FDA points warning about Innova COVID antigen take a look at

Meals and Drug Administration final week requested that Innova Medical Group cease gross sales of its COVID antigen speedy qualitative take a look at and warned the general public towards utilizing the take a look at, citing issues about its efficiency.

Innova promotes the lateral move immunochromatographic assay, which is designed to detect SARS-CoV-2 nucleocapsid protein antigens in nasal swab specimens, as having demonstrated 97{9408d2729c5b964773080eecb6473be8afcc4ab36ea87c4d1a5a2adbd81b758b} sensitivity and 99{9408d2729c5b964773080eecb6473be8afcc4ab36ea87c4d1a5a2adbd81b758b} specificity for detecting infectious sufferers.

In its announcement, nevertheless, the FDA mentioned that it has vital issues concerning the efficiency of the take a look at and the potential for false-negative or false-positive outcomes.

In a warning letter despatched to Pasadena, California-based Innova on Thursday, the FDA wrote that an inspection of the corporate’s facility confirmed that Innova was distributing the take a look at within the US regardless of by no means having obtained advertising and marketing approval, clearance, or authorization. The company additionally mentioned that sure configurations of the take a look at had been labeled with false or deceptive efficiency knowledge.

The FDA requested that Innova instantly stop the sale and distribution of the take a look at and mentioned that every one take a look at customers, healthcare

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Outbreak of Toxic Browntail Moth Caterpillars Plagues Maine

Whereas components of the nation cope with swarms of cicadas this summer season, Maine is fighting an infestation of an invasive species of caterpillar with toxic hairs that may trigger folks to develop painful rashes and even respiration issues.

The caterpillars, often known as browntail moths, are about 1.5 inches lengthy and have white dashes down their sides and two pink dots on their backs.

Browntail moths are most typical alongside Maine’s coast and on Cape Cod, however they’ve been noticed this 12 months in all of Maine’s 16 counties, mentioned Jim Britt, a spokesman for the Maine Division of Agriculture, Conservation and Forestry.

“Persons are discovering them everyplace: on the bottom, on the picnic desk, on {the electrical} field, on the nook — you title it,” Mr. Britt mentioned. “They’re closely current. Of us will see them throughout.”

“We’re within the midst of an outbreak,” he mentioned.

The caterpillars have tiny toxic hairs that may stay poisonous for so long as three years, the Maine Department of Health and Human Services warned.

After people come in contact with the caterpillar’s hairs, they can develop a red and bumpy rash similar to a reaction to poison ivy that can linger

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