RE: Today's RNS22 Mar 2021 14:19
Here you go regulator - last sentence:
"“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. The objective is
to ensure LFDs perform at the minimum threshold levels to be potentially suitable candidates
for use as a nationally deployed LFD as part of the Government’s Test & Trace strategy. It seeks
to validate that LFDs have a low failure rate, are acceptable for use with their operators and
achieve acceptable levels of sensitivity and specificity. It is a clinical laboratory scientist
evaluation assessment using human samples. It uses frozen human samples obtained from a
biorepository. It is important as it enables an assessment against human samples and
determines LFD sensitivity, specificity and kit failure rate. It consists of testing against a panel
of 200 known positive and 1000 negative human samples, which number may be varied as
considered appropriate by PHE Porton Down from time to time. This form of testing is
important as samples from individuals may be different to laboratory manufactured viral
particles and may lead to different performance insights of the devices. 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."
Sign In
Follow the stocks
