Performance of and Severe Acute Respiratory Syndrome Coronavirus 2 Diagnostics Based on Symptom Onset and Close Contact Exposure: An Analysis From the Test Us at Home Prospective Cohort Study-Reference-Cited by-同舟云学术

Performance of and Severe Acute Respiratory Syndrome Coronavirus 2 Diagnostics Based on Symptom Onset and Close Contact Exposure: An Analysis From the Test Us at Home Prospective Cohort Study

Published:2024-05-31 Issue:6 Volume:11 Page:
ISSN:2328-8957
Container-title:Open Forum Infectious Diseases
language:en
Short-container-title:

Author:

Herbert Carly¹²^ORCID,Wang Biqi¹³,Lin Honghuang¹³,Yan Yi⁴,Hafer Nathaniel²⁵,Pretz Caitlin¹,Stamegna Pamela¹,Wright Colton¹,Suvarna Thejas⁶,Harman Emma⁶,Schrader Summer⁶,Nowak Chris⁶,Kheterpal Vik⁶,Orvek Elizabeth⁷,Wong Steven⁷,Zai Adrian⁷,Barton Bruce⁷^ORCID,Gerber Ben S⁷,Lemon Stephenie C⁷,Filippaios Andreas¹,Gibson Laura⁸,Greene Sharone⁸,Colubri Andres⁹,Achenbach Chad¹⁰,Murphy Robert¹⁰,Heetderks William¹¹,Manabe Yukari C¹²,O’Connor Laurel¹³,Fahey Nisha¹⁷¹⁴,Luzuriaga Katherine²⁵,Broach John²¹³,Roth Kristian⁴,McManus David D¹³¹⁵,Soni Apurv¹³⁷^ORCID

Affiliation:

1. Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School , Worcester, Massachusetts , USA

2. University of Massachusetts Center for Clinical and Translational Science, University of Massachusetts Chan Medical School , Worcester, Massachusetts , USA

3. Division of Health System Science, Department of Medicine, University of Massachusetts Chan Medical School , Worcester, Massachusetts , USA

4. Division of Microbiology, OHT7 Office of Product Evaluation and Quality, Center for Devices and Radiological Health, US Food and Drug Administration , Silver Spring, Maryland , USA

5. Program in Molecular Medicine, University of Massachusetts Chan Medical School , Worcester, Massachusetts , USA

6. CareEvolution , Ann Arbor, Michigan , USA

7. Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School , Worcester, Massachusetts , USA

8. Division of Infectious Disease, Department of Medicine, University of Massachusetts Chan Medical School , Worcester, Massachusetts , USA

9. Department of Microbiology and Physiological Systems, University of Massachusetts Chan Medical School , Worcester, Massachusetts , USA

10. Division of Infectious Disease, Department of Medicine, Havey Institute for Global Health, Feinberg School of Medicine, Northwestern University , Chicago, Illinois , USA

11. National Institute of Biomedical Imaging and Bioengineering, NIH, via contract with Kelly Services , Bethesda, Maryland , USA

12. Division of Infectious Disease, Department of Medicine, Johns Hopkins University School of Medicine , Baltimore, Maryland , USA

13. Department of Emergency Medicine, University of Massachusetts Chan Medical School , Worcester, Massachusetts , USA

14. Department of Pediatrics, University of Massachusetts Chan Medical School , Worcester, Massachusetts , USA

15. Division of Cardiology, Department of Medicine, University of Massachusetts Chan Medical School , Worcester, Massachusetts , USA

Abstract

Abstract Background Understanding changes in diagnostic performance after symptom onset and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposure within different populations is crucial to guide the use of diagnostics for SARS-CoV-2. Methods The Test Us at Home study was a longitudinal cohort study that enrolled individuals across the United States between October 2021 and February 2022. Participants performed paired antigen-detection rapid diagnostic tests (Ag-RDTs) and reverse-transcriptase polymerase chain reaction (RT-PCR) tests at home every 48 hours for 15 days and self-reported symptoms and known coronavirus disease 2019 exposures immediately before testing. The percent positivity for Ag-RDTs and RT-PCR tests was calculated each day after symptom onset and exposure and stratified by vaccination status, variant, age category, and sex. Results The highest percent positivity occurred 2 days after symptom onset (RT-PCR, 91.2%; Ag-RDT, 71.1%) and 6 days after exposure (RT-PCR, 91.8%; Ag-RDT, 86.2%). RT-PCR and Ag-RDT performance did not differ by vaccination status, variant, age category, or sex. The percent positivity for Ag-RDTs was lower among exposed, asymptomatic than among symptomatic individuals (37.5% (95% confidence interval [CI], 13.7%–69.4%) vs 90.3% (75.1%–96.7%). Cumulatively, Ag-RDTs detected 84.9% (95% CI, 78.2%–89.8%) of infections within 4 days of symptom onset. For exposed participants, Ag-RDTs detected 94.0% (95% CI, 86.7%–97.4%) of RT-PCR–confirmed infections within 6 days of exposure. Conclusions The percent positivity for Ag-RDTs and RT-PCR tests was highest 2 days after symptom onset and 6 days after exposure, and performance increased with serial testing. The percent positivity of Ag-RDTs was lowest among asymptomatic individuals but did not differ by sex, variant, vaccination status, or age category.

Funder

National Institutes of Health

NIH CTSA

Publisher

Oxford University Press (OUP)

Link

https://academic.oup.com/ofid/advance-article-pdf/doi/10.1093/ofid/ofae304/58035707/ofae304.pdf

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