Pragmatic Strategy for Fecal Specimen Storage and the Corresponding Test Methods for <i>Clostridioides difficile</i> Diagnosis
The quality of fecal specimens is one of the factors responsible for successful <i>Clostridioides difficile</i> 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...
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MDPI AG
2021-08-01
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author | Seong Won Nho Minjae Kim Seong-Jae Kim Steven L. Foley Rajesh Nayak Ohgew Kweon Carl E. Cerniglia |
author_facet | Seong Won Nho Minjae Kim Seong-Jae Kim Steven L. Foley Rajesh Nayak Ohgew Kweon Carl E. Cerniglia |
author_sort | Seong Won Nho |
collection | DOAJ |
description | The quality of fecal specimens is one of the factors responsible for successful <i>Clostridioides difficile</i> 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 <i>C. difficile</i> detection methods. Step 2 provided additional quantitative data on <i>C. difficile</i> 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. |
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spelling | doaj.art-26e6e3f6f3104739bc904fe3b5fd75dc2023-11-22T09:10:04ZengMDPI AGPathogens2076-08172021-08-01108104910.3390/pathogens10081049Pragmatic Strategy for Fecal Specimen Storage and the Corresponding Test Methods for <i>Clostridioides difficile</i> DiagnosisSeong Won Nho0Minjae Kim1Seong-Jae Kim2Steven L. Foley3Rajesh Nayak4Ohgew Kweon5Carl E. Cerniglia6Division of Microbiology, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079, USADivision of Microbiology, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079, USADivision of Microbiology, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079, USADivision of Microbiology, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079, USAOffice of Regulatory Compliance and Risk Management, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079, USADivision of Microbiology, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079, USADivision of Microbiology, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079, USAThe quality of fecal specimens is one of the factors responsible for successful <i>Clostridioides difficile</i> 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 <i>C. difficile</i> detection methods. Step 2 provided additional quantitative data on <i>C. difficile</i> 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.https://www.mdpi.com/2076-0817/10/8/1049<i>Clostridioides difficile</i>CDI diagnosisfecal specimenreal-time PCRstorage conditionbibliomic data |
spellingShingle | Seong Won Nho Minjae Kim Seong-Jae Kim Steven L. Foley Rajesh Nayak Ohgew Kweon Carl E. Cerniglia Pragmatic Strategy for Fecal Specimen Storage and the Corresponding Test Methods for <i>Clostridioides difficile</i> Diagnosis Pathogens <i>Clostridioides difficile</i> CDI diagnosis fecal specimen real-time PCR storage condition bibliomic data |
title | Pragmatic Strategy for Fecal Specimen Storage and the Corresponding Test Methods for <i>Clostridioides difficile</i> Diagnosis |
title_full | Pragmatic Strategy for Fecal Specimen Storage and the Corresponding Test Methods for <i>Clostridioides difficile</i> Diagnosis |
title_fullStr | Pragmatic Strategy for Fecal Specimen Storage and the Corresponding Test Methods for <i>Clostridioides difficile</i> Diagnosis |
title_full_unstemmed | Pragmatic Strategy for Fecal Specimen Storage and the Corresponding Test Methods for <i>Clostridioides difficile</i> Diagnosis |
title_short | Pragmatic Strategy for Fecal Specimen Storage and the Corresponding Test Methods for <i>Clostridioides difficile</i> Diagnosis |
title_sort | pragmatic strategy for fecal specimen storage and the corresponding test methods for i clostridioides difficile i diagnosis |
topic | <i>Clostridioides difficile</i> CDI diagnosis fecal specimen real-time PCR storage condition bibliomic data |
url | https://www.mdpi.com/2076-0817/10/8/1049 |
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