Abbott’s Covid-19 antigen test receives CE mark for use on children
11 May 2021
Abbott has received CE mark for the use of its Panbio COVID-19 Ag Rapid Test Device to detect the SARS-COV-2 virus in paediatric patients aged 15 years and below.
A lateral flow assay for rapid, qualitative detection of the virus, the test provides results in as little as 15 minutes with no instrumentation.
For collecting samples from people to carry out the test, a minimally invasive nasal or nasopharyngeal swab can be used.
In January, Abbott received CE mark for its Panbio COVID-19 Ag Rapid Test Device to detect the SARS-CoV-2 virus for two new uses, in asymptomatic individuals and self-swabbing testing.
Abbott noted that the test has been added to the World Health Organization’s Emergency Use Listing (WHO EUL). The company now plans to submit performance data in children to update the existing label.
The latest approval is based on a study that assessed the performance of a rapid antigen test on children, including infants.
Interim study results on nasal swab samples obtained from 274 children aged 15 years and below showed that the Panbio COVID-19 Ag Rapid Test Device had an overall sensitivity of 76.3% and specificity of 100%, as against PCR test results.
Furthermore, a sensitivity of 92.9% was observed in 42 samples with cycle threshold (Ct) values less than or equal to 30 and 82.7% in 52 samples with Ct values less than or equal to 33.
Abbott rapid diagnostics business UK and Ireland general manager Sam Lloyd said: “We need to help protect the health of children, teachers and other staff from the risk of virus spread.
“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.”
Since the onset of the pandemic, Abbott has introduced 14 Covid-19 diagnostics tests across its portfolio of rapid and lab-based platforms.
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Published on Medicaldevice-network.com