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FDA Tightens Regulations on Antibody Tests Due To Precision Issues and False Claims

On Monday, regulators in the United States decided to pull back a previous decision that enabled a number of blood tests on coronavirus to be available on the market without introducing evidence that they are effective.

The Food and Drug Administration announced that it issued this rule because many companies have provided false claims about the precision of their tests.

Due to mounting pressure to increase options for testing coronavirus, the agency in the previous month allowed firms to start distributing test kits as long as they announced the FDA of their plans as well as informed disclaimers, including the fact that these tests were not approved by the FDA. According to officials, this rule was made to increase flexibility that is needed to boost the production of test kits in the country.

Nevertheless, flexibility never means that the agency could allow frauds. In a recent statement, the deputy commissioner of the FDA said the agency had recorded an increasing number of unethical marketing strategies from many sellers of test kits. They used the current pandemic to take advantage of American customers.

Unlike the nasal swab tests that are currently being used for diagnosing active infections caused by COVID-19, blood tests look for the presence of antibodies, which are a form of blood proteins generated by the body several days or weeks after the infection occurs. Most of them require the pricking of blood from the finger on a test strip.

The action follows a period of criticism from Congress members, lab experts, and doctors who accuse the agency’s lack of regulation worsened the existing pandemic.

On Monday, the FDA said that there have been many issues with false and deceptive marketing among dozens of tests that have been sold in the United States. Many firms have claimed that their products would be used at home, while the agency has never authorized this. Other sellers claimed about the precision. Some local governments and U.S. hospitals have reported purchasing tests that produced inaccurate results.

Up to now, the agency has allowed 11 antibody tests to be sold on the market. This means that the precision, materials, and techniques of these products are qualified. Other firms that have currently been on the market without authorization from the FDA will now be asked to submit formal applications within 10 business days.


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