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 variant validation was conducted at an external site, using samples obtained from patients whose symptoms were consistent with the Delta variant, and subsequently verified as Delta variant by PCR prior to testing the samples on the lateral flow devices. Read more in the announcement HERE or download a copy of the validation study 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|
Disclaimer: The AffiDX® SARS-CoV-2 rapid antigen test is not currently available for sale in the United States.