New Zika Blood Testing Guidance Effective Immediately
On July 6, the FDA issued revised guidance for testing of donated blood for Zika virus. Summary After initially recommending universal nucleic acid testing of individual blood donation units, the agency indicates that it will now allow pooled testing which the guidance describes as more cost effective and “less burdensome” for blood establishments. However, according to the guidance, the need for individual testing may be triggered “when certain threshold conditions are present,” such as an increased risk of local mosquito-borne transmission of Zika virus in a specific geographic area. The final guidance still requires blood establishments to test all donated whole blood and blood components for Zika virus using a nucleic acid test. Since 2016, two assays have been approved under investigational new drug applications: the Cobas Zika (Roche Molecular Systems, Inc.) and the Procleix Zika Virus Assay (Grifols Diagnostic Solutions, Inc.). In May of this year, the FDA approved an additional claim for Roche’s Cobas Zika test for pooled testing of blood or plasma donations. Additional Recommendations All FDA recommendations in the new guidance are classified as nonbinding. Nevertheless, the agency recommends communication between blood establishments, and communication with state or local health departments or other public authorities, if […]
On July 6, the FDA issued revised guidance for testing of donated blood for Zika virus.
Summary
After initially recommending universal nucleic acid testing of individual blood donation units, the agency indicates that it will now allow pooled testing which the guidance describes as more cost effective and "less burdensome" for blood establishments. However, according to the guidance, the need for individual testing may be triggered "when certain threshold conditions are present," such as an increased risk of local mosquito-borne transmission of Zika virus in a specific geographic area.
The final guidance still requires blood establishments to test all donated whole blood and blood components for Zika virus using a nucleic acid test. Since 2016, two assays have been approved under investigational new drug applications: the Cobas Zika (Roche Molecular Systems, Inc.) and the Procleix Zika Virus Assay (Grifols Diagnostic Solutions, Inc.). In May of this year, the FDA approved an additional claim for Roche's Cobas Zika test for pooled testing of blood or plasma donations.
Additional Recommendations
All FDA recommendations in the new guidance are classified as nonbinding.
Nevertheless, the agency recommends communication between blood establishments, and communication with state or local health departments or other public authorities, if Zika virus is detected–and that blood establishments remain up to date on any announcements related to Zika.
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