National Women’s Hockey League partners with Yale on COVID-19 testing
The National Women’s Hockey League (NWHL) is working with Yale to provide saliva-based COVID-19 testing for players and staff during the upcoming season and Isobel Cup playoffs in Lake Placid, New York.
The PCR viral RNA testing method — known as SalivaDirect — was developed by researchers at the Yale School of Public Health (YSPH). It was granted an emergency use authorization by the U.S. Food and Drug Administration after researchers performed clinical validation in collaboration with YSPH, Yale New Haven Hospital, and Yale Pathology Labs (YPL).
“YPL was the first to offer SalivaDirect to the public and the National Women’s Hockey League is the first women’s professional sports league to implement SalivaDirect testing,” said Stephanie Weirsman, physician liaison for YPL.
“Yale Pathology’s mission is dedicated to advancing clinical care and YPL’s outreach program is committed to bringing these standards of excellence to local communities and beyond,” says Dr. Angelique Levi, YPL’s vice chair of outreach. “The NWHL’s partnership with YPL is a natural fit as it supports YPL’s core diversity values by promoting women’s professional athletics, highlighting female leaders and role models, emphasizing health and wellness through innovative diagnostics on a national level, and by increasing testing capacity and access to the public.”
Additionally, NWHL and YPL are working together on a quality improvement initiative which involves obtaining paired saliva and nasal samples for NWHL players and staff for dual-testing purposes. This dual testing is beneficial both to the NWHL players and staff who receive two concurrent results, as well as to the clinical lab which can provide additional data for the COVID-19 diagnostic molecular testing program.
“The NWHL is proud to be working with Yale Pathology Labs,” said NWHL Commissioner Tyler Tumminia. “Our top priority for this season in Lake Placid has been protecting the health and safety of the players and everyone involved, and testing has been a major focus for us. By partnering with YPL, the NWHL not only has the direction of pioneering doctors and scientists, but also the support of an organization that believes in the power of women’s sports.”
The NWHL announced that its upcoming season and playoffs will be held in Lake Placid between Jan. 23 and Feb. 5, 2021.
SalivaDirect™ is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider.
SalivaDirect™ was developed by the Yale School of Public Health (YSPH) and has received an Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA). The FDA limits the emergency use of SalivaDirect™ testing only to high-complexity CLIA-certified laboratories formally designated as authorized laboratories by YSPH under the EUA 202097.
The FDA has authorized the test under its emergency use authority only for detection of nucleic acid from SARS-CoV-2, and not for any other viruses or pathogens. The SalivaDirect™ test has not been FDA cleared or approved. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
For more information about SalivaDirect, visit this webpage.
Fred Mamoun: email@example.com, 203-436-2643