THE test24 Feb 2021 19:25
It was posted earlier but lost in the crap:
The Group announced in Q4 2020 that it would focus on anterior nasal sampling because of the variability of saliva samples, although the test works with both sample types. The UK Department of Health and Social Care has also recently focused on nasal and other swab samples rather than saliva.
In summary, the AffiDX® SARS-CoV-2 Lateral Flow Rapid Antigen Test has excellent analytical sensitivity (LOD) of 50 pg/ml S1 spike protein, which appears sensitive enough to detect the lowest viral loads of relevance to the Intended Use Case, with a read time of 20 minutes. As far the Group is aware, this is the most sensitive S1 spike lateral flow test available.
The analytical specificity of the Affimer reagents has been reported previously with no cross-reactivity with the S1 spike proteins from closely related coronaviruses: MERS-CoV S1, SARS-CoV-1 S1, HC0V-229E S1, HCoV-HKU1 S1, HCoV-NL63 S1 or HCoV-OC43 S1.
The test detects the D641G mutant of the original coronavirus and the Group expects that the test will also detect the newer coronavirus variants. Work is ongoing with Public Health England to confirm this.
Very clear why we changed to nasal swab. The government asked us to!