FDA gives emergency authorization for cutting edge test under umbrella approval
By Eric Horng, Stacey Baca and ABC7 Chicago Digital Team
Illinois health officials reported 2,295 new coronavirus cases and 25 additional deaths Wednesday. Governor JB Pritzker also gave an update at a press conference regarding the state’s response to the virus.
The statewide positivity rate for the period of August 12 – August 18 stands at 4.4%. Within the past 24 hours, laboratories have reported 50,299 specimens for a total of 3,489,571.
As of Tuesday night, 1,519 people in Illinois were reported to be in the hospital with COVID-19. Of those, 334 patients were in the ICU and 144 patients with COVID-19 were on ventilators.
The number of new cases is the highest number since 2,508 new cases were reported on May 24.
Gov. Pritzker announced that state health officials will be using a new groundbreaking saliva-based test developed at the University of Illinois.
The saliva COVID-19 test was created at U of I Urbana Champaign and is now getting emergency use authorization by the Food and Drug Administration under an umbrella approval on the heels of a similar test created by Yale researchers.
“This news puts the University of Illinois and the entire state of Illinois on the cutting edge of testing innovation as a national player,” Governor JB Pritzker said.
U of I researchers say it is faster, cheaper and requires significantly less raw materials than traditional testing. The new test can turn results within 3-6 hours, which scientists say is contributing to the drop in positivity rates.
“The faster we can find individuals who are positive and get them isolated, the better,” said Dr. Martin Burke. “If we can do a fast test and we can do it frequently, finally the numbers tip and suggest we can defeat this virus.”
At just $10 a specimen, tests can be done frequently, giving hope to researchers for widespread use as Illinois cases continue to rise.
“Honestly, it gave me hope. We can go on offense here and figure out a way to innovate our way out of this very difficult situation,” Dr. Burke said.
“We want to be proactive and not be chasing our tail as it spirals out of control,” said Dr. Ngozi Izeke with the Illinois Department of Public Health. “Prevention is always the best plan.”
It’s currently being utilized on the U of I campus where students are returning for the fall semester this week.
“With everything happening right now, it’s always on your mind,” said U of I student Jimmy Kokinis. “It helps you just kind of let go of that worry and focus on the school year and your class, like it’s any other normal school year.”
Once results are complete, they can be accessed on an app that can then be shown at campus events and establishments that require it.
“You need your app to show yellow or green, which means you had a negative test within the past week or two back-to-back negative tests, and if you did test positive you’re actually denied access to every building,” Kokinis said.
The school launced a pilot program over the summer, which officials say drastically lowered U of I’s positivity rate.
Kokinis was one who did test positive during that timeframe, although he says he was asymptomatic.
“The quick results actually allowed me to quarantine myself efficiently and stop any of my roommates from testing positive,” he said.
With FDA approval the goal is to expand the use of the test to other parts of the state, including K-through-12 schools, though officials have no timeline.
As health officials continue to monitor the spread of the virus in the state, they say 14 counties are at a higher risk of COVID-19. According to a map from the state health department, blue counties represent areas where the COVID-19 metrics remain stable, but orange areas are under a warning.
Four of those orange counties are in the Chicago area:
Kane County’s positivity rate is 5.4%, which is within the state’s target of 8%, however, virus cases and deaths are rising.
LaSalle County’s positivity rate is 10%, where coronavirus cases are up more than 4 times the state’s target.
Grundy County’s positivity rate is 8.9%, and Will County’s positivity rate is within state guidelines but cases are up nearly double the state’s target.
“We’ve got hotspots and Illinois is actually one of those areas where we’re there in the yellow solidly in the yellow. And so I want the people of Illinois to understand their measures we can take to continue to drive down spread positivity rates,” said U.S. Surgeon General Jerome M. Adams, M.D.
The Illinois Department of Public Health now reports a total of 211,889 cases and 7,806 deaths.
This comes as new restrictions took effect Tuesday in Illinois’ downstate Region 4.
New data shows the test positivity rate for the Metro East area near St. Louis is at 8.9%. That number is much higher than the statewide positivity rate of 4.3%.
Tuesday’s new restrictions impact bars, restaurants and the size of gatherings.
Will County in the Chicago area is also at a “warning level” for more restrictions. The positivity rate there is 6.8%.
Region 4 includes Bond, Clinton, Madison, Monroe, Randolph, St. Clair and Washington counties.
“Throughout the COVID-19 pandemic, I have made it clear that neither arbitrary dates on a calendar nor political pressure will dictate Illinois’ efforts to protect our people. If the data shows we need to go backward in our reopening, I won’t hesitate to tighten restrictions to protect our collective health,” Pritzker said. “Region 4 of our statewide 11 reopening regions – the Metro East – has now surpassed an 8% seven-day rolling average positivity rate – a trend that I have made clear would trigger stricter mitigations when this plan was announced in July. Working with local officials in the Metro East region and across the border in St. Louis, we are implementing stricter mitigations that account for the unique factors in this region. Dr. Ezike and I are imploring local leaders and residents alike: if you haven’t been taking this seriously yet, now is the time to start.”
Among other restrictions, all restaurants and bars in Region 4 must close by 11 p.m., and dancing or standing in indoor bars is prohibited.
“As we warned when we began reopening Illinois, we are seeing an increase in cases, emergency department visits, and other indicators that the virus is circulating more widely in the community,” said IDPH Director Dr. Ngozi Ezike. “Region 4 is the first of the 11 regions to reach resurgence criteria, but we hope it will be the last. By implementing additional mitigations, such as decreased indoor capacities and limiting hours, we hope to reduce the spread of the virus in the Metro East, and also help prevent an increase in cases, hospitalizations, and death in other regions of the state.”
On Monday, officials launched a travel map to provide guidance on the risks associated with travel.
“Travel may increase the chance of becoming infected and spreading COVID-19,” said IDPH Director Dr. Ngozi Ezike. “To help inform residents where they might be at greater risk of being exposed to COVID-19 when they travel, IDPH has launched a map that clearly shows states and other countries where case rates are elevated. While staying home is the best way to protect yourself and others from COVID-19, we know that it may not be possible to avoid all travel. We encourage people who are traveling, whether for work or otherwise, to check out the map before making plans.”
The map is located at www.dph.illinois.gov/covid19/travel.
This article originally appeared originally appeared on ABC7 News.