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Performance of SARS-CoV-2 antigen testing in symptomatic and asymptomatic adults: a single-center evaluation.
Mitchell, Stephanie L; Orris, Steven; Freeman, Tanner; Freeman, Megan C; Adam, Michelle; Axe, Meredith; Gribschaw, Jamie; Suyama, Joe; Hoberman, Alejandro; Wells, Alan.
  • Mitchell SL; Department of Pathology, University of Pittsburgh, 3477 Euler Way, Clinical Laboratory Building-6th Floor, Pittsburgh, PA, 15213, USA. Slm198@pitt.edu.
  • Orris S; Division of General Internal Medicine, Center for Research On Health Care, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
  • Freeman T; Department of Pathology, University of Pittsburgh, 3477 Euler Way, Clinical Laboratory Building-6th Floor, Pittsburgh, PA, 15213, USA.
  • Freeman MC; Department of Pediatrics, Division of Infectious Diseases, University of Pittsburgh, Pittsburgh, PA, 15213, USA.
  • Adam M; Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, 15213, USA.
  • Axe M; Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, 15213, USA.
  • Gribschaw J; Clinical Microbiology Laboratory, UPMC Hospital System, Pittsburgh, PA, 15261, USA.
  • Suyama J; Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, 15213, USA.
  • Hoberman A; Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, 15213, USA.
  • Wells A; Department of Pathology, University of Pittsburgh, 3477 Euler Way, Clinical Laboratory Building-6th Floor, Pittsburgh, PA, 15213, USA.
BMC Infect Dis ; 21(1): 1071, 2021 Oct 18.
Article in English | MEDLINE | ID: covidwho-1477294
ABSTRACT

BACKGROUND:

Antigen testing offers rapid and inexpensive testing for SARS-CoV-2 but concerns regarding performance, especially sensitivity, remain. Limited data exists for use of antigen testing in asymptomatic patients; thus, performance and reliability of antigen testing remains unclear.

METHODS:

148 symptomatic and 144 asymptomatic adults were included. A nasal swab was collected for testing by Quidel Sofia SARS IFA (Sofia) as point of care. A nasopharyngeal swab was also collected and transported to the laboratory for testing by Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV RT-PCR (Cepheid).

RESULTS:

Overall, Sofia had good agreement with Cepheid (> 95%) in adults, however was less sensitive. Sofia had a sensitivity of 87.8% and 33.3% for symptomatic and asymptomatic patients, respectively. Among symptomatic patients, testing > 5 days post symptom onset resulted in lower sensitivity (82%) when compared with testing within 5 days of symptom onset (90%). Of the four Sofia false-negative results in the asymptomatic cohort, 50% went on to develop COVID-19 disease within 5 days of testing. Specificity in both symptomatic and asymptomatic cohorts was 100%.

CONCLUSIONS:

Sofia has acceptable performance in symptomatic adults when tested < 5 days of symptom onset. Caution should be taken when testing patients with ≥ 5 days of symptoms. The combination of low prevalence and reduced sensitivity results in relatively poor performance of in asymptomatic patients. NAAT-based diagnostic assays should be considered in when antigen testing is unreliable, particularly in symptomatic patients with > 5 days of symptom onset and asymptomatic patients.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study Limits: Adult / Humans Language: English Journal: BMC Infect Dis Journal subject: Communicable Diseases Year: 2021 Document Type: Article Affiliation country: S12879-021-06716-1

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study Limits: Adult / Humans Language: English Journal: BMC Infect Dis Journal subject: Communicable Diseases Year: 2021 Document Type: Article Affiliation country: S12879-021-06716-1