Please Wait a Moment
X

Articles

04Jan

FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma

04 Jan, 2022 | Return|

On December 28, 2021, the FDA updated the emergency use authorization  (EUA) for COVID-19 convalescent plasma.  The update limits the authorization to the use of COVID-19 convalescent plasma with high titers of anti -SARS-CoV-2 antibodies for the treatment of COVID-19 in patients with immunosuppressive disease or who are receiving immunosuppressive treatment.  Additionally, to help assure the manufacture of high titer COVID-19 convalescent plasma, the revisions to the EUA define acceptable tests and increase qualifying result cutoffs to be used for manufacturing COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies.

We are currently evaluating our options to determine if we can provide additional testing services using one of the newly defined assays. Please reach out to your customer service manager if your organization is considering CCP testing under the updated guidelines. 

 

 

 

Related

FDA Releases ZIKV Guidance and Grifols ZIKV Assay Licensed- 1st Update

This is the first update to the original CTS communication distributed on July 6th. As previously co...

Read More >

Reminder-New Learning Center with New Content Launches on March 30!

The new Learning Center website launch today on Monday, March 30, 2020. While the link to the new Le...

Read More >

New Online Learning Center with New Content

The new online Learning Center with new content can still be found under the “Training” folder on ...

Read More >

MD Revised Headers on CTS forms

Dr. Buff Mair is the new CTS Medical Director and replaces Dr. German Leparc who retired at the begi...

Read More >

Creative Testing Solutions and Grifols Forge New Testing Partnership

Creative Testing Solutions, the largest nonprofit blood testing organization in the U.S., today anno...

Read More >

CTS St. Louis Implements New Laboratory Information System

On August 9, 2019, the new CTS Laboratory Information System was successfully implemented in St...

Read More >