Development and implementation of an automated and highly accurate reporting process for NGS-based clonality testing.

ABSTRACT: B and T cells undergo random recombination of the VH/DH/JH portions of the immunoglobulin loci (B cell) and T-cell receptors before becoming functional cells. When one V-J rearrangement is over-represented in a population of B or T cells indicating an origin from a single cell, this indicates a clonal process. Clonality aids in the diagnosis and monitoring of lymphoproliferative disorders and evaluation of disease recurrence. This study aimed to develop objective criteria, which can be automated, to classify B and T cell clonality results as positive (clonal), No evidence of clonality, or invalid (failed). Using clinical samples with "gold standard" clonality data obtained using PCR/CE testing, we ran NGS-based amplicon clonality assays and developed our own model for clonality reporting.

SUBMITTER: Glenn ST 

PROVIDER: S-EPMC10178459 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature