C. difficile Biomarker Testing Protocol

C. difficile testing was done at the hospital clinical microbiology laboratory using tcdB PCR (BD GeneOhm C diff Assay, Becton Dickinson, or Xpert C. difficile, Cepheid) according to the manufacturer’s instructions. A fecal specimen from eligible tcdB-positive subjects on the day of CDI diagnosis was frozen at −80 °C and shipped to TechLab, Blacksburg, VA, USA, for biomarker testing and toxigenic culture, as well as PCR ribotyping. Stool toxin B was detected by tissue culture using the C. DIFFICILE TOX-B Test (TechLab^® Inc., Blacksburg, VA) including a neutral goat serum control as described by Boone et al. [37 (link)]

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Boone J.H., Archbald-Pannone L.R., Wickham K.N., Carman R.J., Guerrant R.L., Franck C.T, & Lyerly D.M. (2014). Ribotype 027 Clostridium difficile infections with measurable stool toxin have increased lactoferrin and are associated with a higher mortality. European Journal of Clinical Microbiology & Infectious Diseases, 33(6), 1045-1051.

Publication 2014

BD GeneOhm C diff Assay Xpert C. difficile

Assay Biomarker Clinical laboratory Diagnosis Frozen Goat Serum Stool Tcdb Tissue Toxin

Corresponding Organization :

Other organizations : TechLab (United States), University of Virginia, Virginia Tech

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Variable analysis

independent variables

C. difficile testing method (BD GeneOhm C diff Assay, Becton Dickinson, or Xpert C. difficile, Cepheid)

dependent variables

Stool toxin B detection by tissue culture using the C. DIFFICILE TOX-B Test (TechLab® Inc., Blacksburg, VA)

control variables

Fecal specimen from eligible tcdB-positive subjects on the day of CDI diagnosis
Neutral goat serum control in the C. DIFFICILE TOX-B Test

controls

Positive control: Not explicitly mentioned
Negative control: Neutral goat serum control in the C. DIFFICILE TOX-B Test

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