30 Million Very-Reliable Coronavirus Tests Shipping in May
The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Illinois based Abbott Labs's SARS-CoV-2 IgG serology blood test.
Abbott announced it plans to ship nearly 30 million antibody tests globally in May and will have the capacity to distribute 60 million tests in June 2020.
This is important since antibody testing provides a greater understanding of the coronavirus pandemic, including how long antibodies stay in the human body, and how much of a population has been infected with SARS-CoV-2.
Announced on May 11, 2020, Abbott confirmed the FDA’s EAU for the company's SARS-CoV-2 IgG lab-based serology blood test on the Alinity™ i system.
The Alinity i system is Abbott's next-generation immunoassay instrument, which was designed to offer greater efficiencies to lab clinicians running tests. These systems are in use around the world in hospitals and academic centers, as well as reference laboratories.
Additionally, Abbott said it is collaborating with leading virology labs to validate test results and is working to quickly install additional instruments to help contribute to large scale testing.
Abbott also expects to submit this week for CE Mark to the IVD Directive (98/79/EC) in the European Union for the Alinity i SARS-CoV-2 IgG test.
"Having more options of highly reliable tests across our platforms will help healthcare workers and health officials as they conduct broad-scale testing for COVID-19," said Robert B. Ford, president, and chief executive officer, Abbott, in a related press release.
"Abbott is a leader in providing antibody testing at large scale on multiple systems, which is helping meet the needs of laboratories as they look to build testing capacity."
A study to determine the clinical performance of Abbott's SARS-CoV-2 IgG assay found it had greater than 99.6% specificity (ability to exclude false positives) and 100% sensitivity (ability to exclude false negatives) in patients tested 17 days or more after symptoms began.
This is Abbott's 4th COVID-19 test to receive FDA EUA, helping to provide hospitals and labs across the U.S. with broad, reliable molecular and antibody testing during this pandemic.
Abbott's Alinity family of harmonized solutions is unprecedented in the diagnostics industry, working together to address the challenges of using multiple diagnostic platforms and simplifying diagnostic testing.
The availability of the Alinity systems and tests varies by geography.
Abbott is a global healthcare leader that helps people live more fully at all stages of life.
Precision Vaccinations publishes COVID-19 testing news.