In a recent Clinical Laboratory News article, industry experts discuss the Zika outbreak, referencing the speed at which global pathogens spread, as well as the preparedness of the medical community to address the threat.
A key challenge found in outbreaks is getting diagnostic tests for rapidly disseminating infections from the point of regulatory approval to clinical use. According to Jane Hata, Ph.D., Director of the Clinical Microbiology Laboratory at Mayo Clinic Florida in Jacksonville, “On the scientific side, there can be lots of progress; new methodologies, new approaches to diagnosis. But then the problem is getting those tests FDA-approved and commercialized.”
For example, in the case of Zika, the U.S. Food and Drug Administration (FDA) didn’t grant emergency use authorization for the Quest Diagnostics Zika Virus RNA Qualitative Real-Time RT-PCR test (Zika RT-PCR test) until late April. Since then, however, the agency has granted several EUAs for Zika test kits that clinical laboratories can use.
"The challenge for laboratories is to be ready constantly to test for these pathogens," said Dr. Hata. “I always recommend that labs think about specific scenarios. What would you do, and how exactly would you do it, if a patient came in one afternoon and needed Zika or Ebola testing?”