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FDA Issues EUA for Adaptive Biotechnologies COVID-19 T-Cell Response Test

NEW YORK – The US Food and Drug Administration on Friday issued Emergency Use Authorization to Adaptive Technologies' T-Detect COVID-19 Test, used to determine whether an individual had been infected with SARS-CoV-2 in the past.

Unlike other tests that detect blood-based antibodies to determine whether a person may have had prior infection with the coronavirus, the T-Detect COVID-19 Test leverages immune repertoire sequencing technology to identify individuals with an adaptive T-cell response to SARS-CoV-2, indicating recent or prior infection. According to the Seattle-based company, the EUA was issued based on a clinical validation study demonstrating sensitivity of 97.1 percent from the date of COVID-19 diagnosis with RT-PCR. The test also showed a specificity of 100 percent.

The FDA noted that while a positive test result indicates prior or recent SARS-CoV-2 infection, and a negative result indicates a person likely was not infected, negative results do not mean the individual may not have an acute or current infection, and the test should not be used to diagnose current SARS-CoV-2 infection.

The blood-based test is for use by qualified healthcare professionals on samples from individuals who experienced the onset of COVID-19 symptoms at least 15 days earlier, the FDA said. Testing can be done only in high-complexity labs designated by Adaptive Bio that are CLIA certified.