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Donor, IVF Female Panel
Test Code93307
CPT Codes
87491, 87591, 86703, 87340, 86704, 86803, 87801, 87798, 86780
Includes
Donor, Chlamydia trachomatis/Neisseria gonorrhoeae, RNA, TMA
Donor, HIV-1/-2 plus O Antibody Screen
Donor, Hepatitis B Surface Antigen with Reflex to Confirm
Donor, Hepatitis B core Total Antibody
Donor, Hepatitis C Antibody (Anti-HCV)
Donor, HIV-1/HBV/HCV NAT Procleix® with Reflex to HIV-1/HBV/HCV Discriminatory
Donor, West Nile Virus NAT
Donor, Syphilis IgG Antibody
If the Donor, Hepatitis B Surface Antigen is reactive, then Donor, Hepatitis B Surface Antigen, Confirmation will be performed at an additional charge (CPT code: 87341).
If Donor, HIV-1/HBV/HCV/NAT Procleix® with Reflex is reactive, then the Donor, HIV-1 Discriminatory (CPT code: 87535), Donor, HBV Discriminatory (CPT code: 87516), and Donor, HCV Discriminatory (CPT code: 87521) will be performed at an additional charge.
Donor, HIV-1/-2 plus O Antibody Screen
Donor, Hepatitis B Surface Antigen with Reflex to Confirm
Donor, Hepatitis B core Total Antibody
Donor, Hepatitis C Antibody (Anti-HCV)
Donor, HIV-1/HBV/HCV NAT Procleix® with Reflex to HIV-1/HBV/HCV Discriminatory
Donor, West Nile Virus NAT
Donor, Syphilis IgG Antibody
If the Donor, Hepatitis B Surface Antigen is reactive, then Donor, Hepatitis B Surface Antigen, Confirmation will be performed at an additional charge (CPT code: 87341).
If Donor, HIV-1/HBV/HCV/NAT Procleix® with Reflex is reactive, then the Donor, HIV-1 Discriminatory (CPT code: 87535), Donor, HBV Discriminatory (CPT code: 87516), and Donor, HCV Discriminatory (CPT code: 87521) will be performed at an additional charge.
Preferred Specimen
5 mL serum collected in a each of two red-top tubes (no gel) or serum separator tubes (SST)
--and--
6 mL plasma collected in each of two EDTA (lavender-top) tubes
--and--
1 Aptima® Unisex Swab collected in a specimen collection kit for endocervical swab specimens, or Vaginal swab specimen in Aptima® vaginal collection, or Multi-Test collection kit, or
2 mL urine submitted in Aptima® urine collection kit for male and female urine specimens
--and--
6 mL plasma collected in each of two EDTA (lavender-top) tubes
--and--
1 Aptima® Unisex Swab collected in a specimen collection kit for endocervical swab specimens, or Vaginal swab specimen in Aptima® vaginal collection, or Multi-Test collection kit, or
2 mL urine submitted in Aptima® urine collection kit for male and female urine specimens
Minimum Volume
5 mL serum • 6 mL plasma • 1 swab • 2 mL urine
Instructions
Label the tubes according to your standard operating procedure, making sure that each tube has at least two unique patient identifiers.
If transport temperatures will be frozen, centrifuge the lavender-top tube and transfer the plasma into a plastic screw-cap vial. The plastic screw-cap vial (aliquot tube) containing plasma must be labeled with the specimen type (plasma) and at least two unique patient identifiers. Aliquot tubes must be processed and labeled at the original collection site. If aliquot tubes are submitted, do not send the original lavender-top tube.
Room temperature stability for raw urine: 24 hours before transfer into Aptima®. Urine in Aptima®: 30 days.
Please note: This test is to be used for the screening of DONORS of human cells, tissues, and cellular and tissue-based products for infectious diseases.
For Shipper collection please see detailed instructions in Test Resources.
If transport temperatures will be frozen, centrifuge the lavender-top tube and transfer the plasma into a plastic screw-cap vial. The plastic screw-cap vial (aliquot tube) containing plasma must be labeled with the specimen type (plasma) and at least two unique patient identifiers. Aliquot tubes must be processed and labeled at the original collection site. If aliquot tubes are submitted, do not send the original lavender-top tube.
Room temperature stability for raw urine: 24 hours before transfer into Aptima®. Urine in Aptima®: 30 days.
Please note: This test is to be used for the screening of DONORS of human cells, tissues, and cellular and tissue-based products for infectious diseases.
For Shipper collection please see detailed instructions in Test Resources.
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Serum and plasma
Room temperature: Unacceptable
Refrigerated: 5 days
Frozen: 28 days
Swab
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 1 year
Urine in Aptima®
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 1 year
Room temperature: Unacceptable
Refrigerated: 5 days
Frozen: 28 days
Swab
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 1 year
Urine in Aptima®
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 1 year
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Sample not marked serum/plasma
Methodology
Immunoassay (IA) • Nucleic Acid Amplification • Transcription Mediated-Amplification (TMA)
Setup Schedule
Set up: Daily; Report available: 24 hours
Reference Range
See Laboratory Report
Clinical Significance
Blood donors and donors of human cells, tissues and cellular and tissue-based products (HCT/Ps) must be tested for infectious diseases using assay kits that are FDA-approved or FDA-cleared specifically for donor screening.
