Beckman Coulter Launches one of the First High-Quality, High-Throughput COVID-19 Antigen Test Ideal for Mass Testing in the U.S.

The Access SARS-CoV-2 Antigen assay is offered to healthcare providers at $4, making reliable and frequent mass testing affordable

Assay’s limit of detection is 2 to 200 times lower therefore more sensitive than most point-of-care (POC) antigen tests

Test runs on Beckman Coulter’s analyzers capable of processing up to 200 samples per hour, enabling high throughput screening in just 30 minutes and addressing the scalability constraints of POC tests

Company is submitting for EUA and can ship up to 25 million tests per month

BREA, CALIF., DEC. 18, 2020 —Beckman Coulter, a leader in clinical diagnostics, today announced the launch of a new test that addresses the three main barriers currently facing schools, businesses, hospitals and communities with the rollout of mass COVID-19 testing. The new Access SARS-CoV-2 Antigen assay is one of the first cost-effective high-quality, high-throughput COVID-19 test available in the U.S. with the volume, workflow and scalable flexibility needed to help fight the COVID-19 pandemic.

The Access SARS-CoV-2 Antigen assay has proven 93% Positive Percent Agreement (PPA) within seven days post symptom onset and 100% Negative Percent Agreement (NPA). Additionally, the assay and has a limit of detection of 33 TCID50/mL, which is 2 to 200 times lower and therefore more sensitive than the reported limits of detection for most of the available point-of-care (POC) antigen tests1. Results of the Beckman Coulter antigen test can be delivered in as little as 30 minutes on the organizations’ immunoassay analyzers, including the DxI 800, a high-throughput analyzer capable of processing 200 samples per hour.

According to the Rockefeller Foundation, 4.3 million COVID-19 tests per day are recommended to help minimize infection spread and save lives2. New York University economist Paul Romer suggested recently that number could be significantly higher3. Currently, only about 1.8 million RT-PCR tests are performed daily in the U.S.

While several point of care (POC) antigen tests are now available to help increase testing beyond current levels, POC tests come with workflow challenges when scaled to large patient populations. Beckman Coulter’s SARS CoV-2 Antigen test is designed to address these challenges. The organization can deliver up to 25 million tests per month, and the assay separates sample collection and processing, enabling test providers to leverage the existing infrastructure and workflows.

Additionally, Beckman Coulter’s new assay is priced at $4 to all healthcare providers, including public and private institutions, governments and non-profits to enable frequent testing.
"To test the masses and test them frequently, we need an affordable, reliable and scalable solution. Beckman Coulter is making this happen with a high-quality $4 COVID-19 test."
Shamiram Feinglass, M.D., MPH
Chief Medical Officer
Beckman Coulter

About Beckman Coulter’s Suite of COVID-19 Testing Solutions
Beckman Coulter’s suite of COVID-19 assays includes the $4 Access SAR-CoV-2 Antigen assay, as well as two qualitative antibody assays: Access SARS-CoV-2 IgM and Access SARS CoV-2 IgG assay, and a SARS-CoV-2 semi-quantitative IgG assay. The company also has an interleukin 6 (IL-6) assay, can be used to aid physicians identifying a severe inflammatory response and determining the risk of intubation with mechanical ventilation in COVID-19 patients.

All of Beckman Coulter’s assay to address COVID-19 can be performed in automated or high-throughput immunoassay formats, as well as with Beckman Coulter’s Access 2 analyzer, a compact, table-top analyzer enabling high-quality serology testing to be carried out in small hospitals and clinics. Additionally, all of the assays seamlessly integrate into laboratory workflows making it easy to add these tests to routine blood tests performed during inpatient and wellness testing.

About Beckman Coulter
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation (NYSE: DHR) since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.

1Based on a comparative of the Access SARS-CoV-2 Antigen assay to competitive Intended for Use (IFU) documents
2 [Accessed: December 10, 2020]
3 [Accessed: December 10, 2020]
4 [Accessed: December 10, 2020]
5 [Accessed: December 10, 2020]