Comparison of the NeuMoDx™ HBV quant assay and artus QS-RGQ® kit for HBV DNA quantitation in plasma samples

Diagn Microbiol Infect Dis. 2024 Aug;109(4):116357. doi: 10.1016/j.diagmicrobio.2024.116357. Epub 2024 May 18.

Abstract

We aimed to compare the NeuMoDx HBV Assay with the artus HBV Assay using residual plasma samples and to evaluate the discordant results. The study included 200 patient samples analyzed with the NMD assay and stored at -80 °C. Samples were analyzed by artus in 2023. Discordant results were evaluated by cobas 6800 HBV DNA Test. Excellent agreement was found between both tests. Of the 100 samples that were HBV DNA negative by NMD, 93 were negative and 7 were positive by artus. With the Cobas test, 5 samples were positive. Of the100 HBV DNA positive samples detected by NMD, 99 were positive with the artus assay. This sample was also HBV DNA negative by the Cobas test. The sensitivity and specificity of NeuMoDx were found 93 % and 99 %, respectively. There was excellent qualitative agreement and strong quantitative correlation between the NeuMoDx and artus assays for HBV DNA detection and quantitation.

Keywords: Assays; HBV DNA; Quantitation.

Publication types

  • Comparative Study

MeSH terms

  • DNA, Viral* / blood
  • Hepatitis B virus* / genetics
  • Hepatitis B virus* / isolation & purification
  • Hepatitis B* / blood
  • Hepatitis B* / diagnosis
  • Hepatitis B* / virology
  • Humans
  • Molecular Diagnostic Techniques / methods
  • Molecular Diagnostic Techniques / standards
  • Plasma / virology
  • Reagent Kits, Diagnostic / standards
  • Sensitivity and Specificity*
  • Viral Load / methods

Substances

  • DNA, Viral
  • Reagent Kits, Diagnostic