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

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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
Issue number4
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.


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

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