Tele: 561.316.3330
Breaking Medical Device News

Monday, September 27, 2021

HomeFDACOVID-19 Update: FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection

COVID-19 Update: FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection

November 6, 2020

FDA today authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection, which are antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells.

FDA issued an emergency use authorization (EUA) for the cPass SARS-CoV-2 Neutralization Antibody Detection Kit, which specifically detects this type of antibody.

Although the FDA has previously issued EUAs to more than 50 antibody (serology) tests, those tests only detect the presence of binding antibodies. Binding antibodies bind to a pathogen, such as a virus, but do not necessarily decrease the infection and destruction of cells. It’s important to note that the effect of neutralizing antibodies for SARS-CoV-2 in humans it is still being researched.

“The ability to detect neutralizing antibodies can help us gain additional insight into what the existence of antibodies may mean for patients as we continue the fight against COVID-19,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “There are still many unknowns about what the presence of SARS-CoV-2 antibodies may tell us about potential immunity, but today’s authorization gives us another tool to evaluate those antibodies as we continue to research and study this virus. Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus.”

The FDA cautions patients against using the results from this test, or any serology test, as an indication that they can stop taking steps to protect themselves and others, such as stopping social distancing, discontinuing wearing masks or returning to work. The FDA also wants to remind patients that serology tests should not be used to diagnose an active infection, as they only detect antibodies that the immune system develops in response to the virus, not the virus itself.

The EUA was issued to GenScript USA Inc. for its cPass SARS-CoV-2 Neutralization Antibody Detection Kit.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

ProSomnus® Sleep Technologies Adds John E. Remmers, MD, to Leadership Team

Dr. John E. Remmers will provide expert medical and strategic guidance on a range of initiatives, including research and development, regulatory clearances, company strategy, medical education, and clinical investigations.

Nanox to Announce Zebra Medical Vision Secures 8th 510K FDA Clearance for its Coronary Artery Calcium (CAC) Solution as Part of Its Population Health Offering

On August 10th, 2021 Nanox announced that it had entered into an acquisition agreement via merger with Zebra Medical Vision LTD.

Christopher Joyce Joins Miach Orthopaedics as VP & CFO

Christopher Joyce has joined as vice president and chief financial officer, and Kevin Sidow has been appointed to the company’s board of directors.

NGMedical GmbH Receives FDA Clearance for Its AM Titanium Lumbar Interbody BEE® PLIF

The BEE® PLIF cage has been created to benefit from additive manufacturing features. The purposefully designed honeycomb endplate design reduces the risk of subsidence, while allowing fusion.

Tyber Medical Reaches Agreement to Acquire CatapultMD

Once the acquisition is complete, Tyber Medical will own and operate a combined 100,000-square feet of manufacturing space between its Pennsylvania headquarters and Florida-based facilities.

Kleiner Device Labs Receives FDA Market Clearance for KG2 Surge Flow-Thru Interbody System

The system maximizes total bone graft delivery volume, better distributes graft bilaterally into the intervertebral disc space, and streamlines the implant delivery, positioning, and grafting process for TLIF and PLIF spinal fusion procedures.

By using this website you agree to accept Medical Device News Magazine Privacy Policy