All-in-One Tests for COVID-19 to Be Offered First to Sutter Patients
Sutter Health, which co-led the study of the first all-in-one molecular test to diagnose COVID-19 infection, is gearing up to offer the test to qualified patients in the next two months after the U.S. Food and Drug Administration granted Emergency Use Authorization today.
The single-use, user-friendly COVID-19 All-In-One Test Kit can produce a positive or negative result within 30 minutes. Lucira’s test kit is differentiated by its simple “swab, stir and detect” design, and all patients in clinical trials were able to perform the Lucira test in about 2 minutes.
Currently, Sutter performs approximately 1,500 COVID-19 tests daily in ambulatory settings (seven-day average). Turnaround times for these lab-based diagnostic tests average 24-48 hours.
The Lucira test is expected to be available for providers in the Sutter Health network to prescribe within the coming months across the 24 California counties where the health system operates. During this time, Sutter will work on the operations necessary for accurate patient evaluation, prescribing and reporting of results. Sutter Health and South Florida’s Cleveland Clinic will be the first U.S. health systems to offer the self-tests.
“With the introduction of entirely at-home test kits, like the Lucira COVID-19 All-In-One Test Kit, the role of the healthcare provider will become more important, not less,” said John Chou, M.D., medical director for anesthesiology, diagnostics and pharmacy at the Palo Alto Foundation Medical Group and a principal investigator on the Lucira Health Community Testing Study submitted to the FDA. “Providers within the Sutter Health network will evaluate patients to determine if they meet FDA guidelines for a test, prescribe the test, review the results with patients, arrange for any follow-up care.”
Since the start of the pandemic, Sutter Health activated and deployed a coordinated response across its integrated network to help protect patients, employees and communities. In that time, the network has worked hard to make health services safe and easily accessible. As COVID-19 cases increase, the demand for testing supplies heightens and potentially creates scarcity concerns for healthcare organizations and extends turnaround times. The need to develop more diverse testing options is critical, and creating greater access and supporting research that examines these options becomes all the more important. The Lucira test kit study is just one example.
Sutter’s Palo Alto Medical Foundation launched the study of the Lucira COVID-19 All-In-One Test Kit in July. Study investigators from Sutter Health will submit detailed study results and analysis to peer-reviewed journals for publication.
”Being able to quickly determine if a person is infected or not has been a global problem,” said Dr. Chou. “We believe this highly mobile test can make a big difference by providing lab-quality results expeditiously and conveniently. Early, accurate detection is vital to delivering appropriate care and controlling the pandemic.”
Research is an integral component of Sutter Health’s mission to improving the wellness of patients and communities throughout Northern California. Many clinicians within Sutter Health’s network are also researchers who publish findings, develop novel protocols, and pioneer new tests and treatments at a rate more commonly found at major universities. All of this activity fosters improved patient care, and enables Sutter Health to recruit and retain clinician-scientists of the highest caliber. For more on Sutter’s research and current clinical trials, go to www.sutterhealth.org/research.