1. Epidemiologic Characteristics Associated With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen-Based Test Results, Real-Time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) Cycle Threshold Values, Subgenomic RNA, and Viral Culture Results From University Testing
- Author
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Jennifer M Folster, Natalie J. Thornburg, Magdalena Medrzycki, Devlin Cole, John Paul Bigouette, Geroncio C Fajardo, Bettina Bankamp, Ryan P. Westergaard, Kimberly Goffard, Collin Pitts, Hannah Browne, Jing Zhang, Miranda J Delahoy, Laura Ford, Jennifer L Harcourt, Michael D. Bowen, Christine Lee, Marie K. Kirby, Brandi Limbago, Ailam Lim, Brett Whitaker, Dena Bushman, Gaston Bonenfant, Kimberly Langolf, Blake Cherney, Tara Zochert, Hannah L Kirking, Bin Zhou, Dustin W Currie, Jacqueline E. Tate, Marie E Killerby, Glen R. Abedi, Motria Caudill, Nicole A. Aulik, Patrick Kelly, Douglas Gieryn, Allen C. Bateman, Azaibi Tamin, Ian W Pray, Krista Queen, Juliana Kahrs, and Patricia L. Shewmaker
- Subjects
0301 basic medicine ,Microbiology (medical) ,Universities ,Epidemiology ,030106 microbiology ,RT-PCR ,Antigen test ,medicine.disease_cause ,Sensitivity and Specificity ,Asymptomatic ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Antigen ,law ,Major Article ,Sofia SARS Antigen FIA ,medicine ,Humans ,030212 general & internal medicine ,Antigens, Viral ,Polymerase chain reaction ,Coronavirus ,Reverse Transcriptase Polymerase Chain Reaction ,SARS-CoV-2 ,Viral culture ,business.industry ,COVID-19 ,Reverse Transcription ,Virology ,Reverse transcriptase ,Reverse transcription polymerase chain reaction ,AcademicSubjects/MED00290 ,Infectious Diseases ,Real-time polymerase chain reaction ,RNA ,medicine.symptom ,business - Abstract
Background Real-time reverse transcription polymerase chain reaction (rRT-PCR) and antigen tests are important diagnostics for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Sensitivity of antigen tests has been shown to be lower than that of rRT-PCR; however, data to evaluate epidemiologic characteristics that affect test performance are limited. Methods Paired mid-turbinate nasal swabs were collected from university students and staff and tested for SARS-CoV-2 using both Quidel Sofia SARS Antigen Fluorescent Immunoassay (FIA) and rRT-PCR assay. Specimens positive by either rRT-PCR or antigen FIA were placed in viral culture and tested for subgenomic RNA (sgRNA). Logistic regression models were used to evaluate characteristics associated with antigen results, rRT-PCR cycle threshold (Ct) values, sgRNA, and viral culture. Results Antigen FIA sensitivity was 78.9% and 43.8% among symptomatic and asymptomatic participants, respectively. Among rRT-PCR positive participants, negative antigen results were more likely among asymptomatic participants (odds ratio [OR] 4.6, 95% confidence interval [CI]: 1.3–15.4) and less likely among participants reporting nasal congestion (OR 0.1, 95% CI: .03–.8). rRT-PCR-positive specimens with higher Ct values (OR 0.5, 95% CI: .4–.8) were less likely, and specimens positive for sgRNA (OR 10.2, 95% CI: 1.6–65.0) more likely, to yield positive virus isolation. Antigen testing was >90% positive in specimens with Ct values Conclusions SARS-CoV-2 antigen test advantages include low cost, wide availability and rapid turnaround time, making them important screening tests. The performance of antigen tests may vary with patient characteristics, so performance characteristics should be accounted for when designing testing strategies and interpreting results.
- Published
- 2021
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