Donor, Tissue Donor Panel
Use
This panel is intended for screening donors of human cells, tissues, and cellular and tissue‑based products (HCT/Ps) for relevant communicable disease agents or diseases (“RCDADs”), as required by FDA regulations. It comprises a comprehensive set of infectious disease assays—including antibody tests and nucleic acid amplification tests (NAT)—to minimize recipient risk of infection from donor-derived materials. (Quest Diagnostics fulfills FDA requirements for donor screening panels.)
Special Instructions
Panel components may be ordered separately. This test is performed at Quest’s FDA‑registered Chantilly, Virginia facility dedicated to donor testing. Specimens must meet specific handling and labeling requirements (e.g., separate serum and plasma tubes, proper tube types, aliquoting).
Limitations
Donor testing must use FDA‑approved or cleared assays without laboratory‑developed test modifications. Some component reflex testing (e.g., confirmation assays) may incur additional charge. The panel does not include sexually transmitted organism screening (e.g., Chlamydia, Gonorrhea) unless appropriate diagnostic tests are used.
Methodology
Immunoassay (Other)
Biomarkers
Result Turnaround Time
Not provided.
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
6 mL each
Minimum Volume
6 mL
Container
red‑top (no‑gel) tube, aliquot in screw‑cap vial
Collection Instructions
Collect 6 mL serum in red‑top (no‑gel) tube; centrifuge and aliquot into screw‑cap vial labeled with specimen type and identifiers.
Storage Instructions
Refrigerated if shipped; frozen if shipment delayed
Causes for Rejection
Sample not marked serum; CMV samples in gel tubes (SST)
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 5 days |
| Frozen | 28 days |