NCT05032339

Evaluation of the Plasma Cell Disorders Panel on the BD FACSLyric™ Flow Cytometer

Evaluation of the Plasma Cell Disorders Panel (BD OneFlow™ PCST and BD OneFlow™ PCD) on the BD FACSLyric™ Flow Cytometer Using Leftover, De-identified Specimens

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 208 (actual)
• Sponsor: Becton, Dickinson and Company · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

Multi-site, prospective performance study to determine equivalency between the investigational OneFlow PCD panel on the FACSLyric system versus the final clinical diagnosis.

Detailed description

Hematology laboratories rely on flow cytometry technology (in addition to classic hematological methods) to aid in screening, diagnosing, and monitoring patients with hematological disorders. High speed and broad applicability of flow cytometry allows for the diagnosis and accurate focus on targets. Currently, there are no general consensus panels being used; as a consequence, the leukemia \& lymphoma (L\&L) testing remains a single-vial antibody being used, with various in-house laboratory developed tests (LDTs) being used to test patient specimens. Furthermore, the analysis of flow cytometer generated data is not standardized and requires a high level of expertise/training for interpretation of complex data. Therefore, optimized and standardized immunostaining protocols for the diagnosis, classification, and prognostic sub-classification of hematological malignancies are needed. This Investigational panel for plasma cell disorders is intended for in vitro diagnostic use for qualitative flow-cytometric immunophenotyping of plasma cell populations on the BD FACSLyric flow cytometer. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, plasma cell disorders. Enrollment will occur at up to 8 investigational sites . Data will be acquired from Eligible remnant/leftover specimens on the BD FACSLyric flow cytometer and evaluated by site personnel and expert analysts . The final diagnosis and the affected cell population will be determined by site standard of care . Analysis of data will evaluate identification of normal vs abnormal cell population of the expert \& site analysts as compared to the final diagnosis.

Conditions

• Plasma Cell Disorder

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	IUO Plasma Cell Disorders Panel	This Investigational Panel , comprised of 2 reagents , is intended for in vitro diagnostic use for qualitative flow-cytometric immunophenotyping of plasma cell populations. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, plasma cell disorders.

Timeline

• Start date: 2021-05-04
• Primary completion: 2023-10-25
• Completion: 2023-10-25
• First posted: 2021-09-02
• Last updated: 2023-10-30

Locations

5 sites across 5 countries: United States, Portugal, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study