A multisite trial comparing two cytomegalovirus (CMV) pp65 antigenemia test kits, biotest CMV Brite and Bartels/Argene CMV Antigenemia

A total of 513 blood specimens, predominantly from organ transplant recipie nts, human immunodeficiency virus-positive patients, and bone marrow transp lant recipients, were tested for cytomegalovirus (CMV) by culture and pp65 antigenemia across four test sites. Peripheral blood leukocytes were examin ed by using both the Biotest CMV Brite and the Bartels/Argene CMV Antigenem ia kits. A total of 109 specimens were positive for CMV, 106 (97%) were pos itive by antigenemia, and 34 (31%) were positive by culture. According to t he manufacturers' instructions, 150,000 cells mere applied per slide for th e Biotest kit and 200,000 cells per slide for the Bartels kit. A total of 9 3 specimens (88%) were positive by the Biotest kit, and 86 (81%) were posit ive by the Bartels kit. In specimens found to be positive by only one kit, the positive cell counts were low (median, I; range, 1 to 7), When the data from all four sites were combined and analyzed, there was no statistical d ifference between the performance of the two kits; the Biotest and Bartels kits were found to be equivalent in sensitivity, specificity, and positive and negative predictive values for the detection of CMV pp65 antigenemia.