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Multiplex Molecular Panels for Diagnosis of Gastrointestinal Infection

December 18, 2018

Health Problem: Infectious gastroenteritis is a significant global health concern characterized by diarrhea, vomiting, and other symptoms; severe cases can lead to life-threatening dehydration. Causes include infections with bacteria (e.g., Clostridium difficile, Escherichia coli, Shigella), viruses (e.g., norovirus, rotavirus), or parasites (e.g., Cryptosporidium, Giardia). In the United States, there were nearly half a million emergency department visits associated with infectious gastroenteritis in 1 year, 39% of which led to hospitalization.

Technology Description: Multiplex molecular panels allow for the qualitative detection of nucleic acid from multiple viral, parasitic, and bacterial pathogens in stool samples collected from patients with symptoms of gastroenteritis or infectious colitis. Currently, 4 such panels have received FDA clearance.

Controversy: There are several controversies and challenges associated with multiplex molecular panels for gastrointestinal infection, including increased detection of asymptomatic carriers of infections, inability to distinguish viable replicating pathogens from nonviable pathogens or remnant nucleic acids, cost, and complexity of interpreting the large amount of data arising from these tests.

Key Questions:

  • Are multiplex molecular panels more accurate than other methods of detection for gastrointestinal pathogens causing diarrhea?
  • Can the information obtained from multiplex molecular panels be used to improve management of patients with gastrointestinal infections causing diarrhea?
  • Do multiplex molecular panels pose any safety issues?
  • Have definitive patient selection criteria been established for multiplex molecular panels?