Avacta’s COVID-19 lateral flow test gains clinical validation

pharmafile | April 20, 2021 | News story | Manufacturing and Production COVID-19 

Avacta have announced positive data from the clinical validation of its AffiDX SARS-CoV-2 antigen lateral flow test, based on a clinical study conducted in Europe on 98 positive COVID-19 samples.

The test showed 98.0% clinical sensitivity, identifying 96 out of 98 samples correctly as positive with a read time of 20 minutes.

The clinical evaluation of Avacta’s lateral flow test was carried out at a single site in Europe with patient samples with viral loads confirmed by PCR. Out of a total of 102 negative samples tested with the lateral flow device, the test correctly identified 101 as negative, giving a clinical specificity of 99.0%.

Dr Alastair Smith, Chief Executive Officer of Avacta Group, said: “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.

“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.”

The company is now completing the technical data set for self-declaration of a CE mark for professional use in early May, followed immediately by commercial launch in Europe.

Lateral flow rapid antigen tests aim to provide a low cost means of identifying individuals with a high viral load, meaning they are more likely to infect others.

Many factors affect whether an individual will infect others or not, as well as viral load, such as the circumstances and length of exposure. However, there is a growing consensus that a viral load as measured by PCR of Ct<27 should be considered as infectious.

Kat Jenkins

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