First-Ever SARS-CoV-2 Antibody Test Indicates Whether Patients Require COVID-19 Booster
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By LabMedica International staff writers Posted on 23 Jun 2022 |
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Image: PictArray SARS-CoV-2 Antibody Test has received CE Mark (Photo courtesy of Pictor)
The COVID-19 pandemic remains a healthcare concern as new strains of the virus have emerged. Now, a first-of-its-kind test enables personalized COVID-19 assessments by detecting if a patient has antibodies from a previous infection of SARS-CoV-2 or from vaccination alone.
The PictArray SARS-CoV-2 IgG enzyme-linked immunosorbent assay (ELISA) antibody test from Pictor Limited (Auckland, New Zealand) detects if a person has antibodies from a previous SARS-CoV-2 infection (from spike protein (SP) and nucleocapsid protein (NP) antibodies) or from COVID-19 vaccination alone (SP antibodies only). The test also indicates whether at-risk patients have failed to mount a detectable antibody response despite vaccination or infection (SP and NP negative).
Pictor has received confirmation of CE registration for its PictArray SARS-CoV-2 IgG ELISA antibody test as per In Vitro Diagnostic Directive (IVDD) regulations, allowing it to market the COVID-19 antibody test in Europe and gain regulatory approval in Southeast Asia.
“Receiving CE registration enables Pictor to establish a footprint with partner laboratories and research bodies within Europe which is an important market for us,” said Howard Moore, CEO of Pictor. “Our recent successful funding round means we are well equipped to support market development and launches within the European Economic Area while continuing existing work across ANZ, the U.S., India and Southeast Asia.”
“As we learn more about COVID-19, the separate detection of SP and NP will enable a more precise assessment of a patient’s immunity against SARS-CoV-2 and help guide any associated clinical interventions whilst also informing wider public health measures when mass serosurveys are conducted,” added Pictor’s Chief Medical Officer Tadd Lazarus, MD.
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