It’s no secret that viruses mutate, and with a virus as deadly and as widely spread as COVID-19, new variants come with new risks and more we-don’t-know-yets. While scientists continue to investigate the new SARS-CoV-2 variants circulating globally, it’s important to understand how current efforts to protect against COVID-19 could be affected.
So, the big question is: Could the new variants affect COVID-19 testing and the COVID-19 vaccine?
We break down what we know so far and what is still unknown about the new variants below.*
Think of it like this: the coronavirus family, like any other family of viruses, is subject to natural selection. It’s continually mutating to survive in new conditions, infect new host bodies, and fight against immunity. These genetic mutations occur over time and can lead to new variants with different characteristics. This includes SARS-CoV-2, the virus that causes COVID-19.
Because these new variants are defined by mutations and deletions in their genetic code that alter their protein composition, thousands of COVID-19 variants have been identified since the beginning of the pandemic in January 2020.
While there are many different strains of SARS-CoV-2, some variants are of particular concern because scientists are still learning if they spread easier, cause more severe disease, or may escape the body’s immune response.
The CDC says we are still trying to learn whether the new variants:
B.1.1.7 lineage (alpha)
B.1.351 lineage (beta)
P.1 lineage (gamma)
B.1.617.2 lineage (delta)
Scientists are working to learn more about the new coronavirus variants, and according to the CDC, more studies are needed to understand the following:
According to the CDC, studies suggest that antibodies generated through vaccination with currently authorized vaccines recognize these new variants. This is being closely investigated, and more studies are underway.
In the meantime, Dr. Anthony Fauci says “if you are vaccinated, you're going to be protected, which is another very good reason to encourage people strongly to get vaccinated. If you are not vaccinated, you are at risk of getting infected with the virus that now spreads more rapidly and gives more serious disease.”
To date, the FDA has not observed evidence to suggest the sensitivity of the tests used by our partner labs or this CareStart COVID-19 Rapid Antigen Test are impacted by known circulating variants.
Our partner labs are taking proactive actions to confirm the existing tests are robust to the detection of these known new variants. These confirmation studies indicate the current tests do detect the virus, even with the new variants. As more information regarding the variants becomes available, further confirmation and potential optimization steps will be taken.
It’s important to continue testing. Testing plays a crucial role in containing and mitigating COVID-19 by identifying infected individuals to prevent further person-to-person transmission. The accuracy of the labs using the FDA-authorized Everlywell COVID-19 Test Home Collection Kit DTC exceeds 95% sensitivity and 98% specificity.
However, with all diagnostic tests, there is a possibility of false-negative and false-positive results, which may increase when testing genetic variants of SARS-CoV-2. For these reasons, health care providers continue to consider all available clinical, diagnostic and epidemiological information.
The CDC recommends continuing to protect yourself and others against the new variants by practicing the same protective measures as before:
The reality is that there is still a lot about the new coronavirus variants that we do not know. Still, we are just as committed to delivering accurate and reliable COVID-19 test results.
We will continue to work with the FDA and our laboratory partners to monitor post-market reports and identify potential changes in the performance of our tests to ensure the assays used to test your sample meets the highest quality standards.
Check back with us for important COVID-19 variant updates.
*Note: This blog was last updated on 7/19/2021. The provided information may change as new developments are announced by the CDC and FDA.
Disclaimer: The COVID-19 Test Home Collection Kit DTC has not been FDA cleared or approved. This home collection kit has been authorized by the FDA under an EUA. Read more at www.everlywell.com/products/covid-19-test.
References 1. Allen H, Vusirikala A, Flannagan J, et al. Increased household transmission of COVID-19 cases associated with SARS-CoV-2 Variant of Concern B.1.617.2: a national case-control study. Public Health England. Retrieved from: khub.net 2. Davies NG, Abbott S, Barnard RC, et al. Estimated transmissibility and impact of SARS-CoV-2 lineage B.1.1.7 in England. Science. April 2019; 372(6538):eabg3055. doi: 10.1126/science.abg3055 3. New and Emerging Respiratory Virus Threats Advisory Group. NERVTAG meeting on SARS-CoV-2 variant under investigation VUI-202012/01. December 18, 2020. Retrieved from: khub.net 4. Pearson CAB, Russell TW, Davies NG, et al. Estimates of severity and transmissibility of novel South Africa SARS-CoV-2 variant 501Y.V2. Retrieved from: cmmid.github.io