Chronic Lymphoproliferative Diseases (CLPD) Clinical Trial
Official title:
Clinical Performance Evaluation of the BD OneFlow CLPD Panel (BD OneFlow LST, and B-CLPD T1 to T4 Assays) on the BD FACSLyric System.
Multi-site, prospective performance study to determine equivalency between the investigational CLPD Full Panel on the FACSLyric system versus the final clinical diagnosis.
This study is a multi-site and multi-regional prospective performance evaluation to determine sensitivity and specificity of the investigational BD OneFlow CLPD Panel on the FACSLyric system when compared to the results from the Expert Analysis for market launch. The study will be conducted at up to eight investigational sites that have previously participated in the BD OneFlow program clinical studies and/or have expertise in flow cytometric immunophenotyping, interpretation, and diagnosis of Leukemia and Lymphoma (L&L). Each site will have one 10- or 12-color FACSLyric instrument with Universal Loader (Loader). This study will enroll at least 250 leftover de-identified PB, BM, and LT specimens from routine flow cytometry laboratory testing for hematological disorders or non-hematological disorders that provide valid results and are considered evaluable specimens. Each site will enroll a minimum of 25 evaluable specimens and a maximum of approximately 70 evaluable specimens with normal and abnormal lymphoid cell immunophenotype. To ensure that the study satisfies enrollment by specimen type, this study will enroll lymphoid tissue specimens. Lymphoid tissue (LT) refers to organs/tissues supporting immune responses, which includes primary lymphoid tissue (BM and thymus), and secondary lymphoid tissue (lymph nodes, tonsils, spleen, and Peyer's patches). Their morphological structure is related to its function in the immune system. For this study, the term LT will be used to refer the secondary lymphoid tissue only. Evaluable specimens will be enrolled to meet the binning requirements for specimen type, normal vs abnormal cell phenotype, and disease type, as described in Tables 3-5. Specimens will be prepared using a minimum of three lots of the OneFlow LST and OneFlow B-CLPD T1 to T4 reagent kits across investigational sites. Stained samples will be acquired on the BD FACSLyric using the BD FACSuite Clinical application with the assay modules for each of the tubes. Results will be analyzed by the laboratory staff. In addition, the sites will collect the "Final Clinical Diagnosis" from each sample. The study includes an "Expert Analysis." This will be conducted by qualified Experts by training and experience, who will receive the files with raw data, analyze and designate cell immune phenotype. Two Experts will analyze the data from each sample. The results from the Expert Analysis will be compared to the site's Final Clinical Diagnosis and the study acceptance criteria for the study endpoints. ;