European Society of Clinical Microbiology and Infectious Diseases: update of the diagnostic guidance document for Clostridium difficile infection.

Clin Microbiol Infect. August 2016 V.22 Suppl 4 S63-81.

Crobach MJ1, Planche T2, Eckert C3, Barbut F3, Terveer EM1, Dekkers OM4, Wilcox MH5, Kuijper EJ6.

Author information

1Department of Medical Microbiology, Centre for Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands.

2Department of Medical Microbiology, St. George’s Hospital, London, UK.

3National Reference Laboratory for Clostridium difficile, Paris, France.

4Departments of Clinical Epidemiology and Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands; Department of Clinical Epidemiology, Aarhus University, Aarhus, Denmark.

5Department of Microbiology, Leeds Teaching Hospitals & University of Leeds, Leeds, UK.

6Department of Medical Microbiology, Centre for Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: E.J.Kuijper@lumc.nl

Abstract

In 2009 the first European Society of Clinical Microbiology and Infectious Diseases (ESCMID) guideline for diagnosing Clostridium difficile infection (CDI) was launched.

Since then newer tests for diagnosing CDI have become available, especially nucleic acid amplification tests.

The main objectives of this update of the guidance document are to summarize the currently available evidence concerning laboratory diagnosis of CDI and to formulate and revise recommendations to optimize CDI testing.

This update is essential to improve the diagnosis of CDI and to improve uniformity in CDI diagnosis for surveillance purposes among Europe. An electronic search for literature concerning the laboratory diagnosis of CDI was performed.

Studies evaluating a commercial laboratory test compared to a reference test were also included in a meta-analysis. The commercial tests that were evaluated included enzyme immunoassays (EIAs) detecting glutamate dehydrogenase, EIAs detecting toxins A and B and nucleic acid amplification tests.

Recommendations were formulated by an executive committee, and the strength of recommendations and quality of evidence were graded using the Grades of Recommendation Assessment, Development and Evaluation (GRADE) system. No single commercial test can be used as a stand-alone test for diagnosing CDI as a result of inadequate positive predictive values at low CDI prevalence.

Therefore, the use of a two-step algorithm is recommended. Samples without free toxin detected by toxins A and B EIA but with positive glutamate dehydrogenase EIA, nucleic acid amplification test or toxigenic culture results need clinical evaluation to discern CDI from asymptomatic carriage.

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