T-SPOT.CMV and T-SPOT.PRT Diagnostic Assays

Approximately 600 subjects who meet inclusion/exclusion criteria will be enrolled in the prospective, non-randomized, observational study. Sample size is based on having an adequate overall number of subjects to assess the T-SPOT.PRT endpoint (350) and the T-SPOT.CMV endpoint (250) in the defined populations. Subjects may be enrolled from pre-transplantation to post-transplantation up to completion of antiviral prophylaxis. Study duration: 37 months; 25 months to enroll all subjects with 12 months (365 days) of patient participation. Study population: All subjects enrolled in this study will be men or women, aged 18 years or older and recipients of a first or subsequent renal transplant.