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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Main Authors: Seong Won Nho, Minjae Kim, Seong-Jae Kim, Steven L. Foley, Rajesh Nayak, Ohgew Kweon, Carl E. Cerniglia
Format: Article
Language:English
Published: MDPI AG 2021-08-01
Series:Pathogens
Subjects:
Online Access:https://www.mdpi.com/2076-0817/10/8/1049
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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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