BATON ROUGE, La. -- Woman’s has always been on the cutting edge of research and technology, and the Woman’s Lab has continued this work throughout the pandemic. As of Monday, April 20, Woman’s is now processing all of its inpatient and outpatient COVID tests in its own lab. This required the completion an Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA).
“Getting tests approved by the FDA can sometimes take years,” explained Beverly Ogden, MD, Board Certified Anatomic and Clinical Pathologist at Woman’s Hospital. “The FDA is allowing an emergency use authorization to allow labs to begin testing earlier during the COVID pandemic. There are many steps required to complete an FDA EUA, and most hospitals are waiting for tests that already have an FDA EUA completed by the company.”
The Woman’s lab, however, completed its own FDA EUA for the Luminex Aries RT-PCR test. There is a significant amount of work required to accomplish this, yet they finished in just a day and a half.
Led by molecular biologists Lori Breland and Lori Stewart, the Woman’s Lab had to perform its own quality control tests to prove its results are reliable. For this particular test, they had to run 30 positive controls, 30 positive patients and 30 negative patients and were able to get accurate test results.
Led by director Jay Latour and manager Kimberly Gruse, the success of the Lab at Woman’s in these efforts can in part be attributed to its participation with the River Road Testing Lab at the LSU School of Veterinary Medicine that was set up to help area hospitals get quick, reliable results for COVID tests. Dr. Ogden serves as medical director of the lab and helped to get it ready to do patient testing.
“The relationship with LSU’s Dr. Stephania Cormier and her team has helped us have better knowledge on how to set up testing and to prevent viral contamination during testing,” said Dr. Ogden. “They have also begun working on research studies to better understand COVID infection, immune response and transmission.”
In the coming weeks, Woman’s anticipates helping other hospitals get results for COVID tests who do not yet have this capability in house.