October 16, 2020
Trump Administration Provides Saliva Test at Surge Testing Site in Waco, TX
Test Bolstered Through NIH Rapid Acceleration of Diagnostics (RADxSM) Initiative
Starting today, communities that are part of the federal surge testing effort for COVID-19, supported by the Trump Administration, have a new option: a test that uses samples of saliva collected by spitting into a sterile container. Made by Fluidigm Corporation and supported in part by the National Institutes of Health (NIH), the easy-to-use saliva test detects SARS-CoV-2, the virus that causes COVID-19, on a molecular level using a microfluidics platform. The accuracy of the test is comparable to other molecular-level tests of nasal swab samples, according to a clinical study conducted by the manufacturer. The U.S. Department of Health and Human Services (HHS) has traditionally provided nasal swab tests from other manufacturers to surge testing sites, which remain a choice for community officials.
Waco, Texas, is the first community to offer saliva testing for COVID-19 through the federal Community-Based Testing Site (CBTS) program starting October 16. Local officials will offer the Fluidigm saliva test at three sites through mid-November. The CBTS program provides COVID-19 "surge testing sites" for a limited period in areas where there has been a recent and significant increase in the number of new COVID-19 cases and hospitalizations. The program is administered by the U.S. Department of Health and Human Services (HHS) in partnership with local communities and private companies.
"Saliva tests are easy to perform, and many people may find them more comfortable than nasal swab tests," said ADM Brett Giroir, M.D., HHS assistant secretary for health. "Our goal is to build our nation's capacity for reliable, accurate and timely testing so that every American who needs a COVID-19 test -- including those who do not have symptoms -- can get one. Offering different types of tests helps us meet this goal."
Since the surge testing site program launched in July, 362,000 tests have been conducted at surge testing sites in 10 states and 21 localities.
"Thanks to the innovation and cooperation of private industry, academia, and communities working hand-in-hand with our federal agencies, we are making great strides in building our testing capacity," Giroir added.
The Fluidigm integrated microfluidics platform used in the saliva test can generate as many as 6,000 test results per day. With many existing Fluidigm instruments in clinical and research labs throughout the U.S., the company is now expanding its microfluidics manufacturing capacity and developing a novel barcoding chemistry to further increase test throughput for each system.
The technology's rapid development and expansion is supported by a $34 million contract with the National Institute of Biomedical Imaging and Bioengineering (NIBIB), part of the National Institutes of Health. The contract is among 22 that have been awarded since July 31 as part of the NIH's Rapid Acceleration of Diagnostics (RADxSM) initiative to fast-track development and commercialization of innovative technologies to significantly increase U.S. testing capacity for COVID-19. The investment will enable tens to hundreds of thousands of these tests to be processed per day, according to Fluidigm.
The Fluidigm saliva test is authorized for use by qualified and trained clinical laboratory staff through emergency use authorization from the FDA granted August 25, 2020. Results are available via email within 3 to 5 days.
HHS has shipped 10,000 Fluidigm saliva tests to select Waco, Texas sites. The saliva tests are being offered through eTrueNorth and processed by Millennium Health, a lab certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity tests.
The Fluidigm project is supported by the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative and has been funded in whole or in part with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under contract No. 75N92020C00009.
Test Availability in Waco, Texas:
Saliva tests will be available on the following dates at the sites listed below. Other sites offer testing using a nasal swab. Please note that you must register for a test and print a test voucher to take with you to your appointment.
Visit https://www.doineedacovid19test.com/ for more information and to register for a test.
October 16 and 17:
Heritage Square Parking Lot
311 Austin Ave
Waco TX 76701
November 2 through November 22 (Including Weekends):
Antioch Community Church
505 N 20th St
Waco TX 76707
November 2 through November 14 (excluding November 8):
Sacred Heart Catholic Church
1724 S 29th St
Waco, TX 76711
Test results will be available to individuals within 3-5 business days after taking the test. You will receive an email notice when results are available. Once you receive the email, go to https://www.doineedacovid19test.com/ and logon to view and print your lab report.