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This protocol describes the pivotal accuracy study for the IdentiClone Dx TRG Assay. The intent of the accuracy study is to demonstrate agreement between the results of the IC TRG Dx Assay and a predicate devise or assay on retrospective and residual de-identified DNA extracted from FFPE (Formalin Fixed Paraffin Embedded) samples from individuals with suspected T-Cell Lymphoproliferations. The predicate device will be the LymphoTrack Dx TRG (FR1/FR2/FR3) Assays - MiSeq (LT Dx TRG-CE-IVD), which is a CE-IVD assay with a similar intended use as the IC TRG Assay on the same sample type.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T-Cell Positive Lymphoproliferative Disorders | FFPE Samples for subjects with T-Cell Positive Lymphoproliferative Disorders |
| |
| FFPE Samples for subjects Negative for T-Cell Lymphoproliferative Disorders | FFPE Samples for subjects Negative for T-Cell Lymphoproliferative Disorders |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IdentiClone Dx TRG Assay | Diagnostic Test | The IdentiClone Dx TRG Assay ("Assay") is an in vitro diagnostic product intended for qualitative capillary electrophoresis based-detection of clonality in T-cell receptor gamma chain (TRG) gene rearrangements in Formalin-Fixed Paraffin-Embedded (FFPE) specimens as an adjunctive method for the diagnosis of T-cell lymphoproliferative disease. This qualitative, non-automated Assay is for use on the ABI 3500xL Dx and ABI 3500xL Genetic Analyzers. |
| Measure | Description | Time Frame |
|---|---|---|
| % Agreement | Agreement between the results of the Invivoscribe IdentiClone Dx TRG Assay and the LymphoTrack Dx TRG (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:
De-identified, residual FFPE specimens with a minimum of 8 curls
Subject Age ≥ 18
For suspected clonal positive specimens, FFPE specimens of subjects diagnosed (at the time the specimen was drawn) with T-cell Lymphoproliferative disease with at least one of the following:
For suspected clonal negative specimens, FFPE specimens of subjects suspected of T-cell lymphoproliferative disease but diagnosed negative for T-cell lymphoproliferative disease. Up to 20% of the negative specimens may be from normal tissue or tissue diagnosed with diseases other than T-cell lymphoproliferative disease
Exclusion Criteria:
1.FFPE specimens that were fixed using formalin substitute (ethanol, methanol, etc.)
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Samples from subjects with diagnosed T-Cell Lymphoproliferative disorders or suspected of T-Cell Lymphoproliferative disorders with negative T-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
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|
| Hallbergmoos |
| 85399 |
| Germany |
| LabPMM GK | Kawasaki-shi | Kanagawa | 210-0821 | Japan |
|