Abbott has been intently monitoring the mutations of COVID-19 so we can ensure our tests can detect them. We have already conducted an assessment of the Omicron variant and we're confident our rapid and PCR tests can detect the virus. While the Omicron variant contains mutations to the spike protein, Abbott's rapid and molecular tests – antigen and PCR – do not rely on the spike gene to detect the virus.

Abbott is currently manufacturing more than 100 million COVID-19 rapid and PCR tests a month to help support increased need for testing around the globe.

The process for evaluating variants and stress-testing our tests doesn't stop with the current variants. We are actively collecting real-world samples and using viral cultures to verify that our tests continually detect circulating strains because we know how important it is that our tests can detect new variants regardless of where they are found.

Through Abbott's Pandemic Defense Coalition, we have a network of research, academic and public health collaborators strategically placed around the world that are actively sequencing viruses to look for the next viral threat including COVID variants. Having this established network allows for the quick sharing of new information and the ability to provide samples quickly – within days rather than the typical weeks or months – so we can verify our tests. We are actively engaged with our partner in South Africa on Omicron. This type of global collaboration is critical to fighting these variants and the pandemic.

We also have an entire team of Abbott scientists dedicated to monitoring COVID-19 variants. To date, we have carefully analyzed over 1.4 million sequences from 63 different variants and none have impacted the ability of our diagnostic tests to detect the virus. And as soon as the Omicron sequence was made available, our scientists worked non-stop to evaluate it and determined the mutations would not impact the ability of our rapid and PCR tests to detect it.

Variants have fundamentally changed the landscape and trajectory of the pandemic across the globe. Now more than ever, testing remains a critical part of our COVID-19 response and Abbott’s top priority remains making reliable, accessible tests available.

Evaluating Delta and Other COVID Variants to Ensure Test Effectiveness

Aug. 10. 2021

Abbott is intently monitoring the mutations of COVID-19 so we can ensure our tests can detect them. We have conducted a thorough analysis of the new variants, including the Delta variant, and we are confident that our tests remain effective. The Delta variant, along with all other variants of concern, are primarily defined by mutations in the spike protein. Abbott's diagnostic tests do not rely on the spike proteins to detect the virus, which means that these new variants do not affect test performance.

Based on our analysis, the sensitivity and specificity of our tests, including our BinaxNOW rapid antigen tests, are not impacted by the Delta variant.

At Abbott, we have an entire team of scientists dedicated to monitoring COVID-19 variants. To date, we have carefully analyzed over 700,000 sequences from 45 different variants and none of these strains were identified to carry a mutation in the target region of our tests. Our scientists were already evaluating Delta variant sequences before there was a known case in the U.S. because we know how important it is that our tests can detect new variants regardless of where they are found.

The process for evaluating variants and stress-testing our diagnostics doesn't stop there. We are actively collecting real-world samples and using viral cultures to verify that our tests continually detect new variants. Through collaboration with the Abbott Pandemic Defense Coalition partners, we've had access to samples from all over the world. By proactively collecting and evaluating variant samples from different countries, we can ensure our tests are effective at detecting new strains even before they spread globally.

As future SARS-CoV-2 mutations are identified, we will continue our rigorous process to stress test our diagnostics -- both through an examination of their genetic sequence to determine if there are viral mutations in the target area of our tests, as well as testing real-world samples. We will also continue working with our global partners to identify new variants and share our learnings back with the scientific and public health communities.

Importance of testing

The best way to combat the Delta variant and prevent the virus from becoming even more dangerous in the future is to do everything we can to slow infections now.

Even as vaccinations become more widespread, variants have fundamentally changed the landscape and trajectory of the pandemic across the globe. Now more than ever, testing remains a critical part of our COVID-19 response to keep communities open, employees in the workplace, students in school and continue travelling. Our top priority remains making tests available to those who need them most.

This story was originally published on Jan. 27, 2021 and updated on August 10, 2021 and on November 27, 2021.