Another Zika Testing Change by the FDA
Advisers to the Food and Drug Administration (FDA) recommended in early December 2017 that the screening for Zika virus in blood donations can be ‘relaxed’.
The FDA said ‘this is due to the diminished risk of transfusion-transmitted Zika virus infection’, according to Reuters.
This FDA advisory panel voted to modify the existing blood testing protocol established during August 2016, when FDA health officials declared Zika a global health emergency. new protocol says that instead of requiring Zika virus testing on each individual blood donation, tests could be conducted on "mini-pools".
This means various blood samples are pooled together before testing.
This new FDA recommendation would bring Zika virus testing more in line with the way U.S. blood banks screen for the West Nile Virus.
Additionally, this panel recommended that criteria be established for resuming individual unit testing if risks increase. This criteria could include the discovery of the Zika infection beginning to spread in a given area.
This new testing protocol change by the FDA comes just weeks after the October 2017 approval of the cobas Zika test.
This cobas Zika test from Roche Labs is intended for use by blood collection establishments to detect Zika virus in blood donations, not for an individual diagnosis of Zika virus infection.
In October 2017, Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research said, "Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply.
Dr. Marks comment was related to the December 2016, FDA notice regarding the number of false-positive, Zika test results.
The FDA alerted physicians who care for pregnant women meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria, that the U.S. commercial testing facility had reported some false positive results from the ZIKV Detect test.
Which means if you have questions or concerns regarding Zika tests, its best to speak with your healthcare provider.
- FDA panel recommends Zika testing of donated blood be relaxed
- FDA advises testing for Zika virus in all donated blood and blood components in the US
- FDA approves first test for screening Zika virus in blood donations
- Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissu
- FDA Warns Health Care Providers Against Relying Solely on Zika Virus Serological IgM Assay Results; Reminds them to Wait for Con