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.



Below are other articles that you may be interested in:

Basic Types of Blood Test

Related Articles

Poverty Associated With Higher Death Rates Due to Heart Failure

Health News
Heart failure is a chronic disease that affects the pumping ability of the heart. The effects are irreversible, though some treatment options could increase...

10 Causes of Colon Polyps

Your Health
Colon polyps are small nodules that can be found along your large intestine's lining. These growths look like tiny mushrooms, but they can grow...

11 Causes of Psoriasis You Should Know

Ailments & Conditions
There are a whole lot of skin diseases out there, and one of them is psoriasis. If you have ever noticed red, dry, scaly...

What Is Vitamin B11?

Your Health
What Is Vitamin B11? Vitamin B11 or salicylic acid is a form of beta hydroxy acid, which is a part of the aspirin family. It...

10 Signs of Binge Eating

Ailments & Conditions
Binge eating is a serious disorder that could result in considerable negative effects on many people. It is often characterized by constant episodes of...

10 Health Benefits of Vitamin E

Diet & Nutrition
The rate at which the cosmetic world is giving significance to vitamin E today is quite exciting and unbelievable. Right from when scientists discovered...

White House Stops Rebate Plans to Reduce the Costs of Drugs

Health News
On Thursday, the White House announced that President Trump will cancel a plan to alleviate the financial burden of expensive drugs for people on...

High Cholesterol Effects to Health

Ailments & Conditions
Cholesterol plays an important role in building healthy cells in the body. However, high cholesterol levels may cause fatty deposits to develop in the...