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for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components,” dated July 2018, has been withdrawn.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

National Blood Donor Month – January 2020

That’s just one of the reasons that National Blood Donor Month, which has taken place each Jan...

Read More >

Seasonal Monitoring for WNV to begin June 1, 2020

Seasonal monitoring of epidemic triggers for West Nile Virus (WNV) NAT tested donations will begin J...

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 Tampa Implementation date change for Ultrio Elite

CTS originally communicated that Tampa will convert from the current Grifols Ultrio Plus NAT triplex...

Read More >

Exhibiting at AABB Annual Meeting- Booth 732

We sincerely hope to see you at this year’s AABB Annual Meeting in San Antonio, TX on October ...

Read More >

2020 Annual CTS Survey

The CTS 2020 Annual Laboratory Survey is on its way to your email box. We would appreciate you takin...

Read More >