• UK
  • World
    • USA
  • Entertainment
    • Celeb
    • Showbiz
    • Magazine
  • Politics
  • Sports
  • Gaming
  • Tech
  • Science
    • Education
  • Insurance
  • Business
  • Auto
  • ToS/Contact
    • ToS
    • Privacy Policy
    • Contact
NewsExplored
  • UK
  • World
    • USA
  • Entertainment
    • Celeb
    • Showbiz
    • Magazine
  • Politics
  • Sports
  • Gaming
  • Tech
  • Science
    • Education
  • Insurance
  • Business
  • Auto
  • ToS/Contact
    • ToS
    • Privacy Policy
    • Contact
  • Facebook

  • Twitter

  • LinkedIn

  • Tumblr

  • RSS

UK

Coronavirus antibodies tests ‘put public at risk’

Coronavirus antibodies tests ‘put public at risk’
Newsexplored
20th August 2020
ShareTweet
SubscribeRedditGoogleWhatsappStumbleuponPinterestDiggLinkedinTumblrTelegram
Views:
2
ScientistImage copyright Getty Images

Poor regulation of antibodies tests – that could indicate if someone has had coronavirus – could be putting the public at risk, doctors have warned.

The Royal College of Pathologists has written to the health secretary, calling for rules to be tightened on kits sold direct to consumers.

The letter warns they can “mislead the public and put individuals at risk”.

No antibodies test has been officially approved for at-home use in the UK – but many different types are available.

It is still not known whether having antibodies will protect people from a second infection.

Coronavirus: Immunity may be more widespread than tests suggest

Coronavirus immunity: Can you catch it twice?

The letter sent to Matt Hancock calls for urgent action.

The doctors say the tests should not be used without “professional back-up”, must “give the right result” and be “properly readable”.

A Medicines and Healthcare products Regulatory Agency official said it had “worked collaboratively with cross-government agencies at 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.

data-ad-format="auto">

“We can’t guarantee that the result will be easy to interpret or that it will be not misleading.”

Image copyright Getty Images
Image caption Coronavirus infection triggers the immune system to produce antibodies

An analysis of 41 antibodies tests sold to the public in the UK, seen by the BBC’s Newsnight programme before publication in the medical journal BMJ Open, found almost a third provided incomplete and inaccurate information.

A number claimed to offer “peace of mind”.

But just 10% had made documents available to support their claims, academics from the Universities of Birmingham and Warwick found.


What information has been released about how kits were assessed shows most were tested on small numbers of patients only – just a few dozen, all of whom had been admitted to hospital.

At the moment, antibodies tests are a class one medical device – meaning companies can self-certify their tests as effective and immediately start selling to consumers, without a rigorous independent testing process.

In contrast, HIV and pregnancy tests are listed on “annex two” of the European Director for Medical Devices – which means manufacturers have to provide information about the efficacy of their tests.

‘Wild West’

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.

“These regulations aren’t fit for purpose and don’t protect the public from bad tests,” he said.

“If you can get a CE mark [indicating compliance with the relevant legislation] for a bad test as there is no scrutiny on whether it works, it is just a marketing claim that is registered and we are left in a Wild West of antibody testing.

“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 favourable results to report.”

‘Tough regulations’

A Department of Health and Social Care official said: “Antibody tests must meet the standards for clinical use.

“And currently no antibody test has been approved for individuals for at-home use. Across government, action is being taken to enforce these tough regulations.

“There have been a number of arrests. And over 47,000 tests have been seized.”

You can see Newsnight’s report on this story on BBC iPlayer.

  • SURVIVING THE VIRUS: ‘Our medical science is struggling to catch-up’
  • COVID-19: How are dentists coping?

Share this:

  • Click to share on Twitter (Opens in new window)
  • Click to share on Facebook (Opens in new window)
  • Click to share on Google+ (Opens in new window)
  • Click to share on LinkedIn (Opens in new window)
  • Click to share on Tumblr (Opens in new window)
  • Click to share on WhatsApp (Opens in new window)
  • Share on Skype (Opens in new window)

Related

Related Itemsantibodiescoronaviruspublictests
UK
20th August 2020
Newsexplored @newsexploredweb

Related Itemsantibodiescoronaviruspublictests

More in UK

  • Read More
    Newspaper headlines: ‘Sleazy access’ in lobbying row and ‘thirst in the queue’

    Views:2 By BBC NewsStaff image captionSeveral papers report on the latest developments over former prime minister David...

    Newsexplored 20th August 2020
  • Read More
    Covid in Wales: Caution over pub reopening ‘isn’t a bad thing’

    Views:2 image captionDr Matt Morgan: We have got to go with the data Erring on the side...

    Newsexplored 20th August 2020
  • Read More
    The challenges of observing a second Ramadan in lockdown

    Views:2 By Miriam BarkerBBC News Published 2 hours ago Related Topics media captionMuslims celebrate a second Ramadan...

    Newsexplored 20th August 2020
  • Read More
    Duke of Edinburgh’s Award: Students share ‘sense of achievement’

    Views:2 image captionDuke of Edinburgh Award participants practice putting up a tent for their expedition The Duke...

    Newsexplored 20th August 2020
  • Read More
    Newspaper headlines: Brothers’ tributes and Cameron ‘welcomes’ inquiry

    Views:2 By BBC NewsStaff image caption“We’ll miss you, grandpa” is the headline on the front page of...

    Newsexplored 20th August 2020
  • Read More
    Covid: ‘I’m very happy to have my hairdresser back’

    Views:2 By Laurence Cawley & Kate ScotterBBC News, East Hairdressers in England have reopened for the first...

    Newsexplored 20th August 2020
  • Read More
    Covid lockdown eases: ‘Sense of celebration’ as pubs and shops reopen

    Views:2 Published 9 minutes ago Related Topics media captionToastmaster opens pub with a gong For the first...

    Newsexplored 20th August 2020
  • Read More
    Covid: Wales’ shops reopen after long lockdown

    Views:2 Published 20 minutes ago Related Topics media captionNon-essential shops in Wales are opening for the first...

    Newsexplored 20th August 2020
  • Read More
    Oxford Street: Wooing shoppers back to Europe’s busiest high street

    Views:2 By Rebecca CafeBBC News “Let’s change the way we shop.” This is the statement emblazoned in...

    Newsexplored 20th August 2020
  • Read More
    Newspaper headlines: Harry ‘arrives in UK’, and ‘shutters come up’

    Views:2 By BBC NewsStaff image captionThe death of the Duke of Edinburgh at the age of 99...

    Newsexplored 20th August 2020
  • Read More
    Gyms re-opening: ‘Everyone’s raring to go – but take it slow’

    Views:2 By Michael BaggsNewsbeat reporter Published 1 hour ago The gains. The pump. The changing room selfie....

    Newsexplored 20th August 2020
  • Read More
    Newspaper headlines: Duke missed ‘enormously’ as funeral plans released

    Views:2 By BBC NewsStaff image captionSunday’s papers are dominated by the Prince of Wales’ tribute to his...

    Newsexplored 20th August 2020
Scroll for more
Tap
data-ad-format="auto">
NewsExplored

NewsExplored - Making sure all the latest news is explored?

Contact us for help

  • Popular

  • Latest

  • Comments

  • The UK professor and the fake Russian agent
    UK26th March 2021
  • Deshaun Watson: Houston Texans quarterback being investigated by police amid 21 civil lawsuits
    USA3rd April 2021
  • Atlanta spa shootings: How we talk about violence
    USA19th March 2021
  • Arsenal 0-3 Liverpool: Diogo Jota scores twice in Premier League win
    Sports3rd April 2021
  • Tiger Woods car crash: Golfing great drove at almost double the speed limit
    USA7th April 2021
  • Georgia voting: Fact-checking claims about the new election law
    USA7th April 2021
  • Deshaun Watson: Houston Texans quarterback being investigated by police amid 21 civil lawsuits
    USA3rd April 2021
  • Derek Chauvin trial: Why role of TV cameras could come into focus
    USA28th March 2021
  • Les Rehrer says:

    Hello Its me :P and thanks for this post

  • optumrx login says:

    Thank For News.

  • Kent Laatsch says:

    Please let me know if you're looking for a writer…

  • Bob says:

    RT News was where I learned that Erdogan controlled isis.…

Copyright © 2018 Top News Theme. Theme by MVP Themes, powered by Wordpress.

Channel crossings: People smugglers ‘not behind migrant death’
Coronavirus: Eviction day fears for worried tenants in England and Wales
We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.Ok