SEATTLE — Bloodworks Northwest today said it will fully comply with the FDA requirements for Zika virus testing on every collected unit of donated blood, while, it said, the American Red Cross “declines” to do the same.
“We know the Zika virus can travel from a pregnant woman to an unborn child with profound consequences, and can be transmitted through blood and sexual contact, giving rise to serious public concern,” Dr. James P. AuBuchon, president and CEO, said in a release. “As directed by the FDA, we will implement the most sensitive, individual-sample testing available to ensure patient safety and public confidence in the blood supply.”
The Food and Drug Administration issued guidance to all U.S. blood organizations on Aug. 23 mandating Zika virus testing on donations collected.
From the Bloodworks Northwest release:
"Despite the FDA's mandate to use the highly accurate individual testing protocol for Zika, the American Red Cross will use a less sensitive "mini-pool" test in lower risk areas such as the Pacific Northwest. This testing method can fail to detect up to 25% of Zika-infected blood, placing patients and the public at risk. The Red Cross was also two weeks late meeting the October 3rd deadline for Zika testing in high risk areas."
A Red Cross statement on Zika virus screening from Aug. 29 said the organization is “working to implement the U.S. Food and Drug Administration’s guidance released ... recommending universal testing of donated blood and blood products in the U.S.”
The Red Cross released the following statement Monday afternoon regarding Zika safety. This statement is from Dr. Susan Stramer, vice president of scientific affairs at the American Red Cross.
The American Red Cross is dedicated to providing the safest, most reliable blood products possible to patients in need. We take strong exception with the safety allegations made by Bloodworks Northwest that irresponsibly and erroneously stokes public health fears. The Red Cross is working aggressively to implement the U.S. Food and Drug Administration’s guidance released August 26, 2016, recommending universal investigational Zika virus nucleic acid testing of donated blood and blood products in the U.S.
The FDA gave blood centers the opportunity to review their implementation plans and timelines with the FDA. The Red Cross has discussed our phased implementation plan with the FDA. The FDA understands our approach and has expressed no concern with our timeline. Claims that we are not in full compliance with FDA regulations are categorically untrue.
It is significant to note that the Red Cross initiated Zika virus testing in June, ahead of most blood centers in the U.S. and prior to the FDA required testing guidance. Currently, the Red Cross conducts individual donation testing (ID-NAT) for Zika virus under an investigational study in ten U.S. states in which our collections occur that are believed to be at greatest risk of local mosquito transmission of Zika virus. Those states include Alabama, Arizona, California, Florida, Georgia, Mississippi, New York, Oklahoma, South Carolina and Texas. (The Red Cross does not collect blood in Hawaii, Louisiana or New Mexico.) Again, this is in full compliance with FDA guidance. The Red Cross began individual donation testing in Florida on July 25 – Florida is the only state in the continental U.S. designated by the CDC as active for local Zika virus transmission.
In the remaining states including those in the Pacific Northwest, the Red Cross will implement mini-pool donation testing (MP-NAT) for Zika virus under an investigational study by November 14. We will then migrate these states from mini-pool to individual testing before the end of the year. As an added layer of safety, we are retaining the health history question regarding travel to areas at risk for Zika virus and deferring accordingly. In addition, the Red Cross continues to provide donors with information regarding other Zika virus risks including travel, sexual contact, symptoms and/or diagnosis, and ask donors who are at risk to self-defer, or postpone their blood donation.
The Red Cross has a strong history of implementing safety initiatives including investigational blood donation screening tests, for example dengue viruses in the Caribbean. This was followed by the implementation of pathogen inactivation in response to the epidemic of dengue and chikungunya viruses in the Caribbean. We also introduced investigational testing for the parasite babesia that is common in New England and the upper Midwest. The Red Cross is now implementing pathogen inactivation in the continental U.S. The highest priority for the Red Cross is the safety of our donors and the recipients of blood.
Cox Media Group