Does my COVID-19 Test Cover the Delta Variant and Others Being Identified?
What we know & don’t know about variants & tests for COVID-19
If you are like me, you are curious as to how many SARS-CoV-2 variants have now been identified and whether the COVID-19 test you are using is effective for one of the new variants. In full disclosure, the science and knowledge in this area is changing DAILY. What you read here is as of August 4, 2021.
In short, there are systems in place to monitor variants and diagnostic test effectiveness against new variants by FDA, NIH RADx and other U.S. and global organizations. Current tests do detect the Delta variant.
What is a Variant?
Viruses, including SARS-CoV-2, constantly change through mutation, and a variant has one or more mutations that differentiate it from other variants in circulation. There are multiple variants of SARS-CoV-2 identified both in the U.S. and globally. Scientists continue to compare genetic differences between viruses to identify new variants and how each relates to each other. As long as the coronavirus spreads through the population, mutations will continue to happen.
Centers for Disease Control and Prevention (CDC) Quote: “If you think about a virus like a tree growing and branching out; each branch on the tree is slightly different than the others. By comparing the branches, scientists can label them according to the differences. These small differences, or variants, have been studied and identified since the beginning of the pandemic.”
A U.S. government SARS-CoV-2 Interagency Group (SIG) has further developed a Variant Classification scheme with the following three classes:
- VOI — Some changes to the virus with increased cases but limited prevalence or expansion.
- VOC Evidence of impact on diagnostics, treatments and vaccines and increased transmissibility/disease severity.
- VOHC — Evidence that prevention measures and countermeasures have reduced effectiveness.
As of this article, there are no VOHC identified in the U.S. If you want to know more about what strains are appearing in the U.S. and where, the CDC has a COVID Data Tracker. You can also get regular updates from the CDC on variants by signing-up here.
COVID-19 Testing and Variants
The FDA is responsible for issuing Emergency Use Authorization (EUA) for COVID-19 tests. Having experience with tracking variants for other evolving infectious diseases, such as the flu, the FDA communicates with manufacturers to provide information and scientific advice on how to evaluate the impact of variants on their products. (2) In February 2021, FDA issued additional guidance for COVID-19 test developers to specifically address variants titled, “Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests.” FDA will continues to update the EUA templates with additional considerations and learnings about the COVID-19 disease as it relates to variants and the impact on test performance. It will be important to watch for FDA notices regarding efficacy of EUA diagnostic tests.
Along with the FDA activity, NIH has just funded a new platform, dubbed ROSALIND, to monitor the impact of SARS-CoV-2 variants on COVID-19 tests through its Rapid Acceleration of Diagnostics (RADx) Tech program. This will help test manufacturers monitor variants and test effectiveness. “ROSALIND continuously queries each test against a database of all available sequencing data and emerging variants. When a risk is detected, an alert is sent via a secure message with a report out of the findings. After receiving the alert, users can engage with interactive dashboards to investigate variant details”(3)
Will the Test Results Tell You Which Variant is Found?
While COVID-19 tests are meant to be diagnostic tests to report positive and negative results, reporting of specific variants will not be included with your test results. Why? These tests were developed and authorized by the FDA with the goal of identifying a current infection, not to identify a specific variant. Results for tests being used to identify variants, specifically molecular tests and not antigen tests, are being communicated by laboratories directly to public health officials.
So What is the Delta Variant and Why Am I Hearing About It in the News?
Delta is one of the Variants of Concern that was first identified in India. It is now prevalent in most countries. The Delta variant is significantly more contagious than other forms of the virus and thus is more easily transmitted person-to-person. While the current vaccines in the U.S. are shown to be effective against the Delta variant in lowering the risk of hospitalization and death, there is new evidence from laboratory studies that show some immune responses driven by current vaccines could be less effective against some of the new strains compared to the previous strains. Also, preliminary evidence suggests that fully vaccinated people who do become infected with the Delta variant can spread the virus to others. It is important to get vaccinated to help reduce the risk of hospitalization from COVID-19 and help limit the development of new strains. Also, stay alert for new guidance from the CDC regarding future vaccination recommendations and coronavirus safety precautions. Use Vaccines.gov to find a vaccination site near you.
Looking for tests that will help you identify positive COVID-19 cases, regardless of the identified COVID-19 variants?
See what is available at the Project N95 Shop. A quick look below of tests that are available both now and in the near future:
Sources
- CDC Classifications: VOI — Some changes to the virus with increased cases but limited prevalence or expansion. VOC Evidence of impact on diagnostics, treatments and vaccines and increased transmissibility/disease severity. VOHC — Evidence that prevention measures and countermeasures have reduced effectiveness
- Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants | FDA
- Platform Launches to Monitor Impact of SARS-CoV-2 Variants on COVID-19 Tests | Business Wire
- COVID-19 Vaccination Guidance for Johns Hopkins Medicine Patients | Johns Hopkins Coronavirus Updates
- Interim Public Health Recommendations for Fully Vaccinated People | CDC
Learn more about Project N95 and donate here to help us make sure everyone has access to the PPE and COVID-19 tests they need to keep them safe.
