Donor, HIV/HCV/HBV NAT Procleix® with Reflexes
Use
The Procleix® Ultrio® Elite HIV/HBV/HCV Assay is a qualitative in vitro nucleic acid assay for the detection of 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 organ, or tissue transplantation. Non-Reactive is the expected reference result. ([jdos.nicholsinstitute.com](https://jdos.nicholsinstitute.com/dos/nmmcpathology/test/572222?utm_source=openai))
Special Instructions
Not provided.
Limitations
Not provided.
FDA Approved
Methodology
PCR-based (PCR)
Biomarkers
HBV DNA
OtherHCV RNA
OtherHIV RNA
Other
Result Turnaround Time
1 day
Related Documents
For more information, please review the documents below
Specimen
Plasma
Volume
6 mL
Minimum Volume
3 mL
Container
EDTA (lavender-top) tube
Collection Instructions
Label tubes per standard operating procedure with at least two unique patient identifiers. If frozen transport, centrifuge and transfer serum/plasma into labeled plastic screw‑cap aliquot vial; do not send original tube.
Causes for Rejection
Sample not marked as plasma/serum
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 72 hours |
| Refrigerated | 13 days |
| Frozen | 15 months |
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