As part of the NHS Scotland response to coronavirus (COVID-19), an innovation workstream has been created to manage the evaluation of antibody and swab (PCR) tests.
The workstream has been convened at the request of Prof. David Crossman, Chief Scientist (Health) and Chair of the Scottish Government COVID-19 Test Strategy Group. It aims to take advantage of rapid innovations in the field whilst avoiding duplication of effort between health boards.
A new process has been developed which enables clinicians and health economists to review new tests coming on stream. Suppliers seeking to offer tests that can support the diagnosis of COVID are advised to email the below address.
Scottish Assay development:
Please follow the document link below to find out more about the COVID-19 Lab Assay landscape
In the link you will find the following documents:
a) COVID-19 Test Evaluation and Novel Approaches - Scotland Governance Arrangements, Operating Procedure and Reporting - May 2020
Large Platform Diagnostic Analysers Process - Scottish Evaluation (SARSCoV-2 IgG to detect antibodies b, c, d)
f) Lateral Flow Evaluation Process
g) Novel approaches to PCR / Antigen Evaluations)
h) IgM Avidity ELISA Evaluation Process
i) Lumira DX POCT Evaluation Report Jan 2021
UK Medicines and Healthcare products Regulatory Agency (MHRA) Guidance on COVID-19 Testing kits
UK Government COVID-19 Lab Evaluation Publications