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Aptima HIV-1 RNA qualitative assay

The Aptima HIV-1 RNA qualitative assay is the only FDA-approved nucleic acid amplified test (NAAT) solution for diagnosis of HIV-1 that delivers the needed sensitivity for early detection:                          

  • Identify HIV-1 acute cases in a shorter window period than immunoassays.
  • Enable initiation of life saving treatment which can reduce the chances of HIV-1 transmission.
  • Only RNA NAAT assay to support CDC HIV testing guidelines.

 

About

The Aptima HIV-1 qualitative assay provides:

  • In vitro nucleic acid assay system for the detection of human immunodeficiency virus (HIV-1) in human plasma and serum.
  • The only commercial FDA-approved nucleic acid amplified test (NAAT) for detection of HIV-1 RNA.
  • Supports the most recent (June, 2014) CDC HIV testing guidelines1and may help prevent the spread of HIV.2-4
  • Presence of HIV-1 RNA in the plasma or serum of patients without antibodies to HIV-1 is indicative of acute or primary HIV-1 infection.
  • RNA NAAT detects the presence of HIV-1 up to 7-10 days earlier than the latest 4th generation immunoassays and 26 days before Western Blot.5-7

The new recommended testing algorithm for HIV infection in the United States outlines that specimens that are reactive on the initial 4th generation assay and negative on the HIV-1/HIV-2 antibody differentiation immunoassays should be tested with an FDA-approved NAAT for HIV-1 RNA. Aptima HIV-1 RNA qualitative assay is the only commercial FDA-approved assay for confirmatory testing.

Performance Data

 

Sensitivity        
Samples N Number of Reactive
on Aptima
% 95% C.I.*
All 1041 1041 100% 99.6-100.0
HIV-1 Only 867 867 100% 99.6-100.0
HIV-1 & HCV 174 174 100% 97.9-100.0

Please see package insert for detailed information.

Regulatory

The Aptima HIV-1 RNA assay was FDA-approved for in vitro diagnostic use in 2006.

For additional availability in other countries beyond the U.S., please contact your local sales representative or distributor.

References
  1. Centers for Disease Control and Prevention and Association of Public Health Laboratories. Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations. Available at http://stacks.cdc.gov/view/cdc/23447. Published June 27, 2014.
  2. Emerson, B., Plough, K., Pangloli, A., Haq, S., Serinaldi, D., & Bannister, E. (2013). Detection of acute HIV-1 infections utilizing NAAT technology in Dallas, Texas. Journal of Clinical Virology, 58, e48-e53.
  3. To, S. W. C., Chen, J. H. K., & Yam, W. C. (2013). Current assays for HIV-1 diagnostics and antiretroviral therapy monitoring: challenges and possibilities.Future Virology, 8(4), 405-419.
  4. Patel, P., Bennett, B., Sullivan, T., Parker, M. M., Heffelfinger, J. D., & Sullivan, P. S. (2012). Rapid HIV screening: missed opportunities for HIV diagnosis and prevention. Journal of Clinical Virology, 54(1), 42-47.
  5. Eller, L. A., Manak, M., Malia, J., de Souza, M., Shikuku, K., Lueer, C., ... & Peel, S. (2013). Reduction of HIV Window Period by 4th Gen HIV Combination Tests.
  6. Long, E. F. (2011). HIV screening via fourth-generation immunoassay or nucleic acid amplification test in the United States: a cost-effectiveness analysis. PloS one, 6(11), e27625.
  7. Pilcher, C. D., Christopoulos, K. A., & Golden, M. (2010). Public health rationale for rapid nucleic acid or p24 antigen tests for HIV. Journal of Infectious Diseases, 201(Supplement 1), S7-S15.tails. Cervista HPV HR PI 2009. Cervista HPV 16-18 PI 2009.