Background/aims: Accurate and rapid laboratory diagnosis of Clostridium difficile infections (CDI) remains a significant challenge. A two-step algorithm for detection of toxigenic C. difficile in stool based on initial screening for glutamate dehydrogenase assay followed by confirmation by toxin A+B detection using an enzyme immunoassay (EIA) or molecular assay has been proposed. We aimed to evaluate the C. difficile Quik Chek Complete® (QCC-EIA) versus the GeneXpert® C. difficile polymerase chain reaction (PCR) assay in this two-step algorithm.
Materials And Methods: Two hundred and ten liquid stool samples obtained between June 2014 and June 2015 from patients suspected of CDI were tested by the QCC-EIA and GeneXpert PCR assay. The GeneXpert assay was used as the reference standard to calculate the QCC-EIA sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Results: Of the 210 stool samples tested, 43 (20.5%) were positive by QCC-EIA, while 31 (14.8%) were positive by GeneXpert assay. The sensitivity and specificity of the QCC-EIA were found to be 100 and 93%, respectively; the PPV and NPV were 72 and 100%, respectively. The binary toxin was detected in 12 (38.7%) and tcdC gene deletion in 3 (9.6%).
Conclusions: The low specificity of QCC-EIA makes it less reliable as a confirmatory test for CDI diagnosis. This test may be used as a screening test in a two-step algorithm when combined with a molecular assay or another confirmatory test.
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http://dx.doi.org/10.4103/sjg.SJG_80_17 | DOI Listing |
Rinsho Biseibutshu Jinsoku Shindan Kenkyukai Shi
December 2024
Department of Clinical Laboratory, Medical Kouhoukai Takagi Hospital. Department of Medical Laboratory Science, Graduate school of Health and Welfare Sciences, International University of Health and Welfare Graduate School.
For infections, highly sensitive rapid diagnostic test kits are necessary for prompt diagnose and infection control. In this study, we evaluated "Quick Chaser CD GDH/TOX" (evaluation kit), a rapid diagnostic kit for , using 65 clinical stool specimens, comparing with GE test immunochromato-CD GDH/TOX "Nissui" (GE test) and TECHLAB QUIK CHEK COMPLETE (QUIK CHEK). The results of the evaluation kit showed a high concordance rate; 100% the positive concordance rate (31/31) and 97.
View Article and Find Full Text PDFMicroorganisms
August 2024
Department of Pathology, Sidra Medicine, Doha P.O. Box 26999, Qatar.
The diagnosis of infection (CDI) in the pediatric population is complicated by the high prevalence of asymptomatic colonization, particularly in infants. Many laboratory diagnostic methods are available, but there continues to be controversy over the optimal laboratory testing approach to diagnose CDI in children. We evaluated commonly used diagnostic commercial tests in our pediatric hospital population at Sidra Medicine in Doha, Qatar.
View Article and Find Full Text PDFJ Clin Microbiol
July 2024
Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
This study compared the performance of two commercial molecular assays, the STANDARD M10 assay (M10) and the Xpert assay (Xpert), for detecting toxigenic in stool specimens. A total of 487 consecutive stool specimens submitted for routine testing between June and November 2023 were included. Following routine testing using C.
View Article and Find Full Text PDFMicroorganisms
June 2024
Department of Pathology, Sidra Medicine, Doha P.O. Box 26999, Qatar.
Better diagnostic tools are needed to improve the diagnosis of infections (CDI) and reduce the overtreatment of colonized children. In this study, we evaluated two polymerase chain reaction (PCR) assays (Cepheid GeneXpert and the Gastroenteritis PCR Panel by QIAstat-Dx) as a standalone method in combination with the PCR cycle threshold (Ct) value in positive samples to predict the presence of free toxins. We also evaluated the clinical impact of reporting toxin production results and provided comments alongside the PCR results in our pediatric population.
View Article and Find Full Text PDFOpen Forum Infect Dis
May 2024
Infectious Diseases Diagnostic Laboratory, Department of Laboratory Medicine and Pathology, University of Minnesota Medical School, Minneapolis, Minnesota, USA.
Background: Multistep laboratory testing is recommended for the diagnosis of infection (CDI). The aim of this study was to present the impact of multistep CDI diagnostic testing in an academic hospital system and evaluate the toxin B gene polymerase chain reaction (PCR) cycle threshold (Ct) values of PCR-positive tests.
Methods: In October 2022, our system began reflex testing all PCR-positive stool samples with the QUIK CHEK COMPLETE (Techlab), an enzyme immunoassay-based test with results for the glutamate dehydrogenase antigen (GDH) and toxin A/B.
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