Portrait Toxigenic Clostridium difficile assay, an isothermal amplification assay detects toxigenic C. difficile in clinical stool specimens

References

• Voth DE, Ballard JD. Clostridium difficile toxins: mechanism of action and role in disease. Clin. Microbiol. Rev. 18, 247–263 (2005).
   PubMed Web of Science ®Google Scholar
• Viswanathan VK, Mallozzi MJ, Vedantam G. Clostridium difficile infection, an overview of the disease and its pathogenesis, epidemiology and interventions. Gut Microbes 1(4), 234–242 (2010).
   PubMedGoogle Scholar
• Kelly CP, LaMont JT. Clostridium difficile – more difficult than ever. N. Engl. Med. 359, 1932–1940 (2008).
   PubMed Web of Science ®Google Scholar
• Cohen SH, Gerding DN, Johnson S et al. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Disease Society of America (IDSA). Infect. Control Hosp. Epidemiol. 31, 431–455 (2010).
   PubMed Web of Science ®Google Scholar
• Dubberke ER, Han Z, Bobo L et al. Impact of clinical symptoms on interpretation of diagnostic assays for Clostridium difficile infections. J. Clin. Microbiol. 49, 2887–2893 (2011).
   PubMed Web of Science ®Google Scholar
• Riggs MM, Sethi AK, Zabarsky TF et al. Asymptomatic carriers are a potential source for transmission of epidemic and nonepidemic Clostridium difficile strains among long-term care facility residents. Clin. Infect. Dis. 45, 992–998(2007).
   PubMed Web of Science ®Google Scholar
• Bartlett JG, Gerding DN. Clinical recognition and diagnosis of Clostridium difficile infection. Clin. Infect. Dis. 46( Suppl. 1), S12–S18(2008).
   PubMed Web of Science ®Google Scholar
• Loo VG, Bourgault A-M, Poirier L et al. Host and pathogen factors for Clostridium difficile infection and colonization. N. Engl. J. Med. 365, 1693–1703 (2011).
   PubMed Web of Science ®Google Scholar
• Bartlett JG. Narrative review: the new epidemic of Clostridium difficile-associated enteric disease. Ann. Intern. Med. 145, 758–764 (2006).
   PubMed Web of Science ®Google Scholar
• Bauer MP, Notermans DW, van Benthem BH et al. ECDIS Study Group. Clostridium difficile infection in Europe: a hospital-based survey. Lancet 377, 63–73 (2011).
   PubMed Web of Science ®Google Scholar
• Carroll KC, Bartlett JG. Biology of Clostridium difficile: implications for epidemiology and diagnosis. Annu. Rev. Microbiol. 65, 501–521 (2011)
   PubMed Web of Science ®Google Scholar
• Freeman J, Bauer MP, Baines SD et al. The changing epidemiology of Clostridium difficile infections. Clin. Microbiol. Rev. 23(3), 529–549 (2010).
   PubMed Web of Science ®Google Scholar
• Kuijper EJ, Coignard B, Tull P et al. Emergence of Clostridium difficile associated disease in North America and Europe. Clin. Microbiol. Infect. 12, 2–18 (2006).
   PubMed Web of Science ®Google Scholar
• Pepin J, Valiquette L, Alary ME et al. Clostridium difficile-associated diarrhea in a region of Quebec from 1991 to 2003: a changing pattern of disease severity. CMAJ 171(5), 466–472 (2004).
   PubMed Web of Science ®Google Scholar
• Limbago BM, Long CM, Thompson AD et al. Clostridium difficile strains from community-associated infections. J. Clin. Microbiol. 47, 3004–3007 (2009).
   PubMed Web of Science ®Google Scholar
• Pituch H. Clostridium difficile is no longer just a nosocomial infection or an infection of adults. Int. J. Antimicrob. Agents 33, 42–45 (2009).
   Web of Science ®Google Scholar
• McFarland LV. Emerging therapies for Clostridium difficile infections. Expert Opin. Emerg. Drugs 16, 425–439 (2011).
   PubMed Web of Science ®Google Scholar
• O’Brien JA, Lahue BJ, Caro JJ et al. The emerging infectious challenge of Clostridium difficile-associated disease in Massachusetts hospitals: clinical and economic consequences. Infect. Control Hosp. Epidemiol. 28, 1219–1227 (2007).
   PubMed Web of Science ®Google Scholar
• Bauer MP, Kuijper EJ, van Dissel T. European Society of Clinical Microbiology and Infectious Diseases (ESCMID): treatment guidelines for Clostridium difficile infection (CDI). Clin. Microbiol. Infect. 15, 1067–1079 (2009).
   PubMed Web of Science ®Google Scholar
• Butler M, Bliss D, Drekonja D et al. Effectiveness of early diagnosis prevention and treatment of Clostridium difficile infection. (Internet) AHRQ Comparative Effectiveness Reviews. Dec. report No. 11(12)- EHCO51-EF (2011).
   Google Scholar
• Surawicz CM, Brandt LJ, Binion DG et al. Guidelines for diagnosis, treatment, and prevention of Clostridium difficile infections. Am. J. Gastroenterol. 108, 478–498 (2013).
   PubMed Web of Science ®Google Scholar
• CDC. Vital signs: preventing Clostridium difficile infection. MMWR Morb. Mortal Wkly Rep. 61(9), 157–162 (2012).
   Google Scholar
• Goorhuis A, Bakker D, Corver J et al. Emergence of Clostridium difficile infection due to a new hypervirulent strain, polymerase chain reaction type 078. Clin. Infect. Dis. 47, 1162–1170 (2008).
   PubMed Web of Science ®Google Scholar
• Akerland T, Persson I, Unemo M et al. Increased sporulation rate of epidemic Clostridium difficile type 027/NAP1. J. Clin. Microbiol. 46, 1530–1533 (2008).
   PubMedGoogle Scholar
• Blossom DB, McDonald LC. The challenges posed by reemerging Clostridium difficile infection. Clin. Infect. Dis. 45, 222–227 (2007).
   PubMed Web of Science ®Google Scholar
• McDonald LC, Killgore GE, Thompson A et al. An epidemic, toxin gene-variant strain of Clostridium difficile. N. Engl. J. Med. 353, 2433–2441 (2005).
   PubMed Web of Science ®Google Scholar
• Merrigan M, Venugopal A, Mallozzi M et al. Human hypervirulent Clostridium difficile strains exhibit increased sporulation as well as robust toxin production. J. Bacteriol. 192, 4904–4911 (2010).
   PubMed Web of Science ®Google Scholar
• Stabler RA, Dawson LF, Phua LT et al. Comparative analysis of BI/NAP1/027 hypervirulent strains reveals novel toxin B-encoding gene (tcdB) sequences. J. Med. Microbiol. 57, 771–775 (2008).
   PubMed Web of Science ®Google Scholar
• Wary M, Pepin J, Fang A et al. Toxin production by an emerging strain of Clostridium difficile associated with outbreaks of severe disease in North America and Europe. Lancet 366, 1079–1084 (2005).
   PubMedGoogle Scholar
• Burns DA, Heap JT, Minton NP. The diverse sporulation characteristics of Clostridium difficile clinical isolates are not associated with type. Anaerobe 16, 618–622 (2010).
   Google Scholar
• Oka K, Osaki T, Hanawa T et al. Molecular and microbiological characterization of Clostridium difficile isolates from single, relapse, and reinfection cases. J. Clin. Microbiol. 50, 915–921 (2012).
   PubMedGoogle Scholar
• Gerding DN, Johnson S. Does infection with specific Clostridium difficile strains or clades influence clinical outcome? Clin. Infect. Dis. 56, 1601–1603 (2013).
   PubMedGoogle Scholar
• Walk ST, Micic D, Jain R et al. Clostridium difficile ribotype does not predict severe infection. Clin. Infect. Dis. 55, 1661–1668 (2012).
   PubMed Web of Science ®Google Scholar
• Walker AS, Eyre DW, Wyllie DH et al. Relationship between bacterial strain type, host biomarkers, and mortality in Clostridium difficile infection. Clin. Infect. Dis. 56, 1589–1600 (2013).
   PubMed Web of Science ®Google Scholar
• Tenover FC, Novak-Weekley S, Woods CW et al. Impact on strain type on detection of toxigenic Clostridium difficile: comparison of molecular diagnostic and enzyme immunoassay approaches. J. Clin. Microbiol. 48, 3719–3724 (2010).
   PubMed Web of Science ®Google Scholar
• Waslawski S, Lo ES, Ewing SA et al. Clostridium difficile ribotype diversity at six health care institutions in the United States. J. Clin. Microbiol. 51, 1938–1941 (2013).
   PubMedGoogle Scholar
• Kim J, Pai H, Seo MR et al. Clinical and microbiologic characteristics of tcdA-negative variant Clostridium difficile infections. BMC Infect. Dis. 12, 109 (2012).
   PubMedGoogle Scholar
• Wilcox MH, Planche T, Fang FC. Point-Counterpoint: What is the role of algorithmic approaches for diagnosis of Clostridium difficile infection? J. Clin. Microbiol. 48, 4347–4353 (2010).
   PubMed Web of Science ®Google Scholar
• Burnham CA, Carroll KC. Diagnosis of Clostridium difficile infection: an ongoing conundrum for clinicians and for clinical laboratories. Clin. Microbiol. Rev. 26(3), 604–630 (2013).
   PubMed Web of Science ®Google Scholar
• Planche T, Wilcox M. Reference assays for Clostridium difficile infection: one or two gold standards? J. Clin. Pathol. 64, 1–5 (2011).
   PubMed Web of Science ®Google Scholar
• Lyerly DM, Krivan HC, Wilkins TD. Clostridium difficile: its disease and toxins. Clin. Microbiol. Rev. 1(1), 1–18 (1988).
   PubMedGoogle Scholar
• Hink T, Burnham CA, Dubberke ER. A systematic evaluation of methods to optimize culture-based recovery of Clostridium difficile from stool specimens. Anaerobe 19, 39–43 (2013).
   PubMed Web of Science ®Google Scholar
• Peterson LR, Robicsek A. Does my patient have Clostridium difficile infection? Ann. Intern. Med. 151, 176–179 (2009).
   PubMed Web of Science ®Google Scholar
• Stamper PD, Alcabasa R, Aird D et al. 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 (2009).
   PubMed Web of Science ®Google Scholar
• Eckert C, Burghoffer B, Lalande V et al. Evaluation of the chromogenic agar chromID C. difficile. J. Clin. Microbiol. 51, 1002–1004 (2013).
   PubMedGoogle Scholar
• Eastwood K, Else P, Charlett A, Wilcox M. Comparison of nine commercially available Clostridium difficile toxin detection assays, a real-time PCR assay for C. difficile, tcdB, and a glutamate dehydrogenase detection assay to cytotoxin testing and cytotoxigenic culture methods. J. Clin. Microbiol. 47, 3211–3217 (2009).
   PubMed Web of Science ®Google Scholar
• Longtin Y, Trottier S, Brochu G et al. Impact of the type of diagnostic assay on Clostridium difficile infection and complication rates in a mandatory reporting program. Clin. Infect. Dis. 56, 67–73(2013).
   PubMed Web of Science ®Google Scholar
• Kaltsas A, Simon M, Unruh LH et al. Clinical and laboratory characteristics of Clostridium difficile infection in patients with discordant diagnostic test results. J. Clin. Microbiol. 50, 1303–1307 (2012).
   PubMed Web of Science ®Google Scholar
• Cullbreath K, Ager E, Nemeyer RJ et al. Evolution of testing algorithms at a university hospital for detection of Clostridium difficile infections. J. Clin. Microbiol. 50, 3073–3076 (2012).
   PubMedGoogle Scholar
• Gilligan PH. Is a two-step glutamate dehydrogenase antigen-cytotoxicity neutralization assay algorithm superior to the premier toxin A and B enzyme immunoassay for laboratory detection of Clostridium difficile? J. Clin. Microbiol. 46, 1523–1525 (2008).
   PubMed Web of Science ®Google Scholar
• Novak-Weekley SM, Marlowe EM, Miller JM et al. Clostridium difficile testing in the clinical laboratory by use of multiple testing algorithms. J. Clin. Microbiol. 48(3), 889–893 (2010).
   PubMed Web of Science ®Google Scholar
• Reller ME, Lema CA, Peri TM et al. Yield of stool culture with isolate toxin testing versus a two-step algorithm including stool toxin testing for detection of toxigenic Clostridium difficile. J. Clin. Microbiol. 45, 3601–3605 (2007).
   PubMed Web of Science ®Google Scholar
• Ticehurst JR, Aird DZ, Dam LM et al. Effective detection of toxigenic by a two-step algorithm including tests for antigen and cytotoxin. J. Clin. Microbiol. 44, 1145–1149 (2006).
   PubMed Web of Science ®Google Scholar
• Larson, AM, Fung AM, Fang FC. Evaluation of tcdB real-time PCR in a three-step diagnostic algorithm for detection of toxigenic Clostridium difficile. J. Clin. Microbiol. 48, 124–130 (2010).
   PubMed Web of Science ®Google Scholar
• Shetty N, Wren MW, Coen PG. The role of glutamate dehydrogenase for the detection of Clostridium difficile in faecal samples: a meta-analysis. J. Hosp. Infect. 77, 1–6 (2011).
   PubMed Web of Science ®Google Scholar
• Kvach EJ, Ferguson D, Riska PF et al. Comparison of BD GeneOhm Cdiff real-time PCR assay 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 (2009).
   PubMedGoogle Scholar
• Peterson LR, Methta MS, Patel PA et al. Laboratory testing for Clostridium difficile infections: light at the end of the tunnel. Am. J. Clin. Path. 136, 372–380 (2011).
   PubMed Web of Science ®Google Scholar
• Terhes G, Urban E, Soki J et al. Comparison of a rapid molecular method, the BD GeneOhm Cdiff assay, to the most frequently used laboratory tests for detection of toxin-producing Clostridium difficile in diarrheal feces. J. Clin. Microbiol. 47, 3478–3481 (2009).
   PubMedGoogle Scholar
• Buchan BW, Mackey TL, Daly JA et al. 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(12), 3932–3936 (2012).
   PubMed Web of Science ®Google Scholar
• Le Guern R, Herwegh S, Grandbastien B et al. Evaluation of a new molecular test, the BD Max Cdiff, for detection of toxigenic Clostridium difficile in fecal samples. J. Clin. Microbiol. 50, 3089–3090 (2012).
   PubMed Web of Science ®Google Scholar
• Sunkesula VC, Kundrapu S, Muganda C et al. Does empirical Clostridium difficile infection (CDI) therapy result in false-negative CDI diagnostic test results? Clin. Infect. Dis. 57(4), 494–500 (2013).
   PubMed Web of Science ®Google Scholar
• Hicke B, Pasko C, Groves B et al. Automation detection of toxigenic Clostridium difficile in clinical samples: isothermal tcdB amplification coupled to array-based detection. J. Clin. Microbiol. 50(8), 2681–2687 (2012).
   PubMed Web of Science ®Google Scholar
• Chapin KC, Dickenson RA, Wu F et al. Comparison of five assays for detection of Clostridium difficile toxin. J. Mol. Diagn. 13, 395–400 (2011).
   PubMed Web of Science ®Google Scholar
• Pancholi P, Kelly C, Raczkowski M et al. Detection of toxigenic Clostridium difficile: comparison of the cell culture neutralization, Xpert C. difficile, Xpert C. difficile/Epi, and Illumigene C. difficile assays. J. Clin. Microbiol. 50, 1331–1335 (2012).
   PubMed Web of Science ®Google Scholar
• Swindells J, Brenwald N, Reading N et al. Evaluation of diagnostic tests for Clostridium difficile infection. J. Clin. Microbiol. 48, 606–608 (2010).
   PubMed Web of Science ®Google Scholar
• Viala C, Le Monnier A, Maataoui N et al. 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 (2012).
   PubMed Web of Science ®Google Scholar
• Catanzaro M, Cirone J. Real-time polymerase chain reaction testing Clostridium difficile reduces isolation time and improves patient management in a small community hospital. Am. J. Infect. Control 40, 663–666 (2012).
   PubMedGoogle Scholar
• Tenover FC, Baron EJ, Peterson LR et al. Laboratory diagnosis of Clostridium difficile infection: can molecular amplification methods move us out of uncertainty? J. Mol. Diagn. 13, 573–582 (2011).
   PubMed Web of Science ®Google Scholar
• Warny M, Pepin J, Fang A et al. Toxin production by an emerging strain of Clostridium difficile associated with outbreaks of severe disease in North America and Europe. Lancet 366, 1079–1084 (2005).
   PubMed Web of Science ®Google Scholar
• Louie TJ, Miller MA, Mullane et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N. Engl. J. Med. 364, 422–431 (2011).
   PubMed Web of Science ®Google Scholar
• Wilcox MH, Shetty N, Fawley WN et al. Changing epidemiology of Clostridium difficile infection following the introduction of a national ribotyping-based surveillance scheme in England. Clin. Infect. Dis. 55, 1056–1063 (2012).
   PubMed Web of Science ®Google Scholar
• Johnson S, Homann SR, Bettin KM et al. Treatment of asymptomatic Clostridium difficile carriers (fecal excretors) with vancomycin or metronidazole: a randomized, placebo-controlled trial. Ann. Intern. Med. 117, 297–302 (1992).
   PubMed Web of Science ®Google Scholar
• Bobo L, Dubberke, ER, Tarr P et al. Fecal activated protein kinase 2 elevation is significantly associated with human Clostridium difficile infection. Program and Abstracts of the 48^th Annual Meettingof the Infectious Disease Society of America. Arlington, VA, USA 2010 (Abstract 1415).
   Google Scholar
• Jiang ZD, DuPont HL, Garey K et al. A common polymorphism in the interleukin 8 gene promoter is associated with Clostridium difficile diarrhea. Am. J. Gastroenterol. 101, 1112–1116 (2006).
   PubMed Web of Science ®Google Scholar
• Steiner TS, Flores CA, Pizarro TT et al. Fecal lactoferrin, interleukin-1 beta, and interleukin-8 are elevated in patients with severe Clostridium difficile colitis. Clin. Diagn. Lab. Immunol. 4, 719–722 (1997).
   PubMedGoogle Scholar