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.

You can also download a copy of our Delta validation study HERE. Our Omicron validation study data is currently being finalised and the full report will be available soon.

Results of Variant of Concern (VoC) validation

WHO LabelLineageCountry first detectedDate first detectedDetected by AffiDX®
SARS-CoV-2 LFD
AlphaB.1.1.7United KingdomSeptember 2020Yes
BetaB.1.351South AfricaSeptember 2020Yes
GammaP.1BrazilDecember 2020Pending availability of virus from PHE
DeltaB.1.617.2IndiaDecember 2020Yes
OmicronB.1.1.529South AfricaNovember 2021Yes

For further information please contact your local Avacta distributor or email us.

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Disclaimer: The AffiDX® SARS-CoV-2 rapid antigen test is not currently available for sale in the United States.