RE: Porton Down2 Mar 2021 09:19
For GB to highlight / hint we are in Porton Down suggests to me we are at least past phase 2!
Phase 1
DHSC will identify a pipeline of products – direct viral antigen detection lateral flow devices and distributed amplification tests – that could enable saturation testing for SARS-CoV-2 through comprehensive and repeated whole population home-testing.
DHSC will undertake a desk-top review, including of manufacturers’ claimed performance and instructions for use, to identify tests which, prima facie, may perform with sufficient sensitivity and very high specificity to enable them to be used to detect and direct responses to emerging outbreaks.
Only products deemed by DHSC to have potential, and agreed as such by the Oversight Group, will be referred to PHE Porton Down for phase 2 evaluation, with the necessary transport and logistic arrangements handled by DHSC in liaison with the companies concerned. A minimum of 500 kits will be shipped for phase 2 testing.
Phase 2
On receipt at PHE Porton Down, the scientific team dedicated to this work will carry out a ‘futility test’ on each product, the objectives of which are to:
identify the kit failure rate (indicator of robustness)identify whether known negative samples give a negative result (indicator of specificity)identify whether known positive samples give a positive result (indicator of sensitivity)provide an initial view on usability of each test, including the time to result, and ease of use
The Director of PHE Porton Down will report the findings for each product to the Oversight Group, who, based on the criteria below, will recommend which tests should proceed to phase 3 evaluation. If results do not meet the required standard at the futility testing stage, no further testing will take place and manufacturers will be advised accordingly by DHSC, who will share the results with them
Mouth watering (excuse pun) to them. We will have to get top marks for "including the time to result, and ease of use" part. :)