Donor IVF Female Panel
Use
Screening panel for female donors of human cells, tissues, and cellular and tissue‑based products (HCT/P) or for use in assisted reproductive technology (IVF) donor screening to detect relevant communicable disease agents, as required by FDA regulations. Ensures donor eligibility under FDA guidelines for communicable disease testing for HCT/P donors, including HIV, HBV, HCV, and syphilis.
Special Instructions
Not provided.
Limitations
Laboratory‑developed tests or modifications to FDA‑approved/cleared assays are prohibited for donor testing. Only FDA‑approved or FDA‑cleared assays specific for donor testing may be used. Does not permit multiplexing outside approved methods or using alternative specimen types not validated for donor screening purposes.
FDA Approved
Methodology
Immunoassay (Multiplex Protein Panel)
Biomarkers
Result Turnaround Time
12-14 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
6 mL preferred, 4 mL minimum
Minimum Volume
4 mL
Container
Aliquot labeled as serum
Collection Instructions
Collect sufficient serum; spin and aliquot, label aliquots as serum vs plasma
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | Refrigerated up to 5 days |
Other tests from different labs that may be relevant