Initial flow cytometric evaluation of the Clearllab lymphoid screen

Flow cytometric immunophenotyping (FCI) is an integral part in the diagnosis and classification of hematologic malignancies. FCI results also influence therapeutic decisions and disease prognosis. ClearLLab LS is a 12‐antibody 10‐color cocktail provided in dry format designed as a screen for patients suspected of having hematolymphoid disease. A blinded comparison between ClearLLab LS, (CD8‐FITC, Kappa‐FITC,CD4‐PE, Lambda‐PE, CD19‐ECD, CD56‐PE‐Cy5.5, CD10‐PE‐Cy7, CD34‐APC, CD5‐APC‐A700, CD20‐APC‐A750, CD3‐PB, and CD45‐KrO), ClearLLab Reagents (five‐color, 17‐antibodies) and individual Laboratory Developed Tests (LDTs), was conducted at four laboratories. Evaluation of ClearLLab LS was performed on 210 specimens, compared to the five‐color ClearLLab Reagents (IVD and CE‐IVD), and a subset (n= 167) to LDTs. ClearLLab LS showed good agreement to ClearLLab Reagents in detecting the absence (104/104) or presence (106/106) of abnormal populations. Of specimens with abnormal populations the ClearLLab LS agreed with the ClearLLab Reagent for neoplasm maturity assessment (70/70 mature and 36/36 immature). Out of 167 specimens with LDTs results, 86 contained abnormal population(s), ClearLLab LS detected 82 (95.3%) of cases. Of the 4 cases not detected by ClearLLab LS, 3 were plasma cell neoplasms and 1 was a mature T cell malignancy. Eighty‐one samples with no hematological malignancy as analyzed by LDT were also negative by ClearLLab LS (100% agreement). ClearLLab LS agreed with LDTs assessment of neoplasms' maturity (55/55 mature and 27/27 immature). ClearLLab LS screening tube showed excellent agreement between ClearLLab Reagents and with LDT's. The presence of CD34 and CD10 in the tube allowed the detection of blast populations in several acute leukemias and myeloid neoplasms that were tested. © 2017 International Clinical Cytometry Society