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Related Experiment Video

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Design to Implementation Study for Development and Patient Validation of Paper-Based Toehold Switch Diagnostics
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Syndromic Diagnostics for Travelers' Diarrhea: Near-Patient Field-Expedient Testing in Resource-Limited Settings.

Romeo Toriro1,2, Christopher T Williams3, Dominic L Wooding3

  • 1Academic Department of Military Medicine, Royal Centre for Defence Medicine, Queen Elizabeth Hospital Birmingham,Edgbaston, Birmingham, United Kingdom.

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The BioFire FilmArray multiplex polymerase chain reaction (PCR) showed moderate diagnostic agreement with Seegene Allplex PCR for enteric pathogen detection in resource-limited settings. FilmArray remains a suitable near-patient diagnostic tool despite variable concordance for certain pathogens.

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Area of Science:

  • Clinical microbiology
  • Infectious disease diagnostics
  • Molecular diagnostics

Background:

  • Assessing diagnostic accuracy of molecular platforms in resource-limited settings is crucial for outbreak response.
  • Diarrhea outbreaks pose significant public health challenges, particularly in areas with limited access to advanced diagnostic tools.

Purpose of the Study:

  • To evaluate the diagnostic agreement between BioFire FilmArray multiplex polymerase chain reaction (PCR) and Seegene Allplex PCR for fecal sample testing.
  • To determine the sensitivity and specificity of the FilmArray platform compared to a reference standard in a resource-limited field setting.

Main Methods:

  • Fecal samples were collected from British military personnel in Kenya during a diarrhea outbreak.
  • Samples were tested onsite using the BioFire FilmArray PCR platform and later with Seegene PCR (reference standard) in the UK.
  • Diagnostic agreement was assessed using Cohen κ coefficients, comparing sensitivity and specificity.

Main Results:

  • Overall pathogen detection rates were similar between FilmArray (91.7%) and Seegene (89.8%).
  • Seegene showed significantly higher detection rates for *Campylobacter* spp. (28.8% vs. 10%).
  • FilmArray sensitivity was moderate for *Cryptosporidium* spp. (65%) but low for *Campylobacter* spp. (35.3%) and norovirus (7.14%); specificity was good to excellent for several pathogens.

Conclusions:

  • Moderate concordance was observed between FilmArray and Seegene PCR for 5 enteropathogens, with poor to fair concordance for 7 others.
  • The FilmArray platform demonstrates versatility and ease of use, making it a suitable near-patient, field-expedient option for diarrhea diagnostics in resource-limited settings.
  • Further high-quality case-control studies are recommended to fully assess platform agreement.