Sam Brusco, Associate Editor01.26.21
Abbott earned a CE mark for asymptomatic testing and self-swabbing using its Panbio COVID-19 Ag Rapid Test Device for detection of the SARS-CoV-2 virus.
Panbio COVID-19 Ag's label was updated with clinical data on asymptomatic people, allowing mass testing (mass screening1) of those currently without symptoms of the disease. A recent study published in JAMA2 showed at least half of COVID-19 infections are estimated to have originated from exposure to asymptomatic individuals.
The other update allows nasal specimen self-collection under a clinician’s supervision. Self-swabbing with a patient-friendly nasal swab improves comfort and reduces risk of accidental exposure to the virus for healthcare workers, since distance can be maintained during the testing procedure.
"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," Robert B. Ford, Abbott president and CEO told the press. "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.
Both Panbio and BinaxNOW rapid antigen tests use similar biologics and are highly portable, reliable and affordable.
The large number of COVID-19 cases and fear of disease spread has resulted in a global economic recession, increased workplace absenteeism and the inability of employers to bring their employees back to the office. As a result, employers and governments around the world are looking for ways to ensure business continuity and restart their economies.
Frequent and fast screening of employees using rapid antigen tests such as Panbio COVID-19 Ag—along with preventative measures such as mask-wearing, social distancing, handwashing, disinfecting facilities and any other actions required by government—can support a safer return to work by quickly identifying and isolating infected and contagious individuals. Employees who test negative can be admitted to facilities and resume their work.
"Since October 2020, Abbott has used rapid antigen tests in a phased rollout of employee testing across multiple sites globally," said Mary Moreland, executive vice president, Human Resources, Abbott. "Our experience proves that testing helps our employees feel safer and more comfortable coming into the office during this time, so they can more effectively collaborate with each other and perform their duties."
Beyond workplace screening, the ability to conduct mass screenings at ports of entry using the Panbio rapid antigen test will facilitate the resumption of global travel. A number of governments now mandate proof of a negative COVID-19 viral test before entering the country.3,4
Additionally, various airlines and cruise ship companies require that passengers present negative test results before boarding. The International Air Transport Association (IATA) and the Airports Council International (ACI) have publicly called for a systematic approach to testing that is fast, accurate, affordable, easy-to-use, scalable and supported by public health authorities. Mass screening can help restore freedom of mobility across borders and will allow people to travel safely and with confidence.
"Being able to effectively screen asymptomatic people—along with other hygienic measures already in place—is the best way to ensure the safety of our passengers and all air transport workers," said Olivier Jankovec, director general, Airports Council International Europe. "Over 100 airports across Europe are already providing COVID-19 testing facilities in close cooperation with their health authorities. Rapid screening using high-quality and affordable antigen tests is a crucial part of resuscitating global travel until the vast majority of the world's travelers and crews are vaccinated."
Digital health technologies play an important role in pandemic response.5 Integrated into testing strategies, digital technologies can support mass screening of people for safe entry into facilities and disease surveillance management to understand epidemiological trends. Abbott is offering two distinct digital solutions to support each of these functions.
Abbott's NAVICA mobile app for iPhone and Android devices allows people who test negative to display a temporary digital health certificate that is renewed each time a person is tested by a healthcare worker together with the date of the test result. Organizations using the NAVICA verifier app can scan and verify the information on a mobile device to manage safe entry into workplaces, airplanes and cruise ships, schools and universities, and other places where people come together in large numbers. NAVICA for use with Panbio Ag is soon to be available at no charge to customers outside the U.S.
In support of public health strategies, Abbott is offering Sympheos, a web-based data collection and visualization tool, for use with Panbio Ag. Sympheos allows healthcare workers to log real-time test results on a smart phone, aggregate the collected data, and display it in a dashboard with heat maps, disease surveillance and testing trends. Sympheos data visualization may help health authorities better understand the epidemiological status of their epidemic and mobilize their COVID-19 response more effectively. Sympheos, which is available now to customers outside the U.S., can also be used to track in parallel other diseases such as malaria and HIV where there are high rates of co-infection.
References
1 Panbio COVID-19 Ag Rapid Test Device is not approved for screening of blood supply.
2 JAMA, SARS-CoV-2 Transmission from People Without COVID-19 Symptoms, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2774707.
3 CDC Expands Negative COVID-19 Test Requirement to All Air Passengers Entering the United States | CDC Online Newsroom | CDC
4 The types of test accepted for travel may vary on a country by country basis.
5 Lancet, Applications of digital technology in COVID-19 pandemic planning and response, https://www.thelancet.com/journals/landig/article/PIIS2589-7500(20)30142-4/fulltext.
Panbio COVID-19 Ag's label was updated with clinical data on asymptomatic people, allowing mass testing (mass screening1) of those currently without symptoms of the disease. A recent study published in JAMA2 showed at least half of COVID-19 infections are estimated to have originated from exposure to asymptomatic individuals.
The other update allows nasal specimen self-collection under a clinician’s supervision. Self-swabbing with a patient-friendly nasal swab improves comfort and reduces risk of accidental exposure to the virus for healthcare workers, since distance can be maintained during the testing procedure.
"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," Robert B. Ford, Abbott president and CEO told the press. "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.
Both Panbio and BinaxNOW rapid antigen tests use similar biologics and are highly portable, reliable and affordable.
The large number of COVID-19 cases and fear of disease spread has resulted in a global economic recession, increased workplace absenteeism and the inability of employers to bring their employees back to the office. As a result, employers and governments around the world are looking for ways to ensure business continuity and restart their economies.
Frequent and fast screening of employees using rapid antigen tests such as Panbio COVID-19 Ag—along with preventative measures such as mask-wearing, social distancing, handwashing, disinfecting facilities and any other actions required by government—can support a safer return to work by quickly identifying and isolating infected and contagious individuals. Employees who test negative can be admitted to facilities and resume their work.
"Since October 2020, Abbott has used rapid antigen tests in a phased rollout of employee testing across multiple sites globally," said Mary Moreland, executive vice president, Human Resources, Abbott. "Our experience proves that testing helps our employees feel safer and more comfortable coming into the office during this time, so they can more effectively collaborate with each other and perform their duties."
Beyond workplace screening, the ability to conduct mass screenings at ports of entry using the Panbio rapid antigen test will facilitate the resumption of global travel. A number of governments now mandate proof of a negative COVID-19 viral test before entering the country.3,4
Additionally, various airlines and cruise ship companies require that passengers present negative test results before boarding. The International Air Transport Association (IATA) and the Airports Council International (ACI) have publicly called for a systematic approach to testing that is fast, accurate, affordable, easy-to-use, scalable and supported by public health authorities. Mass screening can help restore freedom of mobility across borders and will allow people to travel safely and with confidence.
"Being able to effectively screen asymptomatic people—along with other hygienic measures already in place—is the best way to ensure the safety of our passengers and all air transport workers," said Olivier Jankovec, director general, Airports Council International Europe. "Over 100 airports across Europe are already providing COVID-19 testing facilities in close cooperation with their health authorities. Rapid screening using high-quality and affordable antigen tests is a crucial part of resuscitating global travel until the vast majority of the world's travelers and crews are vaccinated."
Digital health technologies play an important role in pandemic response.5 Integrated into testing strategies, digital technologies can support mass screening of people for safe entry into facilities and disease surveillance management to understand epidemiological trends. Abbott is offering two distinct digital solutions to support each of these functions.
Abbott's NAVICA mobile app for iPhone and Android devices allows people who test negative to display a temporary digital health certificate that is renewed each time a person is tested by a healthcare worker together with the date of the test result. Organizations using the NAVICA verifier app can scan and verify the information on a mobile device to manage safe entry into workplaces, airplanes and cruise ships, schools and universities, and other places where people come together in large numbers. NAVICA for use with Panbio Ag is soon to be available at no charge to customers outside the U.S.
In support of public health strategies, Abbott is offering Sympheos, a web-based data collection and visualization tool, for use with Panbio Ag. Sympheos allows healthcare workers to log real-time test results on a smart phone, aggregate the collected data, and display it in a dashboard with heat maps, disease surveillance and testing trends. Sympheos data visualization may help health authorities better understand the epidemiological status of their epidemic and mobilize their COVID-19 response more effectively. Sympheos, which is available now to customers outside the U.S., can also be used to track in parallel other diseases such as malaria and HIV where there are high rates of co-infection.
References
1 Panbio COVID-19 Ag Rapid Test Device is not approved for screening of blood supply.
2 JAMA, SARS-CoV-2 Transmission from People Without COVID-19 Symptoms, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2774707.
3 CDC Expands Negative COVID-19 Test Requirement to All Air Passengers Entering the United States | CDC Online Newsroom | CDC
4 The types of test accepted for travel may vary on a country by country basis.
5 Lancet, Applications of digital technology in COVID-19 pandemic planning and response, https://www.thelancet.com/journals/landig/article/PIIS2589-7500(20)30142-4/fulltext.
