Comparison of Illumigene, Simplexa, and AmpliVue Clostridium difficile molecular assays for diagnosis of C. Difficile infection

Journal of Clinical Microbiology

Volumn 52, Issue 3, 2014, Pages 960-963

  Deak, E ^a   Miller, S A ^a   Humphries, R M ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BACTERIUM CULTURE; BACTERIUM EXAMINATION; BACTERIUM ISOLATE; CLINICAL LABORATORY; CLOSTRIDIUM DIFFICILE INFECTION; CONTROLLED STUDY; CYTOTOXICITY ASSAY; DIAGNOSTIC TEST ACCURACY STUDY; DIAGNOSTIC VALUE; DIARRHEA; FECES ANALYSIS; GOLD STANDARD; INTERMETHOD COMPARISON; LOOP MEDIATED ISOTHERMAL AMPLIFICATION; MOLECULAR DIAGNOSTICS; NONHUMAN; NUCLEIC ACID AMPLIFICATION; PREDICTIVE VALUE; PRIORITY JOURNAL; REAL TIME POLYMERASE CHAIN REACTION; SENSITIVITY AND SPECIFICITY; TOXIGENIC CULTURE;

BACTERIOLOGICAL TECHNIQUES; CLOSTRIDIUM DIFFICILE; CLOSTRIDIUM INFECTIONS; DIARRHEA; FECES; HUMANS; MOLECULAR DIAGNOSTIC TECHNIQUES; SENSITIVITY AND SPECIFICITY;

EID: 84894539362     PISSN: 00951137     EISSN: 1098660X     Source Type: Journal    
DOI: 10.1128/JCM.02354-13     Document Type: Article

References (21)

1. Cohen SH, Gerding DN, Johnson S, Kelly CP, Loo VG, McDonald LC, Pepin J, Wilcox MH, Society for Healthcare Epidemiology of America, Infectious Diseases Society of America. 2010. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the society for healthcare epidemiology of America (SHEA) and the infectious diseases society of America (IDSA). Infect. Control Hosp. Epidemiol. 31:431-455. http://dx.doi.org/10.1086/651706.
2. Kim J, Smathers SA, Prasad P, Leckerman KH, Coffin S, Zaoutis T. 2008. Epidemiological features of Clostridium difficile-associated disease among inpatients at children's hospitals in the United States, 2001-2006. Pediatrics 122:1266-1270. http://dx.doi.org/10.1542/peds.2008-0469.
3. Nylund CM, Goudie A, Garza JM, Fairbrother G, Cohen MB. 2011. Clostridium difficile infection in hospitalized children in the United States. Arch. Pediatr. Adolesc. Med. 165:451-457. http://dx.doi.org/10.1001 /archpediatrics.2010.282.
4. Zilberberg MD, Tabak YP, Sievert DM, Derby KG, Johannes RS, Sun X, McDonald LC. 2011. Using electronic health information to risk-stratify rates of Clostridium difficile infection in US hospitals. Infect. Control Hosp. Epidemiol. 32:649-655. http://dx.doi.org/10.1086/660360.
5. Barbut F, Surgers L, Eckert C, Visseaux B, Cuingnet M, Mesquita C, Pradier N, Thiriez A, Ait-Ammar N, Aifaoui A, Grandsire E, Lalande V. 20 March 2013. Does a rapid diagnosis of Clostridium difficile infection impact on quality of patient management? Clin. Microbiol. Infect. (Epub ahead of print.) http://dx.doi.org/10.1111/1469-0691.12221.
6. Karen M. 2011. Conventional versus molecular methods for the detection of Clostridium difficile. J. Clin. Microbiol. 49:S49 -S52. http://dx.doi.org /10.1128/JCM.00700-11.
7. Tenover FC, Baron EJ, Peterson LR, Persing DH. 2011. Laboratory diagnosis of Clostridium difficile infection can molecular amplification methods move us out of uncertainty? J. Mol. Diagn. 13:573-582. http://dx.doi.org/10.1016/j. jmoldx.2011.06.001.
8. Lalande V, Barrault L, Wadel S, Eckert C, Petit JC, Barbut F. 2011. Evaluation of a loop-mediated isothermal amplification assay for diagnosis of Clostridium difficile infections. J. Clin. Microbiol. 49:2714-2716. http://dx.doi.org/10.1128/JCM.01835-10.
9. Norén T, Alriksson I, Andersson J, Akerlund T, Unemo M. 2011. Rapid and sensitive loop-mediated isothermal amplification test for Clostridium difficile detection challenges cytotoxin B cell test and culture as gold standard. J. Clin. Microbiol. 49:710-711. http://dx.doi.org/10.1128/JCM .01824-10.
10. Buchan BW, Mackey TL, Daly JA, Alger G, Denys GA, Peterson LR, Kehl SC, Ledeboer NA. 2012. Multicenter clinical evaluation of the portrait toxigenic C. Difficile assay for detection of toxigenic Clostridium difficile strains in clinical stool specimens. J. Clin. Microbiol. 50:3932-3936. http://dx.doi.org/ 10.1128/JCM.02083-12.
11. Viala C, Le Monnier A, Maataoui N, Rousseau C, Collignon A, Poilane I. 2012. Comparison of commercial molecular assays for toxigenic Clostridium difficile detection in stools: BD GeneOhm Cdiff, XPert C. Difficile and Illumigene C. Difficile. J. Microbiol. Methods 90:83-85. http://dx.doi .org/10.1016/j.mimet.2012.04.017.
12. Focus Diagnostics. 2012. Simplexa Clostridium difficile Universal Direct kit package insert. Focus Diagnostics, Cypress, CA. http://www.focusdx.com/ product/MOL2975.
13. Quidel Corporation. 2013. AmpliVue Clostridium difficile assay package insert. Quidel Corporation, San Diego, CA. http://www.quidel.com/molecular/ amplivue/amplivue-pi-US.pdf.
14. Meridian Bioscience, Inc. 2013. Illumigene Clostridium difficile package insert. Meridian Bioscience, Inc., Taunton, MA. http://www.meridianbioscience. com/disease-information/c-difficile/.
15. Stamper PD, Alcabasa R, Aird D, Babiker W, Wehrlin J, Ikpeama I, Carroll KC. 2009. Comparison of a commercial real-time PCR assay for tcdB detection to a cell culture cytotoxicity assay and toxigenic culture for direct detection of toxin-producing Clostridium difficile in clinical samples. J. Clin. Microbiol. 47:373-378. http://dx.doi.org/10.1128/JCM.01613-08.
16. Marler LM, Siders JA, Wolters LC, Pettigrew Y, Skitt BL, Allen SD. 1992. Comparison of five cultural procedures for isolation of Clostridium difficile from stools. J. Clin. Microbiol. 30:514-516.
17. Zar FA, Bakkanagari SR, Moorthi KM, Davis MB. 2007. A comparison of vancomycin and metronidazole for the treatment of Clostridium difficile- associated diarrhea, stratified by disease severity. Clin. Infect. Dis. 45: 302-307. http://dx.doi.org/10.1086/519265.
18. Burnham CA, Carroll KC. 2013. Diagnosis of Clostridium difficile infection: an ongoing conundrum for clinicians and for clinical laboratories. Clin. Microbiol. Rev. 26:604-630. http://dx.doi.org/10.1128/CMR.00016-13.
19. Goldenberg SD, Cliff PR, French GL. 2010. Laboratory diagnosis of Clostridium difficile infection. J. Clin. Microbiol. 48:3048-3049. http://dx.doi.org/10.1128/JCM.00223-10.
20. Kvach EJ, Ferguson D, Riska PF, Landry ML. 2010. Comparison of BD GeneOhm Cdiff real-timePCRassay with a two-step algorithm and a toxin A/B enzyme-linked immunosorbent assay for diagnosis of toxigenic Clostridium difficile infection. J. Clin. Microbiol. 48:109-114. http://dx.doi.org/10.1128/JCM.01630-09.
21. Swindells J, Brenwald N, Reading N, Oppenheim B. 2010. Evaluation of diagnostic tests for Clostridium difficile infection. J. Clin. Microbiol. 48: 606-608. http://dx.doi.org/10.1128/JCM.01579-09.