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PrEP HIV-1 RNA, Qualitative Real-Time PCR
Test Code13600
CPT Codes
87535
Preferred Specimen
1.6 mL serum
Minimum Volume
0.8 mL
Other Acceptable Specimens
Plasma collected in: EDTA (lavender-top) tube
Instructions
Serum: Collect in a serum separator tube or red-top tube (no gel). The tube should be centrifuged after clotting. Spun serum separator tubes may be submitted at room temperature or refrigerated unopened without transfer to a plastic, screw-cap vial. Red-top tube (no gel) serum should be transferred to a plastic, screw-cap vial and submitted for testing.
Plasma: Collect in an EDTA (lavender-top) tube and centrifuge tube within 24 hours of collection. Transfer plasma to a plastic, screw-cap vial, label as plasma, and submit for testing.
Submitted tubes must be labeled with patient identifier and submitted only for HIV testing.
Transport Container
Transport tube
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 72 hours
Refrigerated: 5 days
Frozen: 42 days
Refrigerated: 5 days
Frozen: 42 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Frozen specimens submitted in original collection container
Methodology
Real-Time Polymerase Chain Reaction
Setup Schedule
Set up: Mon-Sat; Report available: 2-3 days
Reference Range
Not Detected
Clinical Significance
This assay is part of a multi-step algorithm for determination of HIV status in patients being considered for PrEP. In patients with negative or indeterminate HIV antibody results who have reported an HIV exposure-prone event and have had signs and symptoms of acute HIV within the prior 4 weeks, an HIV-1 Nucleic Acid Amplification test (NAAT) is recommended. The results of the algorithm are used to determine eligibility for PrEP in patients who have not taken oral PrEP within the last 3 months or have not received cabotegravir in the past 12 months.
Please refer to the U.S. Public Health Service "Preexposure Prophylaxis for the Prevention of HIV Infection in the United States-2021 Update Clinical Practice Guideline" for additional information.
Please refer to the U.S. Public Health Service "Preexposure Prophylaxis for the Prevention of HIV Infection in the United States-2021 Update Clinical Practice Guideline" for additional information.
