TABLE 5

Performance summary and characteristics of the FilmArray GI Panel versus those of comparator assays (stool culture or PCR and sequencing)

AnalyteNo. of detectionsaSensitivity/PPAbSpecificity/NPAb
CFATP/(TP+FN)%95% CI (%)TN/(TN+FP)%95% CI (%)
Campylobacter spp.355834/3597.185.1–99.91,497/1,52198.497.7–99.0
C. difficile165204163/16598.895.7–99.91,350/1,39197.196.0–97.9
P. shigelloides3183/310029.2–1001,538/1,55399.098.4–99.5
Salmonella spp.313731/3110088.8–1001,519/1,52599.699.1–99.9
Vibrio spp.020/01,554/1,55699.999.5–100
    V. cholerae010/01,555/1,55699.999.6–100
Y. enterocolitica111/1100NAc1,555/1,55510099.8–100
EAEC8310982/8398.893.5–1001,446/1,47398.297.3–98.8
EPEC317348314/31799.197.3–99.81,167/1,20197.296.1–98.0
ETEC223122/2210084.6–1001,525/1,53499.498.9–99.7
STEC333833/3310089.4–1001,518/1,52399.799.2–99.9
E. coli O157343/310029.2–10034/3597.185.1–99.9
Shigella spp./EIEC (culture)d49 (31)4947/4995.986.0–99.51,505/1,50799.999.5–100
Cryptosporidium spp.182418/1810081.5–1001,532/1,53899.699.2–99.9
C. cayetanensis191919/1910082.4–1001,537/1,53710099.8–100
E. histolytica000/01,556/1,55610099.8–100
G. lamblia202720/2010083.2–1001,529/1,53699.599.1–99.8
Adenovirus F 40/41445542/4495.584.5–99.41,499/1,51299.198.5–99.5
Astrovirus787/710059.0–1001,548/1,54999.999.6–100
Norovirus GI/GII557052/5594.584.9–98.91,483/1,50198.898.1–99.3
Rotavirus A6186/610054.1–1001,538/1,55099.298.7–99.6
Sapovirus465946/4610092.3–1001,497/1,51099.198.5–99.5
  • a C, comparator method as defined in Table 1; FA, FilmArray GI Panel.

  • b Targets that utilized clinical reference standard comparator methods (i.e., stool culture) are reported in terms of sensitivity and specificity. However, the terms positive and negative percent agreement (PPA and NPA, respectively) are typically used to describe performances for analytes that used PCR as a reference. As detailed in Materials and Methods, sensitivity is calculated in the same manner as is PPA, and specificity is calculated in the same manner as is NPA. CI, confidence interval.

  • c NA, not applicable.

  • d Molecular methods targeting both Shigella spp. and EIEC were utilized for comparator testing and calculation of FilmArray GI Panel performance characteristics. However, culture was used by the clinical study sites to identify Shigella spp. for informational purposes, and the culture results are noted in parentheses.