Clostridioides difficile is the leading cause of healthcare-associated diarrhea and the laboratory diagnosis of Clostridioides difficile infection (CDI) continues to be challenging. Accurate and rapid identification of C. difficile will reduce unnecessary antibiotic use and ensure contact isolation to control the spread of CDI. In this study, diagnostic performance of BD MAX Cdiff assay (Becton Dickinson, USA) was evaluated for the detection of C. difficile in 2502 fresh stool samples from hospitalized children and adult patients and the results were compared to toxigenic culture. The frequency of CDI in adults and pediatric patients were found as 3.3% and 6.2%, respectively. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of BD MAX Cdiff assay were found as; 100%, 99.7%, 93%, and 100% for all patients; 100%, 99.7%, 96.2%, and 100% for pediatric patients; and 100%, 99.6%, 90.2%, and 100% for adult patients, respectively. We concluded that BD MAX Cdiff assay with high sensitivity, specificity, and PPV is useful for the diagnosis of CDI. With a high NPV of 100%, BD MAX Cdiff assay is also suitable for the exclusion of CDI.
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http://dx.doi.org/10.1016/j.anaerobe.2019.06.015 | DOI Listing |
Microbiol Spectr
January 2025
Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Current guidelines recommend a two-step algorithm rather than relying solely on a single test for diagnosing 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 , Xpert , and BD MAX Cdiff assays, utilized as confirmatory testing of the two-step algorithm.
View Article and Find Full Text PDFJ Microbiol Methods
November 2024
HUS Diagnostic Center, Clinical Microbiology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland. Electronic address:
We evaluated the analytical performance of three commercial molecular assays for rapid detection of Clostridioides difficile toxin B in stool samples. The results were compared with results from the BD MAX™ Cdiff assay. We analyzed forty negative and thirty-two positive stool samples with three rapid assays: Roche cobas® Liat® Cdiff, SD Biosensor STANDARD™ M10 C.
View Article and Find Full Text PDFAfr J Lab Med
September 2022
National Health Laboratory Service Tygerberg Academic Laboratory, Division of Medical Microbiology, Tygerberg Hospital, Tygerberg, South Africa.
Background: is the number one cause of hospital-acquired diarrhoea. Accurate diagnosis of is of utmost importance as it guides patient management and infection control practices. Studies evaluating the performance of commercially available nucleic acid amplification tests (NAATs) versus algorithms are lacking in resource-limited settings.
View Article and Find Full Text PDFDiagn Microbiol Infect Dis
July 2022
Institute for Infectious Agents, Groupement Hospitalier Nord, Hospices Civils de Lyon, Lyon, France.
Toxigenic Clostridioides difficile infection (CDI) is a high concern because of its increasing prevalence, among both nosocomial infection and community-acquired infection contexts. A total of 1320 prospective stool samples collected on FecalSwab™ (Cary-Blair medium) were screened using BD Max™ CDIFF assay (BDM). Results were compared to the routine algorithm including immunochromatographic testing for glutamate dehydrogenase (GDH) and toxin A/B (tox) using C.
View Article and Find Full Text PDFRev Esp Quimioter
April 2021
Jerónimo Jaqueti Aroca, Laboratorio Clínico, Hospital Universitario de Fuenlabrada, Camino del Molino, 2. 28942 Madrid, Spain.
Objective: Clostridioides difficile (CD) is the most common cause of nosocomial diarrhea. Detection of CD toxin in patients' faecal samples is the traditional rapid method for the diagnosis of CD infection. Various testing algorithms have been proposed: an initial screening test using a rapid test, and a confirmatory test (cytotoxicity neutralization assay, toxigenic culture, nucleic acid amplification test) for discordant results.
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