Evaluation of a nucleic acid amplification assay for the diagnosis of Clostridioides difficile infection

Anaerobe ◽  
2019 ◽  
Vol 59 ◽  
pp. 201-204
Author(s):  
Ozlem Koyuncu-Ozyurt ◽  
Betil Ozhak ◽  
Dilara Ogunc ◽  
Gozde Ongut ◽  
Filiz Gunseren ◽  
...  

2018 ◽  
Vol 36 (1) ◽  
pp. 77-82 ◽  
Author(s):  
Dong Eun Lee ◽  
Hanna Lee ◽  
Seon Duk Lee ◽  
Hyung Soo Han ◽  
Jae Young Choe ◽  
...  


2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S811-S812 ◽  
Author(s):  
Johanna Sandlund ◽  
Joel Estis ◽  
Phoebe Katzenbach ◽  
Niamh Nolan ◽  
Kirstie Hinson ◽  
...  

Abstract Background Clostridioides difficile infection (CDI) is one of the most common healthcare-associated infections, resulting in significant morbidity, mortality, and economic burden. Diagnosis of CDI relies on the assessment of clinical presentation and laboratory tests. We have evaluated the clinical performance of ultrasensitive Single Molecule Counting technology for detection of C. difficile toxins A and B. Methods Stool specimens from 298 patients with suspected CDI were tested with nucleic acid amplification test (NAAT; BD MAX™ Cdiff assay or Xpert® C. difficile assay) and Singulex Clarity® C. difficile toxins A/B assay. Specimens with discordant results were tested with cell cytotoxicity neutralization assay (CCNA), and results were correlated with disease severity and outcome. Results There were 64 NAAT-positive and 234 NAAT-negative samples. Of the 32 NAAT+/Clarity− and 4 NAAT-/Clarity+ samples, there were 26 CCNA− and 4 CCNA- samples, respectively. CDI relapse or overall death was more common in NAAT+/toxin+ patients than in NAAT+/toxin− and NAAT−/toxin− patients, and NAAT+/toxin+ patients were 3.7 times more likely to experience relapse or death (Figure 1). The clinical specificity of Clarity and NAAT was 97.4% and 89.0%, respectively, and overdiagnosis was over three times more common in NAAT+/toxin− than in NAAT+/toxin+ patients (Figure 2). Negative percent agreement between NAAT and Clarity was 98.3%, and positive percent agreement increased from 50.0% to effective 84.2% and 94.1% after CCNA testing and clinical assessment. Conclusion The Clarity assay was superior to NAATs in diagnosis of CDI, by reducing overdiagnosis and thereby increasing clinical specificity, and presence of toxins was associated with disease severity and outcome. Disclosures All authors: No reported disclosures.





2008 ◽  
Author(s):  
Bernhard H. Weigl ◽  
Gonzalo Domingo ◽  
Jay Gerlach ◽  
Dennis Tang ◽  
Darrel Harvey ◽  
...  




1994 ◽  
Vol 49 (2) ◽  
pp. 157-167 ◽  
Author(s):  
Bob van Gemen ◽  
Rinie van Beuningen ◽  
Arjan Nabbe ◽  
Dianne van Strijp ◽  
Suzanne Jurriaans ◽  
...  


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