UI saliva test gets FDA emergency authorization
March 1, 2021
The Food and Drug Administration approved the University’s COVID-19 saliva test on Monday for emergency use.
WIth this emergency use authorization, the U of I system can “broadly expand its covidSHIELD testing beyond its universities,” according to the University.
“It’s good because it is a good test,” said Christopher Brooke, Assistant Professor of Microbiology at the U of I. “It’s really been a success to keep the infection rate really low. The test took about a month to develop, and it could have been done more broadly, nationally, and made a huge difference.”
Ever since the University backtracked its previous claim of approval, the University has pushed for an EUA, submitting its test to the FDA on Dec. 30, 2020 for approval in order to expand the use of its saliva test across the state of Illinois.
“We look forward to SHIELD’s implementation in Urbana, particularly in neighborhoods where our most vulnerable populations live,” said Diane Marlin, mayor of Urbana, in an interview last December.
The test may be conducted in laboratories designated by the University that are certified under the Clinical Laboratory Improvement Amendments (CILA) and “meet requirements to perform high complexity tests,” according to the EUA.
However, the FDA notes that the test should be used in conjunction with other medical information to determine whether someone is infected.
“Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status,” said the EUA.
The FDA also warns that a negative result does not necessarily mean that someone is uninfected with SARS-CoV-2, and other testing methods should be used to confirm suspected cases.
“Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions,” the EUA said. “Negative results for SARS-CoV-2 RNA from saliva should be confirmed by testing of an alternative specimen type if clinically indicated.”
As a result of the new EUA, residents of the Champaign county can potentially gain access to the SHIELD test through their public health services.