Data from this retrospective study indicate that a positive two-color T and/or B cell flow cytometric cross-match (FCXM) is predictive of early renal allograft loss (less than 2 months) in cadaveric kidney donor recipients who had a negative crossmatch by the antihuman globulin complement-dependent cytotoxicity technique. Among 90 cadaveric kidney donor recipients (67 primary, 23 regrafts), 14 (8 primary, 6 regrafts) lost their renal allografts within 2 months, and 10 of the 14 were FCXM positive and HLA sensitized. The remaining 76 allografts survived beyond 2 months, 12 of which were FCXM-positive. Thus, the FCXM sensitivity rate for detecting early graft loss was 71%, and the specificity rate was 84%. Cadaveric graft-loss rates at 2 months were 33% for primary and 60% for FCXM-positive regrafts in contrast to 7% for primary and 0% for FCXM-negative regrafts. The difference in early graft loss between FCXM-positive and FCXM-negative recipients was statistically significant (P<0.0001). Subset anal yses of FCXM-positive graft recipients indicate: (1) pre vious early graft loss contraindicates transplantation o: an FXCM-positive regraft (P=0.03); and (2) panel re active antibody (PRA) <10% at crossmatch is not asso ciated with early graft loss (P=0.04). There was n< significant difference in 1-year graft survival betweei primary and regrafts in either FCXM-negative recipi ents (85% vs. 77%, respectively) or FCXM-positive re cipients (67% vs. 40%). All 12 of the FCXM-positiv< primary and regrafts that survived 2 months continue(to function at 2 years. Stepwise logistic regressioi analysis of 5 independent predictor variables (FCX1V status, gender, primary vs. regraft status, PRA level and HLA mismatched antigens) indicated that the FCX1V test was the best predictor of early graft loss. Whei FCXM results of the 90 cadaveric graft recipients wen ranked in three groups, an FCXM channel shift of 29 oi greater (third tertile) on a 1024 channel log scale wai associated with a 7.0-fold (95% confidence interval 1.9-25.5) increased risk of early graft failure when com pared to the first two tertiles. These data indicate tha the FCXM offers an additional approach for identifyini sensitized patients at risk of early renal allograft loss. © 1990 by Williams & Wilkins.