Oocyte Donor Panel (Female)

Chlamydia/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 C Antibody (HCV)


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




HIV I/II+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




MPX: HBV/HIV/HCV


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




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




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




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





Sperm Donor Panel (Male)

Chlamydia/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: 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 C Antibody (HCV)


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




HIV I/II+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




MPX: HBV/HIV/HCV


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




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




CMV Total Antibody


CPT: 86644 Specimen: Plasma Collection: Lavender (EDTA) Shipping: Ambient Stability: Refrigerated – 10 days; Frozen – Longer than 10 days Method: Solid phase red-cell adherence Approved by FDA for Donor Screening




HTLV – I/II Antibody Screen


CPT: 86688 Specimen: Serum Collection: Tiger SST Shipping: Ambient Stability: Refrigerated – 14 days; Frozen – Longer than 14 days Method: Enzyme-Linked Immunosorbent Assay

Approved by FDA for Donor Screening License #1856




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





FDA Donor Screen: Test Panels & Directory

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