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Laboratory Diagnostic Methods for Clostridioides difficile nfection: the First Systematic Review and Meta-analysis in Korea

Park Jeong Su|Chung Hae-Sun|Shin Bo-Moon
대한진단검사의학회 (Korean Society For Laboratory Medicine)|2021.03|Annals of Laboratory Medicine|제41권 제2호|pp. 171-180|DOI 10.3343/alm.2021.41.2.171

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Systematic reviewMeta-analysisClostridioides difficileClostridioides difficile infectionLaboratory diagnostic methods
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초록

Background: Various methods are used for the diagnosis of Clostridioides difficile infection (CDI). We systematically analyzed and investigated the performance of current laboratory diagnostic methods for CDI. Methods: We performed systematic review and meta-analysis of studies in PubMed, Web of Science, Cochrane Library, and KoreaMed. The following methods were evaluated: glutamate dehydrogenase (GDH) enzyme immunoassays (GDH EIAs), toxin A and B detection by enzyme immunoassays (toxin AB EIAs), and nucleic acid amplification tests (NAATs) for C. difficile toxin genes. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of each method were calculated. Results: Based on 39 studies, the pooled sensitivities/specificities were 92.7%/94.6%, 57.9%/97.0%, and 90.0%/95.8% for GDH EIAs, toxin AB EIAs, and NAATs, respectively, compared with those of toxigenic culture. The pooled sensitivities of automated EIAs were significantly higher than those of non-automated EIAs for both GDH and toxins A and B. The pooled sensitivity of Xpert C. difficile was significantly higher than those of other NAATs. PPVs increased as CDI prevalence increased, and NPVs were excellent when CDI prevalence was low; at CDI prevalence of 5%, PPV=37%–65% and NPV=97%–100%; at CDI prevalence of 50%, PPV=92%–97% and NPV=65%–98%. Conclusions: Toxin AB EIAs still show unsatisfactory sensitivity, whereas GDH EIAs and NAATs show relatively high sensitivity. However, toxin AB EIAs are the most specific tests. This study may provide useful information for CDI diagnosis.

Abstract

Background: Various methods are used for the diagnosis of Clostridioides difficile infection (CDI). We systematically analyzed and investigated the performance of current laboratory diagnostic methods for CDI. Methods: We performed systematic review and meta-analysis of studies in PubMed, Web of Science, Cochrane Library, and KoreaMed. The following methods were evaluated: glutamate dehydrogenase (GDH) enzyme immunoassays (GDH EIAs), toxin A and B detection by enzyme immunoassays (toxin AB EIAs), and nucleic acid amplification tests (NAATs) for C. difficile toxin genes. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of each method were calculated. Results: Based on 39 studies, the pooled sensitivities/specificities were 92.7%/94.6%, 57.9%/97.0%, and 90.0%/95.8% for GDH EIAs, toxin AB EIAs, and NAATs, respectively, compared with those of toxigenic culture. The pooled sensitivities of automated EIAs were significantly higher than those of non-automated EIAs for both GDH and toxins A and B. The pooled sensitivity of Xpert C. difficile was significantly higher than those of other NAATs. PPVs increased as CDI prevalence increased, and NPVs were excellent when CDI prevalence was low; at CDI prevalence of 5%, PPV=37%–65% and NPV=97%–100%; at CDI prevalence of 50%, PPV=92%–97% and NPV=65%–98%. Conclusions: Toxin AB EIAs still show unsatisfactory sensitivity, whereas GDH EIAs and NAATs show relatively high sensitivity. However, toxin AB EIAs are the most specific tests. This study may provide useful information for CDI diagnosis.

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Application of diagnostic algorithms for Clostridioides difficile infection using a GDH/ toxin test for five years from a single center in Korea: a diagnostic accuracy study김희정대한임상미생물학회 · Annals of Clinical Microbiology2025 · 제28권 제3호Laboratory Diagnosis of Clostridium difficile Infection in Korea: The First National Survey박정수, 신보문, 정혜선대한진단검사의학회 · Annals of Laboratory Medicine2019 · 제39권 제3호Laboratory diagnosis of Clostridioides difficile infection: guidelines and status of practice in Korea정혜선대한임상미생물학회 · Annals of Clinical Microbiology2024 · 제27권 제1호Simultaneous Detection of Clostridioides difficile Glutamate Dehydrogenase and Toxin A/B: Comparison of the C. DIFF QUIK CHEK COMPLETE and RIDASCREEN Assays송동준, 유인영, 이남용, 허희재대한진단검사의학회 · Annals of Laboratory Medicine2019 · 제39권 제2호Evaluation of a Rapid Membrane Enzyme Immunoassay for the Simultaneous Detection of Glutamate Dehydrogenase and Toxin for the Diagnosis of Clostridium difficile Infection김명숙, 김완희, 김희정, 이경원, 정석훈대한진단검사의학회 · Annals of Laboratory Medicine2014 · 제34권 제3호Evaluation of the Xpert Clostridium difficile Assay for the Diagnosis of Clostridium difficile Infection김희정, 이경원, Heejung Kim, Minkyung Kim, Myungsook Kim, Saeam Shin, Yunsop Chong대한진단검사의학회 · Annals of Laboratory Medicine2012 · 제32권 제5호

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