CAS ALERT - Results from laboratory-based tests for COVID-19 antibodies using capillary blood sample collection kits may not be reliable

8 June 2020
Attachments
This covers issues with both laboratory based tests for COVID-19 antibodies (unvalidated sample type) and capillary blood sample collection kits (unvalidated for home use)

Actions
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


Action by
Biomedical scientists
Pathology managers
Medical directors
Deadlines for actions
Actions underway: 15 June 2020
Actions complete: 13 July 2020
Problem/background
MHRA is aware that some laboratories are providing COVID-19 testing service whereby the sample type has not been validated or verified by the manufacturer of the assay. This represents off label use and is therefore not covered under the CE mark of the assay.

The test involves collecting a capillary blood sample into a small container following a set of instructions. The container is then sent to a laboratory for analysis and the results are returned direct to the person who took the test or the person’s GP or healthcare professional, with an indication of the reliability of the result.

The laboratory tests are CE marked and safe for use on blood drawn from the vein by a healthcare professional but have not yet been validated by the manufacturer of the test to be used with a capillary blood sample. The sample collection kits have not yet been validated for home use. We can’t be sure that people collecting samples at home are able to do this in a way that the laboratory can process the sample to give reliable results.

All UKAS accredited laboratories offering a COVID-19 testing service should hold evidence of their sample type validation and verification data.

MHRA has updated our guidance for COVID-19 antibody testing services for industry and members of the public.

Distribution
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.

Distribution
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.

Trusts (NHS boards in Scotland) CAS and NICAS liaison officers for onward distribution to all relevant staff including:

Biomedical science departments
Chief pharmacists
Clinical governance leads
Clinical pathologists
Community children’s nurses
Community nurses
Microbiologists
NHS walk-in centres
Outpatient clinics
Outpatient theatre managers
Pharmaceutical advisors
Pharmacists
Phlebotomists
Point of care testing co-ordinators
School nurses
Virologists
Walk-in centres
Public Health England
Directors for onward distribution to:

Consultants in communicable disease control
Divisional directors
Heads of department
Laboratory managers
PHE laboratories
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:

Community pharmacists
General practice managers
General practice nurses
General practitioners (for information only)
Occupational health departments
This Medical Device Alert is being sent to GPs for information only, in circumstances where patients may seek advice about the contents of this notice. GPs need take no further action on receipt of this alert.

Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)

Care homes providing nursing care (adults)
Care homes providing personal care (adults)
Hospitals in the independent sector
Private medical practitioners
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Central Alerting System (CAS) by sending an email to: safetyalerts@mhra.gov.uk and requesting this facility.

Enquiries
England
Send enquiries about this notice to the MHRA, quoting reference number MDA/2020/015 or 2020/006/001/210/002.

Technical aspects
Bina Mackenzie, MHRA
Tel: 020 3080 6000

Email: DSS-TM@mhra.gov.uk

Clinical aspects
Devices Clinical Team, MHRA
Tel: 020 3080 7274

Email: dct@mhra.gov.uk

Reporting adverse incidents in England
Through Yellow Card

Northern Ireland
Northern Ireland Adverse Incident Centre, (NIAIC), CMO Group, Department of Health (Northern Ireland),
Department of Health, Social Services and Public Safety
Tel: 028 9052 3868

Email: niaic@health-ni.gov.uk

https://www.health-ni.gov.uk/niaic

To report an adverse incident involving a medical device in Northern Ireland use the forms on our website.

Alerts in Northern Ireland are distributed via the NICAS system.

Scotland
Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre (IRIC),
Health Facilities Scotland,
NHS National Services Scotland
Tel: 0131 275 7575

Email: nss.iric@nhs.net

Reporting adverse incidents in Scotland
To report an adverse incident involving a medical device in Scotland, email IRIC to request a webform account. For more information, or if you can’t access the webform, visit the website: how to report an adverse incident

Wales
Enquiries in Wales should be addressed to:

Healthcare Quality Division,
Welsh Government
Tel: 02920 823 624 / 02920 825 510

Email: Haz-Aic@wales.gsi.gov.uk

Reporting adverse incidents in Wales
Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).

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