NEW YORK – PerkinElmer said on Tuesday that it received the CE-IVD mark for its dry blood spot-based test for detecting IgG antibodies against SARS-CoV-2 and has launched it.
The test uses the firm's GSP/Delfia platform, which can process up to 5,000 samples per day. The Waltham, Massachusetts-based company said the finger prick sample collection device allows the test to be used in a decentralized setting as well as in a high-throughput lab.
PerkinElmer plans to seek Emergency Use Authorization from the US Food and Drug Administration for the test, which can also be used with serum and plasma samples with PerkinElmer's Victor2D platform.
PerkinElmer Vice President and General Manager of Diagnostics Masoud Toloue said in a statement that dried blood spot samples have been used for decades in large scale population screening programs and can result in cost-savings and ease logistical constraints resulting from collecting, transporting, and process venous blood for SARS-CoV-2 antibody testing.
"This CE-IVD-marked assay enables decentralized collection, a much-needed tool in COVID-19 testing" he said.