Evaluation of the Chronic Lymphoproliferative Diseases Limited Panel (BD OneFlow™ LST and OneFlow™ B-CLPD T1) on the BD FACSLyric™ Flow Cytometer Using Leftover, De-identified Specimens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 371
- 试验地点
- 6
- 主要终点
- Comparison between expert analysts' determination of normal and abnormal specimen and final diagnosis
研究概览
简要总结
Multi-site, prospective performance study to determine equivalency between the investigational CLPD Limited Panel on the FACSLyric system versus the final clinical diagnosis.
详细描述
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. Currently, there are no consensus panels being used; consequently, 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 and 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 reagent panel for chronic lymphoproliferative diseases (CLPD) is intended for in vitro diagnostic use for qualitative flow-cytometric immunophenotyping of mature lymphocyte 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, B-cell CLPD, T-cell CLPD, and NK-cell CLPD.
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Specimen collected/handled prior to enrollment in accordance with site policies and procedures.
- •Specimen with adequate volume (approximately 300 µL) to complete protocol tests.
- •Specimen is leftover PB, BM, or LN from routine flow cytometry laboratory testing for chronic lymphoproliferative disorders, other hematological disorders, non-hematological tumors (e.g., solid tumors), or other non-hematological disorders (non-malignant).
- •Specimen from newly diagnosed or relapsed subject.
- •Only one type of specimen, either PB, BM, or LN shall be enrolled per given subject.
- •Specimen is stored at room temperature, upon receipt by the site.
- •PB and BM specimens are collected in EDTA (K2 or K3) or heparin (sodium or lithium).
- •LN specimens collected in PBS, culture media (e.g., RPMI-1640), saline, or saline wrapped gauze at the discretion of the Investigator.
- •Age of specimen for PB and BM (time of collection to start of first pre-wash): ≤ 24 hours. (Note: No Age of specimen claim is being made for LN)
- •Specimens are from subjects irrespective of race, gender, and ethnicity.
排除标准
- •Specimen is from healthy subject.
- •Specimen is from subject undergoing any treatment for any form of L&L.
- •Specimen from subject <22 years of age.
- •Specimen is from subject with minimal residual disease (MRD) as determined by the site.
- •Specimen is from subject suspected of acute leukemia (e.g., T-ALL, BCP-ALL, AML) or myeloid dysplastic syndrome (MDS).
- •Visibly clotted specimen.
- •Visibly hemolyzed specimen.
- •Frozen specimen.
- •Refrigerated specimen.
- •Fixed specimen.
结局指标
主要结局
Comparison between expert analysts' determination of normal and abnormal specimen and final diagnosis
时间窗: Age of specimen for PB and BM (time of collection to start of first pre-wash): ≤ 24 hours.
Determine equivalence between the investigational OneFlow CLPD Limited Panel on FACSLyric system results analyzed by two independent experts versus the final clinical diagnosis for Normal (T-cell, B-cell, and NK-cell) or Abnormal (T-cell or B-cell or NK-cell) phenotype using leftover, hematologically abnormal specimens . Sensitivity and specificity are calculated
次要结局
- Comparison between expert analysts' determination of normal and abnormal Peripheral Blood (PB) specimen and final diagnosis(Age of specimen for PB (time of collection to start of first pre-wash): ≤ 24 hours.)