Organization Implements Test Ahead of Federal Mandate
Newark, DE – The Zika virus continues to spread throughout the United States and cases have now been detected in all 50 states. In the Delmarva region, Delaware has reported 16 cases while Maryland is reporting 108.
Due to the rapid spread of this virus, mostly through travel with the exception of Florida where the virus has been locally acquired in some patients, the FDA mandated that all blood centers in the United States be required to have all collected blood tested for Zika, beginning November 18, 2016.
Blood Bank of Delmarva (BBD), the main supplier of blood and blood products to the Delmarva region was faced with one of two choices, either conduct their own testing or contract with another laboratory. The FDA had only given blood centers 12 weeks’ notice to comply with the new mandate. To put this in perspective, the normal timeline for a laboratory to implement a new mandatory test would be six months to a year.
To meet the FDA’s deadline would take a true collaborative effort on the part of Blood Bank employees and the testing manufacturer, Roche Molecular Systems, Inc. Working many long hours over this short period of time has resulted in BBD now being a part of a prospective study to evaluate the specificity of the cobas ® Zika Test for use with the cobas ® 6800/8800 system for screening of blood donations for the presence of Zika Virus RNA.
According to Trudell Green, BBD’s Laboratory Operations Manager, “Our awesome project team worked together feverishly to accomplish construction, installation of two new instruments, validation of equipment, assays and four software systems, no small task given the timeline we had to meet.” All blood donated from this point forward will be tested for the Zika Virus. “It’s yet another step being taken for the safety of the blood supply and for the patients who will receive transfusions”, said Green.