Evaluation of Two Commercial Kits on the Automated ELITe InGenius PCR Platform for Molecular Diagnosis of Toxoplasmosis

J Mol Diagn. 2021 Jul;23(7):865-871. doi: 10.1016/j.jmoldx.2021.04.004. Epub 2021 May 4.

Abstract

Molecular diagnosis of toxoplasmosis is essential for establishing the diagnosis of congenital contaminations and for primary infection or reactivation of immunocompromised patients. An integrated extraction and real-time PCR-based system is of particular interest in this context. Commercial kits for automated extraction and amplification steps are now available. Herein, we assessed two commercial PCR assays for this diagnosis, those of Bio-Evolution and Elitech, on the ELITe InGenius platform. The Bio-Evolution assay showed a specificity and a sensitivity of 100% on clinical samples, but a lower analytical detection threshold than the Elitech assay. The latter showed a specificity of 100% and a sensitivity of 96%. The SP1000 cartridges, which allow DNA extraction from 1 mL of template, showed interesting performances on amniotic fluid samples. Overall, the two kits had good performances on the InGenius platform, which offers a turn-key solution suitable for the molecular diagnosis of toxoplasmosis.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Biological Assay / methods*
  • DNA, Protozoan / genetics
  • DNA, Protozoan / isolation & purification
  • Electronic Data Processing / methods*
  • Humans
  • Immunocompromised Host
  • Limit of Detection
  • Molecular Diagnostic Techniques / methods*
  • Real-Time Polymerase Chain Reaction / methods*
  • Retrospective Studies
  • Toxoplasma / genetics*
  • Toxoplasmosis / diagnosis*
  • Toxoplasmosis / parasitology

Substances

  • DNA, Protozoan