The FDA on Feb. 29 loosened diagnostic test restrictions, opening the door for health systems to use their own COVID-19 tests, instead of relying on public health labs or the CDC for testing.
Developing a new diagnostic test usually takes about six months to a year, but microbiologists and other scientists at top health systems have been working around the clock to create new tests for COVID-19 in just about a month.
Here are six health systems that developed their own tests for COVID-19:
1. Rochester, Minn.-based Mayo Clinic developed and validated a COVID-19 test in under a month, Matthew Binnicker, PhD, a clinical microbiologist and director of the system's Clinical Virology Laboratory, said March 12. The health system submitted its data to the FDA seeking emergency use authorization. Initially, Mayo's lab will process up to 300 tests a day. The lab said it plans to double that number over the next few weeks after it obtains additional equipment.
2. Danville, Pa.-based Geisinger is currently offering in-house COVID-19 testing for applicable patients at all its hospitals. The test entails two nasal swabs and a phlegm sample, which are sent to Geisinger's main lab in Danville. Results are available within three to 24 hours, Marc Stempka, a spokesperson for Geisinger, told NorthcentralPA.com. The system plans to roll out testing at some outpatient sites later this week.
3. Stanford (Calif.) Medicine's Clinical Virology Laboratory is testing hundreds of patient samples daily for COVID-19, the system said March 16. The lab is offering the testing services to several hospitals in the Bay Area, which are not all affiliated with Stanford Medicine. Other Stanford labs have donated equipment and reassigned staff members to help increase testing capacity. The lab aims to process more than 1,000 tests per day within the next week.
4. Evanston, Ill.-based NorthShore University HealthSystem rolled out its in-house test March 12. Since then, the health system has conducted about 400 tests, 10 percent of which were positive for COVID-19, reports CBS 2 Chicago. The test entails a nose swab, and results are ready within four to six hours. NorthShore said it is also hoping to boost its capacity to 1,000 tests per day.
5. Pittsburgh-based UPMC implented in-house testing March 14. Patients require a physician referral, approved by the system's infection prevention team, to visit UPMC's specimen collection site in PIttsburgh's south side. UPMC plans to eventually open additional collection sites in the community and ramp up production to process hundreds of tests per week.
6. Charlotte, N.C.-based Atrium Health is offering in-house COVID-19 testing for patients meeting the established criteria at all its hospitals. The test entails a nasopharyngeal swab, which is sent to Atrium Health’s testing laboratory in Charlotte. Test results are available within three to 24 hours, and the lab can process more than 1,000 tests per day, a spkesperson told Becker's via email.
If you'd like to add a hospital or health system to this list, please email Mackenzie Bean at mbean@beckershealthcare.com.
Editor's note: This article was updated March 18 at 3:00 p.m. CDT.