While most antibody blood tests, including the one officially authorized by the FDA last week, have so far focused on providing rapid results at the point-of-care others are working to deploy high-throughput versions capable of running hundreds of tests an hour.
This would allow centralized, lab-based diagnostic hardware to process blood samples at scale, screening patients for previous infections and possible immunity in volumes similar to how molecular testing machines check swabs for active signs of the novel coronavirus.
Global testing company Eurofins announced it will begin offering large-scale, blood-based COVID-19 antibody testing in Massachusetts through its Viracor and Boston Heart Diagnostics subsidiaries.
Starting today, hospitals on the East Coast will be able to ship blood samples to Boston for analysis, according to Eurofins, which expects to start processing 200 tests per hour, or about 4,800 per day. Additionally, Viracor said it plans to offer its own test in mid-April.
Meanwhile, Ortho Clinical Diagnostics’ serological test kit is slated to be available within a few weeks. It will run on its Vitros lines of integrated and immunodiagnostic systems, which the company describes as already in place at more than 1,000 U.S. hospitals and reference labs.
In March, the FDA told COVID-19 antibody test developers that it would not object to companies bringing their products directly to market, describing them as less complex compared to large-scale molecular testing to confirm active infections. Their unreviewed use would be permitted as long as they were clinically validated by the company and not used as the sole method to diagnose the disease.
"Given the incredible demand for information to change the tide of this pandemic, Ortho felt it was necessary to market as quickly as possible with a notification to the FDA," CEO Chris Smith said in a statement. Instead, the test will be used to help better understand the spread of COVID-19 and in combination with other tests.
"We are working to make our antibody test kit available to the areas with the greatest need first and will be working in parallel to both increase our test kit production and follow additional regulatory pathways to secure further approvals," Smith added.
The FDA did, however, grant its first official Emergency Use Authorization to an antibody assay last week. Cellex’s CE marked blood test is designed to provide a single result within 15 to 20 minutes, using a lined test strip not unlike a to a home pregnancy test.
Elsewhere, nearly 50 serological test developers have notified the FDA of their intent to move their tests to market without seeking a full Emergency Use Authorization.
Editor's note: This story has been corrected to clarify that Cellex's blood test is not designed to use blood drawn from a finger-stick, but from a vein.