State health officials: Rapid coronavirus test ‘evolved’ after false negatives

SIOUX FALLS, S.D. (By ) – South Dakota health officials say a rapid coronavirus test used across the country, including in South Dakota, has “evolved” since it was found to have false negative test results.

The U.S. Food and Drug Administration cautioned on Thursday that early data about the Abbott ID Now tests, which produce a coronavirus result in minutes, suggest there’s a potential for false negative results. The FDA says the test can still be used and can correctly identify many positive cases, but the agency will be working with Abbott to further investigate the issue.

The FDA has received 15 reports of adverse events involving Abbott ID machines, and U.S. Health and Human Services Secretary Alex Azur said on Fox Business on Friday that the FDA’s announcement was for transparency in the regulatory process. He said the agency still has confidence in the test and wouldn’t allow it to be on the market it if didn’t.

“It could be as simple as user error,” he said. “With this test, you’re not supposed to collect the swab and then spend time transporting it to get to the test.”

South Dakota has deployed 13 Abbott ID machines to medical facilities, and there are about 13 Abbott ID machines in Indian Health Services facilities in South Dakota, according to state Health Secretary Kim Malsam-Rysdon.

State epidemiologist Josh Clayton said Abbott ID machines have had an issue with false negatives in the past, but the way samples are collected, transported and tested for Abbott ID machines has changed over time. It’s also important that a person is trained in collecting a quality sample for any testing method, he said.

Mass testing events planned

The state is “fully confident” in the ability to complete mass testing of all residents and staff at long-term care facilities beginning next week, Malsam-Rysdon said. The state also plans to complete mass testing events in Native American communities. The supply chain for testing supplies has improved, and the dollars for the mass testing events will come out of the $1.25 billion in federal coronavirus funds the state received, she said.

After the mass testing events, the state plans to continue with random spot testing in long-term care facilities, she said.

Residents in the care facilities are at a higher risk for more serious coronavirus outcomes due to underlying health conditions, and they are the state’s top priority for mass testing, she said.

Latest COVID-19 numbers

One more person has died of the coronavirus in South Dakota, and the number of confirmed coronavirus cases in the state increased by 95 on Friday with 19 new positive cases in Brown County.

Brown County now has 173 cases. A total of 106 cases are connected to DemKota Ranch Beef and 58 of those cases have recovered, according to Clayton. In all 85 of the people in Brown County who have tested positive have recovered as of Friday.

South Dakota has a total of 44 COVID-19 deaths as of Friday, according to the state Department of Health.

The woman who died from the coronavirus was a Minnehaha County resident in the 80+ age range, according to the department.

South Dakota has a total of 3,887 COVID-19 cases, according to the state health department. That doesn’t include people who show symptoms or are asymptomatic but are not tested. The positive rate for coronavirus tests on Friday was 10%.

Cases in Minnehaha County increased by 51 to a total of 3,101, and Lincoln County’s cases increased by three to a total of 198 cases, according to the state health department. Of the cases in the two counties, 2,059 cases have recovered in Minnehaha County, and 149 cases have recovered in Lincoln County.

The state has 1,269 active COVID-19 cases, according to the state health department. Recoveries statewide increased to 2,574. The state health department says 296 total people have been hospitalized during the pandemic, and 80 are currently hospitalized.

Of the 853 Smithfield employee cases, 830 have recovered, according to Clayton. Last week’s mass testing of Smithfield employees and their families resulted in 3,700 tests, 24% of which were positive, Clayton said.