Abbott has received the CE mark for two new uses of its Panbio COVID-19 Ag Rapid Test Device for the detection of the SARS-CoV-2 virus: asymptomatic testing and self-swabbing.
Panbio COVID-19 Ag's label has been updated with clinical data on asymptomatic individuals, which enables mass testing of people who do not currently present symptoms of the disease. According to a recent study published in JAMA at least 50% of COVID-19 infections are estimated to have originated from exposure to asymptomatic individuals.
The other update to the label allows self-collection of nasal specimens under the supervision of a healthcare worker. Self-swabbing with a patient-friendly nasal swab improves patient comfort and reduces the risk of accidental exposure to the virus for healthcare workers as they can maintain distance during the testing procedure.
Robert B. Ford, president and chief executive officer, Abbott, said: "Rapid testing continues to be one of our most important tools for fighting this pandemic, and the ability to perform mass screening allows us to expand testing and reach more people in more places. Now that Abbott's Panbio rapid antigen test has an asymptomatic indication, it becomes an even more valuable tool for enabling a safer return to work, school, travel and other activities of daily life."
Since last August to date, Abbott has shipped 200 million Panbio rapid antigen tests to 120 countries across Europe, the Americas, Asia and Africa. Healthcare professionals globally have seen the clinical utility of the test in detecting COVID-19 infections. In coordination with the Global Fund, the World Health Organization and the Bill & Melinda Gates Foundation, Abbott continues to make Panbio rapid antigen tests available to low- and middle-income countries.
Panbio COVID-19 Ag is not available in the U.S., where Abbott manufactures and sells the BinaxNOW COVID-19 Ag Card, which has received emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA). Abbott is in the process of pursuing FDA EUA of an asymptomatic indication for BinaxNOW.
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 can delivered in 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.
Clinical performance of Panbio COVID-19 Ag Rapid Test Device was determined by testing 483 asymptomatic people for SARS-CoV-2 antigen and comparing results against a PCR reference method.
Positive results (n=50) 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. A lower Ct value corresponds to a higher concentration of the virus.
Specificity of the test across 433 negative samples was 100.0%, which means no false positives were identified. Results for sensitivity were:
- 93.8% in 32 samples with Ct values less than or equal to 30
- 80.0% in 40 samples with Ct values less than or equal to 33
- 66.0% across all 50 positive samples (at all Ct counts)
Abbott has submitted documentation to the World Health Organization for Emergency Use Listing for the two new claims for asymptomatic testing and self-swabbing. Panbio COVID-19 Ag Rapid Test device is available in countries outside of the U.S. and subject to local regulatory and commercialisation requirements.
