ARCHITECT HIV Combo Ag/Ab and RealTime HIV-1 Assays Detect Diverse HIV Strains in Clinical Specimens

AIDS Res Hum Retroviruses. 2018 Mar;34(3):314-318. doi: 10.1089/AID.2017.0244. Epub 2018 Feb 13.


Periodic evaluation of the impact of viral diversity on diagnostic tests is critical to ensure current technologies are keeping pace with viral evolution. To determine whether HIV diversity impacts the ARCHITECT HIV Combo Ag/Ab (HIV Combo) or RealTime HIV-1 (RT) assays, a set of N = 199 HIV clinical specimens from Cameroon, Senegal, Saudi Arabia, and Thailand were sequenced and tested in both assays. The panel included historical groups N and P specimens and a newly identified group N specimen. These and specimens classified as H, U (unclassified)/URF (unique recombinant form), CRF (circulating recombinant form) 01, 02, 06, 09, 11, 13, 18, 22, 37, and 43 were detected by both the RT assay (1.75-6.84 log copies/ml) and the HIV Combo assay (3.26-1121.96 sample to cutoff ratios). Sequence alignment identified 3 or fewer mismatches to the RT assay oligos in 82.4% of samples. Altogether, these data demonstrate the HIV Combo and RT assays detect diverse strains of HIV in clinical specimens.

Keywords: HIV diversity; diagnostics; nucleic acid test; serology.

MeSH terms

  • Adult
  • Diagnostic Tests, Routine / methods*
  • Female
  • Genetic Variation
  • HIV Antibodies / blood*
  • HIV Antigens / blood*
  • HIV Core Protein p24 / blood
  • HIV Core Protein p24 / immunology
  • HIV Infections / diagnosis*
  • HIV Infections / genetics
  • HIV Infections / virology*
  • HIV-1 / classification*
  • HIV-1 / genetics
  • HIV-1 / isolation & purification*
  • Humans
  • Male
  • Middle Aged
  • RNA, Viral / blood*
  • Young Adult


  • HIV Antibodies
  • HIV Antigens
  • HIV Core Protein p24
  • RNA, Viral