Doctors have warned that poor regulation of antibodies tests could indicate if someone has had coronavirus and could be putting the public at risk. The Royal College of Pathologists has written to the health secretary, calling for rules to be tightened on kits sold directly to consumers. And the letter has warned that “mislead the public and put individuals at risk”. Different types of antibodies tests are available but no antibodies test has been officially approved for at-home use in the UK. And it is still not known whether having antibodies will protect people from a second infection.
The Doctors have also warned that the tests should not be used without “professional back-up”, must “give the right result” and be “properly readable”. And Medicines and Healthcare products Regulatory Agency officials have announced that “worked collaboratively with cross-government agencies at a pace to prevent non-compliant antibody test kits being placed into the UK market”. But Royal College of Pathologists president Prof Jo Martin said: “Currently if you buy a test on the internet or you buy it in certain boutiques or shops, we can’t guarantee that the quality of that is of an appropriate standard. “We can’t guarantee that the result will be easy to interpret or that it will be not misleading.”
In the BBC’s Newsnight program it was noticed that there were 41 antibodies tests sold to the public in the UK, before publication in the medical journal BMJ Open, and found incomplete and false information. But the academics from the Universities of Birmingham and Warwick found that only 10% had made documents available to support their claims. And now antibodies tests are a class one medical device, which means the companies can self-certify their tests. Which is known as the effective and immediately start selling to consumers, and this could be a rigorous independent testing process.
Lead researcher Jon Deeks, professor of biostatistics, at the University of Birmingham, said “more studies were needed with much larger sample sizes to assess how tests were used by patients in practice.” He also pointed out that
- “These regulations aren’t fit for purpose and don’t protect the public from bad tests.”
- ” For drug licensing, the onus is on the companies to go through clinical trials. “We need that same obligation to apply for testing devices like the COVID antibody tests as well.
- “In the long term, evaluations of tests should be added to the existing pre-registers for clinical trials.
- “This will stop manufacturers from cherry-picking only the most favorable results to report.
A Department of Health and Social Care official said that currently no antibody test has been approved for individuals for at-home use and the antibody tests must contain the standards of clinical use. “And. Across government, the action is being taken to enforce these tough regulations. “There have been several arrests. And over 47,000 tests have been seized.”
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