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laboratory based tests for COVID-19 antibodies using capill…

Laboratories offering a COVID-19 testing service for the public, private healthcare or NHS:
• Pause the service immediately if your service uses capillary blood samples. Do not process new samples. Before issuing any results for tests already processed, ensure that due consideration has
been given to Article 15 of the GDPR and Data Protection Act 2018 Part 2 of Schedule 3.
• Contact all your customers within a week of receiving this alert to notify them that you have paused your service, at the request of MHRA, as the results from this sample type may not be reliable.
• Only use assays with the sample types covered by the CE mark.
• If you are offering the sample kit, you should undertake a usability study and a stability study to prove it can be used safely by the intended user. This is most important for home users. The sample
collection kit should be additionally CE marked as an IVD kit.
• Verify that the sample collection kit used by your customer is CE marked and suitable for use by the intended user, your laboratory and with the manufacturer’s assay.
• All laboratories offering a COVID-19 testing service should apply to UKAS to include COVID-19 testing in their scope.
• Report suspected or actual adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland,
Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not