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Infectious Diseases

Assessment of Sensitivity and Specificity of Patient-Collected Lower Nasal Specimens for Severe Acute Respiratory Syndrome Coronavirus 2 Testing

Educational Objective
To understand how collecting lower nasal specimens can help test for COVID-19

1 Credit CME

JAMA Network Open

Published Online: June 12, 2020

Research Letter

Article Information and Disclosures

Jonathan Altamirano, MS¹;

Prasanthi Govindarajan, MBBS, MAS²;

Andra L. Blomkalns, MD, MBA²;

Lauren E. Kushner, MD¹;

Bryan Andrew Stevens, MD³;

Benjamin A. Pinsky, MD, PhD³;

Yvonne Maldonado, MD¹

Author Affiliations

¹Department of Pediatrics, Stanford University School of Medicine, Stanford, California
²Department of Emergency Medicine, Stanford University School of Medicine, Stanford, California
³Department of Pathology, Stanford University School of Medicine, Stanford, California

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Since the emergence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) outbreak in Wuhan, China, in December 2019, the virus has spread to 173 countries, resulting in 3 855 788 confirmed cases and 265 862 deaths as of May 9, 2020.¹ Stanford Health Care was one of the first nonfederal facilities to obtain US Food and Drug Administration approval for a proprietary test using reverse transcriptase–polymerase chain reaction for SARS-CoV-2 using nasopharyngeal and oropharyngeal specimens on March 2, 2020. However, specimen collection must be done by health care workers and requires extensive use of personal protective equipment. To minimize the risk of exposure during testing, reduce personal protective equipment use, and increase access to testing, we compared the diagnostic equivalence of a modified specimen collection method, patient-collected lower nasal swabs, with that of the current clinical standard, health care worker–collected oropharyngeal swabs. If the 2 methods proved to be diagnostically equivalent, patients would be able to collect specimens themselves without exposing health care workers to respiratory secretions.

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Article Information

Accepted for Publication: May 18, 2020.

Published: June 12, 2020. doi:10.1001/jamanetworkopen.2020.12005

Correction: This article was corrected on July 13, 2020, to change the term sudden acute respiratory syndrome coronavirus 2 to severe acute respiratory syndrome coronavirus 2 in the title, text, and tables and to correct the corresponding author’s address.

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2020 Altamirano J et al. JAMA Network Open.

Corresponding Author: Jonathan Altamirano, MS, Department of Pediatrics, Stanford University School of Medicine, 300 Pasteur Dr, Stanford, CA 94305 (altamira@stanford.edu).

Author Contributions: Mr Altamirano and Mr Govindarajan 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.

Concept and design: Altamirano, Govindarajan, Blomkalns, Maldonado.

Acquisition, analysis, or interpretation of data: Altamirano, Govindarajan, Kushner, Stevens, Pinsky, Maldonado.

Drafting of the manuscript: Altamirano, Pinsky, Maldonado.

Critical revision of the manuscript for important intellectual content: Govindarajan, Blomkalns, Kushner, Stevens, Pinsky, Maldonado.

Statistical analysis: Altamirano, Govindarajan, Maldonado.

Administrative, technical, or material support: Govindarajan, Blomkalns, Kushner, Stevens, Pinsky.

Supervision: Altamirano, Govindarajan, Blomkalns, Pinsky, Maldonado.

Conflict of Interest Disclosures: None reported.

Additional Contributions: We thank the study participants for their invaluable contributions and time. Karen Heichman, PhD, Andrew Trister, MD, PhD, Dan Wattendorf, MD, and Emily Turner, PhD (all from The Bill & Melinda Gates Foundation) provided technical advice. Shawna Cooper, BA (Audere), and John Tamerius, PhD (Quidel), provided instructional materials and information on lower nasal swab use. Jonasel Roque, BS, Steven Levitte, MD, PhD, Monique B. de Araujo, MD, MPH, and Simran Gambhir, MD (all from Stanford University School of Medicine), performed screening, recruitment, and sample collection. None of these individuals was compensated for these contributions.

References

World Health Organization. Coronavirus disease (COVID-19): situation report 110. Published May 9, 2020. Accessed May 9, 2020. https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200509covid-19-sitrep-110.pdf?sfvrsn=3b92992c_4

Corman VM , Landt O , Kaiser M , et al. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill. 2020;25(3):2000045. doi:10.2807/1560-7917.ES.2020.25.3.2000045 PubMed Google Scholar

Hologic, Inc. SARS-CoV-2 assay (Panther Fusion System) package insert. Published 2020. Accessed May 20, 2020. https://www.hologic.com/package-inserts/diagnostic-products/panther-fusionr-sars-cov-2-assay

US Food and Drug Administration. Coronavirus (COVID-19) update: daily roundup. Published March 23, 2020. Accessed April 4, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup

AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
1.00 CME points in the American Board of Surgery’s (ABS) Continuing Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.