The quality of fecal specimens is one of the factors responsible for successful Clostridioides difficile infection (CDI) diagnosis. The quality depends largely on the storage conditions, including the temperature and time period. In this study, we organized the outputs of previous studies, filled experimental gaps in the knowledge of storage conditions, and introduced a pragmatic strategy for fecal storage for CDI diagnosis. A 5-step pathway was adopted to develop the fecal specimen storage strategy as follows: step 1, bibliomic analysis; step 2, experimental gap-filling; step 3, comparative evaluation; step 4, strategy development; step 5, internal review. Step 1 identified eight articles providing experimental information on the effects of fecal specimen storage conditions on the effectiveness of C. difficile detection methods. Step 2 provided additional quantitative data on C. difficile vegetative and spore cell viability and DNA stability. All previous and current results were compared (step 3). In step 4, fir general and nine special strategies were developed, followed by an internal review of the overall approaches (step 5). It is recommended to separate fecal samples into aliquots before testing and storing them. It is particularly recommended that fecal specimen samples be stored for CDI diagnosis at 4◦C for up to 60 days for all test methods.
|State||Published - Aug 2021|
Bibliographical noteFunding Information:
Funding: This work was supported in part by an appointment to the Postgraduate Research Fellowship Program at the National Center for Toxicological Research, administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the U.S. Department of Energy and the U.S. Food and Drug Administration.
This work was supported in part by an appointment to the Postgraduate Research Fellowship Program at the National Center for Toxicological Research, administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the U.S. Department of Energy and the U.S. Food and Drug Administration.We thank Gerald Noel, Shawar Ribhi, Huizhong Chen, and Kidon Sung for critical review of the manuscript. The opinions and views presented in this article do not necessarily reflect current or future opinions or policies of the U.S. FDA.
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.
- Bibliomic data
- CDI diagnosis
- Clostridioides difficile
- Fecal specimen
- Real-time PCR
- Storage condition
ASJC Scopus subject areas
- Immunology and Allergy
- Molecular Biology
- Immunology and Microbiology (all)
- Microbiology (medical)
- Infectious Diseases