Effect of errors in the sequence of optical densities from the Roche AMPLICOR HIV-1 MONITOR assay on the validity of assay results

J Clin Microbiol. 2001 Mar;39(3):1118-20. doi: 10.1128/JCM.39.3.1118-1120.2001.

Abstract

Specifications for the AMPLICOR HIV-1 MONITOR kit indicate that the results are invalid if the optical densities (ODs) from the PCR-amplified sample that are between 0.1 and 2.3 units are out of sequence. However, among 11,904 assays, results were biased only when ODs of 0.2 to 2.0 units were out of sequence, reducing the rate of invalid results from 3.2 to 0.59%.

Publication types

  • Research Support, U.S. Gov't, P.H.S.
  • Validation Study

MeSH terms

  • Diagnostic Errors*
  • HIV Infections / diagnosis*
  • HIV Infections / virology
  • HIV-1 / physiology*
  • Humans
  • Polymerase Chain Reaction / methods*
  • RNA, Viral / blood*
  • Reagent Kits, Diagnostic / standards

Substances

  • RNA, Viral
  • Reagent Kits, Diagnostic