Comparison of the STANDARD M10 C. difficile, Xpert C. difficile, and BD MAX Cdiff assays as confirmatory tests in a two-step algorithm for diagnosing Clostridioides difficile infection
ABSTRACT Current guidelines recommend a two-step algorithm rather than relying solely on a single test for diagnosing Clostridioides difficile infection. This algorithm starts with enzyme immunoassay (EIA) for detecting glutamate dehydrogenase (GDH) and toxins A/B, followed by nucleic acid amplifica...
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American Society for Microbiology
2025-01-01
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| Series: | Microbiology Spectrum |
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| Online Access: | https://journals.asm.org/doi/10.1128/spectrum.01662-24 |
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| author | Hyunseul Choi Minhee Kang Sun Ae Yun Hui-Jin Yu Eunsang Suh Tae Yeul Kim Hee Jae Huh Nam Yong Lee |
| author_facet | Hyunseul Choi Minhee Kang Sun Ae Yun Hui-Jin Yu Eunsang Suh Tae Yeul Kim Hee Jae Huh Nam Yong Lee |
| author_sort | Hyunseul Choi |
| collection | DOAJ |
| description | ABSTRACT Current guidelines recommend a two-step algorithm rather than relying solely on a single test for diagnosing Clostridioides difficile infection. This algorithm starts with enzyme immunoassay (EIA) for detecting glutamate dehydrogenase (GDH) and toxins A/B, followed by nucleic acid amplification test (NAAT) for GDH-positive but toxin-negative cases. This study compared the performance of three commercial NAATs: the STANDARD M10 C. difficile, Xpert C. difficile, and BD MAX Cdiff assays, utilized as confirmatory testing of the two-step algorithm. Two hundred archived stool specimens, previously tested GDH-positive but toxin-negative by EIA, were analyzed in parallel with these NAATs and toxigenic culture, which served as the reference standard. Sensitivity, specificity, positive predictive value, and negative predictive value were 89.1%, 92.6%, 94.6%, and 85.2%, respectively, for the M10 assay; 95.8%, 86.4%, 91.2%, and 93.3%, respectively, for the Xpert assay; and 89.8%, 91.4%, 93.8%, and 86.0%, respectively, for the BD MAX assay. The rates of invalid results were 1.0%, 0.5%, and 1.0% for the M10, Xpert, and BD MAX assays, respectively. In conclusion, the M10 assay is a reliable diagnostic tool, performing comparably to the Xpert and BD MAX assays when used as confirmatory testing in the two-step algorithm.IMPORTANCEWhile numerous studies have assessed nucleic acid amplification tests (NAATs) as stand-alone tests for diagnosing Clostridioides difficile infection, limited research has compared their performance as confirmatory tests in a two-step algorithm. This study evaluated the performance of three commercial NAATs (M10, Xpert, and BD MAX assays) using 200 archived stool specimens initially tested as glutamate dehydrogenase (GDH)-positive but toxin-negative by GDH/toxin A/B enzyme immunoassay, the first step in the two-step algorithm. All three assays demonstrated high sensitivity (89.1% to 95.8%) and specificity (86.4% to 92.6%), with low rates of invalid results (≤1%). Our findings suggest that the M10 assay performs comparably to the Xpert and BD MAX assays when used as confirmatory testing in the two-step algorithm. Offering similar performance and turnaround time to these widely used assays at a slightly lower cost, the M10 assay serves as a practical alternative in this setting. |
| format | Article |
| id | doaj-art-8fcf68511871417f8f2a57e12e89b14c |
| institution | Kabale University |
| issn | 2165-0497 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | American Society for Microbiology |
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| spelling | doaj-art-8fcf68511871417f8f2a57e12e89b14c2025-01-07T14:05:18ZengAmerican Society for MicrobiologyMicrobiology Spectrum2165-04972025-01-0113110.1128/spectrum.01662-24Comparison of the STANDARD M10 C. difficile, Xpert C. difficile, and BD MAX Cdiff assays as confirmatory tests in a two-step algorithm for diagnosing Clostridioides difficile infectionHyunseul Choi0Minhee Kang1Sun Ae Yun2Hui-Jin Yu3Eunsang Suh4Tae Yeul Kim5Hee Jae Huh6Nam Yong Lee7Biomedical Engineering Research Center, Smart Healthcare Research Institute, Samsung Medical Center, Seoul, South KoreaBiomedical Engineering Research Center, Smart Healthcare Research Institute, Samsung Medical Center, Seoul, South KoreaCenter for Clinical Medicine, Samsung Biomedical Research Institute, Samsung Medical Center, Seoul, South KoreaDepartment of Laboratory Medicine, Seoul Medical Center, Seoul, South KoreaDepartment of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South KoreaDepartment of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South KoreaDepartment of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South KoreaDepartment of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South KoreaABSTRACT Current guidelines recommend a two-step algorithm rather than relying solely on a single test for diagnosing Clostridioides difficile infection. This algorithm starts with enzyme immunoassay (EIA) for detecting glutamate dehydrogenase (GDH) and toxins A/B, followed by nucleic acid amplification test (NAAT) for GDH-positive but toxin-negative cases. This study compared the performance of three commercial NAATs: the STANDARD M10 C. difficile, Xpert C. difficile, and BD MAX Cdiff assays, utilized as confirmatory testing of the two-step algorithm. Two hundred archived stool specimens, previously tested GDH-positive but toxin-negative by EIA, were analyzed in parallel with these NAATs and toxigenic culture, which served as the reference standard. Sensitivity, specificity, positive predictive value, and negative predictive value were 89.1%, 92.6%, 94.6%, and 85.2%, respectively, for the M10 assay; 95.8%, 86.4%, 91.2%, and 93.3%, respectively, for the Xpert assay; and 89.8%, 91.4%, 93.8%, and 86.0%, respectively, for the BD MAX assay. The rates of invalid results were 1.0%, 0.5%, and 1.0% for the M10, Xpert, and BD MAX assays, respectively. In conclusion, the M10 assay is a reliable diagnostic tool, performing comparably to the Xpert and BD MAX assays when used as confirmatory testing in the two-step algorithm.IMPORTANCEWhile numerous studies have assessed nucleic acid amplification tests (NAATs) as stand-alone tests for diagnosing Clostridioides difficile infection, limited research has compared their performance as confirmatory tests in a two-step algorithm. This study evaluated the performance of three commercial NAATs (M10, Xpert, and BD MAX assays) using 200 archived stool specimens initially tested as glutamate dehydrogenase (GDH)-positive but toxin-negative by GDH/toxin A/B enzyme immunoassay, the first step in the two-step algorithm. All three assays demonstrated high sensitivity (89.1% to 95.8%) and specificity (86.4% to 92.6%), with low rates of invalid results (≤1%). Our findings suggest that the M10 assay performs comparably to the Xpert and BD MAX assays when used as confirmatory testing in the two-step algorithm. Offering similar performance and turnaround time to these widely used assays at a slightly lower cost, the M10 assay serves as a practical alternative in this setting.https://journals.asm.org/doi/10.1128/spectrum.01662-24Clostridioides difficileM10XpertBD MAXtwo-step algorithm |
| spellingShingle | Hyunseul Choi Minhee Kang Sun Ae Yun Hui-Jin Yu Eunsang Suh Tae Yeul Kim Hee Jae Huh Nam Yong Lee Comparison of the STANDARD M10 C. difficile, Xpert C. difficile, and BD MAX Cdiff assays as confirmatory tests in a two-step algorithm for diagnosing Clostridioides difficile infection Microbiology Spectrum Clostridioides difficile M10 Xpert BD MAX two-step algorithm |
| title | Comparison of the STANDARD M10 C. difficile, Xpert C. difficile, and BD MAX Cdiff assays as confirmatory tests in a two-step algorithm for diagnosing Clostridioides difficile infection |
| title_full | Comparison of the STANDARD M10 C. difficile, Xpert C. difficile, and BD MAX Cdiff assays as confirmatory tests in a two-step algorithm for diagnosing Clostridioides difficile infection |
| title_fullStr | Comparison of the STANDARD M10 C. difficile, Xpert C. difficile, and BD MAX Cdiff assays as confirmatory tests in a two-step algorithm for diagnosing Clostridioides difficile infection |
| title_full_unstemmed | Comparison of the STANDARD M10 C. difficile, Xpert C. difficile, and BD MAX Cdiff assays as confirmatory tests in a two-step algorithm for diagnosing Clostridioides difficile infection |
| title_short | Comparison of the STANDARD M10 C. difficile, Xpert C. difficile, and BD MAX Cdiff assays as confirmatory tests in a two-step algorithm for diagnosing Clostridioides difficile infection |
| title_sort | comparison of the standard m10 c difficile xpert c difficile and bd max cdiff assays as confirmatory tests in a two step algorithm for diagnosing clostridioides difficile infection |
| topic | Clostridioides difficile M10 Xpert BD MAX two-step algorithm |
| url | https://journals.asm.org/doi/10.1128/spectrum.01662-24 |
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