Evaluation of the BD OneFlow Acute Leukemia Panel on the BD FACSLyric Flow Cytometer

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• Specimen is from subject with minimal residual disease (MRD) as determined by the site.
• Specimen is from subject suspected of plasma cell disorders.

Életkor

• Specimen from subject <3 years of age.

Egyéb

• Specimen is from healthy subject.
• Specimen is from subject undergoing any treatment for any form of leukemia.
• Visibly clotted specimen.
• Visibly hemolyzed specimen.
• Frozen specimen.
• Refrigerated specimen.
• Fixed specimen.

• Specimen collected/handled prior to enrollment in accordance with site policies and procedures.
• Specimen with adequate volume (1 mL) to complete protocol tests.
• Specimen is leftover PB and BM from routine flow cytometry laboratory testing for having or suspected of having acute leukemia disorders (i.e. AML, BCP-ALL, ALAL, etc.), myelodysplastic syndrome (MDS), other hematological, or non-hematological disorders.
• Specimen from newly diagnosed or relapsed subject.
• Only one specimen type (PB or BM) shall be enrolled per given subject.
• Specimen is stored at room temperature, upon receipt by the site.
• Specimens are collected in EDTA (K2 or K3) or heparin (sodium or lithium).
• Age of specimen (BCP ALL T1: time of collection to start of first pre-wash; ALOT, AML T1-T4: time of collection to start of staining): ≤ 24 hours.
• Specimens are from subjects irrespective of race, gender, and ethnicity