Woman’s has always been on the cutting edge of research and technology, and the Lab team has continued to do incredible 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. Being able to do this was no easy feat, as it required an Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA).
Getting tests approved by the FDA can sometimes take years. 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. Linda Johnson, who has been instrumental in validating the Biofire respiratory panel, will be the third medical technologist with COVID testing competency. Laboratory compliance officer Paige McCartney submitted paperwork to the FDA and Woman’s Laboratory was able to begin testing.
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. Beverly 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 Woman’s have better knowledge on how to set up testing and to prevent viral contamination during testing. They have also begun working on research studies to better understand COVID infection, immune response and transmission.
When the River Road Testing Lab closes in the coming weeks, Woman’s is expected to pick up some of the work it was doing and help other hospitals get results for COVID tests who do not have this capability in house yet. The entire Woman’s Lab team was part of these efforts, going above and beyond to bring much needed additional testing for COVID-19.