Industry News: Abbott's Panbio Rapid Antigen Test gains CE Mark for use on children

First rapid antigen test with performance data on children

30 Apr 2021

Abbott announced today 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). 

"As schools implement testing protocols as part of their COVID prevention strategies, it is important to have access to tests that have been proven to work well on children," said Amilcar Tanuri, M.D., Ph.D., Professor of Genetics and Head of the Molecular Virology Laboratory at the Federal University of Rio de Janeiro in Brazil and the lead investigator of the study of the use of Panbio COVID-19 on children. The results of this study show that Abbott's Panbio rapid antigen test does a good job of detecting the virus in children under the age of 15."

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. 

"We need to help protect the health of children, teachers and other staff from the risk of virus spread," said Sam Lloyd, general manager of Abbott's rapid diagnostics business in the UK and Ireland. "We now have science-based evidence that Abbott's Panbio rapid antigen test can reliably detect active virus in children, thereby enabling earlier identification and self-quarantine of positive cases and of other people who have been exposed." 

Interim study results show efficacy of test on children

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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