Abstract: Objective To evaluate the clinical significance of flow cytometric bead assay (FCBA) test in diagnosis of immune-mediated platelet refractoriness (IPR) and in the differential diagnosis of IPR from non-immune mediated platelet refractoriness (NIPR). Methods FCBA was established and used to detect the HLA-Ⅰand HLA-Ⅱantibody of 107 patients with hematopathy who relied on platelet transfusion. There were 29 patients of IPR, 26 patients of NIPR and 52 patients of NPR. The sensitivity and specificity of the approach for the diagnosis of IPR were evaluated, and the correlation between the levels of anti-HLA-Ⅰ/HLA-Ⅱand 24 h corrected count increment (CCI) were analyzed. Results The positive percentage of 55 PR patients' HLA antibodies was 52.73%. The total positive rate of HLA antibodies in IPR group was 100%, which compared with the positive percentage of NIPR group (0.0%) and NPR group (13.46%) both had significant statistical difference(all P<0.01). The results showed that for the diagnosis of IPR, anti- HLA-Ⅰand HLA-Ⅱ had the sensitivity of 89.66% and 55.17%, the specificity of 85.71% and 14.29%, the positive predictive value of 96.30% and 72.72%, the negative predictive value of 66.67% and 7.14%, and the total efficiency of 90.82% and 34.73%, respectively. The concentration of anti-HLA-Ⅰand anti-HLA-Ⅱantibody both was negatively correlated with 24 h CCI(r=-0.594, P<0.05; r=-0.525, P<0.05). Conclusion Flow Cytometric Bead assay in detecting HLA-Ⅰantibody has high specificity, and it is proved to be of great value for the diagnosis of IPR and for differential diagnosis of IPR from NIPR.