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U.S. Department of Health and Human Services


More than 50 Million BARDA-Supported COVID-19 Diagnostic Tests Shipped to Communities across the U.S.

Author: Rodney Wallace, BARDA, Detection, Diagnostics, & Devices Infrastructure (DDDI) Division Director
Published Date: 10/23/2020 10:13:00 AM
Category: Medical Countermeasures; Response & Recovery;

BARDA’s Public-Private Partnerships Support a Range of Tests from Future At-Home Kits to Major Lab Systems

As the coronavirus pandemic continues around the world, the need for rapid, accurate testing remains critical. Testing leads to the identification of active cases, helps spur more rapid treatment of people who are infected, and allows you and your doctor to take immediate action, such as isolating people who are ill.

COVID-19 is highly contagious, and the virus that causes COVID-19, SARS-CoV-2, can be transmitted by people who do not show any symptoms. Many who are infected do not know they are carrying the virus; others might have just very mild symptoms. As people continue with their daily routines, they can infect others inadvertently. To support the American people, schools, employers, healthcare providers, and public health officials in this whole-of-America pandemic response, BARDA is committed to the rapid development and production of test kits across the United States.

It might seem obvious, but testing exponentially increases not only our knowledge but also our ability to act on that knowledge. Knowledge empowers patients, healthcare providers and public health officials. In addition to isolating people who are infected, test results help officials trace contacts of confirmed cases if needed; identify hot spots or flare ups within communities which helps direct local, state and federal healthcare resources; conduct disease surveillance to track COVID-19 infections; and better understand how the disease behaves.

To meet this need, BARDA began supporting development of diagnostic tests as soon as the pandemic spread to the United States and we now have a diverse COVID-19 diagnostics development portfolio which currently contains more than 30 diagnostic tests for a variety of commercially available platforms. Traditional laboratory systems are important in the diagnostic landscape because they perform sophisticated tests with established quality assurance plans while processing a large number of samples.

The BARDA portfolio began with tests that run on platforms commonly available in the United States. Sixteen of these BARDA-supported tests have received emergency use authorization from the U.S. Food and Drug Administration, and BARDA’s partners have shipped more than 50 million tests. By investing in tests that work with the existing infrastructure in laboratories, hospitals, and clinical settings, we are helping increase the chances of fast and widespread use of the tests.

To enable testing in non-traditional laboratory settings, BARDA’s portfolio also contains tests that are small, portable, and easy to use too, such as the Cue Heath test and even in-home tests. Among the portfolio’s point-of-care systems, you’ll find a rapid mobile test designed for hospitals, long-term care facilities, urgent care centers, and doctor’s offices. Using an easy-to-use handheld reader, healthcare professionals can test patients at the first point-of-contact. Another BARDA-funded research project aims to bring COVID-19 testing into people’s homes and could become the first such test for use at home in the United States, if authorized by FDA.   

These point-of-care tests are less complex than laboratory systems’ but offer faster results, which empowers patients and providers to make informed decisions regarding diagnosis and treatment. They can be performed by personnel with little clinical laboratory training, and and individuals may even be able to administer the test in their own home.

As the part of the pandemic response, BARDA also supports development of serological tests that measure antibodies. Unlike tests that detect the presence of the virus itself, antibody tests measure the amount of antibodies in the blood to help determine whether the body has responded to a specific infection caused by a virus. As people across the country continue to demand COVID-19 tests, laboratories need diagnostic testing systems that can quickly process a large number of tests in a short period of time.

On May 29, the first two BARDA-supported antibody tests received emergency use authorization (EUA); one that can run over 400 tests per hour with results in 10 minutes. The symptoms of influenza and COVID-19 are similar and with influenza season starting in the northern hemisphere, healthcare providers, public health professionals, and patients need accurate diagnosis to make sound health decisions. To meet this need, BARDA is supporting four combination tests to provide simultaneous testing of Flu A/B and COVID-19. Often referred to as multiplex tests, these combo tests are important not only to conserve reagents and supplies but also to maximize test capacity. Because symptoms can be similar for both types of respiratory infections, a single test that requires just a single sample from the patient makes sense.

Looking toward the future, another innovative approach is a wearable device that creates an early warning algorithm to identify early symptoms of COVID-19. The device generates de-identified, patient-generated health data. BARDA is supporting a study of the effectiveness of this device to enhance current disease surveillance systems to detect respiratory infections prior to the onset of symptoms. Such a device could be extremely helpful for healthcare workers and others in the U.S. workforce whose jobs must be done in person.

BARDA is supporting another collaboration in a Veterans Health Administration (VHA) nursing home where a patient wears a biosensor to remotely monitor individuals during the COVID-19 outbreak for deterioration of  health indicators, including but not limited to respiratory rate, body temperature, blood oxygen levels (SpO2) and heart arrhythmias, to improve patient outcomes. Residents in the VHA facility volunteered to participate in the study.

BARDA’s support of a large and diverse development portfolio of COVID-19 diagnostic technologies heightens our nation’s ability to respond more effectively to the current pandemic. BARDA also is funding development of six diagnostic technologies through RADx, a partnership with the National Institutes of Health (NIH). The technologies represented in BARDA’s portfolio and in RADx have the potential to fulfill current clinical needs, optimize treatments, and improve outcomes.

There is no single product—in diagnostics, treatment, or vaccines—that alone can end the COVID-19 pandemic. Diagnostic tests are part of a broader strategy to fight the virus and one component of BARDA’s COVID-19 portfolio. We continue to support development of vaccines to help stop the spread of the coronavirus as well as the development of therapeutic medicines to treat patients. All of the medical countermeasures in this portfolio ultimately work together to help save lives.

You can learn more about our COVID-19 medical countermeasures development programs by visiting BARDA’s COVID-19 Portfolio.


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