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Abbott's Panbio™ Rapid Antigen Test Now Has a CE Mark for Use on Children; First Rapid Antigen Test with Performance Data on Children
Panbio COVID-19 Ag delivers results in 15 minutes with no instrumentation, using proven Abbott lateral flow technology
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
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.
About Panbio COVID-19 Ag Rapid Test Device
Panbio COVID-19 Ag Rapid Test Device is a lateral flow assay for rapid, qualitative detection of SARS-CoV-2 virus. A nasal or nasopharyngeal swab is used for collection of specimens from individuals. Test results are delivered in as early as 15 minutes with no instrumentation.
Negative results must be combined with clinical observations, patient history and epidemiological information. Negative results do not preclude COVID-19 infection and cannot be used as the sole basis for treatment or other management decisions.
Abbott has updated its existing label for use to include performance data in children and intends to submit the updated label to the WHO for EUL. The Abbott Panbio COVID-19 Ag Rapid Test device is available in countries outside of the U.S. and subject to local regulatory and commercialisation requirements.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.