The U.S. Food and Drug Administration (FDA) has long been criticized for the slow authorization of tests for new coronavirus infections.Now the FDA has adopted a completely different policy, allowing more than 90 uncensored kits to be sold on the market. But it also leads to product fraud and quality problems in the market.
Antibody or serum tests are currently being conducted to identify those who may have overcome COVID-19, including those who have not been infected and those who develop immunity. but they are not used to detect active infections.
Some officials boast that blood testing is a way to revive the economy by identifying people who have developed immunity and can safely return to work. But many scientists and the World Health Organization claim that even high-quality antibody tests cannot prove that someone is immune to the virus and there is no risk of reinfection.
Critics say FDA's monitoring of test reagents has been lax, and dozens of products that have never been FDA reviewed may confuse doctors, hospitals, businesses and consumers. "Testing is a good thing, but the results aren't going to be worse than no testing at all ," said Kellyrewski, director of infectious disease programs at the American Association of Public Health Laboratories.
Spurred by these concerns, the FDA recently stepped up its warning efforts and worked with agencies such as the National Cancer Institute to determine whether the uncensored test reagents were really effective.
In an on-site interview with the Washington Post on Thursday, FDA Commissioner Stephen Hahn said people should be cautious about testing products that do not have FDA's emergency use license.
The National Cancer Institute will work with the Centers for Disease Control and prevention, the National Institute of allergy and infectious diseases and academic laboratories to conduct a large number of validation work on unauthorized reagents. In a statement on Saturday night, Hahn said it will also verify test products that seek FDA's emergency use license. Our goal, he said, "is to make the test results more credible.".
In mid March, in order to ensure that serum test results can be obtained quickly, FDA said that manufacturers can sell these products after verifying the results and notifying FDA. The labels of these products must indicate that they are not FDA approved or cannot be used as the sole basis for the diagnosis of infection. The agency lists the companies and laboratories that submitted these notifications on its website. Hahn said the FDA updated its website to distinguish whether it was authorized, given that the list might be seen as an endorsement.
Testing experts warn that the risk of inaccurate testing is high. For example, a false result may indicate that when individuals are not immune to the virus, they are immune to the virus, which may lead to behaviors that endanger themselves and their families. Even with high-quality tests, scientists say they don't know what antibody levels will make people immune to the virus or how long the protection will last.
There are two ways to detect antibodies: one is fast detection, which only needs to prick a small amount of blood with fingers, and the cost may be as low as $20 or less; the other is relying on traditional blood test, which costs much more.
Although the government requires all unauthorised tests to be carried out in CLIA( chemiluminescence immunoassay) laboratories for highly complex testing, many finger piercing products are being marketed to doctors' offices and pharmacies, says scott becker, executive director of the american association of public health laboratories.
The supplier believes that doctors should be able to perform field tests in their own offices without the need to use complex laboratory equipment. Some state and local health departments warn consumers and doctors to avoid using unapproved test reagents.
FDA expects to approve more test reagents in the next few days or weeks. FDA officials say more large manufacturers and laboratories are needed to get the number of serum tests the country needs.