Ortho Clinical Diagnostics, one of the world's largest pure-play in vitro diagnostics companies, announced its qualitative COVID-19 Total N antibody test received US FDA emergency use authorization (EUA). This new antibody test is the fifth assay to receive EUA within Ortho's COVID-19 testing solutions. The test detects the individual's immune response or total antibodies to the COVID-19 virus and is intended to help clinicians understand if their patient had a recent or prior COVID-19 infection.
Ortho's new qualitative VITROS® Anti-SARS-CoV-2 Total N antibody test is designed to capture the nucleocapsid protein, detect total antibodies to the COVID-19 virus, and is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. The test offers 99.2% specificity and excellent sensitivity. Ortho is the first company to have an EUA for both a quantitative IgG antibody assay targeting the spike protein and a total assay targeting the nucleocapsid protein.
"Ortho's new Total N test rounds out our portfolio of accurate and scalable COVID-19 testing solutions to meet the continued need for testing in communities across the globe." said Ivan Salgo, MD, head of medical, clinical, and scientific affairs, Ortho Clinical Diagnostics. "From virus detection, to identifying individuals with an adaptive immune response to infection, and measuring antibody response, our customers can support their community's COVID-19 testing needs now and in the future."
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