Clinical Trials Detalhe

Multi-site, prospective performance study to determine equivalency between the investigational CLPD Full Panel on the FACSLyric system versus the final clinical diagnosis.

Chronic Lymphoproliferative Diseases (CLPD)

Inclusion Criteria: 1. Specimen collected/handled prior to enrollment in accordance with site policies and procedures. 2. Specimen with adequate volume (min 700 µL or more) to complete protocol tests. 3. Specimen is leftover PB, BM, or LT from routine flow cytometry laboratory testing for chronic lymphoproliferative disorders, other hematological disorders, non-hematological tumors (e.g., solid tumors), or other hematological disorders (non-malignant). 4. Specimen is from subjects previous diagnosed, newly diagnosed and/or relapsed disease. 5. Only one type of specimen, either PB, BM, or LT shall be enrolled per given subject. 6. Specimen is stored at room temperature, upon receipt by the site. 7. PB and BM specimens are collected in EDTA (K2 or K3) or heparin (sodium or lithium). 8. LT specimens collected in PBS, culture media (e.g., RPMI-1640), saline, or saline wrapped gauze at the discretion of the Investigator. 9. 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 LT) 10. Specimens are from subjects irrespective of race, gender, and ethnicity Exclusion Criteria: 1. Specimen is from healthy subject. 2. Specimen is from subject undergoing any treatment for any form of L\&L. 3. Specimen from subject \<22 years of age. 4. Specimen is from subject with minimal residual disease (MRD) as determined by the site. 5. Specimen is from subject suspected of acute leukemia (e.g., T-ALL, BCP-ALL, AML) or myeloid dysplastic syndrome (MDS). 6. Visibly clotted specimen. 7. Visibly hemolyzed specimen. 8. Frozen specimen. 9. Refrigerated specimen. 10. Fixed specimen.