PrEP HIV-1/2 Antigen/Antibodies, 4th Generation, Reflex to Differentiation

Test Code

13595

CPT Codes
87389

Includes

If HIV Antigen and Antibody, 4th Generation Screen is repeatedly Reactive, then HIV-1/2 Antibody Differentiation will be performed at an additional charge (CPT code(s): 86701, 86702).

Preferred Specimen

2 mL serum

Minimum Volume

1 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)

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 Ab	Negative
PrEP HIV 2 Ab	Negative

Clinical Significance

This profile is for clinician determination of HIV status for PrEP provision for patients without recent or ongoing antiretroviral prophylaxis use who are considering initiating PrEP. If the patient has not taken oral PrEP within the last 3 months or has not received cabotegravir in the past 12 months, then current guidelines recommend screening with an HIV Antibody/Antigen test with reflex to confirmation. If an HIV exposure-prone event and signs and symptoms of acute HIV are reported within the prior 4 weeks and the antibody confirmation is negative or indeterminate, additional testing with an HIV-1 RNA assay on a new specimen is recommended to determine PrEP eligibility.

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.