FDA Authorizes Adaptive Biotechnologies T-Detect COVID Test

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FDA

U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the T-Detect COVID Test developed by Adaptive Biotechnologies.

The T-Detect COVID Test is a next generation sequencing based (NGS) test to aid in identifying individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or prior infection with SARS-CoV-2.

The test analyzes DNA (deoxyribonucleic acid) sequences from T cells (white blood cells) to aid in identifying individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or previous SARS-CoV-2 infection.

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. Negative results do not preclude acute or current SARS-CoV-2 infection.

All results from the test should be used in combination with a clinical examination, patient medical history and other findings. The T-Detect COVID Test should not be used to diagnose current SARS-CoV-2 infection.

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