Professor Jo Martin Project Lead, Pathology Portal
`As an organisation committed to excellence in diagnosis, and high standards in patient care, we are concerned about Covid-19 antibody testing. We are aware that Covid-19 antibody testing devices, intended for professional use only, have been offered for direct sale to consumers without the required reassurance of appropriate laboratory or professional back up. The use of these for unsupervised self use test falls outside current regulations, and can mislead the public and put individuals at risk.
We want everyone to be assured about the tests they receive in healthcare, or that they purchase. We want to make sure that not only are they are of good quality, but that they give the right result and that the result is properly readable - that they are appropriately ‘useable’. The MHRA have done good work in this area, and we are asking that that where devices are unregulated for use, urgent steps are taken to support enforcement and public safety.'
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