Portrait Toxigenic Clostridium difficile assay, an isothermal amplification assay detects toxigenic C. difficile in clinical stool specimens

Gerald A. Denys

Research output: Contribution to journalArticle

4 Scopus citations

Abstract

The Portrait Toxigenic Clostridium difficile assay is a rapid, qualitative assay for the detection of the tcdB gene of C. difficile in stool specimens from patients suspected of C. difficile infections, and received 510(k) clearance by the US FDA in March 2012. The Portrait Toxigenic C. difficile assay combines novel blocked-primer-mediated helicase-dependent multiplex amplification (bpHDA) technology and chip-based detection in an automated sample-to-result format. The assay requires minimal sample preparation and results are available within 90 min. In a multicenter evaluation, the Portrait Toxigenic C. difficile assay had a sensitivity of 98.2% and specificity of 92.8% compared with toxigenic culture. A comparative study between the Portrait Toxigenic C. difficile assay and three FDA-cleared molecular assays for the detection of toxigenic C. difficile exhibited a high degree of agreement (93.8-97.5%). The Portrait Toxigenic C. difficile assay provides a simple, cost-effective method with broad applicability to panel-based approaches, potentially simplifying workflow.

Original languageEnglish (US)
Pages (from-to)17-26
Number of pages10
JournalExpert Review of Molecular Diagnostics
Volume14
Issue number1
DOIs
StatePublished - Jan 1 2014

Keywords

  • C. difficile infections
  • Clostridium difficile
  • Diagnostic test
  • Helicase-dependent amplification
  • Isothermal tcdB amplification
  • Nucleic acid amplification tests
  • Portrait Toxigenic C. difficile assay
  • Sensitivity, specificity
  • Toxigenic culture

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Molecular Medicine
  • Molecular Biology
  • Genetics

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