QualTex Laboratories Implements New Zika Testing Guidance from FDA

Just One Month After Announcement, QualTex Implements Changes
August 22, 2018

QualTex Laboratories is up and running with new guidance for testing blood donations for the Zika virus, just weeks after the Food and Drug Administration issued revised recommendations for blood centers.

In July, the FDA distributed a Guidance for Industry permitting the use of “minipool” testing for Zika, in which samples from a small group of donors are combined and tested for the presence of Zika virus antibodies. Since Zika testing began in 2016, all donations had been required to be tested individually.

The new minipool Zika method began at QualTex Laboratories facilities in San Antonio and Norcross, Georgia, on Aug. 16. QualTex performs blood testing for the South Texas Blood & Tissue Center (STBTC), as well as blood and plasma centers throughout the United States.

“Our partnership with Roche gave us a more-rapid implementation of the minipool Zika testing,” said Ward Carter, chief operating officer of QualTex Laboratories, which along with STBTC is a subsidiary of BioBridge Global. “We had prepared for this change and wanted to be an early adopter of the minipool methodology.”

QualTex was one of the first testing centers in the United States to make the Zika test available, working with the pharmaceutical giant Roche on development of the assay in 2016. The FDA recommended testing all blood and blood products for the presence of the Zika virus in July 2016.

The change will result in lower costs for blood centers, Carter noted, since running in a minipool format has a lower overall cost than the individual method.

The FDA’s revised recommendations noted that if there is a positive test for the Zika virus, or if the Centers for Disease Control or other health agencies determine there is a high risk for Zika virus transmission in a certain area, then all donations will need to be tested individually.

Positive tests have been rare since the FDA released its initial guidelines in2016. QualTex has not had a confirmed positive test, and a study published in the New England Journal of Medicine showed the nation’s largest blood collection organization had just eight positive tests out of more than 4 million donations in the first 15 months of Zika testing.