Beckman Coulter has launched a new cost-effective Covid-19 test, Access SARS-CoV-2 Antigen assay, in the US to address the barriers faced by schools, businesses, hospitals and communities with the rollout of mass testing.
Beckman Coulter noted that the test will have the volume, workflow and scalable flexibility for fighting the pandemic.
The new assay will be retailed for $4 to all healthcare providers, including public and private institutions, governments and non-profits to aid in frequent testing.
It has proven 93% Positive Percent Agreement (PPA) within seven days of developing symptoms and 100% Negative Percent Agreement (NPA).
The Access SARS-CoV-2 Antigen assay runs on Beckman Coulter’s analysers capable of processing up to 200 samples per hour, enabling high throughput screening in just 30 minutes.
Its limit of detection is 33 TCID50/mL, which is two to 200 times lower and is more sensitive as compared to the available point-of-care (POC) antigen tests.
To be available in markets accepting the CE Mark in January next year, Beckman Coulter antigen test delivers results in 30 minutes on its immunoassay analysers like the DxI 800.
Beckman Coulter chief medical officer Shamiram Feinglass said: “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, so institutions and communities can implement, frequent mass Covid-19 testing that is easy to scale.”
Furthermore, for the antigen test, nasopharyngeal swab samples collected at the point of care can be stored at room temperature for up to 24 hours and refrigerated for 48 hours while being transported to the laboratory for processing.
The company plans to seek Emergency Use Authorisation from the US Food and Drug Administration (FDA) for the assay and can initiate shipping 18 million tests per month.
Beckman Coulter also intends to ramp to 25 million tests per month by March next year to its customer base in the US and Puerto Rico.