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Donor, HIV/HCV/HBV NAT Procleix® with Reflexes
Test Code19854
CPT Codes
87801
Includes
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
6 mL plasma collected in EDTA (lavender-top) tube
Minimum Volume
3 mL
Other Acceptable Specimens
Serum
Instructions
Label the tubes according to your standard operating procedure, making sure that each tube has at least two unique patient identifiers.
If transport temperature will be frozen, centrifuge the red/lavender top tube and transfer the serum/plasma into a plastic screw-cap vial. The plastic screw-cap vial (aliquot tube) containing serum or plasma must be labeled with the specimen type (serum or 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 red/lavender top tube.
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.
This test is FDA-Approved (HIV RNA, HBV RNA, and HCV RNA) for the screening of DONORS of human cells, tissues, and cellular and tissue-based products for infectious diseases. It is not intended to be used for routine diagnostic testing.
For Shipper collection please see detailed instructions in Test Resources.
If transport temperature will be frozen, centrifuge the red/lavender top tube and transfer the serum/plasma into a plastic screw-cap vial. The plastic screw-cap vial (aliquot tube) containing serum or plasma must be labeled with the specimen type (serum or 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 red/lavender top tube.
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.
This test is FDA-Approved (HIV RNA, HBV RNA, and HCV RNA) for the screening of DONORS of human cells, tissues, and cellular and tissue-based products for infectious diseases. It is not intended to be used for routine diagnostic testing.
For Shipper collection please see detailed instructions in Test Resources.
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Room temperature: 72 hours
Refrigerated: 13 days
Frozen: 15 months
Refrigerated: 13 days
Frozen: 15 months
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Sample not marked as plasma/serum
Methodology
Nucleic Acid Amplification (NAT)
Setup Schedule
Set up: Daily; Report available: 24 hours
Reference Range
Non-Reactive
Clinical Significance
The Procleix® Ultrio® Elite HIV/HBV/HCV Assay is a qualitative in vitro nucleic acid assay for the detection in Human Immunodeficiency Virus RNA, Hepatitis B Virus DNA, and Hepatitis C Virus RNA in human plasma. The test is intended to be used to screen blood, solid organ, and tissue donors for these agents. When used in conjunction with licensed tests for detecting antibodies to HIV, HBV, and HCV, test results may be used to determine eligibility for blood, solid organs, or tissue transplantation.
