FDA Grants EUA For T-Detect Covid Test To Detect Past COVID-19 Infection

(RTTNews) - The U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) for the first and only clinical T cell-based test for patients to detect the unique T-cell signature specific to SARS-CoV-2, the virus that causes COVID-19. The test confirms recent or prior COVID-19 infection.

Developed by Adaptive Biotechnologies, T-Detect COVID Test is a next generation sequencing based (NGS) test to help identify individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or prior infection with SARS-CoV-2.

T cells are the adaptive immune system's first responders to detect any virus. They quickly multiply and circulate in the blood to attack the virus, often before symptoms appear. T cells can "remember" prior infections and kill pathogens if they reappear.

The test assesses the T cell immune response to COVID-19 after it analyzes DNA (deoxyribonucleic acid) sequences from T cells (white blood cells). A T cell response may be detected in blood several days after initial infection.

From a simple blood draw, T-Detect will leverage the map to provide an immunostatus for an individual, enabling early disease diagnosis, disease monitoring, and critical insights into immunity.

The T cell-based test is the first indication resulting from Adaptive's TCR-Antigen Map collaboration with Microsoft. The test uses immunosequencing, proprietary computational modeling, and Microsoft's AI and machine learning to map T-cell receptor sequences.

Though the T-Detect COVID Test confirms recent or prior COVID-19 infection, it does not diagnose current SARS-CoV-2 infection.

Until now, antibody tests have been the primary way to determine recent or prior COVID-19 infection. T-cell tests take an entirely new approach to determine prior infection. T-cell responses arise earlier than antibodies and persist in the blood for longer.

The FDA granted EUA based on a clinical validation study showing that T-Detect COVID Test demonstrated sensitivity or ability to identify a positive case, of 97.1 percent from date of diagnosis using RT-PCR. It also showed 100 percent specificity, the ability to identify a negative case.

A positive test result indicates recent or prior infection with SARS-CoV-2, while a negative test result indicates that a patient is unlikely to have been infected with SARS-CoV-2. However, a negative result does not preclude acute or current SARS-CoV-2 infection.

The test is indicated for use by qualified healthcare professionals on samples from individuals who are 15 days or more post-symptom onset. Testing is currently limited to laboratories designated by Adaptive Biotechnologies. Patients can opt to visit one of nearly 2,000 Labcorp patient service centers or arrange for a mobile phlebotomy service at their home to have their blood drawn for testing.