Document Type

Article

Publication Date

11-2011

Publication Source

The Journal of Molecular Diagnostics

Abstract

The laboratory diagnosis of Clostridium difficile infection (CDI) continues to be challenging. Recent guidelines from professional societies in the United States note that enzyme immunoassays for toxins A and B do not have adequate sensitivity to be used alone for detecting CDI, yet the optimal method for diagnosing this infection remains unclear. Nucleic acid amplification tests (NAATs) that target chromosomal toxin genes (usually the toxin B gene, tcdB) show high sensitivity and specificity, provide rapid results, and are amenable to both batch and on-demand testing, but these tests were not universally recommended for routine use in the recent guidelines. Rather, two-step algorithms that use glutamate dehydrogenase (GDH) assays to screen for C. difficile in stool specimens, followed by either direct cytotoxin testing or culture to identify toxin-producing C. difficile isolates, were recommended in one guideline and either GDH algorithms or NAATs were recommended in another guideline. Unfortunately, neither culture nor direct cytotoxin testing is widely available. In addition, this two-step approach requires 48 to 92 hours to complete, which may delay the initiation of therapy and critical infection control measures. Recent studies also show the sensitivity of several GDH assays to be <90%. This review considers the role of NAATs for diagnosing CDI and explores their potential advantages over two-step algorithms, including shorter time to results, while providing comparable, if not superior, accuracy.

Inclusive pages

573-582

ISBN/ISSN

Print: 1525-1578

Document Version

Postprint

Comments

The document available for download is the authors' accepted manuscript from PubMed Central. To view the version of record, use the DOI: https://doi.org/10.1016/j.jmoldx.2011.06.001

PMC ID: PMC3194048

Articles from The Journal of Molecular Diagnostics are provided to PubMed Central courtesy of the American Society for Investigative Pathology.

Publisher

Elsevier

Volume

13

Peer Reviewed

yes

Issue

6


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