Labs Must Rapidly Implement Zika Blood Supply Testing

The U.S. Food and Drug Administration (FDA) recently classified the Zika virus as a transfusion-transmitted infection and called on all U.S. blood centers to start universal screening of donated whole blood and blood components for the virus. While a necessary step to protect the nation’s blood supply, experts say that immediate implementation is likely to pose a challenge for some blood banks and for the third-party laboratories.

According to the American Red Cross nearly 14 million units of whole blood and red blood cells are collected each year from about seven million donors. While the number of confirmed U.S. cases of Zika is still small in comparison, Zika has been detected in blood donated from asymptomatic individuals in Puerto Rico and there are reports of probable transfusion-transmission of Zika in Brazil.

As “precautionary measures” the FDA called for immediate implementation of nucleic acid testing of all donations and use of an approved pathogen reduction technology for platelets and plasma donations. Currently there are no approved Zika tests, however two tests are available under an investigational new drug application—Roche’s cobas Zika assay and Hologic’s Procleix Zika virus blood screening assay. The cost of adding Zika testing to the blood screening process is less than $10, according to the South Texas Blood and Tissue Center.

Implementation of the guidance is to be immediate for blood centers in states and territories with local transmission—Florida and Puerto Rico, which has already been screening since March. Blood centers in Alabama, Arizona, California, Georgia, Hawaii, Louisiana, Mississippi, New Mexico, New York, South Carolina and Texas have four weeks to comply, while all other states and territories have 12 weeks. Several blood centers began voluntary testing ahead of the FDA’s Aug. 26 guidance.

• In late August the American Red Cross said it is conducting blood donor tests for Zika virus under an investigational study in five southeastern states at greatest risk of local mosquito transmission of Zika virus. However in September the organization will expand this testing to four additional states in the south central and southwestern United States.
• As of Aug. 1, OneBlood began using an investigational donor screening test throughout the company’s service area in Florida, Georgia, Alabama and South Carolina, although the FDA had asked for testing in just the two affected Florida counties of Miami-Dade and Broward. The company says it has capacity to test 3,000 samples per day at its facility in St. Petersburg, Fla.
• In mid-July the South Texas Blood and Tissue Center became one of the first centers to begin testing blood donations for the Zika virus. Zika testing is being performed in the QualTex labs in Georgia, because of space and capacity requirements for the Roche testing equipment.

Takeaway: Metabolomic profiles in serum may be useful in screening women for early- stage ovarian cancer. While further validation in larger populations is necessary, the researchers say a clinical assay based on the 16 markers is technically feasible.