UK-based company Oxford Immunotec Global has unveiled its CE-marked T-SPOT.COVID test to detect a cell-mediated (T cell) immune response to SARS-CoV-2 in human whole blood.
The company has submitted an application to the US Food and Drug Administration (FDA) to obtain emergency use authorisation (EUA) for the ELISPOT-based test.
The T-SPOT.COVID test was shown to identify a SARS-CoV-2 cell-mediated (T cell) immune response in PCR positive individuals with negative serology test results in a clinical study, using specimens collected in the US.
It could complement results obtained by antibody serology to provide a thorough view of a person’s adaptive immune response to Covid-19.
Furthermore, the test can be used in conjunction with serology tests to aid in the clinical assessment of people suspected of Covid-19 but are PCR negative.
Oxford Immunotec CEO Dr Peter Wrighton-Smith said: “Our T-SPOT.COVID test is tailored specifically for the detection and measurement of an individual’s T cell response to SARS-CoV-2 infection.
“Having the ability to determine an individual’s immune response to SARS-CoV-2 has the potential to support a wide range of needs in our battle against the Covid-19 pandemic.”
The T-SPOT.COVID test has been developed as an evolution of the company’s research use-only T-SPOT Discovery SARS-CoV-2 test, which is used to obtain insights about the immune response to the virus.
In a separate development, the US FDA has granted a EUA to Adaptive Biotechnologies’ T-Detect COVID Test.
The next-generation sequencing (NGS)-based test can detect people with an adaptive T cell immune response to SARS-CoV-2, indicating recent or prior infection by assessing deoxyribonucleic acid sequences from T cells.