Keywords
PCR
immunochromatographic assay
toxigenic culture
sensitivity
specificity
How to Cite
Abstract
Introduction: Clostridioides difficile is the most commonly identified cause of antibiotic-associated diarrhea. Objectives: This study aimed to compare the performance of four diagnostic methods on a set of standardized stool samples from patients with suspected C. difficile infection during January-May 2018. Materials and methods: A total of 97 liquid fecal samples were processed with: 1) toxigenic culture; 2) an immunochromatographic assay using the C. DIFF QUICK CHECK COMPLET kit E for the detection of glutamate dehydrogenase (GDH) and toxins (Tx) A and B; 3) real-time PCR (RT-PCR) using the TIB MOLBIOL kit; and 4) conventional PCR. Results: Toxigenic culture allowed isolating C. difficile from 14 of the 97 samples. The RT-PCR and conventional PCR had a concordance of 92.9% and 100% with toxigenic culture, respectively. Six samples were positive for GDH and Tx (Ag+Tx+), conventional PCR and toxigenic culture. Seven out of 15 GDH-positive and Tx-negative (Ag+Tx-) samples were positive by both PCRs and toxigenic culture. Non-toxigenic C. difficile was isolated from 8 samples (Ag+Tx-) but were negative by PCR. By using toxigenic culture as the “gold standard”, the sensitivity (S), specificity (E), and positive and negative predictive values of the assays were 42.9%, 100%, 100%, and 91.2%, respectively, for the immunochromatographic assay; 92.9%, 100%, 100%, and 98.8%, respectively, for the RT-PCR; and 100%, 100%, 100%, and 100%, respectively, for the conventional PCR. Conclusions: According to these results, the molecular methods have a S and E higher than the immunochromatographic assay. For inconclusive results (Ag+Tx-), we recommend performing a molecular method for the diagnosis of certainty.
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