As COVID-19 Variants Evolve, We Stay One Step Ahead

We know that viruses evolve and variants emerge. Here's how we're monitoring and ensuring our tests hold up.

As COVID-19 Variants Evolve, We Stay One Step Ahead
Diagnostics Testing | Apr. 29, 2022

Viruses evolve.  That's what our nearly three decades of virus hunting and developing tests that detect infectious diseases has taught us. And as they evolve and encounter new places and people, variants will emerge.

On the front lines of the COVID-19 pandemic, we expected no different. That's why at the start of the pandemic, we developed 12 COVID-19 tests globally to detect the virus and our team of virus hunters make sure that our tests can continue to detect the different variants – from alpha to omicron to the next variant of interest.

While there are still unknowns about future waves and when we may see the pandemic shift to epidemic or endemic, we can expect variants to emerge, making the identification, analysis, tracking and testing of COVID-19 paramount.

Variants of Concern: What You Need to Know

Because viruses can spread rapidly, developing myriad mutations along the way, the CDC raises a red flag when a new variant has evidence of:

  1. An increase in transmissibility
  2. More severe disease (for example, increased hospitalizations or deaths)
  3. Significant reduction in neutralization by antibodies generated during previous infection or vaccination
  4. Reduced effectiveness of treatments or vaccines
  5. Diagnostic detection failures

Variants that meet these criteria are known as variants of concern (VOC), and potentially require one or more public health actions like increased testing, research or local and regional efforts to control spread.

We asked our virus hunters about the latest variants of concerns to keep you informed on how our tests perform.

Current Variants of Concern

  • BA. 4 and BA. 5 are sub-lineages of the Omicron variant that have the potential to escape the antibodies that typically protect the body from COVID-19. This makes these variants more likely to raise the risk of breakthrough infections, though vaccines remain important to protect against severe disease.

    Our team of researchers has confirmed that our rapid (including BinaxNOW and Panbio) and PCR tests continue to detect BA.2, BA.4 and BA. 5 variants.
  • BA.2, a sub-lineage of the Omicron variant (also referred to as "stealth omicron," because of its genetic mutations that could make it harder to distinguish from the Delta variant) that spread rapidly throughout the fall and winter of 2021-2022, has been classified by the WHO as a variant of concern and a variant to continue to monitor, appearing more transmissible than a previous sub-lineage of Omicron and having the potential to drag out current omicron surges.

    Our team of researchers confirmed that our tests, including BinaxNOW and Panbio, continue to detect the BA.2. variant at comparable viral load levels as all other variants and the original SARS-CoV-2 strain.
  • Omicron (a collection of many BA lineages), a variant of COVID-19 that proved its ability to spread more easily than the original SARS-CoV-2 virus this past fall and winter, generally causes less severe illness than infection with previous variants of COVID-19. While vaccines are expected to continue to prevent severe illness in the face of Omicron, breakthrough infections have been and continue to be likely to occur.

    Fortunately, testing remains an effective method of detecting and preventing further spread of Omicron. While the Omicron variant contains mutations to the spike protein, our tests do not rely on the spike gene to detect the virus, and we’re confident that our tests continue to detect Omicron.
  • Delta (a collection of many AY lineages), a variant of concern that was first identified in India in late 2020 and spread throughout the world to ultimately cause a surge in the U.S. by summer of 2021, has been known to possibly spread more easily and cause more severe illness than other variants.

    Though vaccine breakthrough were expected, our August 2021 analysis found that our tests can detect the Delta variant and remain effective, helping to prevent further community spread of COVID-19.
  • Mu, a World Health Organization (WHO) variant of interest (VOI) that rose to prevalence in the summer of 2021, was thought to be more transmissible than all other variants with the exception of Delta, though it quickly fell to less than 1% of U.S. COVID-19 cases just weeks later.

    Our tests were confirmed to hold up against Mu in the fall of 2021.
  • R.1, a variant that the CDC noted had "mutations of importance" and "demonstrates evidence of increasing virus transmissibility," in the spring of 2021, was not classified as a variant of interest for the U.S.

    We ensured that our tests could detect R.1 in June of 2021.

Thankfully, with each variant of concern, we're not back at square one.

Thanks to the work of scientists, public health experts and officials across the world, the global community has an arsenal of critical tools in the fight against COVID-19:

  • Vaccinations and boosters to prevent severe illness
  • Public health measures like distancing and hand washing to prevent viral spread
  • Testing to isolate those infected with COVID-19 quickly and effectively to keep our workplaces, schools and communities safe.

As one of our lead virus hunters, Dr. Mary Rodgers, puts it: "We've been tracking viral mutations for over 27 years with our Viral Surveillance Program, so we expected SARS-CoV-2 to mutate since the beginning, as we've seen other viruses do."

Anticipating and monitoring viral evolution through initiatives like our Pandemic Defense Coalition, the first-ever industry-led scientific and global health partnership dedicated to the early detection of and rapid response to future pandemic threats, keeps us vigilant and prepared for future COVID-19 surges.

We know that testing remains an important line of defense against COVID-19. We'll stay on the lookout to ensure that our tests hold up to new variants, and are prepared to ramp up capacity of rapid testing solutions like our BinaxNOW COVID-19 Antigen Self Test and our Panbio COVID-19 Antigen Self Test to provide peace of mind where and when it’s needed most.

While viruses evolve, we are too.

The Panbio COVID-19 test is not available in all countries. Not approved for sale in the USA.

This story was originally published on April 29, 2022 and updated July 22, 2022.

Important safety information

The BinaxNOW™ COVID-19 Antigen Self Test has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization. It has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. For serial testing, the BinaxNOW COVID-19 Antigen Self Test should be performed twice over 3 days, at least 24 hours (and no more than 48 hours) apart. For symptomatic use, a single test can be used.

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