PHOENIX, April 12, 2016 /PRNewswire-USNewswire/ -- In response to the Zika virus outbreak, Creative Testing Solutions is the first testing laboratory in the US to implement a Zika test to ensure the safety of the U.S. blood supply. Currently, the CTS laboratory in Tampa, Fla. tests only Puerto Rico blood donations for Zika, since that is the only US state or territory collecting blood in an area with active local transmission of mosquito-borne Zika infections. Creative Testing Solutions tests approximately 35 percent of the US blood supply at four high volume laboratories, and is the primary provider of blood donor testing services for the U.S. Territory of Puerto Rico.
On February 16, 2016, the U.S. Food and Drug Administration released Guidance with recommendations to reduce the likelihood of a transfusion transmission of Zika virus in areas identified by the Centers for Disease Control and Prevention as having "active transmission." One of the FDA recommended strategies was the development and implementation of a Zika test for all blood donations in such areas. The territorial islands of Puerto Rico were immediately classified by the CDC as an area with active transmission.
"The speed at which this test was implemented is unprecedented in blood donation screening history," said Dr. Phillip Williamson, vice president of Operations and Scientific Affairs, who led the team that implemented the Zika test in conjunction with the test manufacturer and under the FDA investigational new drug (IND) mechanism. "Previously, a similar process was enacted to address the need for West Nile virus screening. We accomplished in 6 weeks the same process that took approximately 12 months for WNV."
The aggressive implementation timetable was possible because the new Zika test is based on a Nucleic Acid Amplification (NAT) testing platform already in use at all four Creative Testing Solutions laboratories. NAT testing technology has been in use for more than two decades to screen blood donations for hepatitis B and C, HIV and, more recently, West Nile virus.
There are no known transfusion transmissions of Zika in the U.S., and as of April 6, 2016, no local mosquito-borne Zika virus disease cases have been reported in the continental U.S. Dr. Williamson said, "While the current IND is limited to the territorial islands of Puerto Rico, planning is already underway that would enable Creative Testing Solutions to expand Zika testing to the continental US should it become necessary."
Sally Caglioti, president of Creative Testing Solutions, said, "I am extremely proud of the way our team worked together to address this critical blood safety need to support our partners in their lifesaving missions. Our collective response to the Zika threat may represent a paradigm changing in the way that blood centers, testing labs, industry and the FDA interact with each other to respond to an emergency." Ms. Caglioti went on to say, "I hope this experience will significantly improve the way blood donor screening tests are implemented in the future."
Creative Testing Solutions is the largest nonprofit independent blood donor testing laboratory organization in the United States. In 2015, Creative Testing Solutions tested approximately 4.5 million donor samples, or 35 percent of the U.S. blood supply, at four high volume laboratory facilities located in Dallas, Phoenix, Seattle and Tampa. Creative Testing Solutions is owned by four of the leading U.S. blood service providers: Blood Systems, OneBlood, the Institute for Transfusion Medicine and Bloodworks Northwest.
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SOURCE Creative Testing Solutions