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21st April 2021

Avacta eyes CE marking for COVID-19 test after receiving clinical validation

After Avacta’s SARS-CoV-2 antigen test showed 98% clinical sensitivity, the group now prepares the technical file for CE marking

Avacta prepare the technical file for CE marking the AffiDX SARS-CoV-2 antigen lateral flow test after receiving clinical approval. Avacta’s SARS-CoV-2 antigen test passed with flying colours after a study found 96 out of 98 of the samples correctly as positive, showing 98% clinical sensitivity.
The study, conducted in Europe, was carried out on 98 COVID-19 positive samples with viral loads confirmed by polymerase chain reaction (PCR).
Avacta CEO Dr Alastair Smith explained the technicalities surrounding the clinical trial in a statement:

As part of the study the same clinical samples were tested with two leading, commercially available lateral flow antigen tests, and the data show that the AffiDX test had better clinical sensitivity across the range of Ct value and in particular at lower viral loads.
We are very excited by the potential of this high quality SARS-CoV-2 rapid antigen test and we are looking forward to updating the market as we commercially roll-out the AffiDX® test in the coming months.

Going forward, the data collected from the test alongside other performance data from other studies will help contribute towards the file for CE marking the SARS-CoV-2 antigen test.
Dr Alastair Smith commented:

I am delighted with the clinical data from this larger clinical study, which has robustly evaluated the AffiDX antigen test with lower viral loads of Ct>26 as well as with higher viral load samples. The results are very impressive and marks a major step in obtaining a CE mark for professional use.
We are completing the necessary assessment of the product from our manufacturing partner Global Access Diagnostics, including stability testing that will complete the technical file for CE marking, which we expect will happen in early May.

See also: Vatic 15 minute non-invasive COVID-19 test gets CE mark
Source: Medical Device Network