Contributions
Abstract: PB1959
Type: Publication Only
Background
The BD OneFlow solution for plasma cell disorders 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 plasma cell disorders (PCD) panel is composed of the BD OneFlow PCST (Plasma Cell Screening Tube) and BD OneFlow PCD. BD OneFlow PCST helps differentiate normal plasma cell populations from those requiring follow-up. The BD OneFlow PCD classification tube helps differentiate abnormal from normal plasma cell populations. The BD OneFlow PCD tube, when run in parallel with BD OneFlow PCST tube, characterizes the abnormal plasma cell population for identification of plasma cell disorders.
Aims
The objective of this study was to compare the accuracy between the BD OneFlow PCD system and the EF liquid comparator system.
Methods
De-identified remnant human bone marrow specimens (n = 48) were collected at two study sites and tested in an unblinded manner within 26 hours of draw. Specimens were simultaneously stained with BD OneFlow PCD and BD OneFlow PCST tubes and EF specified liquid reagents. Acquisition and analysis were performed on a BD FACSCanto II instrument using standardized acquisition and analysis templates in BD FACSDiva software. For qualitative endpoints, overall agreement, negative agreement, and positive agreement, along with their one-sided lower 95% confidence limits, were calculated. For accuracy quantitative endpoints (% positive plasma cell population), the slope, intercept, and 95% confidence limits of the slope from a Deming regression were calculated for the BD OneFlow vs EF methods.
Results
The BD OneFlow PCD system is in 100% agreement (26 of 26) with the EF system in classifying patients as having normal plasma cell populations. BD OneFlow PCD system is in 100% agreement (22 of 22) with the EF system in identifying patients with a plasma cell disorder. Furthermore, the BD OneFlow PCD system correctly identified 100% of patients who had a plasma cell disorder based on clinical results.
Conclusion
The multisite evaluation between the BD OneFlow PCD system (PCST and PCD tubes) and the EF liquid reagent system was fully concordant in identifying patients with abnormal plasma cell populations. Additionally, all subjects identified as having plasma cell disorder based on clinical results were identified as having plasma cell disorder by the BD OneFlow PCD system.
Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical
Keyword(s): Clinical Trial, Plasma cells, Myeloma, Diagnosis
Abstract: PB1959
Type: Publication Only
Background
The BD OneFlow solution for plasma cell disorders 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 plasma cell disorders (PCD) panel is composed of the BD OneFlow PCST (Plasma Cell Screening Tube) and BD OneFlow PCD. BD OneFlow PCST helps differentiate normal plasma cell populations from those requiring follow-up. The BD OneFlow PCD classification tube helps differentiate abnormal from normal plasma cell populations. The BD OneFlow PCD tube, when run in parallel with BD OneFlow PCST tube, characterizes the abnormal plasma cell population for identification of plasma cell disorders.
Aims
The objective of this study was to compare the accuracy between the BD OneFlow PCD system and the EF liquid comparator system.
Methods
De-identified remnant human bone marrow specimens (n = 48) were collected at two study sites and tested in an unblinded manner within 26 hours of draw. Specimens were simultaneously stained with BD OneFlow PCD and BD OneFlow PCST tubes and EF specified liquid reagents. Acquisition and analysis were performed on a BD FACSCanto II instrument using standardized acquisition and analysis templates in BD FACSDiva software. For qualitative endpoints, overall agreement, negative agreement, and positive agreement, along with their one-sided lower 95% confidence limits, were calculated. For accuracy quantitative endpoints (% positive plasma cell population), the slope, intercept, and 95% confidence limits of the slope from a Deming regression were calculated for the BD OneFlow vs EF methods.
Results
The BD OneFlow PCD system is in 100% agreement (26 of 26) with the EF system in classifying patients as having normal plasma cell populations. BD OneFlow PCD system is in 100% agreement (22 of 22) with the EF system in identifying patients with a plasma cell disorder. Furthermore, the BD OneFlow PCD system correctly identified 100% of patients who had a plasma cell disorder based on clinical results.
Conclusion
The multisite evaluation between the BD OneFlow PCD system (PCST and PCD tubes) and the EF liquid reagent system was fully concordant in identifying patients with abnormal plasma cell populations. Additionally, all subjects identified as having plasma cell disorder based on clinical results were identified as having plasma cell disorder by the BD OneFlow PCD system.
Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical
Keyword(s): Clinical Trial, Plasma cells, Myeloma, Diagnosis