FDA Donor Screen: Surrogate Testing
- 01
CPT: 87491, 87591
Specimen: Urine or Swab
Collection: BD ProbeTec Urine Preservative Transport (UPT) or Swab
Shipping: Ambient
Stability: UPT: Ambient - 30 days; Refrigerated - 30 days; Frozen - 2 months
Swab: Ambient - 6 days; Refrigerated - 30 days; Frozen - Unacceptable
Method: Strand Displacement Amplification (SDA)/ Fluorescent Energy Transfer (ET)
Approved by FDA for Donor Screening License # K012351
- 02
CPT: 86704
Specimen: Serum
Collection: Tiger SST
Shipping: Ambient
Stability: Refrigerated – 7 days; Frozen – Longer than 7 days
Method: Enzyme-Linked Immunosorbent Assay
Approved by FDA for Donor Screening License #1236
- 03
CPT: 87340
Specimen: Serum
Collection: Tiger SST
Shipping: Ambient
Stability: Refrigerated – 7 days; Frozen – Longer than 7 days
Method: Enzyme-Linked Immunosorbent Assay
Approved by FDA for Donor Screening License #1109
- 04
CPT: 86803
Specimen: Serum
Collection: Tiger SST
Shipping: Ambient
Stability: Refrigerated – 7 days; Frozen – Longer than 7 days
Method: Enzyme-Linked Immunosorbent Assay
Approved by FDA for Donor Screening License #1236
- 05
CPT: 86703
Specimen: Serum
Collection: Tiger SST
Shipping: Ambient
Stability: Refrigerated – 7 days; Frozen – Longer than 7 days
Method: Enzyme-Linked Immunosorbent Assay
Approved by FDA for Donor Screening License #1109
- 06
CPT: 86592
Specimen: Serum
Collection: Tiger SST
Shipping: Ambient
Stability: Refrigerated – 7 days; Frozen – Longer than 7 days
Method: Flocculation
Cleared by FDA for Donor Screening
- 07
CPT: 87516, 87521, 87535
Specimen: Plasma
Collection: Lavender (EDTA)
Shipping: Ambient
Stability: Ambient - 3 days; Refrigerated – 5 days
Method: Real time PCR
Approved by FDA Donor Screening License #1636
- 08
CPT: 87798
Specimen: Plasma
Collection: Lavender (EDTA)
Shipping: Ambient
Stability: Ambient - 3 days; Refrigerated – 5 days
Method: Real time PCR
Note: FDA recommends performing WNV testing on samples collected from June 1st through October 31st
Approved by FDA Donor Screening License #1636