COVID-19 Rapid Antigen Test Receives CE Mark for Use on Children

Abbott has announced it now has a CE Mark for use of its Panbio™ COVID-19 Ag Rapid Test Device to detect the SARS-COV-2 virus in children age 15 years and younger. The CE Mark is based on the first-ever study focused on the performance of a rapid antigen test on children, including infants.

Abbott has received a CE Mark for the use of Panbio COVID-19 Ag with a nasal swab in asymptomatic and symptomatic individuals and for self-collection of samples under the supervision of trained professionals. The test with these performance data has also been added to the World Health Organisation's Emergency Use Listing (WHO EUL). 

Abbott has launched fourteen COVID-19 diagnostics tests across its portfolio of rapid and lab-based platforms in response to the pandemic. Since August 2020, Abbott has shipped more than 200 million Panbio rapid antigen tests to over 140 countries worldwide. 

Interim results on samples collected by nasal swab from 274 children ages 15 and younger showed that Panbio COVID-19 Ag demonstrated overall sensitivity of 76.3% and specificity of 100% when compared with PCR test results.

Positive results (n=59) were stratified by cycle threshold (Ct) counts in order to understand the correlation between product performance and the amount of virus present in the clinical sample. Ct counts are the number of times a PCR instrument must cycle through to amplify enough genetic material of the SARS CoV-2 virus for it to be detectable. The greater the amount of virus present (viral load), the fewer cycles required to detect the virus. A person with a higher viral load (and lower Ct count) is more likely to be infectious.

Results for sensitivity were: 92.9% in 42 samples with Ct values less than or equal to 30; 82.7% in 52 samples with Ct values less than or equal to 33.

Specificity of the test across 215 negative samples was 100.0%, which means no false positives were identified.

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