The company plans to seek the Emergency Use Authorization (EUA) for the test from the US Food and Drug Administration (FDA)
PerkinElmer headquarters in Waltham. (Credit: Coolcaesar at English Wikipedia.)
PerkinElmer has launched its dry blood spot (DBS) based test to detect SARS-CoV-2 IgG using its GSP/DELFIA platform, capable of processing up to 5,000 samples per day.
The diagnostic technology company is marketing the serology test as a CE-IVD test, and is planning to seek the Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).
In addition, the new finger-prick sample collection device would facilitate both decentralised sample collection and high-throughput testing for Covid-19, said the company.
PerkinElmer diagnostics vice president and general manager Masoud Toloue said: “Dried blood spot samples have been used in large scale population screening programs for decades and can help alleviate the costs and logistical constraints associated with collecting, transporting and processing venous blood for SARS-CoV-2 antibody testing.”
PerkinElmer designed the new The SARS-CoV-2 IgG assay to run on GSP analyser
PerkinElmer has designed the new The SARS-CoV-2 IgG assay to run on its fully automated and high throughput analysis system GSP analyser, and can also be run with serum or plasma samples through its Victor2D platform.
The traceable DBS workflow comprises five primary elements that include sample collection, punching, measurement on the GSP analyser, reagents, and software, to detect anti-SARS-CoV-2 IgG antibodies.
The company’s comprehensive SARS-COV-2 offerings include RT-PCR, high throughput RNA extraction, automation, ELISA and other laboratory solutions.
Furthermore, the new DBS based test has been rolled out after the recent CE mark approval of its ELISAs for detection of IgG antibodies.
In May, FDA granted EUA for PerkinElmer company Euroimmun’s Anti-SARS-CoV-2 ELISA (IgG) serology test.
The Anti-SARS-CoV-2 ELISA (IgG) serology test will help detect individuals with an adaptive immune response to SARS-CoV-2, specifying recent or prior infection.