Contributions
Abstract: PB1788
Type: Publication Only
Background
The BD OneFlow solution for diagnostic screening of chronic lymphoproliferative disorders (CLPDs) includes a standardized flow cytometry approach based on the EuroFlow (EF) Consortium liquid reagent system. The BD OneFlow solution enables reproducible identification and discrimination of normal from aberrant mature cell populations by combining standardized assays, setup reagents, and protocols. The BD OneFlow LST (Lymphoid Screening Tube) is intended for flow-cytometric immunophenotyping of normal and aberrant mature lymphocyte populations of B, T, and NK lineages in specimens (peripheral blood, bone marrow, and lymph node) from patients with hematological disorders. BD OneFlow LST acquisition and analysis template version 1.0 was revised to version 2.0 to include determination of lymphocytes as a percentage of total leucocytes. The FCS files from evaluable specimens of the original LST clinical trial were regressed using BD OneFlow LST template v2.0.
Aims
The objective of this study was to regress the FCS files from all the evaluable specimens previously collected using LST template v1.0 in the original clinical study to demonstrate equivalency between the investigational BD OneFlow LST system and the comparator EF liquid reagent system on a BD FACSCanto II flow cytometer with the 4-2H-2V CE-IVD configuration and LST template v2.0.
Methods
The FCS files using LST v1.0 template from the original clinical study included de-identified remnant peripheral blood (n = 123), bone marrow (n = 53), and lymph node (n = 31) specimens from patients and healthy donors. Specimens were collected in EDTA or heparin anticoagulants or PBS (for lymph nodes) at three external study sites. Informed consent was not required in this clinical study. All specimens in the original study were simultaneously stained with investigational BD OneFlow LST and comparator EF liquid reagents within 24 hours of collection and were acquired within 60 minutes of staining.
Results
The BD OneFlow LST system compared to the EF system gave 100% (207 of 207) overall agreement (lower 95% CI: 98.6%) in delineating patients into normal (no follow-up) or follow-up, and 100% overall agreement in identifying the B-, T-, NK-, and other-cell lineages (lower 95% CI: 98.6%). There was 100% positive agreement and 100% negative agreement between BD OneFlow and EF for follow-up vs no-follow-up (normal) and for all cell lineages from specimens that required follow-up. Furthermore, compared to the EF system, the BD OneFlow LST system met the acceptance criteria for the quantitative assessment (Deming regression) of the defined cell populations.
Conclusion
The multisite performance evaluation of the BD OneFlow LST system and the comparator EF liquid reagent system was concordant in identifying abnormal from normal mature populations in patients with CLPDs.
Session topic: 6. Chronic lymphocytic leukemia and related disorders - Clinical
Keyword(s): Lymphoproliferative disorder, flow cytometry, Diagnosis, Clinical Trial
Abstract: PB1788
Type: Publication Only
Background
The BD OneFlow solution for diagnostic screening of chronic lymphoproliferative disorders (CLPDs) includes a standardized flow cytometry approach based on the EuroFlow (EF) Consortium liquid reagent system. The BD OneFlow solution enables reproducible identification and discrimination of normal from aberrant mature cell populations by combining standardized assays, setup reagents, and protocols. The BD OneFlow LST (Lymphoid Screening Tube) is intended for flow-cytometric immunophenotyping of normal and aberrant mature lymphocyte populations of B, T, and NK lineages in specimens (peripheral blood, bone marrow, and lymph node) from patients with hematological disorders. BD OneFlow LST acquisition and analysis template version 1.0 was revised to version 2.0 to include determination of lymphocytes as a percentage of total leucocytes. The FCS files from evaluable specimens of the original LST clinical trial were regressed using BD OneFlow LST template v2.0.
Aims
The objective of this study was to regress the FCS files from all the evaluable specimens previously collected using LST template v1.0 in the original clinical study to demonstrate equivalency between the investigational BD OneFlow LST system and the comparator EF liquid reagent system on a BD FACSCanto II flow cytometer with the 4-2H-2V CE-IVD configuration and LST template v2.0.
Methods
The FCS files using LST v1.0 template from the original clinical study included de-identified remnant peripheral blood (n = 123), bone marrow (n = 53), and lymph node (n = 31) specimens from patients and healthy donors. Specimens were collected in EDTA or heparin anticoagulants or PBS (for lymph nodes) at three external study sites. Informed consent was not required in this clinical study. All specimens in the original study were simultaneously stained with investigational BD OneFlow LST and comparator EF liquid reagents within 24 hours of collection and were acquired within 60 minutes of staining.
Results
The BD OneFlow LST system compared to the EF system gave 100% (207 of 207) overall agreement (lower 95% CI: 98.6%) in delineating patients into normal (no follow-up) or follow-up, and 100% overall agreement in identifying the B-, T-, NK-, and other-cell lineages (lower 95% CI: 98.6%). There was 100% positive agreement and 100% negative agreement between BD OneFlow and EF for follow-up vs no-follow-up (normal) and for all cell lineages from specimens that required follow-up. Furthermore, compared to the EF system, the BD OneFlow LST system met the acceptance criteria for the quantitative assessment (Deming regression) of the defined cell populations.
Conclusion
The multisite performance evaluation of the BD OneFlow LST system and the comparator EF liquid reagent system was concordant in identifying abnormal from normal mature populations in patients with CLPDs.
Session topic: 6. Chronic lymphocytic leukemia and related disorders - Clinical
Keyword(s): Lymphoproliferative disorder, flow cytometry, Diagnosis, Clinical Trial