Evaluation of ClearLLab LS Screening Panel

Beckman Coulter

Status: Completed

Conditions: Hematologic Malignancy; Hematologic Neoplasms; Hematologic Diseases

Treatments: Diagnostic Test: Flow Cytometry

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05819762

CHN186

Details and patient eligibility

About

This is a multi-center study to evaluate the clinical performance of ClearLLab LS screening panel with specimens from subjects for the diagnosis of hematologic malignancies.

Full description

This study aims to evaluate the clinical accuracy of ClearLLab LS screening panel in the diagnosis of hematologic malignancies. The residual specimens, which from subjects presenting to the flow cytometry laboratory as part of their standard of care for hematologic diseases work-up, will be tested by ClearLLab LS screening panel. ClearLLab LS screening panel is CE-IVD marked immunophenotyping reagents under the European Union (EU) regulation, and this study is aimed to validate its clinical performance in Chinese population.

Enrollment: 831 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Residual whole blood, bone marrow, or lymph node tissue samples from subjects with hematologic tumor-related symptoms and/or signs that are clinically recommended for Flow Cytometry Immunophenotyping

Exclusion criteria

• Specimens and/or spent samples that are visibly hemolyzed
• Specimens and/or spent samples that are visibly clotted
• Specimens and/or spent samples collected in Ethylene Diamine Tetraacetic Acid (EDTA) anticoagulant older than 24 hours from time of collection
• Specimens and/or spent samples collected in Heparin or Acid Citrate-Dextrose (ACD) anticoagulant older than 48 hours from time of collection
• Samples with insufficient volume to complete the protocol tests
• Samples from subjects with known myeloid malignancies or multiple myeloma