Graeme Wall wrote:
On 20/06/2020 11:43, Recliner wrote:
Graeme Wall wrote:
On 20/06/2020 11:28, Roland Perry wrote:
Medicines and Healthcare products Regulatory Agency

UK
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency


I assumed that even Roland could work out that the MHRA was based in the
UK.


Though the following is relevant to your earlier post:

Not really. The type of test on offer isn't affected by this warning.


Published 29 May 2020

The MHRA is asking providers of laboratory-based COVID-19 antibody
testing services using capillary blood collected by a fingerprick, to
temporarily stop providing this service until home collection of this
sample type has been properly assessed and validated for use with these
laboratory tests.

This does not affect rapid, point of care tests or laboratory tests
performed using blood taken from the vein.

The Agency has recently updated its guidance on home antibody testing
kits, to ensure that the public and industry have the latest information
on the reliability of test results and what they mean.

Graeme Tunbridge, MHRA Interim Director of Devices, comments:

Patient safety and public health are our main priorities and it is in
the interests of everyone for antibody tests to be as reliable and
meaningful as they can be.

There are several UK providers of testing services who offer COVID-19
antibody testing using a fingerprick sample of capillary blood collected
in a small container.

We are asking all providers of laboratory-based COVID-19 antibody
testing services using capillary blood collected by a fingerprick to
temporarily stop providing this service until home collection of this
sample type has been properly assessed and validated for use with these
laboratory tests.

Use of unvalidated sample types may lead to unreliable results and as
such we are working closely with the service providers, laboratories and
test manufacturers to resolve the regulatory and patient safety issues.

People who have purchased one of these sampling kits, and received an
antibody test result, should not consider the result to be reliable and
should not take any action based on it.