All blood centers interested in joining the Procleix Zika Virus Assay IND study should consult the FDA’s revised guidance for industry (August 26, 2016): “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components."
The current Hologic IND study protocol (No. B10383-ZIKVPS-CSP-01) entitled “Pre-pivotal Procleix® Zika Virus Assay Testing of Donations from Donors of Whole Blood and Blood Components” follows the FDA's recommendations set forth in the above mentioned FDA guidance document. Blood donations from blood centers will be tested in accordance with this protocol.
In addition, the following documentation is required from each site in order to join the Procleix Zika Virus Assay IND study:
- Site Specific Standard Informed Consent Form and/or Donor History Questionnaire - To document donor consent to donate blood.
- Site Specific Donor Follow-Up Informed Consent Form - To document a donor’s consent to participate in the Procleix Zika Virus Assay Follow-Up study when the donor has tested reactive for Zika virus. If the donor is a minor (younger than 18 years old), the donor’s parent or legal guardian must sign the Donor Follow-Up Informed Consent Form.
- Donor Follow-Up Notification Letter - To notify donor of a reactive result using the investigational Procleix Zika Virus Assay test. Donors with reactive Procleix Zika Virus Assay results should be deferred for at least 120 days from the date of the reactive test or the resolution of the Zika virus symptoms, whichever timeframe is longer.
- Label for Blood Units - All blood units that are nonreactive using the investigational Procleix Zika Virus Assay should be labeled “Neg for Zika by Investigational NAT” prior to distribution for transfusion.
- Circular of Information - Should be updated to include the following wording per the FDA’s recommendation: “Units labeled as negative for Zika virus RNA were tested with an Investigational nucleic acid test (NAT) and found to be nonreactive."
- Principal Investigators - Curriculum Vitae, Financial Disclosure Form and Form FDA1572 are required from each Principal Investigator responsible for testing of blood donations under the Procleix Zika Virus Assay IND study protocol.
- Sub-Investigators (if any) - Curriculum Vitae and Financial Disclosure Form are required for each sub-investigator listed on the Principal Investigator’s Form FDA 1572.
- Optional - Information Sheet with information about Zika virus (e.g., clinical symptoms, transmission, traveling to a Zika active area), and participation in the investigational Procleix Zika Virus Assay IND study is no longer required. However, blood centers can provide this document to all donors prior to donation if they choose to do so.
For more information, please contact Hologic at ZikaIND@hologic.com.
Procleix is a registered trademark of Grifols, S.A. and/or its subsidiaries in the United States and/or other countries.