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Optimal strategies for diagnosing Clostridioides difficile infection (CDI) are lacking. Specifically, the nucleic acid amplification test (NAAT) is highly sensitive but does not distinguish between infection and colonization. Enzyme immunoassay (EIA) is specific but clinically insensitive. To address this gap, researchers developed an ultrasensitive quantitative toxin immunoassay based on single molecule array (Simoa) technology. Stool concentrations ≥20 pg/mL for either toxin were considered positive.
A total of 615 adult patients were prospectively enrolled at two medical centers. All had acute diarrhea, a positive NAAT, and initiation of therapy for CDI. Highly significant correlations were found between the quantitative stool concentrati…