Longitudinal Assessment of Diagnostic Test Performance Over the Course of Acute SARS-CoV-2 Infection

Author:

Smith Rebecca L123,Gibson Laura L4,Martinez Pamela P156,Ke Ruian7,Mirza Agha8,Conte Madison8,Gallagher Nicholas9,Conte Abigail10,Wang Leyi11,Fredrickson Richard11,Edmonson Darci C1,Baughman Melinda E1,Chiu Karen K1,Choi Hannah1,Jensen Tor W112,Scardina Kevin R1,Bradley Shannon1,Gloss Stacy L1,Reinhart Crystal1,Yedetore Jagadeesh1,Owens Alyssa N13,Broach John1415,Barton Bruce1617,Lazar Peter16,Henness Darcy18,Young Todd18,Dunnett Alastair18,Robinson Matthew L8,Mostafa Heba H9,Pekosz Andrew10ORCID,Manabe Yukari C8,Heetderks William J19,McManus David D20,Brooke Christopher B15ORCID

Affiliation:

1. Carl R. Woese Institute for Genomic Biology, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA

2. Department of Pathobiology, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA

3. Carle Illinois College of Medicine, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA

4. Division of Infectious Diseases and Immunology, Departments of Medicine and Pediatrics, University of Massachusetts Medical School, Worcester, Massachusetts, USA

5. Department of Microbiology, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA

6. Department of Statistics, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA

7. T-6, Theoretical Biology and Biophysics, Los Alamos National Laboratory, Los Alamos, New Mexico, USA

8. Division of Infectious Diseases, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA

9. Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA

10. W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA

11. Veterinary Diagnostic Laboratory, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA

12. Cancer Center at Illinois, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA

13. Center for Clinical and Translational Research, University of Massachusetts Medical School, Worcester, Massachusetts, USA

14. UMass Memorial Medical Center, Worcester, Massachusetts, USA

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

16. Division of Biostatistics and Health Services Research, University of Massachusetts Medical School, Worcester, Massachusetts, USA

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

18. Carle Foundation Hospital, Urbana, Illinois, USA

19. National Institute for Biomedical Imaging and Bioengineering, Bethesda, Maryland, USA

20. Division of Cardiology, University of Massachusetts Medical School, Worcester, Massachusetts, USA

Abstract

Abstract Background Serial screening is critical for restricting spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by facilitating timely identification of infected individuals to interrupt transmission. Variation in sensitivity of different diagnostic tests at different stages of infection has not been well documented. Methods In a longitudinal study of 43 adults newly infected with SARS-CoV-2, all provided daily saliva and nasal swabs for quantitative reverse transcription polymerase chain reaction (RT-qPCR), Quidel SARS Sofia antigen fluorescent immunoassay (FIA), and live virus culture. Results Both RT-qPCR and Quidel SARS Sofia antigen FIA peaked in sensitivity during the period in which live virus was detected in nasal swabs, but sensitivity of RT-qPCR tests rose more rapidly prior to this period. We also found that serial testing multiple times per week increases the sensitivity of antigen tests. Conclusions RT-qPCR tests are more effective than antigen tests at identifying infected individuals prior to or early during the infectious period and thus for minimizing forward transmission (given timely results reporting). All tests showed >98% sensitivity for identifying infected individuals if used at least every 3 days. Daily screening using antigen tests can achieve approximately 90% sensitivity for identifying infected individuals while they are viral culture positive.

Funder

National Heart, Lung, and Blood Institute

National Institutes of Health

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Immunology and Allergy

Reference14 articles.

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4. SARS-CoV-2 transmission in intercollegiate athletics not fully mitigated with daily antigen testing. Clin Infect Dis;Moreno;2021: ciab343

5. Performance of an antigen-based test for asymptomatic and symptomatic SARS-CoV-2 testing at two university campuses—Wisconsin, September–October 2020;Pray;MMWR Morb Mortal Wkly Rep,2021

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