FDA Issues EUA for COVID-19 Diagnostic Test to Confirm Recent or Prior COVID-19 Infection

March 8, 2021
Alana Hippensteele, Editor

The FDA has issued an emergency use authorization (EUA) for a COVID-19 diagnostic test that can confirm recent or prior COVID-19 infection.

The FDA has issued an emergency use authorization (EUA) for a COVID-19 diagnostic test (T-Detect™ COVID, Adaptive Biotechnologies Corporation) that can confirm recent or prior COVID-19 infection. The diagnostic test is T cell-based and is the first indication for the test, which resulted from a recent collaboration between Adaptive Biotechnologies Corporation and Microsoft.

“People who have been unsure about a prior infection will now have another way to know if they had the virus,” said Chad Robins, chief executive officer of Adaptive Biotechnologies, in a press release. “The authorization of T-Detect COVID represents a true breakthrough for patients and a pivotal milestone for the diagnostic testing paradigm. We have proven that it is possible to read how T cells detect disease in the blood, and this is just the beginning of a pipeline of tests for many other indications.”

The FDA based its assessment of the issuance of the EUA on a clinical validation study that demonstrated that the diagnostic test has a sensitivity of 97.1% through the use of RT-PCR. Since sensitivity is the ability of a diagnostic test to accurately identify a positive case of COVID-19, or present with a true positive, the significant level of sensitivity demonstrates a high level of diagnostic accuracy, according to the FDA.

Additionally, the FDA found that the diagnostic test had a specificity of 100%. Specificity evaluates the test’s ability to accurately identify a negative COVID-19 case, or present with a true negative, and 100% specificity shows the test has complete accuracy in this area.

Although COVID-19 is the first indication for the diagnostic test, it is being developed for multiple disease states. The diagnostic capacity of the T cell-based test is a translation of the diagnostic capability of T cells into the clinical practice domain.

T cells, which are the adaptive immune system’s first responders in the detection of any virus, multiply and circulate in the blood in order to defend the body against a virus upon its detection. Due to their role in the immune system, T cells contain information that may provide a trackable measure of the body’s immune response to COVID-19, as T cells “remember” prior infections in order to more effectively kill pathogens upon reappearance.

Since research has demonstrated that antibodies to SARS-CoV-2 may decline over time, T cells may be a valuable source of information to help researchers assess how long patients remain resistant to reinfection. Because T cells circulate freely in the blood, they are also an easy way to assess exposure to SARS-CoV-2 and potentially immunity as well.

“This is the first commercially available T-cell test that confirms recent or prior SARS-CoV-2 infections in people. T-Detect is accurate and what I find especially remarkable is how rapidly it was developed. Going from the lab to real-world human impact in a matter of months demonstrates the true value of our collaboration and the power of merging biology with cloud-scale machine learning technology,” said Peter Lee, corporate vice president, Research & Incubations, Microsoft, in the press release. “We are hopeful that this technology will have a meaningful impact not only in the global fight against COVID-19, but in many other disease areas in the future.”

REFERENCE

Adaptive Biotechnologies Announces FDA Emergency Use Authorization for T-Detect™ COVID to Confirm Recent or Prior COVID-19 Infection. Seattle, WA: Adaptive Biotechnologies Corporation; March 5, 2021. [email] Accessed March 8, 2021.