HIV-1/HIV-2 QUALITATIVE RNA

Test Code
LAB3964


Quest Code
14312


CPT Codes
87535, 87538

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
Serum separator tube (SST)


Transport Temperature
Room temperature


Specimen Stability
Room temperature: 72 hours
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

Reference Range
HIV 1 RNA, QL RT PCRNot Detected
HIV 2 RNA, QL RT PCRNot Detected


Clinical Significance
This test is an in vitro nucleic acid amplification test (NAAT) for the qualitative detection of human immunodeficiency virus (HIV) types 1 and 2 RNA in human serum and plasma. The test is intended to be used as an aid in diagnosis of HIV-1 and 2 infections. In individuals without antibodies to HIV-1 or HIV-2, the presence of HIV-1 or 2 nucleic acid in the plasma or serum is indicative of acute infection. The HIV-1 and 2 Qualitative PCR may be used as part of a multi-step diagnostic algorithm to confirm the presence of HIV-1 or 2 infection in specimens reactive for HIV-1 and 2 antibodies or HIV antigen1. For infants with perinatal HIV exposure for whom HIV antigen/ antibody assays are not recommended, an HIV NAAT such as this test can aid in diagnosis.
This assay is not intended to be used for monitoring patient status, or for screening donors of blood, plasma, or human cells, tissues, and cellular and tissue-based products (HCT/Ps) for HIV.

1. Centers for Disease Control and Prevention. Clinical Testing Guidance for HIV. https://www.cdc.gov/hivnexus/hcp/diagnosis-testing/index.html
Published September 10, 2024. Accessed January 27, 2025.
2. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. HHS Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV-A Working Group of the NIH Office of AIDS Research Advisory Council(OARAC). https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/pediatric-arv/guidelines-pediatric-arv.pdf


Performing Laboratory
Quest Diagnostics - Great Lakes Region



Last Updated: June 24, 2025


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.