Roche gets USFDA approval for New Test Measuring Level of COVID Antibodies
New Delhi: Roche recently announced that its Elecsys Anti-SARS-CoV-2 S antibody test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (USFDA). The semi-quantitative serology (blood) test can be used to measure the level of antibodies in people who have been exposed to the SARS-CoV-2 virus.
The new test targets antibodies that are directed against the region of the novel coronavirus known as the spike protein, specifically the area that enables the virus cell to bind to the host cell receptor, which is required for the virus to enter the host cell.1,2 The test also provides a numerical result from 0.40-250 U/mL as well as a qualitative result.
Many current candidate vaccines aim to induce an antibody response against the SARS-CoV-2 spike protein. Tests that quantify antibodies to the spike protein could be used to measure the level of that response and track that measurement over time.
"Since the start of this pandemic, our focus has been to bring effective diagnostic testing solutions to the fight against COVID-19," said Matt Sause, president and CEO of Roche Diagnostics Corporation. "Antibody tests like these will play a critical role in measuring a person's vaccine-induced immune response, and supporting the development of convalescent plasma therapy to help other patients fight the disease."
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.