PrEP HIV-1/2 Antigen and Antibodies, Fourth Generation, Screen and HIV-1 RNA

Test Code

13590

CPT Codes
87389, 87535

Includes

PrEP HIV-1/2 Antigen and Antibodies, Fourth Generation, Screen
PrEP HIV-1 RNA, Qualitative Real-Time PCR

Preferred Specimen

3 mL serum

Minimum Volume

2 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: 30 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Gross hemolysis • Frozen specimens submitted in original collection container

Methodology
Immunoassay (IA) • Real-Time Polymerase Chain Reaction

Setup Schedule

Set up: Mon-Sat; Report available: 2-3 days

Reference Range

PrEP HIV 1/2 Ag and Ab, Fourth Gen, Screen	Non-Reactive
PrEP HIV 1 RNA, QL Real Time PCR	Not Detected

Clinical Significance

This profile is for clinician determination of HIV status for PrEP provision for patients with recent or ongoing antiretroviral prophylaxis use. If the patient has taken oral PrEP within the last 3 months or has received cabotegravir in the past 12 months, then both an HIV Antibody/Antigen assay and an HIV-1 Qualitative Nucleic Acid Amplification test (NAAT) are indicated. Results are utilized to monitor patients who are HIV-1 negative and currently on oral or injectable PrEP and to inform ongoing patient management.

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.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.