Single-Step IGHV Next-Generation Sequencing Detects Clonality and Somatic Hypermutation in Lymphoid Malignancies: A Phase III Diagnostic Accuracy Study.

ABSTRACT:

Background

Multiplex PCR based on consensus primers followed by capillary electrophoresis and Sanger sequencing are considered as the gold standard method for the evaluation of clonality and somatic hypermutation in lymphoid malignancies. As an alternative, the next-generation sequencing (NGS) of immune receptor genes has recently been proposed as a solution, due to being highly effective and sensitive. Here, we designed a phase III diagnostic accuracy study intended to compare the current gold standard methods versus the first commercially available NGS approaches for testing immunoglobulin heavy chain gene rearrangements.

Methods

We assessed IGH rearrangements in 68 samples by means of both the NGS approach (LymphoTrack^® IGH assay, and LymphoTrack^® IG

SUBMITTER: Gazzola A 

PROVIDER: S-EPMC10526376 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature