Please Wait a Moment
X

Articles

12May

FDA announces withdrawal of Guidance for ZIKV Testing

12 May, 2021 | Return|

We are informing you that the FDA has announced their withdrawal of Guidance for ZIKV Testing. In their announcement, FDA indicated the Zika virus (ZIKV) is no longer a relevant transfusion-transmitted infection (RTTI) under FDA’s regulations, and the available evidence demonstrates that ZIKV no longer has sufficient incidence and/or prevalence to affect the potential donor population.  Accordingly, the guidance titled, “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components,” dated July 2018, has been withdrawn. Since ZIKV is no longer an RTTI, blood establishments may discontinue testing for ZIKV. FDA further advised that licensed blood establishments that discontinue testing blood donations for ZIKV must report this change to FDA in the annual report under 21 CFR 601.12(d), noting the date testing was discontinued. We are aware that our clients need information regarding the transition plans at CTS to inform their change group to cease ZIKV testing. We are forming a project team beginning today to evaluate the requirements for all stakeholders involved to define the requirements and timeline to eliminate ZIKV as a required donor panel test. We will provide an update with more information next week, but clients can begin plans to cease ZIKV testing.

Related

Convalescent Plasma Testing for COVID-19

CTS Tampa has implemented the Ortho Vitros Anti-SARS-CoV-2 Total test which qualitatively detects an...

Read More >

CTS Testing Algorithm to be Revised on December 17, 2018

The CTS Medical Advisory Board recently agreed upon a revision to our standard testing algorithm. Th...

Read More >

National Blood Donor Month

National Blood Donor Month has been observed in January since 1970, with the goal of increasing bloo...

Read More >

World Patient Safety Day 2020

The COVID-19 pandemic has unveiled the huge challenges and risks health workers are facing globally ...

Read More >

Shipping conditions for Monolisa anti-HBs EIA

After a recent reevaluation of the Monolisa anti-HBs EIA package insert, the CTS QA/Scientific team ...

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 >