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.
The recent communication regarding the recent Anti-SARS-CoV-2 Total assay in Tampa has brought about...
CTS will implement the Bio-Rad Geenius HIV 1/2 supplemental assay on Monday September 21, 2020. The ...
The FDA Guidance ZIKV video for the webinar held on 08/15/18 has been posted in the Wh...
As the US coast prepares for Hurricane Florence to make landfall, we have received importan...
Daylight Saving Time Begins March 10, 2019. As a friendly reminder, airlines often change their rout...
On May 9, 2019 the Food and Drug Administration issued a “Recommendations for Reducing the Ris...