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| UWHC Lab Test Details | |
|---|---|
| Test Name | STR Engraftment Separated Lineages |
| Test Code(s) | HCSTRSEP |
| CPT Code(s) | 81268x2 |
| Methodology | PCR |
| Clinical Information | 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. |
| Days Performed | Once a week. |
| In-Lab Turnaround Time | 10 days. |
| Stat In-Lab Turnaround Time | Not available stat. |
| Collection Requirements | |||
|---|---|---|---|
| Specimen | Blood | ||
| Collection Container |
| ||
| Collection Instructions | Extracted nucleic acid specimens may occasionally be received in cases where no primary sample is available for testing. All nucleic acid specimens received for testing must have been extracted in a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by the CAP and/or the CMS.
Specific sub-populations of white blood cells may be submitted for analysis. If separated by an outside lab, please identify the population on the label.
Specimens must be received by the UWHC Molecular Diagnostics Lab no later than noon on Fridays or the day before a holiday in order to be processed in a timely manner. Specimens do not remain stable for more than 24 hours. | ||
| Collection Volume | 8 mL | ||
| Pediatric Collection Volume | 2 mL | ||
| Specimen Processing Requirements | |||||||
|---|---|---|---|---|---|---|---|
| Stability |
| ||||||
| Testing Volume | 2 mL | ||||||
| Pediatric Testing Volume | 2 mL | ||||||
| Specimen Processing | Do not refridgerate, freeze or centrifuge. | ||||||
| Outreach Specimen Processing | Do not refridgerate, freeze or centrifuge | ||||||
| Specimen Transport | Transport specimen to laboratory immediately. | ||||||
| Unacceptable Criteria | Whole blood specimens greater than 24 hours old when received by laboratory, refridgerated, frozen or centrifuged specimens are not acceptable. | ||||||
| Interpretation | |||||||
|---|---|---|---|---|---|---|---|
| Interpretive Guidelines | Sensitivity of detection of donor(s) in recipient is assessed for each combination of donor(s)/recipient.
| ||||||
| Additional Information | 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. | ||||||
