Initial flow cytometric evaluation of the Clearllab lymphoid screen

B D Hedley1, G Cheng2, J Luider3

  • 1Pathology and Laboratory Medicine, London Health Sciences Center, London, Ontario, N6A 5W9, Canada.

Insights

ClearLLab LS, a new flow cytometry screening tool, demonstrated high accuracy in identifying hematologic malignancies. It showed excellent agreement with established reagents and laboratory tests for detecting abnormal cell populations and assessing neoplasm maturity.

Area of Science:

  • Hematology
  • Immunophenotyping
  • Clinical Cytometry

Background:

  • Flow cytometric immunophenotyping (FCI) is crucial for diagnosing hematologic malignancies, guiding treatment, and predicting prognosis.
  • ClearLLab LS is a novel 12-antibody, 10-color cocktail in a dry format designed for screening patients with suspected hematolymphoid diseases.

Purpose of the Study:

  • To evaluate the diagnostic performance of the ClearLLab LS screening tube.
  • To compare ClearLLab LS against existing ClearLLab Reagents and laboratory-developed tests (LDTs) for hematologic malignancy screening.

Main Methods:

  • A blinded comparison study was conducted across four laboratories.
  • ClearLLab LS was evaluated on 210 specimens against ClearLLab Reagents and on 167 specimens against LDTs.

Main Results:

  • ClearLLab LS showed excellent agreement with ClearLLab Reagents in detecting abnormal cell populations and assessing neoplasm maturity.
  • The screening tube detected 95.3% of abnormal cases identified by LDTs, with 100% agreement on negative cases.
  • ClearLLab LS successfully identified blast populations in acute leukemias and myeloid neoplasms due to the inclusion of CD34 and CD10.

Conclusions:

  • ClearLLab LS is a reliable screening tool for hematologic malignancies, demonstrating high concordance with established methods.
  • The inclusion of specific markers enhances its capability to detect critical cell populations in various hematologic neoplasms.
Abstract