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Laboratory diagnosis of Clostridioides difficile infection in symptomatic patients: what can we do better?

  • Clinical Microbiology - Research Paper
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Abstract

The laboratory diagnosis of Clostridioides difficile infection (CDI) is challenging since this bacteria may be detected in healthy people and toxin production detection is not sensitive enough to be used alone. Thus, there is no single test with adequate sensitivity and specificity to be used in laboratory diagnosis. We evaluated the performance of tests used in the diagnosis of CDI in symptomatic patients with risk factors in hospitals in southern Brazil. Enzyme immunoassays (EIA) for glutamate dehydrogenase antigen (GDH) and toxins A/B, real-time polymerase chain reaction (qPCR), GeneXpert system, and a two-step algorithm comprising GDH/TOXIN EIA performed simultaneously followed by GeneXpert for outliers were evaluated. Toxigenic strain in stool culture was considered CDI positive (gold standard). Among 400 samples tested, 54 (13.5%) were positive for CDI and 346 (86.5%) were negative. The diagnosis of the two-step algorithm and qPCR had an excellent performance with an accuracy of 94.5% and 94.2%, respectively. The Youden index showed that GeneXpert as a single test (83.5%) and the two-step algorithm (82.8%) were the most effective assays. Diagnosing CDI and non-CDI diarrhea could be successfully attained by the combination of clinical data with accuracy of laboratory tests.

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All data generated or analyzed during this study are included in this published article.

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Acknowledgements

We are grateful to our colleagues at the Complexo Hospital de Clínicas, Cajuru University Hospital, Hospital das Nações, Hospital Santa Casa, Hospital Ônix, Hospital Erasto Gaertner Hospital do Idoso Zilda Arns, Hospital São Vicente, and Hospital Infantil Pequeno Príncipe, who provided the samples and clinical data and assisted with the research.

Funding

This research was supported by a Brazilian Research Program for the Unified Health System: Management Shared Health—PPSUS 2015 edition—Fundação Araucária-PR/SESA-PR/CNPq/MS-Decit.

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Authors and Affiliations

  1. Laboratório de Bacteriologia, Complexo Hospital de Clínicas da Universidade Federal do Paraná, Rua Padre Camargo, 280-Alto da Glória, CEP: 80.062-240, Curitiba, Paraná, Brazil

    Adriane C. Maestri & Keite S. Nogueira

  2. Programa de Pós-Graduação em Medicina Interna e Ciências da Saúde, Universidade Federal do Paraná, Rua General Carneiro, 181–Alto da Glória, CEP–80060-900, Curitiba, Paraná, Brazil

    Adriane C. Maestri & Sonia M. Raboni

  3. Departamento de Patologia Básica, Universidade Federal do Paraná, Centro Politecnico, Av. Cel. Francisco H. dos Santos, 100-Jardim das Americas, CEP-81531-980, Curitiba, Paraná, Brazil

    Keite S. Nogueira

  4. Hospital Pequeno Principe, Rua Desembargador Motta, 1070-Agua Verde, Curitiba-PR, 80250-060, Brazil

    Erika Medeiros dos Santos & Leticia Kraft

  5. Instituto de Pesquisa Pele Pequeno Principe, Av. Silva Jardim, 1632-Agua Verde, Curitiba-PR, 80250-060, Brazil

    Erika Medeiros dos Santos

  6. Departamento de Infectologia, Complexo Hospital de Clínicas da Universidade Federal do Paraná, Rua General Carneiro, 181–Alto da Glória, CEP–80060-900, Curitiba, Paraná, Brazil

    Rafael Mialski & Sonia M. Raboni

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  1. Adriane C. Maestri
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All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

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Correspondence to Sonia M. Raboni.

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The Institutional Research and Ethics Committee approved the study, and the need for informed consent was waived for all participating patients (CEAE = 59027716.5.1001.0096).

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Maestri, A.C., Nogueira, K.S., Mialski, R. et al. Laboratory diagnosis of Clostridioides difficile infection in symptomatic patients: what can we do better?. Braz J Microbiol 54, 849–857 (2023). https://doi.org/10.1007/s42770-023-00956-w

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