Editor's note: A previous version of this story misstated how the test is permitted for distribution, including in the headline. It's permitted under emergency guidance issued by FDA on March 16.
- BD on Tuesday announced it's making available a rapid, point-of-care blood test that identifies antibodies to confirm exposure to COVID-19. BD said the serology test can detect current or past exposure to the virus.
- The product, developed and manufactured by Morrisville, North Carolina-based biotech BioMedomics, will be distributed by Henry Schein to U.S. healthcare providers. BD expects to begin shipping the tests in April.
- Unlike molecular tests that detect SARS-CoV-2 nucleic acids or antigen-based tests, the serological assay identifies antibodies in the blood that the body produces in response to coronavirus infection. The antibodies develop in the middle to late stages of infection but may remain present after exposure, which could help identify people who were exposed to the virus but are asymptomatic
Serological diagnostics can be used to identify people who have recovered from the disease and have immunity to the infection. Theoretically, those people could return to work and serve in high-risk roles on the frontlines of healthcare and other community efforts to fight the pandemic, giving way to the idea of "immunity passports" in countries like Germany.
Policymakers in the U.S. have also elevated serological testing as a tool for "restarting" society as epidemic transmission is eventually brought under control.
"To use serology in this way, serological assays are needed and should be widely available, accurate, rapid, and low cost," the American Enterprise Institute wrote in a roadmap for "reopening America for businesses and families" released this weekend. "Such assays have already been developed by researchers, but they have not yet been fully validated and are not available at scale."
Unlike molecular tests that detect SARS-CoV-2 nucleic acids or antigen-based tests, the serological assay identifies antibodies in the blood that the body produces in response to coronavirus infection. The antibodies develop in the middle to late stages of infection but may remain present after exposure, which could help identify people who were exposed to the virus but are asymptomatic. BD said data on past exposure also could aid researchers in tracking the occurrence of SARS-CoV-2 infection across a population.
However, FDA Commissioner Stephen Hahn warned in a March 16 statement serology tests are "solely used to identify antibodies, which limits their effectiveness for diagnosis" and "antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status" as opposed to molecular tests which actually detect the presence of viral DNA and are a more definitive indicator of active infection.
While serology tests are less complex than molecular testing, Dave Hickey, president of BD's integrated diagnostic solutions business, said in a statement: "Initial evidence suggests that nearly all patients infected with SARS-CoV-2 will have developed a detectable antibody response within days of symptom onset, at which time a negative serologic test, along with molecular diagnostics, could be helpful in ruling out COVID-19."
The BD-BioMedomics test can detect within 15 minutes the presence of immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies associated with coronavirus. IgM antibodies indicate recent exposure to COVID-19 while IgG antibodies indicate later-stage infection. The screening requires no special equipment to process the results and can be used in a laboratory or at the point of care.
BioMedomics said the test was clinically validated at several hospitals and laboratories in both the U.S. and China. Data published in the Journal of Medical Virology showed an overall testing sensitivity rate of 88.66% and a specificity rate of 90.63%.
BD said it will have capacity to supply more than 1 million of the tests in the coming months and can scale up based on demand.
The company is also working with Birmingham, Alabama-based biotech BioGX on a COVID-19 test designed to be run on its widespread BD Max molecular diagnostic platform. BD said March 16 the companies submitted an EUA to FDA for the screening, but FDA doesn't appear to have yet authorized the test.
As of March 31, FDA had issued EUAs for 20 diagnostic tests from commercial labs and test kit manufacturers related to the novel coronavirus.
Separately, FDA also posted a new category of coronavirus EUAs on Tuesday covering high complexity molecular-based laboratory developed tests. One such test from Yale New Haven Hospital gained an EUA Tuesday.