Validation of AffiDX® SARS-CoV-2 Antigen Lateral Flow Test with Variants of Concern
Approach to monitoring and validation
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.
Results of Variant of Concern (VoC) validation
|WHO Label||Lineage||Country first detected||Date first detected||Detected by AffiDX®|
|Alpha||B.1.1.7||United Kingdom||September 2020||Yes|
|Beta||B.1.351||South Africa||September 2020||Yes|
|Gamma||P.1||Brazil||December 2020||Pending availability of virus from PHE|
|Omicron||B.1.1.529||South Africa||November 2021||Yes|
Disclaimer: The AffiDX® SARS-CoV-2 rapid antigen test is not currently available for sale in the United States.