Home Antigen Testing vs RT-PCR and Viral Culture During the Course of SARS-CoV-2 Infection | Infectious Diseases | JN Learning | AMA Ed Hub [Skip to Content]
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Coronavirus (COVID-19)

Comparison of Home Antigen Testing With RT-PCR and Viral Culture During the Course of SARS-CoV-2 Infection

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME
JAMA Internal Medicine
April 29, 2022
Original Investigation
Victoria T. Chu, MD, MPH1,2;
Noah G. Schwartz, MD1,2;
Marisa A. P. Donnelly, PhD1,2;
Meagan R. Chuey, PhD, RN1,2,3;
Raymond Soto, PhD1,2;
Anna R. Yousaf, MD1,2;
Emily N. Schmitt-Matzen, DVM, MPH1,2;
Sadia Sleweon, MPH1;
Jasmine Ruffin, MPH1;
Natalie Thornburg, PhD1;
Jennifer L. Harcourt, PhD1;
Azaibi Tamin, PhD1;
Gimin Kim, BS1;
Jennifer M. Folster, PhD1;
Laura J. Hughes, PhD1;
Suxiang Tong, PhD1;
Ginger Stringer, PhD, MPH4;
Bernadette A. Albanese, MD, MPH5;
Sarah E. Totten, DrPH4;
Meghan M. Hudziec, BS4;
Shannon R. Matzinger, PhD4;
Elizabeth A. Dietrich, PhD1;
Sarah W. Sheldon, MS1;
Sarah Stous, MPH3;
Eric C. McDonald, MD, MPH3;
Brett Austin, MA3;
Mark E. Beatty, MD, MPH3;
J. Erin Staples, MD, PhD1;
Marie E. Killerby, VetMB, MPH1;
Christopher H. Hsu, MD, PhD1;
Jacqueline E. Tate, PhD1;
Hannah L. Kirking, MD1;
Almea Matanock, MD, MS1;
for the COVID-19 Household Transmission Team
Author Affiliations
  • 1COVID-19 Response Team, US Centers for Disease Control and Prevention, Atlanta, Georgia
  • 2Epidemic Intelligence Service, US Centers for Disease Control and Prevention, Atlanta, Georgia
  • 3County of San Diego Health and Human Services Agency, San Diego, California
  • 4Colorado Department of Public Health and Environment, Denver
  • 5Tri-County Health Department, Greenwood Village, Colorado
  • COVID-19 Household Transmission Teamfor the
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Key Points

Question  How does the diagnostic performance of home antigen tests change during the course of SARS-CoV-2 infection?

Findings  In this prospective cohort study of 225 adults and children with reverse transcription–polymerase chain reaction (RT-PCR)–confirmed SARS-CoV-2 infection, antigen test sensitivity was 64% and 84% when compared with same-day RT-PCR and viral culture, respectively. Antigen test sensitivity peaked 4 days after illness onset (77%); a second test 1 to 2 days later showed improved sensitivity (81%-85%).

Meaning  The study results suggest that symptomatic individuals with an initial negative home antigen test result for SARS-CoV-2 infection should test again 1 to 2 days later because test sensitivity seems to peak several days after illness onset.

Abstract

Importance  As self-collected home antigen tests become widely available, a better understanding of their performance during the course of SARS-CoV-2 infection is needed.

Objective  To evaluate the diagnostic performance of home antigen tests compared with reverse transcription–polymerase chain reaction (RT-PCR) and viral culture by days from illness onset, as well as user acceptability.

Design, Setting, and Participants  This prospective cohort study was conducted from January to May 2021 in San Diego County, California, and metropolitan Denver, Colorado. The convenience sample included adults and children with RT-PCR–confirmed infection who used self-collected home antigen tests for 15 days and underwent at least 1 nasopharyngeal swab for RT-PCR, viral culture, and sequencing.

Exposures  SARS-CoV-2 infection.

Main Outcomes and Measures  The primary outcome was the daily sensitivity of home antigen tests to detect RT-PCR–confirmed cases. Secondary outcomes included the daily percentage of antigen test, RT-PCR, and viral culture results that were positive, and antigen test sensitivity compared with same-day RT-PCR and cultures. Antigen test use errors and acceptability were assessed for a subset of participants.

Results  This study enrolled 225 persons with RT-PCR–confirmed infection (median [range] age, 29 [1-83] years; 117 female participants [52%]; 10 [4%] Asian, 6 [3%] Black or African American, 50 [22%] Hispanic or Latino, 3 [1%] Native Hawaiian or Other Pacific Islander, 145 [64%] White, and 11 [5%] multiracial individuals) who completed 3044 antigen tests and 642 nasopharyngeal swabs. Antigen test sensitivity was 50% (95% CI, 45%-55%) during the infectious period, 64% (95% CI, 56%-70%) compared with same-day RT-PCR, and 84% (95% CI, 75%-90%) compared with same-day cultures. Antigen test sensitivity peaked 4 days after illness onset at 77% (95% CI, 69%-83%). Antigen test sensitivity improved with a second antigen test 1 to 2 days later, particularly early in the infection. Six days after illness onset, antigen test result positivity was 61% (95% CI, 53%-68%). Almost all (216 [96%]) surveyed individuals reported that they would be more likely to get tested for SARS-CoV-2 infection if home antigen tests were available over the counter.

Conclusions and Relevance  The results of this cohort study of home antigen tests suggest that sensitivity for SARS-CoV-2 was moderate compared with RT-PCR and high compared with viral culture. The results also suggest that symptomatic individuals with an initial negative home antigen test result for SARS-CoV-2 infection should test again 1 to 2 days later because test sensitivity peaked several days after illness onset and improved with repeated testing.

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Infectious Diseases Pathology and Laboratory Medicine Coronavirus (COVID-19)
Article Information

Accepted for Publication: April 5, 2022.

Published Online: April 29, 2022. doi:10.1001/jamainternmed.2022.1827

Corresponding Author: Noah G. Schwartz, MD, US Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Mailstop US12-4, Atlanta, GA 30329 (nschwartz@cdc.gov).

Author Contributions: Drs Chu and Schwartz 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. Drs Chu, Schwartz, and Matanock contributed equally to this work as lead authors.

Concept and design: Chu, Schwartz, Donnelly, Chuey, Yousaf, Ruffin, Thornburg, Hughes, Stringer, Albanese, Sheldon, Beatty, Killerby, Hsu, Tate, Kirking, Matanock.

Acquisition, analysis, or interpretation of data: Chu, Schwartz, Donnelly, Chuey, Soto, Yousaf, Schmitt-Matzen, Sleweon, Thornburg, Harcourt, Tamin, Kim, Folster, Hughes, Tong, Stringer, Totten, Hudziec, Matzinger, Dietrich, Sheldon, Stous, McDonald, Austin, Beatty, Staples, Killerby, Hsu, Tate, Kirking, Matanock, Tamin, Totten.

Drafting of the manuscript: Chu, Schwartz, Schmitt-Matzen, Matzinger, Sheldon, McDonald, Austin, Beatty, Matanock.

Critical revision of the manuscript for important intellectual content: Chu, Schwartz, Donnelly, Chuey, Soto, Yousaf, Sleweon, Ruffin, Thornburg, Harcourt, Tamin, Kim, Folster, Hughes, Tong, Stringer, Albanese, Totten, Hudziec, Dietrich, Sheldon, Stous, McDonald, Austin, Beatty, Staples, Killerby, Hsu, Tate, Kirking, Matanock.

Statistical analysis: Chu, Schwartz, Sleweon.

Obtained funding: Kirking.

Administrative, technical, or material support: Chu, Donnelly, Chuey, Schmitt-Matzen, Thornburg, Harcourt, Kim, Folster, Hughes, Stringer, Matzinger, Sheldon, Stous, McDonald, Austin, Beatty, Staples, Killerby, Kirking, Matanock.

Supervision: Thornburg, Hughes, Tong, Stringer, Sheldon, Beatty, Hsu, Tate, Kirking, Matanock, Sleweon.

Other: Ruffin.

Conflict of Interest Disclosures: Dr Stringer reported grants from the US Centers for Disease Control and Prevention (CDC) Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases during the conduct of the study. No other disclosures were reported.

Funding/Support: This investigation was funded by the CDC. The investigation was supported by the County of San Diego Health and Human Services Agency, California Department of Public Health, Colorado Department of Public Health and Environment, and Tri-County Health Department.

Role of the Funder/Sponsor: Investigators from the CDC, County of San Diego Health and Human Services Agency, California Department of Public Health, Colorado Department of Public Health and Environment, and Tri-County Health Department were involved in all aspects of the study, including 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.

Group Information: A full list of COVID-19 Household Transmission Team contributors is available in Supplement 2.

Disclaimer: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the CDC, County of San Diego Health and Human Services Agency, California Department of Public Health, Colorado Department of Public Health and Environment, or Tri-County Health Department.

Additional Contributions: We thank the investigation participants and state and local health department and laboratory staff.

References
1.
Dinnes  J , Deeks  JJ , Berhane  S ,  et al; Cochrane COVID-19 Diagnostic Test Accuracy Group.  Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection.   Cochrane Database Syst Rev. 2021;3(3):CD013705. doi:10.1002/14651858.CD013705.pub2PubMedGoogle ScholarCrossref
2.
Hanson  KE , Altayar  O , Caliendo  AM ,  et al.  The Infectious Diseases Society of America guidelines on the diagnosis of COVID-19: antigen testing.   Clin Infect Dis. Published online June 23, 2021. doi:10.1093/cid/ciab557PubMedGoogle ScholarCrossref
3.
Smith  RL , Gibson  LL , Martinez  PP ,  et al.  Longitudinal assessment of diagnostic test performance over the course of acute SARS-CoV-2 infection.   J Infect Dis. 2021;224(6):976-982. doi:10.1093/infdis/jiab337PubMedGoogle ScholarCrossref
4.
Donnelly  MAP , Chuey  MR , Soto  R ,  et al; COVID-19 Household Transmission Team.  Household transmission of SARS-CoV-2 Alpha variant—United States, 2021.   Clin Infect Dis. Published online February 11, 2022. doi:10.1093/cid/ciac125PubMedGoogle ScholarCrossref
5.
National Archives. Code of Federal Regulations. Accessed January 15, 2021. https://www.ecfr.gov/
6.
US House of Representatives. US Code. Accessed January 15, 2021. https://uscode.house.gov/
7.
von Elm  E , Altman  DG , Egger  M , Pocock  SJ , Gøtzsche  PC , Vandenbroucke  JP ; STROBE Initiative.  The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.   Lancet. 2007;370(9596):1453-1457. doi:10.1016/S0140-6736(07)61602-XPubMedGoogle ScholarCrossref
8.
US Centers for Disease Control and Prevention. Case investigation & contact tracing guidance: appendices. Accessed June 16, 2021. https://www.cdc.gov/coronavirus/2019-ncov/php/contact-tracing/contact-tracing-plan/appendix.html#contact
9.
Office of Management and Budget. Revisions to the standards for the classification of federal data on race and ethnicity. Accessed April 1, 2021. https://www.govinfo.gov/content/pkg/FR-1997-10-30/pdf/97-28653.pdf
10.
Quidel. QuickVue At-Home COVID-19 Test: user instructions. Accessed June 16, 2021. https://www.fda.gov/media/146313/download
11.
ThermoFisher Scientific. TaqPath COVID-19 Combo Kit and TaqPath COVID-19 Combo Kit Advanced: instructions for use. Accessed June 16, 2021. https://www.fda.gov/media/136112/download
12.
PerkinElmer. Instructions for PerkinElmer New Coronavirus Nucleic Acid Detection Kit v 8.0. Accessed June 16, 2021. https://www.fda.gov/media/136410/download
13.
Paden  CR , Tao  Y , Queen  K ,  et al.  Rapid, sensitive, full-genome sequencing of severe acute respiratory syndrome coronavirus 2.   Emerg Infect Dis. 2020;26(10):2401-2405. doi:10.3201/eid2610.201800PubMedGoogle ScholarCrossref
14.
Martin Webb  L , Matzinger  S , Grano  C ,  et al.  Identification of and surveillance for the SARS-CoV-2 variants B.1.427 and B.1.429—Colorado, January-March 2021.   MMWR Morb Mortal Wkly Rep. 2021;70(19):717-718. doi:10.15585/mmwr.mm7019e2PubMedGoogle ScholarCrossref
15.
Harcourt  J , Tamin  A , Lu  X ,  et al.  Severe acute respiratory syndrome coronavirus 2 from patient with coronavirus disease, United States.   Emerg Infect Dis. 2020;26(6):1266-1273. doi:10.3201/eid2606.200516PubMedGoogle ScholarCrossref
16.
Killerby  ME , Ata Ur Rasheed  M , Tamin  A ,  et al.  Shedding of culturable virus, seroconversion, and 6-month follow-up antibody responses in the first 14 confirmed cases of coronavirus disease 2019 in the United States.   J Infect Dis. 2021;224(5):771-776. doi:10.1093/infdis/jiab125PubMedGoogle ScholarCrossref
17.
Huang  C-G , Lee  K-M , Hsiao  M-J ,  et al.  Culture-based virus isolation to evaluate potential infectivity of clinical specimens tested for COVID-19.   J Clin Microbiol. 2020;58(8):e01068-e20. doi:10.1128/JCM.01068-20PubMedGoogle ScholarCrossref
18.
Basile  K , McPhie  K , Carter  I ,  et al.  Cell-based culture informs infectivity and safe de-isolation assessments in patients with coronavirus disease 2019.   Clin Infect Dis. 2021;73(9):e2952-e2959. doi:10.1093/cid/ciaa1579PubMedGoogle ScholarCrossref
19.
US Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19): 2020 interim case definition, approved August 5, 2020. Accessed September 19, 2020. https://ndc.services.cdc.gov/case-definitions/coronavirus-disease-2019-2020-08-05/
20.
Brown  LD , Cai  TT , DasGupta  A .  Interval estimation for a binomial proportion.   Stat Sci. 2001;16(2):101-133. doi:10.1214/ss/1009213286Google ScholarCrossref
21.
US Centers for Disease Control and Prevention. Ending isolation and precautions for people with COVID-19: interim guidance. Accessed April 1, 2022. https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html
22.
World Health Organization. COVID-19 target product profiles for priority diagnostics to support response to the COVID-19 pandemic v.1.0. Accessed November 1, 2021. https://www.who.int/publications/m/item/covid-19-target-product-profiles-for-priority-diagnostics-to-support-response-to-the-covid-19-pandemic-v.0.1
23.
Lindner  AK , Nikolai  O , Rohardt  C ,  et al.  Diagnostic accuracy and feasibility of patient self-testing with a SARS-CoV-2 antigen-detecting rapid test.   J Clin Virol. 2021;141:104874. doi:10.1016/j.jcv.2021.104874PubMedGoogle ScholarCrossref
24.
Shah  MM , Salvatore  PP , Ford  L ,  et al.  Performance of repeat BinaxNOW severe acute respiratory syndrome coronavirus 2 antigen testing in a community setting, Wisconsin, November 2020-December 2020.   Clin Infect Dis. 2021;73(suppl 1):S54-S57. doi:10.1093/cid/ciab309PubMedGoogle ScholarCrossref
25.
Pray  IW , Ford  L , Cole  D ,  et al.  Performance of an antigen-based test for asymptomatic and symptomatic SARS-CoV-2 testing at two university campuses—Wisconsin, September-October 2020.   MMWR Morb Mortal Wkly Rep.  2021;69(5152):1642-1647. doi:10.15585/mmwr.mm695152a3PubMedGoogle ScholarCrossref
26.
Prince-Guerra  JL , Almendares  O , Nolen  LD ,  et al.  Evaluation of Abbott BinaxNOW rapid antigen test for SARS-CoV-2 infection at two community-based testing sites—Pima County, Arizona, November 3-17, 2020.   MMWR Morb Mortal Wkly Rep. 2021;70(3):100-105. doi:10.15585/mmwr.mm7003e3PubMedGoogle ScholarCrossref
27.
Cevik  M , Tate  M , Lloyd  O , Maraolo  AE , Schafers  J , Ho  A .  SARS-CoV-2, SARS-CoV, and MERS-CoV viral load dynamics, duration of viral shedding, and infectiousness: a systematic review and meta-analysis.   Lancet Microbe. 2021;2(1):e13-e22. doi:10.1016/S2666-5247(20)30172-5PubMedGoogle ScholarCrossref
28.
He  X , Lau  EHY , Wu  P ,  et al.  Temporal dynamics in viral shedding and transmissibility of COVID-19.   Nat Med. 2020;26(5):672-675. doi:10.1038/s41591-020-0869-5PubMedGoogle ScholarCrossref
29.
Cheng  H-Y , Jian  S-W , Liu  D-P , Ng  T-C , Huang  W-T , Lin  H-H ; Taiwan COVID-19 Outbreak Investigation Team.  Contact tracing assessment of COVID-19 transmission dynamics in Taiwan and risk at different exposure periods before and after symptom onset.   JAMA Intern Med. 2020;180(9):1156-1163. doi:10.1001/jamainternmed.2020.2020PubMedGoogle ScholarCrossref
30.
Surie  D , Huang  JY , Brown  AC ,  et al.  Infectious period of severe acute respiratory syndrome coronavirus 2 in 17 nursing home residents—Arkansas.   Open Forum Infect Dis. 2021;8(3):ofab048. doi:10.1093/ofid/ofab048PubMedGoogle ScholarCrossref
31.
Li  N , Wang  X , Lv  T .  Prolonged SARS-CoV-2 RNA shedding: not a rare phenomenon.   J Med Virol. 2020;92(11):2286-2287. doi:10.1002/jmv.25952PubMedGoogle ScholarCrossref
32.
Liu  W-D , Chang  S-Y , Wang  J-T ,  et al.  Prolonged virus shedding even after seroconversion in a patient with COVID-19.   J Infect. 2020;81(2):318-356. doi:10.1016/j.jinf.2020.03.063PubMedGoogle ScholarCrossref
33.
Mallett  S , Allen  AJ , Graziadio  S ,  et al.  At what times during infection is SARS-CoV-2 detectable and no longer detectable using RT-PCR-based tests? a systematic review of individual participant data.   BMC Med. 2020;18(1):346. doi:10.1186/s12916-020-01810-8PubMedGoogle ScholarCrossref
34.
US Centers for Disease Control and Prevention. COVID-19 quarantine and isolation. Accessed April 1, 2022. https://www.cdc.gov/coronavirus/2019-ncov/your-health/quarantine-isolation.html
35.
Kidd  M , Richter  A , Best  A ,  et al.  S-variant SARS-CoV-2 lineage B1.1.7 is associated with significantly higher viral load in samples tested by TaqPath polymerase chain reaction.   J Infect Dis. 2021;223(10):1666-1670. doi:10.1093/infdis/jiab082PubMedGoogle ScholarCrossref
36.
Calistri  P , Amato  L , Puglia  I ,  et al.  Infection sustained by lineage B.1.1.7 of SARS-CoV-2 is characterised by longer persistence and higher viral RNA loads in nasopharyngeal swabs.   Int J Infect Dis. 2021;105:753-755. doi:10.1016/j.ijid.2021.03.005PubMedGoogle ScholarCrossref
37.
Jones  TC , Biele  G , Mühlemann  B ,  et al.  Estimating infectiousness throughout SARS-CoV-2 infection course.   Science. 2021;373(6551):eabi5273. doi:10.1126/science.abi5273PubMedGoogle ScholarCrossref
38.
Lyngse  FP , Mølbak  K , Skov  RL ,  et al; Danish Covid-19 Genome Consortium.  Increased transmissibility of SARS-CoV-2 lineage B.1.1.7 by age and viral load.   Nat Commun. 2021;12(1):7251. doi:10.1038/s41467-021-27202-xPubMedGoogle ScholarCrossref
39.
Singanayagam  A , Hakki  S , Dunning  J ,  et al; ATACCC Study Investigators.  Community transmission and viral load kinetics of the SARS-CoV-2 delta (B.1.617.2) variant in vaccinated and unvaccinated individuals in the UK: a prospective, longitudinal, cohort study.   Lancet Infect Dis. 2022;22(2):183-195. doi:10.1016/S1473-3099(21)00648-4PubMedGoogle ScholarCrossref
40.
Schrom  J , Marquez  C , Pilarowski  G ,  et al.  Comparison of SARS-CoV-2 reverse transcriptase polymerase chain reaction and BinaxNOW rapid antigen tests at a community site during an Omicron surge: a cross-sectional study.   Ann Intern Med. Published online March 15, 2022. doi:10.7326/M22-0202PubMedGoogle ScholarCrossref
41.
US Centers for Disease Control and Prevention. COVID data tracker: nationwide COVID-19 infection- and vaccination-induced antibody seroprevalence (blood donations). Accessed April 1, 2022. https://covid.cdc.gov/covid-data-tracker/#nationwide-blood-donor-seroprevalence
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