Development and performance of a point-of-care rapid antigen test for detection of SARS-COV-2 variants
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 targe...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-08-01
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| Series: | Journal of Clinical Virology Plus |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2667038022000199 |
| _version_ | 1811340005367349248 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Lihong Liu |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-13T18:34:54Z |
| format | Article |
| id | doaj.art-1e49f45485da4fa6bdea22f19f9e718f |
| institution | Directory Open Access Journal |
| issn | 2667-0380 |
| language | English |
| last_indexed | 2024-04-13T18:34:54Z |
| publishDate | 2022-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Journal of Clinical Virology Plus |
| spelling | doaj.art-1e49f45485da4fa6bdea22f19f9e718f2022-12-22T02:34:55ZengElsevierJournal of Clinical Virology Plus2667-03802022-08-0123100080Development and performance of a point-of-care rapid antigen test for detection of SARS-COV-2 variantsLihong Liu0Kathrine Meyers1Lawrence J. Purpura2Nadia Nguyen3Hiroshi Mohri4Jennifer Y. Chang5Medini K. Annavajhala6Leo Lopez, III7Sang Won Lee8Jayesh Shah9Benjamin Lane10Anyelina Cantos11Sade A. Tukuru12Yicheng Guo13Kenra Ford14Yueh-Ting Chiu15Zizhang Sheng16Tenzin Choesang17Delivette Castor18Maple Wang19Christina Pili20Michael N. Van Hoy21Andrew Wallach22Jamie Horton23Zhiqiang Chen24Susan Rosenthal25Son McLaren26Baowei Jiang27Frank Wang28Helen H. Lu29Anne-Catrin Uhlemann30David D. Ho31Michael T. Yin32Aaron Diamond AIDS Research Center, Columbia University, New York, NY, United StatesAaron Diamond AIDS Research Center, Columbia University, New York, NY, United StatesDepartment of Medicine, Infectious Diseases, Columbia University, New York, NY, United StatesAaron Diamond AIDS Research Center, Columbia University, New York, NY, United StatesAaron Diamond AIDS Research Center, Columbia University, New York, NY, United StatesDepartment of Medicine, Infectious Diseases, Columbia University, New York, NY, United StatesDepartment of Medicine, Infectious Diseases, Columbia University, New York, NY, United StatesNYC Health and Hospitals and NYU Grossman School of Medicine, New York, NY, United StatesDepartment of Biomedical Engineering, Columbia University, New York, NY, United StatesDepartment of Medicine, Infectious Diseases, Columbia University, New York, NY, United StatesAaron Diamond AIDS Research Center, Columbia University, New York, NY, United StatesDepartment of Medicine, Infectious Diseases, Columbia University, New York, NY, United StatesDepartment of Medicine, Infectious Diseases, Columbia University, New York, NY, United StatesAaron Diamond AIDS Research Center, Columbia University, New York, NY, United StatesNYC Health and Hospitals, New York, NY, United StatesDepartment of Biomedical Engineering, Columbia University, New York, NY, United StatesAaron Diamond AIDS Research Center, Columbia University, New York, NY, United StatesNYC Health and Hospitals, New York, NY, United StatesDepartment of Medicine, Infectious Diseases, Columbia University, New York, NY, United StatesAaron Diamond AIDS Research Center, Columbia University, New York, NY, United StatesNYC Health and Hospitals, New York, NY, United StatesBioMedomics Inc, Morrisville, NC, United StatesNYC Health and Hospitals and NYU Grossman School of Medicine, New York, NY, United StatesEconomic Development Corporation, New York, NY, United StatesBioMedomics Inc, Morrisville, NC, United StatesEconomic Development Corporation, New York, NY, United StatesDepartment of Emergency Medicine, Columbia University, New York NY United StatesBioMedomics Inc, Morrisville, NC, United StatesBioMedomics Inc, Morrisville, NC, United StatesDepartment of Biomedical Engineering, Columbia University, New York, NY, United StatesDepartment of Medicine, Infectious Diseases, Columbia University, New York, NY, United StatesAaron Diamond AIDS Research Center, Columbia University, New York, NY, United States; Corresponding authors.Department of Medicine, Infectious Diseases, Columbia University, New York, NY, United States; Corresponding authors.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.http://www.sciencedirect.com/science/article/pii/S2667038022000199SARS-CoV-2 rapid antigen testsCOVID-19Variants of concern (VOCs)Cross-reactivity |
| spellingShingle | 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 Development and performance of a point-of-care rapid antigen test for detection of SARS-COV-2 variants Journal of Clinical Virology Plus SARS-CoV-2 rapid antigen tests COVID-19 Variants of concern (VOCs) Cross-reactivity |
| title | Development and performance of a point-of-care rapid antigen test for detection of SARS-COV-2 variants |
| title_full | Development and performance of a point-of-care rapid antigen test for detection of SARS-COV-2 variants |
| title_fullStr | Development and performance of a point-of-care rapid antigen test for detection of SARS-COV-2 variants |
| title_full_unstemmed | Development and performance of a point-of-care rapid antigen test for detection of SARS-COV-2 variants |
| title_short | Development and performance of a point-of-care rapid antigen test for detection of SARS-COV-2 variants |
| title_sort | development and performance of a point of care rapid antigen test for detection of sars cov 2 variants |
| topic | SARS-CoV-2 rapid antigen tests COVID-19 Variants of concern (VOCs) Cross-reactivity |
| url | http://www.sciencedirect.com/science/article/pii/S2667038022000199 |
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