Syndromic Diagnostics for Travelers’ Diarrhea Near-Patient Field-Expedient Testing in Resource-Limited Settings

Romeo Toriro; Christopher T. Williams; Dominic L. Wooding; Thomas Edwards; Matthew K. O’Shea; Thomas E. Fletcher; Nicholas J. Beeching; Daniel S. Burns; Stephen D. Woolley

doi:10.1093/ofid/ofag076

Syndromic Diagnostics for Travelers’ Diarrhea Near-Patient Field-Expedient Testing in Resource-Limited Settings

Academic Department of Military Medicine
University Hospitals Birmingham NHS Foundation Trust
University of Birmingham

Research output: Contribution to journal › Article › peer-review

Abstract

Background We assessed the diagnostic agreement of BioFire FilmArray multiplex polymerase chain reaction (PCR) with Seegene Allplex PCR for testing fecal samples collected during a diarrhea outbreak in resource-limited settings.

Methods Fecal samples from consented British military personnel training in Kenya were collected without preservative and tested onsite with the FilmArray PCR platform. Anonymized corresponding samples frozen near the point of care were tested 16–18 months later in the United Kingdom using Seegene PCR (reference standard). We compared test sensitivity and specificity and assessed agreement using Cohen κ coefficients.

Results Samples were analyzed from 60 individuals (80% male; median age [interquartile range], 24 [22–28] years). The overall pathogen detection rates did not differ significantly between FilmArray and Seegene PCR (55 of 60 [91.7%] vs 53 of 59 [89.8%], respectively [P >.9]). Campylobacter spp detection was significantly higher with Seegene (17 of 59 [28.8%] vs 6 of 60 [10%] for FilmArray PCR P =.03). The sensitivity of FilmArray PCR was moderate for Cryptosporidium spp (65% [95% confidence interval, 45.37%–80.77%]), and low for Campylobacter spp (35.3% [14.21%–61.67%%) and norovirus (7.14% [.18%–33.87%]). Its specificity was good to excellent for detection of Campylobacter spp, Cryptosporidium spp, enteroaggregative Escherichia coli, and sapovirus.

Conclusions The study shows moderate concordance of FilmArray with Seegene PCR in the detection of 5 enteropathogens and poor to fair concordance for 7 others, but high-quality case-control studies are needed to assess agreement between these platforms. However, based on performance characteristics, including platform versatility and ease of use, and in the absence of a gold (reference) standard test, the FilmArray platform remains a suitable near-patient field-expedient platform for diarrhea diagnostics in resource-limited settings.

Original language	English
Article number	ofag076
Journal	Open Forum Infectious Diseases
Volume	13
Issue number	3
DOIs	https://doi.org/10.1093/ofid/ofag076
Publication status	Published - 17 Feb 2026

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@article{76881e50a4c149d4b606a6f3b6c7ec49,

title = "Syndromic Diagnostics for Travelers{\textquoteright} Diarrhea Near-Patient Field-Expedient Testing in Resource-Limited Settings",

abstract = "Background We assessed the diagnostic agreement of BioFire FilmArray multiplex polymerase chain reaction (PCR) with Seegene Allplex PCR for testing fecal samples collected during a diarrhea outbreak in resource-limited settings. Methods Fecal samples from consented British military personnel training in Kenya were collected without preservative and tested onsite with the FilmArray PCR platform. Anonymized corresponding samples frozen near the point of care were tested 16–18 months later in the United Kingdom using Seegene PCR (reference standard). We compared test sensitivity and specificity and assessed agreement using Cohen κ coefficients. Results Samples were analyzed from 60 individuals (80\% male; median age [interquartile range], 24 [22–28] years). The overall pathogen detection rates did not differ significantly between FilmArray and Seegene PCR (55 of 60 [91.7\%] vs 53 of 59 [89.8\%], respectively [P >.9]). Campylobacter spp detection was significantly higher with Seegene (17 of 59 [28.8\%] vs 6 of 60 [10\%] for FilmArray PCR P =.03). The sensitivity of FilmArray PCR was moderate for Cryptosporidium spp (65\% [95\% confidence interval, 45.37\%–80.77\%]), and low for Campylobacter spp (35.3\% [14.21\%–61.67\%\%) and norovirus (7.14\% [.18\%–33.87\%]). Its specificity was good to excellent for detection of Campylobacter spp, Cryptosporidium spp, enteroaggregative Escherichia coli, and sapovirus. Conclusions The study shows moderate concordance of FilmArray with Seegene PCR in the detection of 5 enteropathogens and poor to fair concordance for 7 others, but high-quality case-control studies are needed to assess agreement between these platforms. However, based on performance characteristics, including platform versatility and ease of use, and in the absence of a gold (reference) standard test, the FilmArray platform remains a suitable near-patient field-expedient platform for diarrhea diagnostics in resource-limited settings.",

author = "Romeo Toriro and Williams, \{Christopher T.\} and Wooding, \{Dominic L.\} and Thomas Edwards and O{\textquoteright}Shea, \{Matthew K.\} and Fletcher, \{Thomas E.\} and Beeching, \{Nicholas J.\} and Burns, \{Daniel S.\} and Woolley, \{Stephen D.\}",

year = "2026",

month = feb,

day = "17",

doi = "10.1093/ofid/ofag076",

language = "English",

volume = "13",

journal = "Open Forum Infectious Diseases",

issn = "2328-8957",

publisher = "Oxford University Press",

number = "3",

}

TY - JOUR

T1 - Syndromic Diagnostics for Travelers’ Diarrhea Near-Patient Field-Expedient Testing in Resource-Limited Settings

AU - Toriro, Romeo

AU - Williams, Christopher T.

AU - Wooding, Dominic L.

AU - Edwards, Thomas

AU - O’Shea, Matthew K.

AU - Fletcher, Thomas E.

AU - Beeching, Nicholas J.

AU - Burns, Daniel S.

AU - Woolley, Stephen D.

PY - 2026/2/17

Y1 - 2026/2/17

N2 - Background We assessed the diagnostic agreement of BioFire FilmArray multiplex polymerase chain reaction (PCR) with Seegene Allplex PCR for testing fecal samples collected during a diarrhea outbreak in resource-limited settings. Methods Fecal samples from consented British military personnel training in Kenya were collected without preservative and tested onsite with the FilmArray PCR platform. Anonymized corresponding samples frozen near the point of care were tested 16–18 months later in the United Kingdom using Seegene PCR (reference standard). We compared test sensitivity and specificity and assessed agreement using Cohen κ coefficients. Results Samples were analyzed from 60 individuals (80% male; median age [interquartile range], 24 [22–28] years). The overall pathogen detection rates did not differ significantly between FilmArray and Seegene PCR (55 of 60 [91.7%] vs 53 of 59 [89.8%], respectively [P >.9]). Campylobacter spp detection was significantly higher with Seegene (17 of 59 [28.8%] vs 6 of 60 [10%] for FilmArray PCR P =.03). The sensitivity of FilmArray PCR was moderate for Cryptosporidium spp (65% [95% confidence interval, 45.37%–80.77%]), and low for Campylobacter spp (35.3% [14.21%–61.67%%) and norovirus (7.14% [.18%–33.87%]). Its specificity was good to excellent for detection of Campylobacter spp, Cryptosporidium spp, enteroaggregative Escherichia coli, and sapovirus. Conclusions The study shows moderate concordance of FilmArray with Seegene PCR in the detection of 5 enteropathogens and poor to fair concordance for 7 others, but high-quality case-control studies are needed to assess agreement between these platforms. However, based on performance characteristics, including platform versatility and ease of use, and in the absence of a gold (reference) standard test, the FilmArray platform remains a suitable near-patient field-expedient platform for diarrhea diagnostics in resource-limited settings.

AB - Background We assessed the diagnostic agreement of BioFire FilmArray multiplex polymerase chain reaction (PCR) with Seegene Allplex PCR for testing fecal samples collected during a diarrhea outbreak in resource-limited settings. Methods Fecal samples from consented British military personnel training in Kenya were collected without preservative and tested onsite with the FilmArray PCR platform. Anonymized corresponding samples frozen near the point of care were tested 16–18 months later in the United Kingdom using Seegene PCR (reference standard). We compared test sensitivity and specificity and assessed agreement using Cohen κ coefficients. Results Samples were analyzed from 60 individuals (80% male; median age [interquartile range], 24 [22–28] years). The overall pathogen detection rates did not differ significantly between FilmArray and Seegene PCR (55 of 60 [91.7%] vs 53 of 59 [89.8%], respectively [P >.9]). Campylobacter spp detection was significantly higher with Seegene (17 of 59 [28.8%] vs 6 of 60 [10%] for FilmArray PCR P =.03). The sensitivity of FilmArray PCR was moderate for Cryptosporidium spp (65% [95% confidence interval, 45.37%–80.77%]), and low for Campylobacter spp (35.3% [14.21%–61.67%%) and norovirus (7.14% [.18%–33.87%]). Its specificity was good to excellent for detection of Campylobacter spp, Cryptosporidium spp, enteroaggregative Escherichia coli, and sapovirus. Conclusions The study shows moderate concordance of FilmArray with Seegene PCR in the detection of 5 enteropathogens and poor to fair concordance for 7 others, but high-quality case-control studies are needed to assess agreement between these platforms. However, based on performance characteristics, including platform versatility and ease of use, and in the absence of a gold (reference) standard test, the FilmArray platform remains a suitable near-patient field-expedient platform for diarrhea diagnostics in resource-limited settings.

U2 - 10.1093/ofid/ofag076

DO - 10.1093/ofid/ofag076

M3 - Article

AN - SCOPUS:105033037968

SN - 2328-8957

VL - 13

JO - Open Forum Infectious Diseases

JF - Open Forum Infectious Diseases

IS - 3

M1 - ofag076

ER -

Syndromic Diagnostics for Travelers’ Diarrhea Near-Patient Field-Expedient Testing in Resource-Limited Settings

Abstract

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