Real-time cellular analysis coupled with a specimen enrichment accurately detects and quantifies clostridium difficile toxins in stool

Journal of Clinical Microbiology

Volumn 52, Issue 4, 2014, Pages 1105-1111

  Huang, Bin ^a,b   Jin, Dazhi ^b,c   Zhang, Jing ^d   Sun, Janet Y ^b   Wang, Xiaobo ^d   Stiles, Jeffrey ^b   Xu, Xiao ^d   Kamboj, Mini ^b,e   Babady, N Esther ^b   Tang, Yi Wei ^b,e  

^a SUN YAT SEN UNIVERSITY   (China)

^b MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^c ZHEJIANG PROVINCIAL CENTER FOR DISEASE CONTROL AND PREVENTION   (China)

^d ACEA Biosciences Inc   (United States)

^e WEILL CORNELL MEDICAL COLLEGE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BACTERIAL TOXIN; CLOSTRIDIUM DIFFICILE TOXIN; FIDAXOMICIN; METRONIDAZOLE; UNCLASSIFIED DRUG; VANCOMYCIN;

ADOLESCENT; ADULT; AGED; ARTICLE; BACTERIAL LOAD; BACTERIUM CULTURE; CHILD; CLOSTRIDIUM DIFFICILE INFECTION; CONTROLLED STUDY; DIAGNOSTIC ACCURACY; DIAGNOSTIC KIT; DIAGNOSTIC TEST ACCURACY STUDY; DIARRHEA; DISEASE SEVERITY; FECES ANALYSIS; FEMALE; HUMAN; IMMUNOASSAY; IMMUNOMAGNETIC SEPARATION ENRICHMENT; INTERMETHOD COMPARISON; LIMIT OF DETECTION; MAJOR CLINICAL STUDY; MALE; NONHUMAN; POLYMERASE CHAIN REACTION SYSTEM; PREDICTIVE VALUE; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; REAL TIME CELLULAR ANALYSIS; REAL TIME CELLULAR ANALYSIS SYSTEM; REAL TIME POLYMERASE CHAIN REACTION; SENSITIVITY AND SPECIFICITY; TOXIN ANALYSIS; CHEMISTRY; CLOSTRIDIUM INFECTIONS; FECES; IMMUNOMAGNETIC SEPARATION; ISOLATION AND PURIFICATION; MICROBIOLOGY; MIDDLE AGED; PEPTOCLOSTRIDIUM DIFFICILE; PRESCHOOL CHILD; PROCEDURES; TIME; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; BACTERIAL TOXINS; CHILD; CHILD, PRESCHOOL; CLOSTRIDIUM DIFFICILE; CLOSTRIDIUM INFECTIONS; FECES; FEMALE; HUMANS; IMMUNOMAGNETIC SEPARATION; MALE; MIDDLE AGED; PREDICTIVE VALUE OF TESTS; SENSITIVITY AND SPECIFICITY; TIME FACTORS; YOUNG ADULT;

EID: 84897005021     PISSN: 00951137     EISSN: 1098660X     Source Type: Journal    
DOI: 10.1128/JCM.02601-13     Document Type: Article

References (36)

1. Carroll KC, Bartlett JG. 2011. Biology of Clostridium difficile: implications for epidemiology and diagnosis. Annu. Rev. Microbiol. 65:501-521. http://dx.doi.org/10.1146/annurev-micro-090110-102824.
2. He M, Miyajima F, Roberts P, Ellison L, Pickard DJ, Martin MJ, Connor TR, Harris SR, Fairley D, Bamford KB, D'Arc S, Brazier J, Brown D, Coia JE, Douce G, Gerding D, Kim HJ, Koh TH, Kato H, Senoh M, Louie T, Michell S, Butt E, Peacock SJ, Brown NM, Riley T, Songer G, Wilcox M, Pirmohamed M, Kuijper E, Hawkey P, Wren BW, Dougan G, Parkhill J, Lawley TD. 2013. Emergence and global spread of epidemic healthcare-associated Clostridium difficile. Nat. Genet. 45:109-113. http://dx.doi.org/10.1038/ng.2478.
3. Wilcox MH, Planche T. 2009. Clostridium difficile infection. BMJ 338:b2528. http://dx.doi.org/10.1136/bmj.b2528.
4. Williams OM, Spencer RC. 2009. The management of Clostridium difficile infection. Br. Med. Bull. 91:87-110. http://dx.doi.org/10.1093/bmb/ldp021.
5. Chitnis AS, Holzbauer SM, Belflower RM, Winston LG, Bamberg WM, Lyons C, Farley MM, Dumyati GK, Wilson LE, Beldavs ZG, Dunn JR, Gould LH, Maccannell DR, Gerding DN, McDonald LC, Lessa FC. 2013. Epidemiology of community-associated Clostridium difficile infection, 2009 through 2011. JAMA Intern. Med. 173:1359-1367. http://dx.doi.org/10.1001/jamainternmed.2013.7056.
6. Freeman J, Bauer MP, Baines SD, Corver J, Fawley WN, Goorhuis B, Kuijper EJ, Wilcox MH. 2010. The changing epidemiology of Clostridium difficile infections. Clin. Microbiol. Rev. 23:529-549. http://dx.doi.org/10.1128/CMR. 00082-09.
7. Rupnik M, Wilcox MH, Gerding DN. 2009. Clostridium difficile infection: new developments in epidemiology and pathogenesis. Nat. Rev. Microbiol. 7:526-536. http://dx.doi.org/10.1038/nrmicro2164.
8. 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.
9. Bamber AI, Fitzsimmons K, Cunniffe JG, Beasor CC, Mackintosh CA, Hobbs G. 2012. Diagnosis of Clostridium difficile-associated disease: examination of multiple algorithms using toxin EIA, glutamate dehydrogenase EIA and loop-mediated isothermal amplification. Br. J. Biomed. Sci. 69:112-118.
10. 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.
11. Hoegh AM, Nielsen JB, Lester A, Friis-Moller A, Schonning K. 2012. A multiplex, internally controlled real-time PCR assay for detection of toxigenic Clostridium difficile and identification of hypervirulent strain 027/ ST-1. Eur. J. Clin. Microbiol. Infect. Dis. 31:1073-1079. http://dx.doi.org/10.1007/ s10096-011-1409-5.
12. Kelly CP, LaMont JT. 2008. Clostridium difficile-more difficult than ever. N. Engl. J. Med. 359:1932-1940. http://dx.doi.org/10.1056/NEJMra0707500.
13. Knetsch CW, Bakker D, de Boer RF, Sanders I, Hofs S, Kooistra-Smid AM, Corver J, Eastwood K, Wilcox MH, Kuijper EJ. 2011. Comparison of real-time PCR techniques to cytotoxigenic culture methods for diagnosing Clostridium difficile infection. J. Clin. Microbiol. 49:227-231. http://dx.doi.org/10.1128/JCM.01743- 10.
14. Wren MW, Kinson R, Sivapalan M, Shemko M, Shetty NR. 2009. Detection of Clostridium difficile infection: a suggested laboratory diagnostic algorithm. Br. J. Biomed. Sci. 66:175-179.
15. Babady NE, Stiles J, Ruggiero P, Khosa P, Huang D, Shuptar S, Kamboj M, Kiehn TE. 2010. Evaluation of the Cepheid Xpert Clostridium difficile Epi assay for diagnosis of Clostridium difficile infection and typing of the NAP1 strain at a cancer hospital. J. Clin. Microbiol. 48:4519-4524. http://dx.doi.org/10. 1128/JCM.01648-10.
16. Pancholi P, Kelly C, Raczkowski M, Balada-Llasat JM. 2012. 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. http://dx.doi.org/10.1128/JCM.06597-11.
17. 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.
18. Jangi S, Lamont JT. 2010. Asymptomatic colonization by Clostridium difficile in infants: implications for disease in later life. J. Pediatr. Gastroenterol. Nutr. 51:2-7. http://dx.doi.org/10.1097/MPG.0b013e3181d29767.
19. Surawicz CM, Brandt LJ, Binion DG, Ananthakrishnan AN, Curry SR, Gilligan PH, McFarland LV, Mellow M, Zuckerbraun BS. 2013. Guidelines for diagnosis, treatment, and prevention of Clostridium difficile infections. Am. J. Gastroenterol. 108:478-498; quiz 499. http://dx.doi.org/10.1038/ajg.2013.4.
20. Brecher SM, Novak-Weekley SM, Nagy E. 2013. Laboratory diagnosis of Clostridium difficile infections: there is light at the end of the colon. Clin. Infect. Dis. 57:1175-1181. http://dx.doi.org/10.1093/cid/cit424.
21. Planche TD, Davies KA, Coen PG, Finney JM, Monahan IM, Morris KA, O'Connor L, Oakley SJ, Pope CF, Wren MW, Shetty NP, Crook DW, Wilcox MH. 2013. Differences in outcome according to Clostridium difficile testing method: a prospective multicentre diagnostic validation study of C difficile infection. Lancet Infect. Dis. 13:936-945. http://dx.doi.org/10.1016/S1473-3099(13)70200-7.
22. Leslie JL, Cohen SH, Solnick JV, Polage CR. 2012. Role of fecal Clostridium difficile load in discrepancies between toxin tests and PCR: is quantitation the next step in C. difficile testing? Eur. J. Clin. Microbiol. Infect. Dis. 31:3295-3299. http://dx.doi.org/10.1007/s10096-012-1695-6.
23. Ryder AB, Huang Y, Li H, Zheng M, Wang X, Stratton CW, Xu X, Tang YW. 2010. Assessment of Clostridium difficile infections by quantitative detection of tcdB toxin by use of a real-time cell analysis system. J. Clin. Microbiol. 48:4129-4134. http://dx.doi.org/10.1128/JCM.01104-10.
24. Atienza JM, Zhu J, Wang X, Xu X, Abassi Y. 2005. Dynamic monitoring of cell adhesion and spreading on microelectronic sensor arrays. J. Biomol. Screen. 10:795-805. http://dx.doi.org/10.1177/1087057105279635. (Pubitemid 41818155)
25. Solly K, Wang X, Xu X, Strulovici B, Zheng W. 2004. Application of real-time cell electronic sensing (RT-CES) technology to cell-based assays. Assay Drug Dev. Technol. 2:363-372. http://dx.doi.org/10.1089/adt.2004.2.363. (Pubitemid 39276278)
26. Larson AM, Fung AM, Fang FC. 2010. Evaluation of tcdB real-time PCR in a three-step diagnostic algorithm for detection of toxigenic Clostridium difficile. J. Clin. Microbiol. 48:124-130. http://dx.doi.org/10.1128/JCM.00734- 09.
27. Chang CH, Lai ZX, Lin HL, Yang CC, Chen HH, Yang SY, Horng HE, Hong CY, Yang HC, Lin HC. 2012. Use of immunomagnetic reduction for C-reactive protein assay in clinical samples. Int. J. Nanomedicine 7:4335-4340. http://dx.doi.org/10.2147/IJN.S31030.
28. Cheng HY, Lai LJ, Ko FH. 2012. Rapid and sensitive detection of rare cancer cells by the coupling of immunomagnetic nanoparticle separation with ELISA analysis. Int. J. Nanomedicine 7:2967-2973. http://dx.doi.org/10.2147/IJN. S32240.
29. Kekarainen T, Mannelin S, Laine J, Jaatinen T. 2006. Optimization of immunomagnetic separation for cord blood-derived hematopoietic stem cells. BMC Cell Biol. 7:30. http://dx.doi.org/10.1186/1471-2121-7-30.
30. Boone JH, Goodykoontz M, Rhodes SJ, Price K, Smith J, Gearhart KN, Carman RJ, Kerkering TM, Wilkins TD, Lyerly DM. 2012. Clostridium difficile prevalence rates in a large healthcare system stratified according to patient population, age, gender, and specimen consistency. Eur. J. Clin. Microbiol. Infect. Dis. 31:1551-1559. http://dx.doi.org/10.1007/s10096-011-1477-6.
31. O'Connor D, Hynes P, Cormican M, Collins E, Corbett-Feeney G, Cassidy M. 2001. Evaluation of methods for detection of toxins in specimens of feces submitted for diagnosis of Clostridium difficile-associated diarrhea. J. Clin. Microbiol. 39:2846-2849. http://dx.doi.org/10.1128/JCM.39.8.2846-2849.2001. (Pubitemid 32743999)
32. Fenner L, Widmer AF, Goy G, Rudin S, Frei R. 2008. Rapid and reliable diagnostic algorithm for detection of Clostridium difficile. J. Clin. Microbiol. 46:328-330. http://dx.doi.org/10.1128/JCM.01503-07.
33. Wilcox MH. 2012. Overcoming barriers to effective recognition and diagnosis of Clostridium difficile infection. Clin. Microbiol. Infect. 18(Suppl 6):13-20. http://dx.doi.org/10.1111/1469-0691.12057.
34. Tian D, Zhang W, He J, Liu Y, Song Z, Zhou Z, Zheng M, Hu Y. 2012. Novel, real-time cell analysis for measuring viral cytopathogenesis and the efficacy of neutralizing antibodies to the 2009 influenza A (H1N1) virus. PLoS One 7:e31965. http://dx.doi.org/10.1371/journal.pone.0031965.
35. Xing JZ, Zhu L, Gabos S, Xie L. 2006. Microelectronic cell sensor assay for detection of cytotoxicity and prediction of acute toxicity. Toxicol. In Vitro 20:995-1004. http://dx.doi.org/10.1016/j.tiv.2005.12.008. (Pubitemid 43959842)
36. Xing JZ, Zhu L, Jackson JA, Gabos S, Sun XJ, Wang XB, Xu X. 2005. Dynamic monitoring of cytotoxicity on microelectronic sensors. Chem. Res. Toxicol. 18:154-161. http://dx.doi.org/10.1021/tx049721s. (Pubitemid 40256233)