After FDA warns of inaccuracies, Abbott coronavirus tests to ‘be used less’ in Illinois

The U.S. Food and Drug Administration alerted the public Thursday to potential inaccurate results – giving false negatives – from Abbott Laboratories’ ID NOW rapid testing machines.

Illinois Gov. JB Pritzker said Friday that the state has used ID NOW machines for about 50,000 of its 538,602 total COVID-19 tests since the pandemic began.

“I think they’ll probably be used less for COVID-19,” Pritzker said. “They are used for other purposes. For COVID-19, we’ve all been put on warning by the FDA.”

Abbott Laboratories is headquartered in Lake County. Its ID NOW tests were considered an early success on the testing front when the pandemic began. The testing machines have been used to test staff at the White House, where two staffers tested positive last week.

Pritzker said he has spoken with leaders at Abbott on a number of occasions, calling the lab “a great company.” The ID NOW tests can return results in five to 13 minutes. Last week, Abbott received positive marks for a separate antibody test.

According to the FDA, the ID NOW machines still can positively identify the coronavirus, but some negative test results might require further scrutiny.

“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue. We will continue to study the data available and are working with the company to create additional mechanisms for studying the test,” said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.

The FDA warning went on to say that inaccuracies could be caused by performance characteristics of the machines, specimen handling or even user error.

Pritzker said the federal government gave Illinois 15 ID NOW machines weeks ago. He advised labs to follow the FDA guidelines.

“What we can do is look at the data as it comes to us, as it gets reported to us, and just make sure we’re aware where that data came from,” Pritzker said. “Of course, I want to repeat that I want to discourage [labs] from using it until they know what the FDA guidance will be, to make sure that the sensitivity is proper to get the results that we all hope and expect to get from a COVID-19 test.”

This came as Illinois announced 130 more deaths from COVID-19 and an additional 2,432 confirmed cases throughout the state Friday.

The state has a seven-day rolling positivity rate of 16%. Illinois has seen 90,369 cases of the virus, and 4,058 people have died since the pandemic began.

"The positivity rate in Illinois is coming down," Pritzker said. "Right now ... every region is meeting our positivity rate standard to move to Phase 3 [of the Restore Illinois plan]."

As of late Thursday, Illinois had 4,367 COVID-19 patients in the hospital. Of those, 1,129 were in intensive care units, and 675 were on ventilators.

Regional update: As of Tuesday, the Northeast region (Cook, DuPage, Grundy, Kane, Kankakee, Kendall, McHenry, Lake and Will counties) had a positivity rate average of 19.4%. The region also had an average of 17.2% of medical/surgical beds available, 18.4% of ICU beds available and 63.1% of ventilators available.

The North Central region (Bureau, DeKalb, La Salle, Lee, Ogle, Whiteside, Carroll, Boone, Winnebago, Stephenson, Putnam and Jo Daviess counties) had a positivity rate average of 7.5%. On average, there was an availability of 42% of medical/surgical beds, 42.7% of ICU beds and 59% of ventilators.

The Central region had an average positivity rate of 5.3%. On average, there was an availability of 51.3% of medical/surgical beds, 47.6% of ICU beds and 81.6% of ventilators.

The Southern region had an average positivity rate of 8.2%. On average, there was an availability of 45.6% of medical/surgical beds, 29.3% of ICU beds and 75.3% of ventilators.

Threshold for next phase: In addition to having testing available for patients, health care workers, first responders, people with underlying conditions, and residents and staff in congregate living facilities, and contact tracing and monitoring in place 24 hours after diagnosis, regions must hit the following thresholds to move on to the next phase in the Restore Illinois plan:

• At or less than a 20% positive rate and increasing no more than 10 percentage points over a 14-day period

• No overall increase (i.e. stability or decrease) in hospital admissions for COVID-19-like illness for 28 days

• Available surge capacity of at least 14%of ICU beds, medical and surgical beds, and ventilators.

Newly reported deaths:

• Boone County: 1 male 70s

• Champaign County: 1 female 40s

• Cook County: 1 male youth, 2 males 30s, 2 females 40s, 4 males 40s, 5 males 50s, 4 females 60s, 8 males 60s, 10 females 70s, 8 males 70s, 18 females 80s, 9 males 80s, 3 unknown 80s, 6 females 90s, 5 males 90s, 1 male 100+

• DuPage County: 1 male 60s, 1 female 70s, 2 males 70s, 3 females 80s, 1 male 90s

• Kane County: 2 females 60s, 1 male 80s

• Lake County: 1 male 40s, 2 males 50s, 1 female 60s, 1 female 80s

• La Salle County: 1 female 60s, 1 female 80s

• Macon County: 1 male 80s

• Madison County: 1 female 80s, 2 females 90s

• McHenry County: 1 female 50s, 1 male 50s, 1 male 70s, 1 female 80s, 1 male 80s

• McLean County: 1 female 70s

• Rock Island: 1 female 90s

• Sangamon County: 1 female 60s

• St. Clair County: 1 male 60s, 1 female 80s

• Union County: 1 female 80s, 1 male 80s, 1 female 90s

• Will County: 1 female 70s, 4 females 80s, 1 female 90s

• Winnebago County: 1 female 90s