Roche has launched a growing number of diagnostic solutions to address the global COVID-19 healthcare crisis. With one of the broadest portfolios for COVID-19 testing to detect and help diagnose infections in patients, Roche has received eight Food and Drug Administration (FDA) emergency use authorizations, or EUAs, in the U.S. since the start of the pandemic, including the first PCR test in March 2020. Additionally, we partnered with SD Biosensor to distribute the COVID-19 At-Home Test, which received FDA authorization on December 24, 2021. Since the emergence of SARS-CoV-2 in late 2019, the virus has mutated to generate variants that can be more transmissible and replicate faster, resulting in increased viral loads and potentially evading vaccine neutralization. The omicron variant has spread throughout the world and is rapidly replacing the delta variant in all countries. The CDC recently estimated that omicron represents the majority of all new COVID-19 infections in the U.S.
Due to concerns around the novel omicron variant, federal health officials continue to update guidance on the impact of variants, including omicron, on over-the-counter COVID-19 tests. Generally, these tests have high clinical value because they are able to quickly and conveniently detect people who have high viral loads and are most likely to be infectious. It’s critical to determine whether existing COVID-19 tests that have received EUAs can detect newly emerging variants.
Through the Rapid Acceleration of Diagnostics (RADx) Independent Test Assessment Program, the National Institutes of Health (NIH) evaluated the performance of the COVID-19 At-Home Test in detecting the omicron variant. The study, which has not been peer reviewed, consisted of patient samples that were positive for the omicron variant.
The Covid-19 At Home test identified 100% of the samples with high viral loads (less than a cycle threshold (Ct)-value of 23.9), which is good news.
A Ct value measures how much virus is present in an individual. The higher the Ct value, the lower the viral load, and individuals with low viral loads (Ct value above 25) are less likely to infect others.
Pertaining to the omicron variant specifically, and compared to the emergency-authorized RT-PCR method, the COVID-19 At-Home Test detected:
In this study, the COVID-19 At-Home Test did not detect omicron dilutions at lower viral concentrations (greater than 26.0) for live virus samples.
In a clinical study, the COVID-19 At-Home Test showed a relative sensitivity* of 95.3% and a relative specificity* of 100%. This study included 138 symptomatic individuals and was part of the test’s EUA submission.
“We are committed to bringing high-quality tests to the public, and we’re proud that the rapid antigen at-home test will be made available for free to American families through the U.S. government’s efforts to increase access to testing,” said Jamie Phillips Deeter, MS, Ph.D., senior scientific partner at Roche Diagnostics. “This test provides accurate results quickly and is an important tool in the fight against COVID-19.”
It’s important to remember that rapid antigen tests, including the Covid-19 At Home Test, are less sensitive than PCR tests, which remain the gold standard. PCR tests typically have a 98% sensitivity and provide extremely accurate results. PCR is appropriate when it’s important to minimize the risk of infecting others, or if you want to be extremely confident about your diagnosis – for example, before visiting vulnerable loved ones or going to a hospital. Rapid antigen tests are most effective when individuals are tested in the week of showing symptoms.
*Study data on file with National Institutes of Health, dated December 21, 2021. Sensitivity is the test's ability to correctly identify a positive result, and specificity is the test's ability to correctly identify a negative result.
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