PARIS: Novacyt S.A, an international specialist in clinical diagnostics, has launched a CE-Mark approved serology (antibody) 96-well plate ELISA (enzyme-linked immunosorbent assay) test for the detection of IgG antibodies to SARS-CoV-2 derived from plasma and serum samples.
The test has been launched by Microgen Bioproducts Limited (Microgen), which is part of Novacyt’s protein diagnostics division Lab21. The new antibody test complements Novacyt’s existing COVID-19 product portfolio, in particular the Company’s polymerase chain reaction (PCR) test for COVID-19, to provide clinicians with the diagnostic tools to detect and differentiate between active and prior SARS-CoV-2 infections in patients.
The new antibody test has been validated in a study where 1,673 patient samples (112 positive samples and 1,561 negative samples) were evaluated. The test demonstrated 100% sensitivity in patients that were tested at 14 days after testing positive for COVID-19 by a PCR test. The antibody test also demonstrated 99.4% specificity.
The ELISA test has been designed for use in all established central laboratories and follows a standard ELISA protocol that makes it compatible with most 96-well plate automation systems. Novacyt has sufficient manufacturing capacity to deliver more than three million antibody tests per month initially and the Company is working with its manufacturing partner to ensure this can be increased depending on demand.
Graham Mullis, Chief Executive Officer of Novacyt, commented: “Novacyt remains committed to supporting the global response to COVID-19 through the delivery of high performance diagnostics. We continue to strengthen our product offering in COVID-19 testing as demand continues and we are delighted to launch an antibody test. We believe an antibody test plays an important role in aiding the diagnosis of COVID-19, as well as increasing our understanding of the disease through screening of populations for infection rates and immunity.”
The Novacyt Group is an international diagnostics business generating an increasing portfolio of in vitro and molecular diagnostic tests. Its core strengths lie in diagnostics product development, commercialisation, contract design and manufacturing. The Company’s lead business units comprise of Primerdesign and Lab21 Products, supplying an extensive range of high-quality assays and reagents worldwide. The Group directly serves microbiology, haematology and serology markets as do its global partners, which include major corporates.