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Updated: Feb 18, 2026

Isolation of Uterine Innate Lymphoid Cells for Analysis by Flow Cytometry
Published on: October 14, 2021
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.
Introduction:
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.
Methods:
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.
Results:
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).
Conclusion:
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.

