Comparison of two human immunodeficiency virus (HIV) RNA surrogate assays to the standard HIV RNA assay

J Clin Microbiol. 2005 Dec;43(12):5950-6. doi: 10.1128/JCM.43.12.5950-5956.2005.

Abstract

Human immunodeficiency virus (HIV) RNA testing is the gold standard for monitoring antiretroviral therapy in HIV-infected patients. However, equipment and reagent costs preclude widespread use of the assay in resource-limited settings. The Perkin-Elmer Ultrasensitive p24 assay and the Cavidi Exavir Load assay both offer potentially simpler, less costly technologies for monitoring viral load. These assays were compared to the Roche Amplicor HIV-1 Monitor Test, v1.5, using panels of clinical samples (subtype B) from HIV-positive subjects and HIV-spiked samples (subtypes A, C, D, CRF_01AE, CRF_02AG, and F). The Ultrasensitive p24 assay detected 100% of the spiked samples with virus loads of >250,000 copies/ml and 61% of the clinical samples with virus loads of 219 to 288,850 copies/ml. Detection rates were improved substantially if an external lysis buffer was added to the procedure. The Cavidi assay detected 54 to 100% of spiked samples with virus loads >10,000 copies/ml and 68% of the clinical samples. These detection rates were also greatly improved with a newly implemented version of this kit. Coefficients of variation demonstrate good reproducibility for each of these kits. The results from the Cavidi v1.0, Cavidi v2.0, and Perkin-Elmer, and the Perkin-Elmer Plus external buffers all correlated well with the results from the Roche Monitor Test (r = 0.83 to 0.96, r = 0.84 to 0.99, r = 0.58 to 0.67, and r = 0.59 to 0.95, respectively). Thus, the use of these two assays for monitoring patients, together with less-frequent confirmation testing, offers a feasible alternative to frequent HIV RNA testing in resource-limited settings.

Publication types

  • Comparative Study
  • Evaluation Study
  • Research Support, N.I.H., Extramural

MeSH terms

  • HIV Core Protein p24 / blood*
  • HIV Infections / diagnosis*
  • HIV Infections / virology
  • HIV Reverse Transcriptase / metabolism
  • HIV-1 / enzymology
  • HIV-1 / genetics
  • HIV-1 / physiology*
  • Humans
  • RNA, Viral / blood*
  • Reagent Kits, Diagnostic* / economics
  • Reverse Transcriptase Polymerase Chain Reaction
  • Viral Load

Substances

  • HIV Core Protein p24
  • RNA, Viral
  • Reagent Kits, Diagnostic
  • HIV Reverse Transcriptase