Performance of the Sofia SARS-CoV-2 Rapid Antigen Test in Symptomatic and Asymptomatic Pediatric Patients

Area of Science:

• Pediatric Infectious Diseases
• Diagnostic Test Evaluation
• Virology

Background:

• Limited data exists on the diagnostic accuracy of SARS-CoV-2 antigen tests in pediatric populations.
• Accurate and rapid diagnostic tools are crucial for managing pediatric respiratory infections.

Purpose of the Study:

• To evaluate the sensitivity and specificity of the Quidel Sofia SARS-CoV-2 antigen test (Sofia-Ag-RDT) in children presenting to outpatient care.
• To compare the performance of the Sofia-Ag-RDT against a molecular benchmark test.

Main Methods:

• A comparative diagnostic accuracy study was conducted from November 2020 to April 2021.
• Children presenting to outpatient care were tested using the Sofia-Ag-RDT.
• Results were compared against the Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV reverse transcriptase-polymerase chain reaction (RT-PCR) test.

Main Results:

• The Sofia-Ag-RDT demonstrated the highest sensitivity in symptomatic children, with an estimated sensitivity of 82% (95% confidence interval, 68%-91%).
• Specificity data was also collected but not detailed in the provided abstract.

Conclusions:

• The Quidel Sofia SARS-CoV-2 antigen test exhibits notable sensitivity for detecting SARS-CoV-2 in symptomatic children within an outpatient setting.
• Further research may be warranted to confirm specificity and performance across diverse pediatric populations.