RE: £8Bn DPS - Full Test Specification6 Mar 2021 11:21
This is the first time I've seen mention of the fact that other equivalent regimes of “Phase 3A Validation" will be considered as the equivalent of that undertaken at Porton Down. This, to me, leaves the door open to qualification for the DPS via Avacta's European validation, even in the worse case where we do not currently have a test at PD.
8.4 “Phase 3A Validation” is an evaluation against human samples containing a) SARS-CoV-2
antigens and b) samples that are confirmed as SARS-CoV-2 negative by PCR.
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Phase 3A Validation is currently undertaken at PHE Porton Down. During the duration of the DPS, DHSC may identify
another regime(s), whether or not undertaken at PHE Porton Down, that may or shall be used to achieve the same objective in which event “Phase 3A Validation” shall, for the purposes of this Specification, the DPS Information Document, and any Application, mean validation by such regime.