WARNING! Many COVID-19 Rapid Antibody Diagnostic Test Kits Are Either Inaccurate Or Fake And Have Not Been Approved By US FDA, EU or Japan Regulatory Bodies
: The new antibody blood test kits for the SARS-CoV-2 coronavirus that causes the COVID-19 disease could play a key role in deciding whether millions of individuals can safely return to work and school. But US and EU public health officials are warning that many of these test kits have not been checked for accuracy and approved by regulatory bodies.
Example of a product making fake claims that it is US FDA approved
In America alone, more than 70 companies have signed up to sell so-called antibody tests in recent weeks, according to U.S. regulators. Governments around the world hope that the rapid tests, which typically use a finger-prick of blood on a test strip, could soon ease public restrictions by identifying people who have previously had the virus and have developed some immunity to it.
However key questions linger. How accurate are the tests, how much protection is needed and how long that protection will last.
Furthermore with emerging cases of reinfections being reported in many countries, it seems that the antibodies or immunity does not long last for long.
These new blood tests are different from the nasal swab-based tests currently used to diagnose active COVID-19 infections. Instead, the tests look for blood proteins called antibodies, which the body produces days or weeks after fighting an infection. The same approach is used for HIV, hepatitis, Lyme disease, lupus and many other diseases.
As a result of the relative simplicity of the technology, the Food and Drug Administration decided to waive initial review of the tests as part of its emergency response to the coronavirus outbreak.
Currently, the new antibody tests are most useful for researchers studying how the virus has spread through the U.S. population. The government said Friday it has started testing 10,000 volunteers. The White House has not outlined a broader plan for testing and how the results might be used.
Eric Blank of the Association for Public Health Laboratories told Thailadn Medical News
, ‘With almost no FDA oversight of the tests, right now it's a wild west show out there. It really has created a mess that's going to take a while to clean up. In the meantime, you've got a lot of companies marketing a lot of stuff and nobody has any idea of how good it is."
Most of the members of Blank's group, which represents state and local lab officials, have urged the FDA to revisit its lax approach toward the tests. That approach essentially allows companies to launch as long as they notify the agency and include disclaimers. Companies are supposed to state that their tests have not been FDA-approved and cannot rule out whether someone is currently infected.
Few days ago, US FDA Commissioner Stephen Hahn said in a statement that the agency will "take appropriate action" against companies making false claims or selling inaccurate tests.
Already there has been reports fo faulty test kist and worse some that are totally fake. Many countries are also reporting of such fake kits originating from China, Pakistan and also Bangladesh.
Allison Rakeman of New York City's Public Health Laboratory commented, “some l
ocal hospitals are assuming the tests, which are listed on FDA's website have been vetted, when they have not. The danger of faulty testing is that people will mistakenly conclude that they are immune or are no longer spreading the virus. Then somebody goes home and kisses their 90-year-old grandmother. You don't want to give someone a false sense of security."
The new coronavirus causes mild or moderate symptoms for most people, such as fever and cough that clear up in two to three weeks. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia, and death.
Typically for many infections, antibody levels above a certain threshold indicate that the person's immune system has successfully fought off the virus and is likely protected from reinfection. For COVID-19, it's not yet clear what level of antibodies render patients immune or how long immunity might last.
Compounding to the confusion is the fact that both legitimate companies and fraudulent operators appear to be selling the kits. Distinguishing between the two can be a challenge.
Health officials in Laredo, Texas, reported this month that some 2,500 antibody tests set for use at a local drive-thru testing site were likely frauds. City officials had ordered what they were told were "FDA-approved COVID-19 rapid tests," from a local clinic. But when they checked the test's accuracy, it fell well below the range promised, the city said in a statement.
There are many examples of companies skirting the rules appear online and in emails sent to hospitals. Promotional emails sent to hospitals and reviewed by the media failed to include required disclaimers. Some kits sold on websites promote themselves as "FDA-approved" for home testing. The agency has not yet approved any COVID-19 home test. The blood tests have to still be processed by a lab.
So far the US FDA has only authorized one COVID-19 antibody test from North Carolina diagnostics company Cellex. The agency used its emergency powers, meaning a formal review is still needed.
The American White House has also tried to temper expectations for the tests, while still promising that millions will soon be available.
The federal health official overseeing American testing, Dr Brett Giroir, told the media a week ago that the US FDA and other agencies are working to confirm the accuracy of the antibody tests.
Dr Giroir added, "We're going to be very careful to make sure that when we tell you you're likely immune from the disease ... the test really said that."
Thailand Medical News also warns that basically the EU, US FDA, Canadian, Australian, Singapore and Japanese regulatory bodies approvals are the gold standards for drugs, diagnostics equipment, medical equipment and devices as these are the only countries with the right testing labs and also the right kinds of experts. One should disregards approvals or guidelines from health authorities from other countries especially from certain other South-East Asian countries as the medical experts there literally are clueless but tend to have lots of ego and act to be experts, spewing out lots of misinformation.
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