Abbott, a leading transformational health technology company, recently announced that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its BinaxNOW COVID-19 Ag Self Test for over-the-counter, non-prescription, and asymptomatic use. This marks a major milestone in America's effort to control the spread of COVID-19.
The BinaxNOW COVID-19 Ag Self Test is a lateral flow immunoassay that uses nasal swab samples to detect SARS-CoV-2 in patients who are suspected to be infected with the virus. The test produces results in just 15 minutes, making it an essential tool for detecting asymptomatic COVID-19 cases in individuals who may otherwise unknowingly spread the virus to others.
"We're not out of the woods yet, but we're making progress in the fight against COVID-19," said Robert B. Ford, president and CEO of Abbott. "Our BinaxNOW self test expands access to rapid testing and helps Americans get back to doing the things they love."
Abbott's BinaxNOW COVID-19 Ag Self Test is intended for individuals 15 years old and above who are suspected to have contracted COVID-19 within the past seven days. The test does not require the supervision of a healthcare professional and can be used at home or in any other location, such as schools, workplaces, airports, and other community settings.
"The BinaxNOW COVID-19 Ag Self Test is an important tool for public health, with potential applications in healthcare settings, schools, and other community environments," said John Frels, Ph.D., vice president of research and development at Abbott Rapid Diagnostics. "This self test provides individuals with access to rapid and reliable testing, which is essential for effective infectious disease control."
The availability of rapid antigen self testing is critical in the fight against COVID-19, as it enables individuals to detect the presence of the virus before they become symptomatic or develop severe illness. This helps curtail the spread of the virus in the community, especially among those who are asymptomatic and may unknowingly infect others.
Moreover, rapid antigen self testing provides a more affordable and easy-to-use alternative to PCR testing, which is typically conducted in laboratories and takes several hours to produce results. Rapid antigen tests like the BinaxNOW COVID-19 Ag Self Test are more accessible and can produce results in minutes, allowing for faster and more efficient disease surveillance.
Guangdong Hecin Scientific, Inc., a leading in-vitro diagnostics (IVD) company with over 5,000 m² GMP factory and biosafety level II laboratory of respiratory pathogens, has played a crucial role in developing and producing the BinaxNOW COVID-19 Ag Self Test. The company has the largest database of respiratory pathogens in China and has leveraged its expertise in molecular biology, immunology, and bioengineering to develop innovative diagnostic solutions for COVID-19.
"We are proud to partner with Abbott to bring this game-changing self test to the market," said Li Ming, CEO of Guangdong Hecin Scientific, Inc. "This technology has the potential to curb the transmission of COVID-19 and provide individuals with greater peace of mind in their daily lives."
In conclusion, the introduction of the BinaxNOW COVID-19 Ag Self Test for over-the-counter, non-prescription, and asymptomatic use is a significant breakthrough in the fight against COVID-19. Rapid antigen self testing can help detect asymptomatic cases of COVID-19 and curtail the spread of the virus in the community, while also providing a more affordable and accessible alternative to PCR testing. By partnering with innovative companies like Guangdong Hecin Scientific, Inc., Abbott is advancing the frontiers of healthcare technology and making a tangible impact in the fight against COVID-19.