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HIV-1 RNA, Qualitative TMA

HIV-1 RNA, Qualitative TMA

Test Summary

HIV-1 RNA, Qualitative TMA


Clinical Use

  • Diagnose human immunodeficiency virus (HIV-1) infection prior to seroconversion

  • Confirm HIV-1 infection in patients who test positive for HIV-1 antibody

  • Resolve inconclusive HIV-1 antibody test results

Clinical Background

Acute HIV infection is the period before seroconversion when HIV RNA and/or p24 antigen is detectable but HIV antibodies are not. Patients with acute infection may be asymptomatic, but 40% to 90% will manifest 1 or more symptoms of acute retroviral syndrome, including arthralgia, diarrhea, fatigue, fever, lymphadenopathy, myalgia, nausea, and rash. HIV replicates rapidly during the acute phase, resulting in a high circulating viral load (>100,000 copies/mL). Identifying HIV-1 infection prior to seroconversion is important because the rates of transmission are highest during this period.1 In addition, treatment of early infection may be beneficial1-3 and current guidelines indicate that it should be offered to individuals with acute infection.4

Testing with an HIV-1/HIV-2 antibody enzyme immunoassay (EIA) with confirmation by Western blot has been the primary tool for detecting HIV infection. However, it may not accurately reflect infection status during acute infection. Newer HIV screening tests that include p24 antigen in addition to HIV-1/2 antibodies will detect many acute infections that would have been missed by screening assays, but antibody-based supplemental testing will yield negative or indeterminate results prior to seroconversion. HIV-1 RNA can often be detected approximately 12 days prior to seroconversion5,6 and several days before p24 antigen. Testing for HIV-1 RNA is thus recommended for patients who have negative or indeterminate antibody test results but are suspected of having acute infection.4

The qualitative HIV-1 RNA assay can be used to detect HIV-1 infection, including acute infection5; to confirm positive screening test results; and to confirm infection in patients with positive results on a serologic HIV screening test but negative or indeterminate results on supplemental antibody testing.7 It may also be used to detect or confirm HIV-1 infection in infants born to infected mothers, as maternal antibodies may interfere with serologic testing.8

Individuals Suitable for Testing

  • Individuals having a known or potential exposure to HIV-1 in the previous 12 weeks

  • Individuals with repeatedly reactive results on an HIV antibody or antigen/antibody screening test, including those who have negative or indeterminate results on supplemental testing4,5

  • Infants born to HIV-1-infected mothers8


  • Qualitative transcription-mediated amplification (TMA)

  • Analytical sensitivity: 30 copies/mL

  • Analytical specificity: HIV-1 groups M (subtypes A, B, C, D, E, F, G), N, and O are detected

  • Aliases: Aptima® HIV-1 TMA

Interpretive Information

A “detected” result supports the diagnosis of HIV-1 infection. A “detected” result in combination with a negative antibody test result is consistent with acute or primary infection; this diagnosis should be confirmed by verifying seroconversion over the next 3 to 6 months.4,7

A “not detected” result is consistent with the absence of HIV-1 infection. However, this result does not preclude the possibility of exposure to or infection with HIV-1 or HIV-2.


  1. Wawer MJ, Gray RH, Sewankambo NK, et al. Rates of HIV-1 transmission per coital act, by stage of HIV-1 infection, in Rakai, Uganda. J Infect Dis. 2005;191:1403-1409.

  2. Steingrover R, Pogány K, Garcia EF, et al. HIV-1 viral rebound dynamics after a single treatment interruption depends on time of initiation of highly active antiretroviral therapy. AIDS. 2008;22:1583-1588.

  3. Hecht FM, Wang L, Collier A, et al. A multicenter observational study of the potential benefits of initiating combination antiretroviral therapy during acute HIV infection. J Infect Dis. 2006;194:725-733.

  4. Panel on Antiretroviral Guidelines for Adults and Adolescents.Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents.Department of Health and Human Services. February 12, 2013. http://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf. Accessed May 1, 2013.

  5. Aptima™ HIV-1 RNA Qualitative Assay [package insert]. San Diego, CA: Gen-Probe Inc; 501623-ART Rev. A, 2009-01. Available at: http://www.gen-probe.com/pdfs/pi/501623RevA.pdf. Accessed April 26, 2009.

  6. Fiebig EW, Wright DJ, Rawal BD, et al. Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS. 2003;17:1871-1879.

  7. CLSI. Criteria for laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline. M53-A ed. Wayne, PA: Clinical and Laboratory Standards Institute, 2011.

  8. Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children.Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.Department of Health and Human Services. November 5, 2012. http://aidsinfo.nih.gov/contentfiles/lvguidelines/pediatricguidelines.pdf. Accessed May 1, 2013.

Content reviewed 07/2013

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