Validation of an At-Home Direct Antigen Rapid Test for COVID-19 | Infectious Diseases | JN Learning | AMA Ed Hub [Skip to Content]
[Skip to Content Landing]

Validation of an At-Home Direct Antigen Rapid Test for COVID-19

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME

Sign in to take quiz and track your certificates

Buy This Activity

CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

Article Information

Accepted for Publication: July 26, 2021.

Published: August 27, 2021. doi:10.1001/jamanetworkopen.2021.26931

Correction: This article was corrected on October 1, 2021, to fix errors in the Results, Discussion, and Table.

Open Access: This is an open access article distributed under the terms of the CC-BY-NC-ND License. © 2021 Harmon A et al. JAMA Network Open.

Corresponding Author: Laura E. Holberger, PhD, BioLabs (BioInnovation Labs, LLC), 139 Main St, 4th Floor, Cambridge, MA 01239 (laura@biolabs.io).

Author Contributions: Drs Holberger and Bosch had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Mr Harmon and Ms Chang contributed equally as co–first authors.

Concept and design: Harmon, Chang, Sena, Herrera, Bosch, Holberger.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Salcedo, Sena, Herrera, Bosch, Holberger.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Harmon, Salcedo, Herrera, Bosch, Holberger.

Obtained funding: Chang, Bosch, Holberger.

Administrative, technical, or material support: Chang, Sena, Bosch, Holberger.

Supervision: Chang, Sena, Herrera, Bosch, Holberger.

Conflict of Interest Disclosures: Ms Salcedo, Ms Sena, and Dr Herrera are employed by and have a financial interest in E25Bio, Inc, a biotechnology company that develops rapid tests for infectious diseases. At the time of the study, Mr Harmon and Dr Bosch were employed by E25Bio, Inc, and have a financial interest in the company. No other disclosures were reported.

Funding/Support: Funding was provided by E25Bio, Inc, LabCentral, Inc, and BioLabs, LLC, in 3 equal parts.

Role of the Funder/Sponsor: The 3 funding entities formed the Cambridge Consortium for Rapid COVID-19 Tests and were each involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Additional Contributions: We thank all the participants in the study. Elena Naumova, PhD (Tufts University), assisted with the statistical analysis for this manuscript. Nikhil Lal, MEng (E25Bio, Inc), developed the digital platform. Adam R. Gomez, MS (E25Bio, Inc), and Dimitris P. Papageorgiou, PhD (E25Bio, Inc), assisted with data collection. Johannes Fruehauf, MD, PhD (BioLabs, LLC, and LabCentral, Inc), Sina Hoche, MA (Harvard University), and Prerna Sekhri, MS (LabCentral, Inc), assisted with study design. Sally Aubrey, BA (LabCentral, Inc), assisted with study execution. None of these individuals was compensated beyond their normal salaries.

Additional Information: LabCentral, Inc, donated operational support, laboratory space, and equipment for this work. BioLabs, LLC, and E25Bio, Inc, donated oversight and scientist time. Integra Biosciences, Scismic, and BioIT each contributed equipment or services.

References
1.
Zhou  P , Yang  XL , Wang  XG ,  et al.  A pneumonia outbreak associated with a new coronavirus of probable bat origin.   Nature. 2020;579(7798):270-273. doi:10.1038/s41586-020-2012-7PubMedGoogle ScholarCrossref
2.
World Health Organization. WHO coronavirus (COVID-19) dashboard. Accessed August 2, 2021. https://covid19.who.int/
3.
Ashcroft  P , Lehtinen  S , Angst  DC , Low  N , Bonhoeffer  S .  Quantifying the impact of quarantine duration on COVID-19 transmission.   eLife. 2021;10:e63704. doi:10.7554/eLife.63704PubMedGoogle Scholar
4.
Lu  X , Wang  L , Sakthivel  SK ,  et al.  US CDC real-time reverse transcription PCR panel for detection of severe acute respiratory syndrome coronavirus 2.   Emerg Infect Dis. 2020;26(8). doi:10.3201/eid2608.201246PubMedGoogle Scholar
5.
Bosch  I , de Puig  H , Hiley  M ,  et al.  Rapid antigen tests for dengue virus serotypes and Zika virus in patient serum.   Sci Transl Med. 2017;9(409):eaan1589. doi:10.1126/scitranslmed.aan1589PubMedGoogle Scholar
6.
Larremore  DB , Wilder  B , Lester  E ,  et al.  Test sensitivity is secondary to frequency and turnaround time for COVID-19 screening.   Sci Adv. 2021;7(1):eabd5393. doi:10.1126/sciadv.abd5393PubMedGoogle Scholar
If you are not a JN Learning subscriber, you can either:
Subscribe to JN Learning for one year
Buy this activity
jn-learning_Modal_Multimedia_LoginSubscribe_Purchase
Close
If you are not a JN Learning subscriber, you can either:
Subscribe to JN Learning for one year
Buy this activity
jn-learning_Modal_Multimedia_LoginSubscribe_Purchase
Close
With a personal account, you can:
  • Access free activities and track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
Education Center Collection Sign In Modal Right
Close

Name Your Search

Save Search
Close
With a personal account, you can:
  • Track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
jn-learning_Modal_SaveSearch_NoAccess_Purchase
Close

Lookup An Activity

or

Close

My Saved Searches

You currently have no searches saved.

Close
With a personal account, you can:
  • Access free activities and track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
Education Center Collection Sign In Modal Right
Close