PerkinElmer Releases New Dried Blood Spot Based COVID-19 Serology Test
Fully automated kit detects human antibodies of immunoglobulin class IgG to help identify individuals with adaptive immune response
WALTHAM, MA — (BUSINESS WIRE) — July 21, 2020 — PerkinElmer, Inc. (NYSE:PKI), a global leader committed to innovating for a healthier world, today announced the launch of a dry blood spot (DBS) based test for SARS-CoV-2 IgG using its GSP®/DELFIA® platform, enabling processing of up to 5,000 samples per day. The finger-prick sample collection device allows for both decentralized sample collection and high-throughput testing. The product is being marketed as a CE-IVD test, and the company plans to apply for Emergency Use Authorization (EUA) with the US Food and Drug Administration (FDA).
Serological tests detect antibodies that are formed after an immune reaction to the pathogen has taken place. These tests can determine if an individual has developed immunity to a virus. Researchers are still studying how long antibodies last and whether they are protective against the COVID-19 virus.
The DBS assay is run on PerkinElmer’s GSP® analyzer, a fully automated and high throughput system for large population testing. The GSP combined with the universal TRF (time resolved fluorescence) of the DELFIA platform screens more than 30 percent of all newborn babies worldwide, spanning 32 countries. The traceable DBS workflow consists of five main elements: sample collection, punching, measurement on the GSP analyzer, reagents, and software, to detect anti-SARS-CoV-2 IgG antibodies. The SARS-CoV-2 IgG assay can also be run with serum or plasma samples via the Company’s Victor2™D platform. With an install base of over 2,500 GSP and Victor2D instruments, the capability for laboratories to meet heightened demand for COVID-19 testing is robust.
“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,” said Masoud Toloue, PhD, vice president and general manager, diagnostics, PerkinElmer. “This CE-IVD marked assay enables decentralized collection, a much-needed tool in COVID-19 testing.”
PerkinElmer’s comprehensive SARS-COV-2 offerings span RT-PCR, high throughput RNA extraction, automation, ELISA and other laboratory solutions. This DBS based test follows the recently CE-Marked ELISAs for detection of IgG antibodies from EUROIMMUN, a PerkinElmer company.