Diagnostic performance of the ClearLLab 10C B cell tube

Cytometry B Clin Cytom. 2021 Jul;100(4):519-530. doi: 10.1002/cyto.b.21955. Epub 2020 Sep 22.

Abstract

Introduction: Pre-analytical and analytical errors can threaten the reliability of flow cytometry (FC) results. A potential solution to some of these is the use of dry, pre-mixed antibodies, such as the ClearLLab 10C system. The purpose of the present study was to compare the diagnostic performance of the ClearLLab 10C B cell tube with that of our standard laboratory practice.

Methods: We compared the diagnoses made with the ClearLLab 10C B cell tube (experimental strategy) with those made with standard laboratory practice (standard strategy). Samples were selected aiming for representation of the full spectrum of B cell disorders, with an emphasis on mature B cell malignancies, as well as healthy controls.

Results: We included 116 samples (34 normal controls, 4 acute lymphoblastic leukemias, 54 mature lymphoproliferative disorders in peripheral blood and bone marrow, 3 myelomas, 6 bone marrow samples with involvement by lymphoma and 1 with elevated hematogone count, 14 lymph node samples, 1 cerebrospinal fluid, and 1 pleural effusion). There were two diagnostic errors (1.7%). The agreement between the two strategies in the percentage of CD19 cells and fluorescence intensity of CD5, CD19, CD20, CD200, and CD10 was very good.

Conclusions: In this study, the ClearLLab 10C B cell tube performed similarly to our standard laboratory practice to diagnose and classify mature B cell malignancies.

Keywords: ALL; B cells; chronic lymphocytic leukemia; flow cytometry; lymphoma, lymphoproliferative disorder, multiple myeloma.

MeSH terms

  • Antigens, CD / blood
  • Antigens, CD19 / blood
  • Antigens, CD20 / blood
  • B-Lymphocytes / immunology*
  • B-Lymphocytes / pathology
  • Female
  • Flow Cytometry / instrumentation*
  • Flow Cytometry / methods
  • Humans
  • Immunophenotyping / instrumentation*
  • Immunophenotyping / methods
  • Leukemia, Lymphocytic, Chronic, B-Cell / blood
  • Leukemia, Lymphocytic, Chronic, B-Cell / diagnosis
  • Leukemia, Lymphocytic, Chronic, B-Cell / pathology
  • Leukemia, Lymphoid / blood
  • Leukemia, Lymphoid / pathology
  • Lymphoma / blood
  • Lymphoma / pathology
  • Lymphoproliferative Disorders / blood*
  • Lymphoproliferative Disorders / diagnosis
  • Lymphoproliferative Disorders / immunology
  • Lymphoproliferative Disorders / pathology
  • Male
  • Neprilysin / blood

Substances

  • Antigens, CD
  • Antigens, CD19
  • Antigens, CD20
  • Neprilysin
  • antigens, CD200