department of Medicine, Infectious Diseases, Columbia University, New York, NY, United States. |
| المصدر: | Journal of clinical virology plus [J Clin Virol Plus] 2022 Aug; Vol. 2 (3), pp. 100080. Date of Electronic Publication: 2022 May 04. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Ltd Country of Publication: England NLM ID: 9918283581506676 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2667-0380 (Electronic) Linking ISSN: 26670380 NLM ISO Abbreviation: J Clin Virol Plus Subsets: PubMed not MEDLINE |
| أسماء مطبوعة: | Original Publication: [Oxford] : Elsevier Ltd., [2021]- |
| مستخلص: | 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 <30 and 93.8% of nasal swab specimens with the Omicron variant, even within the first 2 days after symptom onset. Conclusions: The unique construction of CoV-SCAN using two pairs of monoclonal antibodies has resulted in a test with high performance that remains durable across multiple variants in both laboratory and clinical evaluations. CoV-SCAN should identify almost all individuals harboring infectious SARS-CoV-2. Summary: Unique construction of a point-of-care rapid antigen test using two pairs of monoclonal antibodies has led to good performance that remained durable across multiple variants in laboratory and clinical evaluations. Test should identify almost all individuals harboring infectious SARS-CoV-2. (© 2022 The Authors. Published by Elsevier Ltd.) |
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| فهرسة مساهمة: | Keywords: COVID-19; Cross-reactivity; SARS-CoV-2 rapid antigen tests; Variants of concern (VOCs) |
| تواريخ الأحداث: | Date Created: 20220509 Latest Revision: 20230116 |
| رمز التحديث: | 20231215 |
| مُعرف محوري في PubMed: | PMC9067019 |
| DOI: | 10.1016/j.jcvp.2022.100080 |
| PMID: | 35528048 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 2667-0380 |
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| DOI: | 10.1016/j.jcvp.2022.100080 |