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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B-Cell Positive Lymphoproliferative Disorders | DNA Samples for subjects with B-Cell Positive Lymphoproliferative Disorders |
| |
| B-Cell Negative Lymphoproliferative Disorders | DNA Samples for subjects suspected of B-Cell Positive Lymphoproliferative Disorders with negative B-Cell Clonality testing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IdentiClone Dx IGH (IC IGH Dx) Assay | Diagnostic Test | The IdentiClone Dx IGH Assay is an in vitro diagnostic product intended for qualitative, capillary electrophoresis based-detection of clonality in immunoglobulin heavy chain gene rearrangements (IGH) in peripheral blood specimens as an adjunctive method for the diagnosis of B-cell lymphoproliferative disease |
| Measure | Description | Time Frame |
|---|---|---|
| % Agreement | Agreement between the results of the Invivoscribe IdentiClone Dx IGH Assay and the LymphoTrack Dx IGH (FR1/FR2/FR3) Assays - MiSeq by assessing the positive and negative percent agreement between the two assays. | Through Study Completion at one year |
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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:
1. PB specimens that have been frozen prior to extraction
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Samples from subjects with diagnosed B-Cell Lymphoproliferative disorders or suspected of B-Cell Lymphoproliferative disorders with negative B-Cell Clonality Testing results
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Invivoscribe, Inc. | San Diego | California | 92103 | United States | ||
| LabPMM GmbH |
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Deidentified residual DNA samples
|
| Hallbergmoos |
| 85399 |
| Germany |
| LabPMM GK | Kawasaki-shi | Kanagawa | 210-0821 | Japan |