Development and Performance of a Point-of-Care Rapid Antigen Test for Detection of SARS-CoV-2 Variants

24 Pages Posted: 2 Apr 2022

See all articles by Lihong Liu

Lihong Liu

Columbia University - Aaron Diamond AIDS Research Center

Kathrine Meyers

affiliation not provided to SSRN

Lawrence J. Purpura

affiliation not provided to SSRN

Nadia Nguyen

affiliation not provided to SSRN

Hiroshi Mohri

affiliation not provided to SSRN

Jennifer Y. Chang

Columbia University - Division of Infectious Diseases; Columbia University - Irving Medical Center

Medini K. Annavajhala

Columbia University - Department of Medicine

Leo Lopez

affiliation not provided to SSRN

Sang Won Lee

Columbia University

Jayesh Shah

Columbia University

Benjamin Lane

affiliation not provided to SSRN

Anyelina Cantos

affiliation not provided to SSRN

Sade A. Tukuru

affiliation not provided to SSRN

Yicheng Guo

Columbia University - Aaron Diamond AIDS Research Center; Columbia University - Irving Medical Center

Kenra Ford

affiliation not provided to SSRN

Yueh-Ting Chiu

Columbia University

Zizhang Sheng

Columbia University - Aaron Diamond AIDS Research Center; Columbia University - Mortimer B. Zuckerman Mind, Brain and Behavior Institute

Tenzin Choesang

affiliation not provided to SSRN

Delivette Castor

Columbia University - Irving Medical Center

Maple Wang

Columbia University - Aaron Diamond AIDS Research Center; Columbia University - Irving Medical Center

Christina Pili

affiliation not provided to SSRN

Michael N. Van Hoy

affiliation not provided to SSRN

Andrew Wallach

New York City Health and Hospitals Corporation

Jamie Horton

affiliation not provided to SSRN

Zhiqiang Chen

affiliation not provided to SSRN

Susan Rosenthal

affiliation not provided to SSRN

Baowei Jiang

affiliation not provided to SSRN

Frank Wang

affiliation not provided to SSRN

Helen Lu

Columbia University

Anne-Catrin Uhlemann

Columbia University

David D. Ho

Columbia University - Aaron Diamond AIDS Research Center; Columbia University - Aaron Diamond AIDS Research Center

Michael Yin

Columbia University - Aaron Diamond AIDS Research Center

Abstract

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 (N) protein 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.

Note:
Funding Information: The authors gratefully acknowledge support from Andrew and Peggy Cherng for all aspects of the work reported in this manuscript. In Summer 2020, NYCEDC held the Rapid Testing Innovation Competition, a request for expressions of interest that sought to identify innovative and cost-effective rapid COVID tests. CoV-Scan was identified as an outstanding candidate and Columbia University was awarded grant funding to further develop and study the test [Rapid Testing Innovation Competition to D.D.H. and M.T.Y.]; Study 2, performed at New York City Health & Hospitals, was supported by the New York Economic Development Cooperation (EDC); additional support was provided from the National Institute on Drug Abuse [U01DA053949-01 to A.U.].

Conflict of Interests: Potential conflicts of interest: MNVH, WS, ZC, BJ, FW are employed by BioMedomics, Inc, the manufacturer of the CoV-SCAN rapid antigen test. Potential conflicts of interest: DDH and LL are inventors on a patent application on monoclonal antibodies used in the construction of CoV-SCAN, and the rights to this invention has been licensed to Biomedomics by Columbia University. No other authors declare any conflict of interest.

Ethical Approval: Columbia University Irving Medical Center Institutional Review Board approved Study 1. BRANY IRB approved Study 2. All participants provided informed consent.

Keywords: SARS-CoV-2 rapid antigen tests, covid-19, Variants of concern (VOCs), Cross-reactivity

Suggested Citation

Liu, Lihong and Meyers, Kathrine and Purpura, Lawrence J. and Nguyen, Nadia and Mohri, Hiroshi and Chang, Jennifer Y. and Annavajhala, Medini K. and Lopez, Leo and Lee, Sang Won and Shah, Jayesh and Lane, Benjamin and Cantos, Anyelina and Tukuru, Sade A. and Guo, Yicheng and Ford, Kenra and Chiu, Yueh-Ting and Sheng, Zizhang and Choesang, Tenzin and Castor, Delivette and Wang, Maple and Pili, Christina and Van Hoy, Michael N. and Wallach, Andrew and Horton, Jamie and Chen, Zhiqiang and Rosenthal, Susan and Jiang, Baowei and Wang, Frank and Lu, Helen and Uhlemann, Anne-Catrin and Ho, David D. and Yin, Michael, Development and Performance of a Point-of-Care Rapid Antigen Test for Detection of SARS-CoV-2 Variants. Available at SSRN: https://ssrn.com/abstract=4073340

Lihong Liu

Columbia University - Aaron Diamond AIDS Research Center ( email )

NY
United States

Kathrine Meyers

affiliation not provided to SSRN ( email )

No Address Available

Lawrence J. Purpura

affiliation not provided to SSRN ( email )

No Address Available

Nadia Nguyen

affiliation not provided to SSRN ( email )

No Address Available

Hiroshi Mohri

affiliation not provided to SSRN ( email )

No Address Available

Jennifer Y. Chang

Columbia University - Division of Infectious Diseases ( email )

Columbia University - Irving Medical Center ( email )

Medini K. Annavajhala

Columbia University - Department of Medicine ( email )

United States

Leo Lopez

affiliation not provided to SSRN ( email )

No Address Available

Sang Won Lee

Columbia University ( email )

3022 Broadway
New York, NY 10027
United States

Jayesh Shah

Columbia University ( email )

Benjamin Lane

affiliation not provided to SSRN ( email )

No Address Available

Anyelina Cantos

affiliation not provided to SSRN ( email )

No Address Available

Sade A. Tukuru

affiliation not provided to SSRN ( email )

No Address Available

Yicheng Guo

Columbia University - Aaron Diamond AIDS Research Center ( email )

Columbia University - Irving Medical Center ( email )

Kenra Ford

affiliation not provided to SSRN ( email )

No Address Available

Yueh-Ting Chiu

Columbia University ( email )

3022 Broadway
New York, NY 10027
United States

Zizhang Sheng

Columbia University - Aaron Diamond AIDS Research Center ( email )

Columbia University - Mortimer B. Zuckerman Mind, Brain and Behavior Institute ( email )

New York, NY
United States

Tenzin Choesang

affiliation not provided to SSRN ( email )

No Address Available

Delivette Castor

Columbia University - Irving Medical Center ( email )

Maple Wang

Columbia University - Aaron Diamond AIDS Research Center ( email )

Columbia University - Irving Medical Center ( email )

Christina Pili

affiliation not provided to SSRN ( email )

No Address Available

Michael N. Van Hoy

affiliation not provided to SSRN ( email )

No Address Available

Andrew Wallach

New York City Health and Hospitals Corporation ( email )

Jamie Horton

affiliation not provided to SSRN ( email )

No Address Available

Zhiqiang Chen

affiliation not provided to SSRN ( email )

No Address Available

Susan Rosenthal

affiliation not provided to SSRN ( email )

No Address Available

Baowei Jiang

affiliation not provided to SSRN ( email )

No Address Available

Frank Wang

affiliation not provided to SSRN ( email )

No Address Available

Helen Lu

Columbia University ( email )

3022 Broadway
New York, NY 10027
United States

Anne-Catrin Uhlemann

Columbia University ( email )

David D. Ho

Columbia University - Aaron Diamond AIDS Research Center ( email )

Columbia University - Aaron Diamond AIDS Research Center ( email )

3022 Broadway
New York, NY 10027
United States

Michael Yin (Contact Author)

Columbia University - Aaron Diamond AIDS Research Center ( email )

3022 Broadway
New York, NY 10027
United States

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