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This protocol describes the pivotal accuracy study for the IdentiClone Dx IGH (IC IGH Dx) Assay. The intent of the accuracy study is to demonstrate agreement between the results of the IC IGH Dx Assay and a predicate devise or assay on retrospective and residual de-identified DNA extracted from peripheral blood (PB) samples from individuals with suspected B-Cell Lymphoproliferations. The predicate device will be the LymphoTrack Dx IGH (FR1/FR2/FR3) Assays - MiSeq (LT Dx IGH-CE-IVD), which is a CE-IVD assay with a similar intended use as the IC IGH Assay on the same sample type.
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Inclusion criteria
DNA extracted from Peripheral Blood (PB) with EDTA as anticoagulant with minimum total DNA ≥ 2 µg with concentration at ≥ 50ng/µl
DNA extracted from PB specimens no more than 7 days
DNA stored at -15°C to -30°C up to 5 years
Donor Age: ≥ 18
For positive sample, DNA from PB of subjects diagnosed (at the time the specimen was drawn) with Lymphoproliferative disease, with:
For negative sample, DNA from PB of subjects suspected of Lymphoproliferative disease
Exclusion criteria
250 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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