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

Assessment of Sensitivity and Specificity of Patient-Collected Lower Nasal Specimens for Severe... Research Letter | Infectious Diseases Assessment of Sensitivity and Specificity of Patient-Collected Lower Nasal Specimens for Severe Acute Respiratory Syndrome Coronavirus 2 Testing Jonathan Altamirano, MS; Prasanthi Govindarajan, MBBS, MAS; Andra L. Blomkalns, MD, MBA; Lauren E. Kushner, MD; Bryan Andrew Stevens, MD; Benjamin A. Pinsky, MD, PhD; Yvonne Maldonado, MD Introduction Since the emergence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) outbreak Author affiliations and article information are listed at the end of this article. 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. 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. Methods This prognostic study was approved by the Stanford University institutional review board. Participants provided oral informed consent to clinical research coordinators and then signed a consent form with the physician who collected the oropharyngeal swab. This study complies with the Standards for Reporting of Diagnostic Accuracy (STARD) reporting guideline. The target population was Stanford Health Care outpatients with a reverse transcriptase– polymerase chain reaction test that was positive for SARS-CoV-2 in March 2020. We included a convenience sample of patients who consented to be contacted by our study staff. Our study staff obtained informed consent remotely, to minimize exposure of research staff to infected patients and to reduce the duration of study visits, and sent instructional materials electronically. Health care workers were excluded because of their familiarity with specimen collection, as were patients enrolled in drug trials for SARS-CoV-2. After informed consent was obtained, participants were scheduled to return to Stanford Health Care for drive-through collection of 3 specimens using a patient-collected lower nasal swab (Puritan Sterile Foam Tipped Applicator; Puritan Medical Products), a physician-collected lower nasal swab (Puritan Sterile Foam Tipped Applicator; Puritan Medical Products), and a physician-collected oropharyngeal swab (FLOQ Swabs; Copan Diagnostics). During the visit, participants received a $20 incentive. The 3 specimens were placed in separate 3-mL tubes of viral transport medium (M4RT Transport; Remel MicroTest), stored in a cooler, and delivered to the Stanford Clinical Virology Laboratory. Specimens were tested for SARS-CoV-2 using reverse transcriptase–polymerase chain 2,3 reaction targeting the envelope or open reading frame 1 ab genes. We report participant demographic characteristics, sensitivity and specificity, and discordant probabilities with 95% binomial CIs of patient-collected lower nasal compared with physician- collected oropharyngeal specimens. All analyses were performed with SAS statistical software version 9.4 (SAS Institute). Data analysis was performed in May 2020. Open Access. This is an open access article distributed under the terms of the CC-BY License. JAMA Network Open. 2020;3(6):e2012005. doi:10.1001/jamanetworkopen.2020.12005 (Reprinted) June 12, 2020 1/4 JAMA Network Open | Infectious Diseases Sensitivity and Specificity of Patient-Collected Lower Nasal Specimens for SARS-CoV-2 Testing Table 1. Demographic Characteristics of Participants With a Positive Severe Acute Respiratory Syndrome Coronavirus 2 Diagnosis in Stanford, California, March 2020 Characteristic Participants, No. (%) Sex Male 16 (53) Female 14 (47) Race/ethnicity White 20 (66) Asian 3 (10) Hispanic or Latino 2 (7) Native Hawaiian or Pacific Islander 1 (3) Other 2 (7) Unknown 2 (7) Age, y 19-30 3 (10) 31-40 8 (27) 41-50 5 (17) 51-60 7 (23) 61-70 3 (10) 71-80 4 (13) Possible exposure Travel 5 (17) Close contact with a patient with coronavirus disease 2019 4 (13) Close contact with influenza-like illness 3 (10) Exposure unknown 18 (60) Symptoms at initial visit Cough 20 (67) Fever 13 (43) Sore throat 8 (27) Shortness of breath 7 (23) Congestion 6 (20) Myalgia 6 (20) Chest pain 5 (17) Headache 4 (13) Rhinorrhea 3 (10) Diarrhea 2 (7) Fatigue 2 (7) Weakness 1 (3) Decreased sense of taste 1 (3) Syncope 1 (3) Comorbidities Any comorbidity 16 (53) Hypertension 5 (17) Hyperlipidemia 5 (17) Asthma 3 (10) Diabetes 2 (7) Obesity (body mass index >30) 2 (7) Other 11 (37) Coinfections Any coinfections 5 (17) Rhinovirus 1 (3) Body mass index is calculated as weight in kilograms Respiratory syncytial virus 1 (3) divided by height in meters squared. Seasonal coronavirus 1 (3) Includes comorbidities such as chronic pain, arthritis, Parainfluenza (1, 3, or 4) 2 (7) anxiety, depression, and constipation. JAMA Network Open. 2020;3(6):e2012005. doi:10.1001/jamanetworkopen.2020.12005 (Reprinted) June 12, 2020 2/4 JAMA Network Open | Infectious Diseases Sensitivity and Specificity of Patient-Collected Lower Nasal Specimens for SARS-CoV-2 Testing Results Of 129 eligible SARS-CoV-2–infected patients, 30 participated in the study (mean [SD] age, 48.2 [16.0] years; 16 men [53%]). We do not have reasons for refusal for nonparticipants. Participants were predominantly white (20 participants [66%]), with no sex or age group predominance. Twelve participants (40%) self-reported possible exposure to SARS-CoV-2. Cough (20 participants [67%]), fever (13 participants [43%]), and sore throat (8 participants [27%]) were commonly reported symptoms during the first visit. Approximately one-half of the participants had documentation of chronic medical conditions (16 participants [53%]), and 5 participants (17%) tested positive for coinfections with other respiratory viruses (Table 1). We observed diagnostic equivalence across the 3 methods of specimen collection (Table 2). Eleven participants (37%) had test results that were positive for SARS-CoV-2 across patient- and physician-collected specimens, and 18 participants (60%) had results that were negative for SARS- CoV-2 across patient- and physician-collected specimens. The only discordant result was a participant whose self-collected nasal specimen tested positive, whereas both of their physician- collected specimens tested negative (3.30%; 95% CI, 0.08%-17.00%). The sensitivity of the patient- collected specimens was 100% (95% CI, 72%-100%), and the specificity was 95% (95% CI, 74%-100%). Table 2. Detection of Severe Acute Respiratory Syndrome Coronavirus 2 by Sampling Method and Days from Symptom Onset to Study Sample Collection in Stanford, California, March 2020 Time from self-reported Self-collected Physician-collected Physician-collected Participant symptom onset, d nasal swab nasal swab oropharyngeal swab 1 18 Detected Detected Detected 2 10 Not detected Not detected Not detected 3 8 Detected Detected Detected 4 13 Detected Detected Detected 5 22 Not detected Not detected Not detected 6 9 Not detected Not detected Not detected 7NA Not detected Not detected Not detected 8 26 Not detected Not detected Not detected 9 28 Detected Detected Detected 10 9 Detected Detected Detected 11 8 Detected Detected Detected b a 12 NA Detected Not detected Not detected 13 16 Not detected Not detected Not detected 14 14 Not detected Not detected Not detected 15 NA Not detected Not detected Not detected 16 10 Not detected Not detected Not detected 17 37 Not detected Not detected Not detected 18 24 Not detected Not detected Not detected 19 NA Detected Detected Detected 20 16 Not detected Not detected Not detected Abbreviation: NA, not applicable. 21 9 Not detected Not detected Not detected Symptom onset was not recorded in the electronic 22 NA Not detected Not detected Not detected medical record for participants 7, 12, 15, 19, 22, 28, 23 21 Not detected Not detected Not detected and 30. 24 15 Not detected Not detected Not detected Participant 12 presented with discordant results, 25 23 Not detected Not detected Not detected with a positive result for the self-collected nasal 26 10 Detected Detected Detected sample but negative results from both physician- collected samples. 27 4 Detected Detected Detected Participant 27 was asymptomatic but had been 28 NA Not detected Not detected Not detected exposed to severe acute respiratory syndrome 29 10 Detected Detected Detected coronavirus 2 by close contact 4 days before the 30 NA Detected Detected Detected study swab was obtained. JAMA Network Open. 2020;3(6):e2012005. doi:10.1001/jamanetworkopen.2020.12005 (Reprinted) June 12, 2020 3/4 JAMA Network Open | Infectious Diseases Sensitivity and Specificity of Patient-Collected Lower Nasal Specimens for SARS-CoV-2 Testing Discussion These findings contribute to the recently released US Food and Drug Administration guidance that lists patient-collected lower nasal swab as an acceptable specimen collection method for SARS-CoV-2 testing. Self-collected lower nasal swabs could also be used for home- or office-based testing of asymptomatic patients. However, these preliminary findings are limited by small sample size, have limited generalizability, and need to be validated further in diverse clinical settings. These validation efforts are currently under way at our institution. 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 Jetal. 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 Affiliations: Department of Pediatrics, Stanford University School of Medicine, Stanford, California (Altamirano, Kushner, Maldonado); Department of Emergency Medicine, Stanford University School of Medicine, Stanford, California (Govindarajan, Blomkalns); Department of Pathology, Stanford University School of Medicine, Stanford, California (Stevens, Pinsky). 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 Heich- man, 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, Mo- nique 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 1. 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 2. 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 3. 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 4. 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 JAMA Network Open. 2020;3(6):e2012005. doi:10.1001/jamanetworkopen.2020.12005 (Reprinted) June 12, 2020 4/4 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Network Open American Medical Association

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

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Abstract

Research Letter | Infectious Diseases Assessment of Sensitivity and Specificity of Patient-Collected Lower Nasal Specimens for Severe Acute Respiratory Syndrome Coronavirus 2 Testing Jonathan Altamirano, MS; Prasanthi Govindarajan, MBBS, MAS; Andra L. Blomkalns, MD, MBA; Lauren E. Kushner, MD; Bryan Andrew Stevens, MD; Benjamin A. Pinsky, MD, PhD; Yvonne Maldonado, MD Introduction Since the emergence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) outbreak Author affiliations and article information are listed at the end of this article. 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. 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. Methods This prognostic study was approved by the Stanford University institutional review board. Participants provided oral informed consent to clinical research coordinators and then signed a consent form with the physician who collected the oropharyngeal swab. This study complies with the Standards for Reporting of Diagnostic Accuracy (STARD) reporting guideline. The target population was Stanford Health Care outpatients with a reverse transcriptase– polymerase chain reaction test that was positive for SARS-CoV-2 in March 2020. We included a convenience sample of patients who consented to be contacted by our study staff. Our study staff obtained informed consent remotely, to minimize exposure of research staff to infected patients and to reduce the duration of study visits, and sent instructional materials electronically. Health care workers were excluded because of their familiarity with specimen collection, as were patients enrolled in drug trials for SARS-CoV-2. After informed consent was obtained, participants were scheduled to return to Stanford Health Care for drive-through collection of 3 specimens using a patient-collected lower nasal swab (Puritan Sterile Foam Tipped Applicator; Puritan Medical Products), a physician-collected lower nasal swab (Puritan Sterile Foam Tipped Applicator; Puritan Medical Products), and a physician-collected oropharyngeal swab (FLOQ Swabs; Copan Diagnostics). During the visit, participants received a $20 incentive. The 3 specimens were placed in separate 3-mL tubes of viral transport medium (M4RT Transport; Remel MicroTest), stored in a cooler, and delivered to the Stanford Clinical Virology Laboratory. Specimens were tested for SARS-CoV-2 using reverse transcriptase–polymerase chain 2,3 reaction targeting the envelope or open reading frame 1 ab genes. We report participant demographic characteristics, sensitivity and specificity, and discordant probabilities with 95% binomial CIs of patient-collected lower nasal compared with physician- collected oropharyngeal specimens. All analyses were performed with SAS statistical software version 9.4 (SAS Institute). Data analysis was performed in May 2020. Open Access. This is an open access article distributed under the terms of the CC-BY License. JAMA Network Open. 2020;3(6):e2012005. doi:10.1001/jamanetworkopen.2020.12005 (Reprinted) June 12, 2020 1/4 JAMA Network Open | Infectious Diseases Sensitivity and Specificity of Patient-Collected Lower Nasal Specimens for SARS-CoV-2 Testing Table 1. Demographic Characteristics of Participants With a Positive Severe Acute Respiratory Syndrome Coronavirus 2 Diagnosis in Stanford, California, March 2020 Characteristic Participants, No. (%) Sex Male 16 (53) Female 14 (47) Race/ethnicity White 20 (66) Asian 3 (10) Hispanic or Latino 2 (7) Native Hawaiian or Pacific Islander 1 (3) Other 2 (7) Unknown 2 (7) Age, y 19-30 3 (10) 31-40 8 (27) 41-50 5 (17) 51-60 7 (23) 61-70 3 (10) 71-80 4 (13) Possible exposure Travel 5 (17) Close contact with a patient with coronavirus disease 2019 4 (13) Close contact with influenza-like illness 3 (10) Exposure unknown 18 (60) Symptoms at initial visit Cough 20 (67) Fever 13 (43) Sore throat 8 (27) Shortness of breath 7 (23) Congestion 6 (20) Myalgia 6 (20) Chest pain 5 (17) Headache 4 (13) Rhinorrhea 3 (10) Diarrhea 2 (7) Fatigue 2 (7) Weakness 1 (3) Decreased sense of taste 1 (3) Syncope 1 (3) Comorbidities Any comorbidity 16 (53) Hypertension 5 (17) Hyperlipidemia 5 (17) Asthma 3 (10) Diabetes 2 (7) Obesity (body mass index >30) 2 (7) Other 11 (37) Coinfections Any coinfections 5 (17) Rhinovirus 1 (3) Body mass index is calculated as weight in kilograms Respiratory syncytial virus 1 (3) divided by height in meters squared. Seasonal coronavirus 1 (3) Includes comorbidities such as chronic pain, arthritis, Parainfluenza (1, 3, or 4) 2 (7) anxiety, depression, and constipation. JAMA Network Open. 2020;3(6):e2012005. doi:10.1001/jamanetworkopen.2020.12005 (Reprinted) June 12, 2020 2/4 JAMA Network Open | Infectious Diseases Sensitivity and Specificity of Patient-Collected Lower Nasal Specimens for SARS-CoV-2 Testing Results Of 129 eligible SARS-CoV-2–infected patients, 30 participated in the study (mean [SD] age, 48.2 [16.0] years; 16 men [53%]). We do not have reasons for refusal for nonparticipants. Participants were predominantly white (20 participants [66%]), with no sex or age group predominance. Twelve participants (40%) self-reported possible exposure to SARS-CoV-2. Cough (20 participants [67%]), fever (13 participants [43%]), and sore throat (8 participants [27%]) were commonly reported symptoms during the first visit. Approximately one-half of the participants had documentation of chronic medical conditions (16 participants [53%]), and 5 participants (17%) tested positive for coinfections with other respiratory viruses (Table 1). We observed diagnostic equivalence across the 3 methods of specimen collection (Table 2). Eleven participants (37%) had test results that were positive for SARS-CoV-2 across patient- and physician-collected specimens, and 18 participants (60%) had results that were negative for SARS- CoV-2 across patient- and physician-collected specimens. The only discordant result was a participant whose self-collected nasal specimen tested positive, whereas both of their physician- collected specimens tested negative (3.30%; 95% CI, 0.08%-17.00%). The sensitivity of the patient- collected specimens was 100% (95% CI, 72%-100%), and the specificity was 95% (95% CI, 74%-100%). Table 2. Detection of Severe Acute Respiratory Syndrome Coronavirus 2 by Sampling Method and Days from Symptom Onset to Study Sample Collection in Stanford, California, March 2020 Time from self-reported Self-collected Physician-collected Physician-collected Participant symptom onset, d nasal swab nasal swab oropharyngeal swab 1 18 Detected Detected Detected 2 10 Not detected Not detected Not detected 3 8 Detected Detected Detected 4 13 Detected Detected Detected 5 22 Not detected Not detected Not detected 6 9 Not detected Not detected Not detected 7NA Not detected Not detected Not detected 8 26 Not detected Not detected Not detected 9 28 Detected Detected Detected 10 9 Detected Detected Detected 11 8 Detected Detected Detected b a 12 NA Detected Not detected Not detected 13 16 Not detected Not detected Not detected 14 14 Not detected Not detected Not detected 15 NA Not detected Not detected Not detected 16 10 Not detected Not detected Not detected 17 37 Not detected Not detected Not detected 18 24 Not detected Not detected Not detected 19 NA Detected Detected Detected 20 16 Not detected Not detected Not detected Abbreviation: NA, not applicable. 21 9 Not detected Not detected Not detected Symptom onset was not recorded in the electronic 22 NA Not detected Not detected Not detected medical record for participants 7, 12, 15, 19, 22, 28, 23 21 Not detected Not detected Not detected and 30. 24 15 Not detected Not detected Not detected Participant 12 presented with discordant results, 25 23 Not detected Not detected Not detected with a positive result for the self-collected nasal 26 10 Detected Detected Detected sample but negative results from both physician- collected samples. 27 4 Detected Detected Detected Participant 27 was asymptomatic but had been 28 NA Not detected Not detected Not detected exposed to severe acute respiratory syndrome 29 10 Detected Detected Detected coronavirus 2 by close contact 4 days before the 30 NA Detected Detected Detected study swab was obtained. JAMA Network Open. 2020;3(6):e2012005. doi:10.1001/jamanetworkopen.2020.12005 (Reprinted) June 12, 2020 3/4 JAMA Network Open | Infectious Diseases Sensitivity and Specificity of Patient-Collected Lower Nasal Specimens for SARS-CoV-2 Testing Discussion These findings contribute to the recently released US Food and Drug Administration guidance that lists patient-collected lower nasal swab as an acceptable specimen collection method for SARS-CoV-2 testing. Self-collected lower nasal swabs could also be used for home- or office-based testing of asymptomatic patients. However, these preliminary findings are limited by small sample size, have limited generalizability, and need to be validated further in diverse clinical settings. These validation efforts are currently under way at our institution. 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 Jetal. 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 Affiliations: Department of Pediatrics, Stanford University School of Medicine, Stanford, California (Altamirano, Kushner, Maldonado); Department of Emergency Medicine, Stanford University School of Medicine, Stanford, California (Govindarajan, Blomkalns); Department of Pathology, Stanford University School of Medicine, Stanford, California (Stevens, Pinsky). 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 Heich- man, 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, Mo- nique 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 1. 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 2. 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 3. 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 4. 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 JAMA Network Open. 2020;3(6):e2012005. doi:10.1001/jamanetworkopen.2020.12005 (Reprinted) June 12, 2020 4/4

Journal

JAMA Network OpenAmerican Medical Association

Published: Jun 12, 2020

References