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for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components,” dated July 2018, has been withdrawn.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

IPFA welcomes Marion Lanteri as Executive Board member, CTS as new member organization

IPFA welcomes Marion Lanteri as Executive Board member, CTS as new member organization

Read More >

Confirmatory Testing Delay for HIV-1 Western Blot and HIV-2 EIA

Currently, there are limited supplies of the reagents used for HIV-1 Western Blot and HIV-2 EIA test...

Read More >

Reminder-Confirmatory Algorithm and Assay Changes Effective September 30, 2019

On June 13, 2019, CTS provided information regarding the manufacturer’s discontinuation of HIV...

Read More >

Reminder- The CTS Reentry form- CTS-00172 implements 7/2/18

Reminder - The CTS Reentry form, CTS-00172, will be updated on Monday July 2, 2018. It's posted ...

Read More >

Reminder- Check flights and cargo hours for the Christmas holiday

As a friendly reminder, airlines often change their routine flights and cargo hours for hol...

Read More >

COVID-19 Antibody Testing Frequently Asked Questions

The recent communication regarding the recent Anti-SARS-CoV-2 Total assay in Tampa has brought about...

Read More >