FREQUENCY OF CLOSTRIDIOIDES DIFFICILE AND CONCORDANCE BETWEEN DIAGNOSTIC TESTS IN STOOL SAMPLES AT A LABORATORY IN LIMA, PERU

Hueda-Zavaleta M.; Gómez de La Torre J.C.; Hernandez-Vargas A.; Tapia-Sequeiros G.; Choquegonza S.; Arias G.A. · Revista de la Facultad de Medicina Humana (2026) · DOI: 10.25176/rfmh.v26i2.7727

Resumen

Introduction: Clostridioides difficile is a common cause of healthcare-associated infectious diarrhea; therefore, timely and accurate diagnosis is relevant to clinical practice. Objectives: To determine the frequency of Clostridioides difficile and evaluate the concordance between the Toxin A/B ELISA test and Xpert® C. difficile in stool samples. Methods: An observational diagnostic test study was conducted using a database from a private laboratory in Lima, Peru. Stool samples from patients older than 18 years with diarrhea and suspected C. difficile infection were included. Records with incomplete data or indeterminate results were excluded. The positivity rate, overall agreement, and Kappa coefficient between ELISA and Xpert® were estimated. Results: A total of 6,705 samples were analyzed; 55.6% were from women, and the median age was 62 years (interquartile range: 39–78). The overall frequency of C. difficile was 5.7%. Positivity was higher with Xpert® C. difficile than with ELISA: 11.1% and 4.2%, respectively. Binary toxin was detected in 1.2% of the samples evaluated. Among samples tested with both methods, overall agreement was 85.5%, with a Cohen's Kappa coefficient of 0.199 (p<0.001). In addition, 86.6% of Xpert®-positive cases were negative by ELISA. Conclusion: The frequency of C. difficile was 5.7%. The low concordance between ELISA and Xpert® suggests limitations of ELISA in detecting cases identified by molecular methods. Article published by the Revista de la Facultad de Medicina Humana of Universidad Ricardo Palma. It is an open access article, distributed under the terms of the Creative Commons License: Creative Commons Attribution 4.0 International, CC BY 4.0 (https://creativecommons.org/licenses/by/4.0/), which allows non-commercial use, distribution and reproduction in any medium, provided that the original work is duly cited. For commercial use, please contact revista.medicina@urp.edu.pe

Instituciones: Universidad Nacional Daniel Alcides Carrión; Universidad Privada de Tacna