Validation of AffiDX^® SARS-CoV-2 Antigen Lateral Flow Test with Variants of Concern

Avacta^® Diagnostics monitors the emergence of new SARS-CoV-2 Variants of Concern (VOC) using the Public Health England (PHE) and World Health Organisation (WHO) lists. A Variant of Concern is one that has been shown to be associated with one or more of the following changes:

• Increase in transmissibility or detrimental change in COVID-19 epidemiology
• Increase in virulence or change in clinical disease presentation
• Decrease in effectiveness of public health and social measures or available diagnostics, vaccines, therapeutics.

When a variant is designated as a VOC, Avacta^® obtains the irradiated virus, when it becomes available, and tests it on the AffiDX^® SARS-CoV-2 Antigen Lateral Flow Test*.

The irradiated virus strains are diluted in assay running buffer and tested at 10⁴, 10³, 600 and 500 pfu/mL.

All new VOCs are tested against the ‘A-lineage old England 02’ strain, the wild-type strain that was in circulation at the time of the AffiDX^® test development.

 

* Delta and Omicron VOC validations were conducted at an external site, using prospective samples obtained from patients whose symptoms were consistent with COVID-19 and were subsequently verified as carrying the specific mutations by Next Generation Sequencing (NGS) prior to testing the samples on the AffiDX^® lateral flow devices. Read more in our announcements HERE and HERE.

You can also download a copy of our Delta VOC application note HERE. For the latest information on Omicron detection click HERE.