Finncap Broker Note21 Apr 2021 08:38
Positive clinical validation of AffiDX® SARS-CoV-2 rapid antigen lateral flow
test. The study, carried out at a single site in Europe, tested 98 positive samples and
102 negative samples as confirmed by PCR testing. AffiDX SARS-CoV-2 antigen
lateral flow test identified 96/98 of these correctly as positive with a 20-minute read
time, resulting in a clinical sensitivity of 98.0%.
This included 31 samples with Ct<26;
65 with Ct 26-30 and 2 with Ct 30-31. The LFT demonstrated 100% sensitivity for
identifying infectious individuals with a PCT Ct<27, a level considered by many
virologists to be the cutoff for infectiousness.
Ct or cycle time indicates the number of
cycles of amplification required before the virus gene can be detected by PCR – the
higher the Ct value the lower the viral load and less infectious. The test correctly
identified 101/102 as negative, giving a clinical specificity of 99.0%.
Next steps – CE marking in early May. These data will be combined with stability
and other performance data from ongoing studies from its manufacturing partner,
Global Access Diagnostics, to finalise the technical file for CE marking the AffiDX
SARS-CoV-2 antigen lateral flow test for professional use. Avacta expects CE mark
in early May enabling it to begin commercial roll-out in Europe immediately thereafter.
Our thoughts. These data confirm that Avacta has an LFT with high sensitivity and
arguably superior performance to leading competitor LFTs, which should satisfy the
UK government’s drive for increased lateral flow testing, as well as comply with the
broader EU Commission directive for Member States to use LFTs with sensitivity =
80% and specificity = 97%. With demand for LFTs expected to remain high across
Europe, we look forward to news of first orders in the coming months.
https://www.finncap.com/research-portal?#/portal/finncap/research/8_27559
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