The T-SPOT®.CMV test is available in the United States as a Laboratory Developed Test.
T cell immunity against CMV is a factor in controlling viral latency and susceptibility to CMV disease. CMV can affect individuals with weaknesses in their T cell response and it is therefore an important and common cause of morbidity and mortality in solid organ and hematopoietic stem cell transplant recipients. The T-SPOT.CMV test measures the strength of T cell responses to CMV specific antigens. The T-SPOT.CMV test has the potential to assist clinicians with monitoring anti-viral prophylaxis and evaluating patients at risk from CMV disease.
The T-SPOT.CMV test leverages Oxford Immunotec’s proprietary T-SPOT technology platform. The new test will be performed at Oxford Diagnostic Laboratories® in Memphis, TN, where validation was performed. The test results will be available to customers within two days of receipt of a whole blood sample.
This test was developed and its performance characteristics determined by Oxford Diagnostic Laboratories. It has not been cleared or approved by the U.S. Food and Drug Administration. Oxford Diagnostic Laboratories is regulated under the Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP) as an accredited laboratory to perform high complexity clinical laboratory testing.
Dr. Chemaly is not a member of the Oxford Immuntoec staff, nor does he promote or endorse the T-SPOT.CMV test. The T-SPOT.CMV test may not be available in all states.