Contributions
Abstract: PB1794
Type: Publication Only
Background
The BD OneFlow solution for B-cell chronic lymphoproliferative diseases (B-CLPDs) incorporates a standardized flow cytometry approach based on the EuroFlow (EF) Consortium liquid reagent system. The BD OneFlow solution enables reproducible identification and discrimination of distinct cell populations by combining standardized assays, setup reagents, and protocols. The previously launched BD OneFlow LST (Lymphocyte Screening Tube) is intended for flow-cytometric immunophenotyping of normal (no follow-up required) and aberrant (follow-up required) mature lymphocyte populations of B, T, and NK lineages in specimens from patients with hematological disorders. The BD OneFlow B-CLPD T1 is being developed to work in conjunction with BD OneFlow LST for the immunophenotyping of B cells and distinguishing chronic lymphocytic leukemia (CLL) from other B-CLPDs such as atypical CLL, follicular cell lymphoma, mantle cell lymphoma, etc.
Aims
The objective of this study was to demonstrate equivalency (accuracy) between the investigational BD OneFlow LST and BD OneFlow B-CLPD T1 system and the corresponding comparator EF liquid reagent system on the BD FACSCanto II flow cytometer using BD FACSDiva software.
Methods
De-identified remnant peripheral blood (PB) (n = 70) and bone marrow (BM) (n = 31) patient specimens were collected in EDTA or heparin anticoagulants at four external study sites and tested within 26 hours of draw. Informed consent was not required in this clinical study. Specimens were stained with BD OneFlow LST in combination with OneFlow B-CLPD T1 tubes and comparator EF liquid reagents. Acquisition and analysis were performed on a BD FACSCanto II instrument using BD OneFlow LST and B-CLPD T1 templates in BD FACSDiva software v8.0.1. Categorization of samples with abnormal B-cell populations into CLL (typical) or other B-CLPDs, overall agreement, negative agreement, and positive agreement, along with their one-sided lower 95% confidence limits, were calculated. For qualitative categorization of relative fluorescence intensity (positive or negative) of the aberrant cell populations, overall agreement with one-sided lower 95% confidence limits was calculated.
Results
All evaluable specimens were identified by the OneFlow LST as having B-cell populations requiring follow-up by both methods. Compared to the EF system, the BD OneFlow LST in combination with the BD OneFlow B-CLPD T1 system gave 100% (101 of 101) overall agreement in classifying patients as having CLL (54 of 54 concordant) and in identifying patients with other B-CLPD diseases (47 out of 47 concordant) with a lower 95% CI of the overall agreement of 97.4%. The BD OneFlow B-CLPD T1 system, compared to the EF system, gave 100% (101 of 101 concordant) agreement for the qualitative assessment of the relative fluorescence intensity of CD45+CD19+ aberrant populations for CD20+, CD200+, and CD23+ subsets and 99.1% agreement for the CD79b+ subset.
Conclusion
The multisite performance evaluation between the BD OneFlow system (LST and B-CLPD T1) and the comparator EF liquid reagent system was concordant in distinguishing abnormal B-cell populations in patients with CLL from patients with other B-CLPDs, including presumptive cases of atypical CLL. The BD OneFlow B-CLPD T1 is a fully standardized and validated system for aiding in the diagnosis of CLL from other B-CLPDs in PB and BM specimens.
Session topic: 6. Chronic lymphocytic leukemia and related disorders - Clinical
Keyword(s): flow cytometry, Diagnosis, Clinical Trial, Chronic Lymphocytic Leukemia
Abstract: PB1794
Type: Publication Only
Background
The BD OneFlow solution for B-cell chronic lymphoproliferative diseases (B-CLPDs) incorporates a standardized flow cytometry approach based on the EuroFlow (EF) Consortium liquid reagent system. The BD OneFlow solution enables reproducible identification and discrimination of distinct cell populations by combining standardized assays, setup reagents, and protocols. The previously launched BD OneFlow LST (Lymphocyte Screening Tube) is intended for flow-cytometric immunophenotyping of normal (no follow-up required) and aberrant (follow-up required) mature lymphocyte populations of B, T, and NK lineages in specimens from patients with hematological disorders. The BD OneFlow B-CLPD T1 is being developed to work in conjunction with BD OneFlow LST for the immunophenotyping of B cells and distinguishing chronic lymphocytic leukemia (CLL) from other B-CLPDs such as atypical CLL, follicular cell lymphoma, mantle cell lymphoma, etc.
Aims
The objective of this study was to demonstrate equivalency (accuracy) between the investigational BD OneFlow LST and BD OneFlow B-CLPD T1 system and the corresponding comparator EF liquid reagent system on the BD FACSCanto II flow cytometer using BD FACSDiva software.
Methods
De-identified remnant peripheral blood (PB) (n = 70) and bone marrow (BM) (n = 31) patient specimens were collected in EDTA or heparin anticoagulants at four external study sites and tested within 26 hours of draw. Informed consent was not required in this clinical study. Specimens were stained with BD OneFlow LST in combination with OneFlow B-CLPD T1 tubes and comparator EF liquid reagents. Acquisition and analysis were performed on a BD FACSCanto II instrument using BD OneFlow LST and B-CLPD T1 templates in BD FACSDiva software v8.0.1. Categorization of samples with abnormal B-cell populations into CLL (typical) or other B-CLPDs, overall agreement, negative agreement, and positive agreement, along with their one-sided lower 95% confidence limits, were calculated. For qualitative categorization of relative fluorescence intensity (positive or negative) of the aberrant cell populations, overall agreement with one-sided lower 95% confidence limits was calculated.
Results
All evaluable specimens were identified by the OneFlow LST as having B-cell populations requiring follow-up by both methods. Compared to the EF system, the BD OneFlow LST in combination with the BD OneFlow B-CLPD T1 system gave 100% (101 of 101) overall agreement in classifying patients as having CLL (54 of 54 concordant) and in identifying patients with other B-CLPD diseases (47 out of 47 concordant) with a lower 95% CI of the overall agreement of 97.4%. The BD OneFlow B-CLPD T1 system, compared to the EF system, gave 100% (101 of 101 concordant) agreement for the qualitative assessment of the relative fluorescence intensity of CD45+CD19+ aberrant populations for CD20+, CD200+, and CD23+ subsets and 99.1% agreement for the CD79b+ subset.
Conclusion
The multisite performance evaluation between the BD OneFlow system (LST and B-CLPD T1) and the comparator EF liquid reagent system was concordant in distinguishing abnormal B-cell populations in patients with CLL from patients with other B-CLPDs, including presumptive cases of atypical CLL. The BD OneFlow B-CLPD T1 is a fully standardized and validated system for aiding in the diagnosis of CLL from other B-CLPDs in PB and BM specimens.
Session topic: 6. Chronic lymphocytic leukemia and related disorders - Clinical
Keyword(s): flow cytometry, Diagnosis, Clinical Trial, Chronic Lymphocytic Leukemia