|STR Engraftment Separated Lineages [STRSEP]|
| WSLH Department:|| Cytogenetics|
|WSLH Test Code:||840C49|
STR Engraftment Population 1 (CD3+) and STR Engraftment Population 2 (CD33+).
Typically used to assess proportions of donor- and recipient-derived CD3+ and CD33+ cells post stem cell transplant or in cases of suspected graft-vs-host disease.|
|Methodology:||**(CPT Code: 81268x2)** PCR|
|Turn-around Time:||10 Days|
|Specimen Requirements:||8 mL, (2 mL pediatric)
Lavender top EDTA|
|Collection Kit/Container:|| |
|Patient Preparation:|| |
|Collection Instructions:|| |
|Specimen Handling and Transport:||Stability Ambient:
|Requisition Form:||Cytogenetics Lab Neoplasia Diagnosis Form #132|
|Required Information:|| |
|Results include:||Sensitivity of detection of donor(s) in recipient is assessed for each combination of donor(s)/recipient.
> 95-98% Donor Predominantly Donor,
< 2-5% Donor Predominantly Recipient,
2-98%, 5-95% Donor Donor/Recipient Chimeric|
|Additional Tests Recommended:|| |
|Additional Comments:||The specimen collected is processed by the UWHC Molecular Diagnostics Laboratory to extract CD3+ and CD33+ cell lineages. Each lineage is tested separately to quantitate and report independently the percentages of donor-derived cells. Test requires pre-transplant DNA samples on file in the laboratory for recipient and donor.
The performance characteristics of this test were validated by UWHC Clinical Laboratories. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test; however, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. The UWHC Clinical Laboratories is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.|
|Additional Tests Performed:|| |