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Reproductive Donor Female with Reflex to HIV Differentiation
Test Code13989
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 with Reflex to Differentiation
Donor, Hepatitis B Surface Antigen with Reflex to Confirm
Donor, Hepatitis B Core Total Antibody
Donor, Hepatitis C Antibody (Anti-HCV)
Donor, HIV/HCV/HBV NAT Procleix® with Reflexes
Donor, West Nile Virus, NAT
Donor, Syphilis IgG Antibody
If HIV-1/2 plus O Antibody Screen is reactive or indeterminate, then HIV-1/2 Antibody Differentiation (Supplemental Use Only) will be performed at an additional charge (CPT codes: 86701, 86702).
If Donor Hepatitis B Surface Antigen is reactive, then Donor, Hepatitis B Surface Antigen Confirmation will be performed at an additional charge (CPT code(s): 87341).
If Donor, HIV/HCV/HBV NAT Procleix® is reactive, then Donor, HIV-1 Discriminatory (CPT code(s): 87535), Donor, HBV Discriminatory (CPT code(s): 87516), and Donor, HCV Discriminatory (CPT code(s): 87521) will be performed at an additional charge.
Donor, HIV-1/2 plus O Antibody Screen with Reflex to Differentiation
Donor, Hepatitis B Surface Antigen with Reflex to Confirm
Donor, Hepatitis B Core Total Antibody
Donor, Hepatitis C Antibody (Anti-HCV)
Donor, HIV/HCV/HBV NAT Procleix® with Reflexes
Donor, West Nile Virus, NAT
Donor, Syphilis IgG Antibody
If HIV-1/2 plus O Antibody Screen is reactive or indeterminate, then HIV-1/2 Antibody Differentiation (Supplemental Use Only) will be performed at an additional charge (CPT codes: 86701, 86702).
If Donor Hepatitis B Surface Antigen is reactive, then Donor, Hepatitis B Surface Antigen Confirmation will be performed at an additional charge (CPT code(s): 87341).
If Donor, HIV/HCV/HBV NAT Procleix® is reactive, then Donor, HIV-1 Discriminatory (CPT code(s): 87535), Donor, HBV Discriminatory (CPT code(s): 87516), and Donor, HCV Discriminatory (CPT code(s): 87521) will be performed at an additional charge.
Preferred Specimen
5 mL serum collected in each of two tubes 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 Multitest Collection Kit or 2 mL random urine collected in Aptima Urine Specimen Collection Kit
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 Multitest Collection Kit or 2 mL random urine collected in Aptima Urine Specimen Collection Kit
Minimum Volume
5 mL serum • 6 mL plasma • 2 mL random 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
Aptima swab
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 1 year
Aptima urine
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 1 year
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Sample not marked as serum or plasma • Gross hemolysis • Frozen serum separator tube • CMV samples submitted in gel tubes (serum separator tube)
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.
