The U.S. Food and Drug Administration has announced a recall of over 2 million at-home COVID-19 tests from the Australian medical technology company Ellume due to potential false positives.
The FDA’s recall is a Class I, meaning it is “the most serious” of the types of recalls. The FDA warned that “Use of these tests may cause serious adverse health consequences or death.”
“The Ellume COVID-19 Home Test is an antigen test that detects proteins from the SARS-CoV-2 virus from a nasal sample in people two years of age or older. The Ellume COVID-19 Home Test is available without a prescription for use by people with or without COVID-19 symptoms,” the FDA explained, adding, “The FDA issued an Emergency Use Authorization (EUA) on December 15, 2020 and authorized a revision to the EUA on February 11, 2021 to allow emergency use of the Ellume COVID-19 Home Test.”
“The company first informed the FDA about the defect in some lots in October,” NPR reported. “On Wednesday, the FDA said it had identified additional lots that have been affected by the manufacturing defect. The defective tests were manufactured by Ellume between Feb. 24, 2021 and Aug. 11, 2021. So far, 35 false positives from these tests have been reported to the FDA.”
As reported by CNN, “In February, the Biden administration announced a $231.8 million award for Ellume USA for production of its at-home tests for the US. But demand for home tests has remained high and supply limited. This fall, the Biden administration announced billions more dollars to help make more tests available.”
A spokesperson for Ellume told The New York Times that the cause of the defects has now been identified.
“Ellume has investigated the issue, identified the root cause, implemented additional controls, and we are already producing and shipping new product to the U.S.,” the spokesperson said. “Importantly, not all of the positive results of the affected tests were false positives, and negative results were not affected by this issue.”
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Remote Learning Lowered Test Scores in Every State; Minority Students Hit the Worst
A paper published by the National Bureau of Economic Research (NBER) shows remote learning has had a negative impact on students’ test scores in every state. Not only were students across the country affected, minority students were impacted the most.
According to the publication, remote learning led to declines in test scores for English and math, when compared to scores of students who went to schools with more in-person learning. “Our research shows that test score losses are significantly larger in districts with less in-person learning,” said Emily Oster, professor of economics at Brown University.
“This suggests, yes, that virtual learning was – and is – less effective than in-person learning, at least as measured by school-based testing” added Oster. “Passing rates in math declined by 14.2 percentage points on average; we estimate this decline was 10.1 percentage points smaller for districts fully in-person,” the study found.
The research combined “district-level schooling mode data from the 2020-21 school year,” “district-level test score data from 2015 to 2021” and “demographic data from the NCES,” according to the study.
Data was collected from students in third to eighth grades in 12 states: Colorado, Connecticut, Florida, Massachusetts, Minnesota, Nevada, Ohio, Rhode Island, Virginia, West Virginia, Wisconsin, and Wyoming.
Score declines showed variations by state, as well. Virginia “which had the most complete virtual learning time, along with Colorado, saw an almost 32% drop on math test scores in the 2020-21 school year when compared to the 2018-19 school year” reports Tampa Free Press.
Wyoming, however, “which had the most in-person learning, along with Florida, saw just a 2.3% drop in English, the study found.”
“Changes in English Language Arts (ELA) were smaller than math scores overall, but drops in scores were greater in districts with larger black and Hispanic populations and students eligible for free and reduced lunch prices” reports Tampa Free Press.
“Districts that have a larger share of black and Hispanic students and less in-person schooling also saw a greater decline in ELA test scores than those with more in-person schooling. “
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