FDA Donor Screen: Surrogate Testing

Surrogate Test Panel & Directory

Chlamydia trachomatis/Neisseria gonorrhea Amplified DNA Assay


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




Hepatitis B Core Antibody Total


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




Hepatitis B Surface Antigen


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




Hepatitis C Antibody


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




MPX (HIV/HCV/HBV)


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




HIV 1/2+O Antibody Screen


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




RPR


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




WNV


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