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Abbott Receives CE Mark For Two New Uses Of Panbio COVID-19 Ag Rapid Test Device

Abbott (ABT) said it has received 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 (mass screening) of people who do not currently present symptoms of the disease.

Panbio Rapid Antigen Test is approved for use with a patient-friendly and minimally invasive nasal swab. Patients can self-administer sample collection under a healthcare professional's supervision, the company said.

Panbio COVID-19 Ag delivers results in as early as 15 minutes with no instrumentation, using Abbott lateral flow technology.

Test performance in clinical study demonstrated 93.8% sensitivity and 100.0% specificity in asymptomatic people with high viral loads.

Abbott said it will offer complementary digital solutions: the NAVICA mobile app to allow people to display negative results for proof of testing and Sympheos for surveillance management to understand epidemiological trends.

Abbott has shipped 200 million Panbio rapid antigen tests to 120 countries worldwide, since August 2020 to date.

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 or EUA by the U.S. Food and Drug Administration. Abbott is in the process of pursuing FDA EUA of an asymptomatic indication for BinaxNOW.

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