Standardization and performance evaluation of "modified" and "ultrasensitive" versions of the Abbott RealTime HIV-1 assay, adapted to quantify minimal residual viremia

Research output: Contribution to journalArticle

Abstract

Background: Numerous studies investigating clinical significance of HIV-1 minimal residual viremia (MRV) suggest potential utility of assays more sensitive than those routinely used to monitor viral suppression. However currently available methods, based on different technologies, show great variation in detection limit and input plasma volume, and generally suffer from lack of standardization. Objectives: In order to establish new tools suitable for routine quantification of minimal residual viremia in patients under virological suppression, some modifications were introduced into standard procedure of the Abbott RealTi. me HIV-1 assay leading to a "modified" and an "ultrasensitive" protocols. Study design: The following modifications were introduced: calibration curve extended towards low HIV-1 RNA concentration; 4 fold increased sample volume by concentrating starting material; reduced volume of internal control; adoption of "open-mode" software for quantification. Analytical performances were evaluated using the HIV-1 RNA Working Reagent 1 for NAT assays (NIBSC). Both tests were applied to clinical samples from virologically suppressed patients. Results: The "modified" and the "ultrasensitive" configurations of the assay reached a limit of detection of 18.8 (95% CI: 11.1-51.0. cp/mL) and 4.8. cp/mL (95% CI: 2.6-9.1. cp/mL), respectively, with high precision and accuracy. In clinical samples from virologically suppressed patients, "modified" and "ultrasensitive" protocols allowed to detect and quantify HIV RNA in 12.7% and 46.6%, respectively, of samples resulted "not-detectable", and in 70.0% and 69.5%, respectively, of samples "detected

Original languageEnglish
Pages (from-to)17-22
Number of pages6
JournalJournal of Clinical Virology
Volume52
Issue number1
DOIs
Publication statusPublished - Sep 2011

Keywords

  • HIV-1
  • Low level viremia
  • Minimal residual viremia
  • Real-time PCR

ASJC Scopus subject areas

  • Virology
  • Infectious Diseases

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