2021-03-04 17:27:16 OXFD Oxford Immunotec
03/04/21 03/0417:27 03/04/2117:27 | Oxford Immunotec submits EUA request to FDA for T-Spot Covid testOxford Immunotec Global announced that it has released the T-SPOT.COVID test, a CE marked ELISPOT based test intended for qualitative detection of a cell mediated immune response to SARS-CoV-2 in human whole blood. The company has filed an EUA request to the FDA for the test. Serology does not give the full picture of the adaptive immune response to SARS-CoV-2 infection. Antibodies are not always produced in response to SARS-CoV-2 infection, or may be delayed1,2. Antibodies can also wane quickly after infection4 and reports show T cells may be more long lived than the antibody response3. In the absence of an antibody response, the T cell response may be protective from SARS-CoV-2 infection5. In a clinical study using samples collected in the US, the T-SPOT.COVID test was proven to detect a SARS-CoV-2 cell mediated immune response in PCR positive individuals, even with negative serology test results6. The T-SPOT.COVID test therefore complements results obtained by antibody serology to give a more comprehensive view of an individual's adaptive immune response to SARS-CoV-2 infection. The test could also be used, for example, alongside serology tests to support clinical assessment of individuals who present with suspected COVID-19 but are PCR negative. | |
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