GDH and toxin immunoassay for the diagnosis of Clostridioides (Clostridium) difficile infection is not a ‘one size fit all’ screening test

Publication date: Available online 29 December 2018

Source: Diagnostic Microbiology and Infectious Disease

Author(s): Zuhha Ashraf, Elham Rahmati, Jeffrey M. Bender, Neha Nanda, Rosemary C. She

Abstract

Diagnosing Clostridioides (Clostridium) difficile infection is challenged by lack of a clear gold standard. We sought to determine if the two-step algorithm (screening GDH and toxin lateral flow assay followed by tcdB PCR) would have adequate clinical performance at a tertiary care center. Of 486 patients, 310 (63.8%) were immunocompromised. Of 150 PCR-positive specimens, 52 (34.7%) were toxin-positive and 126 (84.0%) were GDH positive. Positive GDH or toxin results corresponded to lower PCR cycle threshold values (p < 0.01). PCR-positive patients had more frequently documented antibiotic usage (78.4% vs 66.9%, p = 0.05) and diarrhea (91.0% vs. 79.4%, p < 0.01) and less frequent alternate etiologies of diarrhea (27.3% vs. 41.1%, p = 0.004) or laxative use (24.6% vs 36.1%, p = 0.02). Toxin positivity was associated with antibiotic use (p < 0.01), but not with neutropenia, diarrhea, malignancy, or chemotherapy (p > 0.05). The application of the 2-step algorithm should be thoroughly evaluated in immunocompromised patient populations before implementation.

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