Roche receives USFDA emergency use authorization for new test to measure the level of SARS-CoV-2 antibodies

▴ Roche receives USFDA emergency use authorization for new test to measure the level of SARS-CoV-2 antibodies
This test may help identify recovering patients who could potentially be serum and plasma donors for developing treatments for COVID-19

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 (FDA). The 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 EUA in the United States follows the launch of the Elecsys Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark announced on 18 September.

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 to bind to a host cell receptor, which is required for the virus to enter the host cell. 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. The test provides a numerical result describing the concentration of antibodies from 0.40-250 U/mL as well as a qualitative result.

“Since the start of this pandemic, our focus has been to bring effective diagnostic testing solutions to the fight against COVID-19,” said Thomas Schinecker, CEO of Roche Diagnostics. “Antibody tests like these will play a critical role in measuring a person’s vaccine-induced immune response”.

In addition to its role in helping to measure a patient’s immune response, the test may help guide the allocation of plasma donations from recovered COVID-19 patients to current patients by identifying donors that have antibodies to SARS-CoV-2 virus. Convalescent plasma therapy is an investigational procedure that separates and removes the plasma from a patient’s blood. This plasma is then replaced with plasma from a donor to give the ill patient antibodies to help fight the virus.

The laboratory-based Elecsys Anti-SARS-CoV-2 S test runs on Roche’s widely available cobas e analyzers and is the latest addition to Roche’s growing diagnostic portfolio to help healthcare systems combat COVID-19 through testing in the laboratory and at the point of care. Currently, this portfolio includes molecular, serology and digital solutions that help healthcare professionals diagnose COVID-19 and provide optimal patient care during the initial stages of infection and the recovery phase, as well as following the resolution of infection.

Tags : #Roche #LatestNewsonRoche3rdDec #LatestPharmaNews3rdDec #LatestUSFDAApproval3rdDec #LatestCOVIDNews3rdDec #LatestNewsonCOVIDTreatment3rdDec #ConvalescentPlasmaTherapy #SpikeProtein

About the Author


Team Medicircle

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

NRAI cautions restaurants about the dangers of aggregator payment gateways and deep discounting on diningDecember 09, 2024
Hot Cocoa: A Surprising Ally in Fighting Stress and Boosting Heart HealthDecember 09, 2024
What Your Headache Says About Your Health And Why It Can Be More Than Just a Temporary PainDecember 09, 2024
Hot Cocoa: A Surprising Ally in Fighting Stress and Boosting Heart HealthDecember 09, 2024
Is Your Favorite Snack a Secret Weapon Against Diabetes?December 07, 2024
Is the Fountain of Youth Hidden in Your Cells? Discover the Future of Ageing With Indian AIDecember 07, 2024
Does Your Heart Have a Mind of Its Own? Science Says Yes!December 07, 2024
Does Your Heart Have a Mind of Its Own? Science Says Yes!December 07, 2024
Heart Risks Are Shrinking Men’s Brains: What Science Reveals About Gender and AgingDecember 06, 2024
P&G India Celebrates 20 Years of P&G Shiksha with its largest ever Employee Volunteer Day Initiative across all offices and sitesDecember 06, 2024
Air India SATS Scales up Green Initiative with AeroWash Now Serving Two of India's Busiest AirportsDecember 06, 2024
The Silent Culprit Behind Osteoarthritis: Are Ultra-Processed Foods Eating Away our BonesDecember 06, 2024
From Daily Pills to 2 Shots Per Year: The Future of HIV ProtectionDecember 06, 2024
BREAKTHROUGH CLINICAL STUDY, FIRST OF ITS KIND, PROVES TRAYA CUSTOMIZED REGIMEN DELIVERS 3X* BETTER RESULTS THAN THE MOST PRESCRIBED HAIR GROWTH SERUM December 06, 2024
The Airborne Mutation: Is Bird Flu Becoming a Human Threat? December 05, 2024
Aster CMI Hospital collaborate with Government of Arunachal Pradesh Provide Affordable Liver Transplantation Services.December 05, 2024
Women missing out on treatment for their number one killerDecember 05, 2024
Packaged Water Under Fire: What FSSAI’s ‘High-Risk’ Tag Means for YouDecember 05, 2024
Life or Death: A New Breakthrough in Detecting Sepsis Before It’s Too LateDecember 05, 2024
Marble Centre International Unveils 'A Shared Memory' at Designuru 4.5December 05, 2024