Prospective investigation of an automated PCR/ nucleic acid microarray-based platform for enteric pathogentesting

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Abstract

Background: The Verigene Enteric Pathogens Test (Luminex Corporation) is a polymerase chain reaction (PCR)/nucleic acid microarray-based assay targeting 8 bacterial and viral pathogens that cause diarrhea. Objective: To compare traditional enteric culture methods with stool testing by Verigene EP (PCR/microarray). Methods: Tests were performed using PCR/microarray between February and August 2016. All specimens also underwent culture for Salmonella and Shigella; specimens that tested positive for bacterial pathogen(s) had confirmatory cultures. Results: Valid results were obtained for 99.3% of the 3795 stool specimens. Among these, 497 (13.2%) specimens tested positive for at least 1 pathogen by PCR/microarray; 45.5% of these tested positive for 1 or more bacterial pathogens. Agreement between positive bacterial PCR/microarray results and culture-based testing was 85.3%. Compared with cultures, PCR/microarray demonstrated 95.2% and 87.5% sensitivity and 99.8% and 99.8% specificity for Salmonella and Shigella, respectively. Conclusions: The Verigene EP generated evaluable results for most stool specimens tested and demonstrated good agreement with bacterial cultures.

Original languageEnglish (US)
Pages (from-to)390-395
Number of pages6
JournalLab Medicine
Volume50
Issue number4
DOIs
StatePublished - Oct 10 2019

Bibliographical note

Funding Information:
We thank Sam Berger, BS, and Kari Nelson, BS, senior technical staff members of the University of Minnesota Infectious Diseases Diagnostic Laboratory, for their assistance in gathering data for this study.

Keywords

  • Acute diarrhea
  • Gastroenteritis
  • Gastrointestinal illness
  • Gastrointestinal pathogens
  • Luminex
  • Molecular assay
  • Multiplex PCR
  • Multiplex panel
  • Nanosphere
  • Stool testing

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