HIV-1 RNA

Laboratory assay overview

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 antigen [1]. 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 [2]. 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

Quest Diagnostics population reference ranges

Quest Diagnostics calculates these statistical intervals for this specific assay and demographic group, not as universal optimal targets.

Laboratory assay overview

This test is intended for use as an aid in the diagnosis of HIV-1 or HIV-2 infection, including acute or primary infection. Presence of HIV-1 or HIV-2 RNA in the plasma of patients without antibodies to HIV-1 or HIV-2 is indicative of acute or primary HIV-1 or HIV-2 infection. This assay may also be used as an additional test, when it is reactive, to confirm HIV-1 infection in an individual whose specimen is repeatedly reactive for HIV-1 and/or HIV-2 antibodies. This assay is not intended for use in donor testing.

Laboratory assay overview

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.

Laboratory assay overview

PrEP use only: This profile includes HIV p24 antigen/antibody with reflex to antibody differentiation and HIV-1/2 qualitative RNA to support baseline assessment and monitoring of patients on PrEP for HIV infection.

Laboratory assay overview

PrEP use only: This test is intended for patients being evaluated for pre-exposure prophylaxis (PrEP) regimens as an aid in the diagnosis of HIV-1 or HIV-2 infection, including acute or primary infection. Presence of HIV-1 or HIV-2 RNA in the plasma of patients without antibodies to HIV-1 or HIV-2 is indicative of acute or primary HIV-1 or HIV-2 infection. This assay may also be used as an additional test, when it is reactive, to confirm HIV-1 infection in an individual whose specimen is repeatedly reactive for HIV-1 and/or HIV-2 antibodies. This assay is not intended for use in donor testing.

Laboratory assay overview

This profile aligns with current guidelines for assessment of female patients prior to the initiation of injectable HIV PrEP. The profile includes HIV Antibody/p24 Antigen and HIV-1/2 RNA for the detection of HIV infection; Chlamydia trachomatis and Neisseria gonorrhoeae nucleic acid amplification; serologic testing for syphilis; serological assessment of HBV infection status; reflexive testing for the detection of HCV infection; and assessment of pregnancy status.

Laboratory assay overview

This profile aligns with current guidelines for monitoring female patients on injectable HIV PrEP. The profile includes HIV Antibody/p24 Antigen and HIV-1/2 RNA for the detection of HIV infection; Chlamydia trachomatis and Neisseria gonorrhoeae nucleic acid amplification; serologic testing for syphilis; and assessment of pregnancy status.

Laboratory assay overview

This profile aligns with current guidelines for assessment of female patients prior to the initiation of oral HIV PrEP. The profile includes HIV Antibody/p24 Antigen and HIV-1/2 RNA for the detection of HIV infection; Chlamydia trachomatis and Neisseria gonorrhoeae nucleic acid amplification; serologic testing for syphilis; serological assessment of HBV infection status; reflexive testing for the detection of HCV infection; assessment of pregnancy status; and assessment of filtering capacity of the kidney (eGFR).

Laboratory assay overview

This profile aligns with current guidelines for monitoring female patients on oral HIV PrEP. The profile includes HIV Antibody/p24 Antigen and HIV-1/2 RNA for the detection of HIV infection; Chlamydia trachomatis and Neisseria gonorrhoeae nucleic acid amplification; serologic testing for syphilis; and assessment of pregnancy status.

Laboratory assay overview

This profile aligns with current guidelines for assessment of male patients prior to the initiation of injectable HIV PrEP. The profile includes HIV Antibody/p24 Antigen and HIV-1/2 RNA for the detection of HIV infection; Chlamydia trachomatis and Neisseria gonorrhoeae nucleic acid amplification; serologic testing for syphilis; serological assessment of HBV infection status; and reflexive testing for the detection of HCV infection.

Laboratory assay overview

This profile aligns with current guidelines for monitoring male patients on injectable HIV PrEP. The profile includes HIV Antibody/p24 Antigen and HIV-1/2 RNA for the detection of HIV infection; Chlamydia trachomatis and Neisseria gonorrhoeae nucleic acid amplification; serologic testing for syphilis.

Laboratory assay overview

This profile aligns with current guidelines for assessment of male patients prior to the initiation of oral HIV PrEP. The profile includes HIV Antibody/p24 Antigen and HIV-1/2 RNA for the detection of HIV infection; Chlamydia trachomatis and Neisseria gonorrhoeae nucleic acid amplification; serologic testing for syphilis; serological assessment of HBV infection status; reflexive testing for the detection of HCV infection; and assessment of filtering capacity of the kidney (eGFR).

Laboratory assay overview

This profile aligns with current guidelines for monitoring male patients on oral HIV PrEP. The profile includes HIV Antibody/p24 Antigen and HIV-1/2 RNA for the detection of HIV infection; Chlamydia trachomatis and Neisseria gonorrhoeae nucleic acid amplification; serologic testing for syphilis.