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





Contact

Unilab of Dade

2145 W. Davie Blvd., Suite 106
Fort Lauderdale, Florida 33312

Toll Free Phone: (877) 522-5678  

Fax: (954) 797-9494

Email: lab@infertilitylab.com

Website: www.infertilitylab.com

About Unilab

Unilab is an FDA-registered medical laboratory specializing in infertility and reproductive testing. Unilab is trusted by fertility doctors everywhere to provide accurate and timely results.

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