Analytical performance of four molecular platforms used for HIV-1, HBV and HCV viral load determinations

Expert Rev Mol Diagn. 2019 Oct;19(10):941-949. doi: 10.1080/14737159.2019.1624162. Epub 2019 Jun 19.

Abstract

Background: Viral load (VL) quantification is important for the management of HBV, HCV, and HIV-1-infected patients. Several semi- or fully automated systems and assays are available that can be used to measure VL for these and other targets. Research design and methods: We assessed the accuracy, genotype/subtype inclusivity, and precision of four VL assays for three viral targets: cobas 4800 (Roche), cobas 6800 (Roche), Aptima (Hologic) and VERIS (Beckman), using WHO standards, cell culture supernatants and clinical samples. Results: Most results were close to expected values, except for significant under-quantification of HIV-1 group O, HBV genotype C, and D at high VL, and HCV genotype 3 by Aptima, and of HIV-1 CRF01_AE and group N and HCV genotype 3 by VERIS. Precision was comparable between tests except for VERIS HCV, which showed more variability. Aptima and cobas 6800 results agreed well with each other except HBV VL at lower VL (<10,000 IU/mL) where Aptima results tended to be higher. Conclusions: Results from different VL assays may not always agree in certain subsets of patients. Clinicians should we aware of these findings when making treatment decisions.

Keywords: Aptima; HBV; HCV; HIV; VERIS; cobas; viral load.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Automation, Laboratory / methods
  • DNA, Viral / genetics*
  • Genotype
  • HIV-1 / genetics*
  • Hepacivirus / genetics*
  • Hepatitis B virus / genetics*
  • Humans
  • Molecular Diagnostic Techniques / methods
  • RNA, Viral / genetics*
  • Reagent Kits, Diagnostic
  • Viral Load / genetics*

Substances

  • DNA, Viral
  • RNA, Viral
  • Reagent Kits, Diagnostic