Impact of strain type on detection of toxigenic Clostridium difficile: Comparison of molecular diagnostic and enzyme immunoassay approaches

Fred C. Tenover, Susan Novak-Weekley, Christopher W. Woods, Lance R. Peterson, Thomas Davis, Paul Schreckenberger, Ferric C. Fang, Andre Dascal, Dale N. Gerding, Jim H. Nomura, Richard V. Goering, Thomas Akerlund, Alice S. Weissfeld, Ellen Jo Baron, Edith Wong, Elizabeth M. Marlowe, Joseph Whitmore, David H. Persing

Research output: Contribution to journalArticle

146 Citations (Scopus)

Abstract

A multicenter clinical trial assessed the performance of the Cepheid Xpert C. difficile assay on stool specimens collected from patients suspected of having Clostridium difficile infection (CDI). A total of 2,296 unformed stool specimens, collected from seven study sites, were tested by Xpert C. difficile enrichment culture followed by cell culture cytotoxicity testing of the isolates (i.e., toxigenic culture with enrichment) and the study sites' standard C. difficile test methods. The methods included enzyme immunoassay (EIA), direct cytotoxin testing, and two- and three-step algorithms using glutamate dehydrogenase (GDH) screening followed by either EIA or EIA and an in-house PCR assay. All C. difficile strains were typed by PCR-ribotyping. Compared to results for toxigenic culture with enrichment, the sensitivity, specificity, and positive and negative predictive values of the Xpert assay were 93.5, 94.0, 73.0, and 98.8%, respectively. The overall sensitivity of the EIAs compared to that of enrichment culture was 60.0%, and the sensitivity of combined GDH algorithms was 72.9%; both were significantly lower than that of Xpert C. difficile (P <0.001 and P = 0.03, respectively). The sensitivity of the EIA was significantly lower than that of the Xpert C. difficile assay for detection of ribotypes 002, 027, and 106 (P <0.0001, P <0.0001, and P = 0.004, respectively, Fisher's exact test), and the sensitivity of GDH algorithms for ribotypes other than 027 was lower than that for Xpert C. difficile (P <0.001). The Xpert C. difficile assay is a simple, rapid, and accurate method for detection of toxigenic C. difficile in unformed stool specimens and is minimally affected by strain type compared to EIA and GDH-based methods.

Original languageEnglish
Pages (from-to)3719-3724
Number of pages6
JournalJournal of Clinical Microbiology
Volume48
Issue number10
DOIs
StatePublished - Oct 2010

Fingerprint

Molecular Pathology
Clostridium difficile
Immunoenzyme Techniques
Glutamate Dehydrogenase
Ribotyping
Clostridium Infections
Polymerase Chain Reaction
Cytotoxins
Multicenter Studies
Cell Culture Techniques
Clinical Trials
Sensitivity and Specificity

All Science Journal Classification (ASJC) codes

  • Microbiology (medical)

Cite this

Tenover, F. C., Novak-Weekley, S., Woods, C. W., Peterson, L. R., Davis, T., Schreckenberger, P., ... Persing, D. H. (2010). Impact of strain type on detection of toxigenic Clostridium difficile: Comparison of molecular diagnostic and enzyme immunoassay approaches. Journal of Clinical Microbiology, 48(10), 3719-3724. https://doi.org/10.1128/JCM.00427-10

Impact of strain type on detection of toxigenic Clostridium difficile : Comparison of molecular diagnostic and enzyme immunoassay approaches. / Tenover, Fred C.; Novak-Weekley, Susan; Woods, Christopher W.; Peterson, Lance R.; Davis, Thomas; Schreckenberger, Paul; Fang, Ferric C.; Dascal, Andre; Gerding, Dale N.; Nomura, Jim H.; Goering, Richard V.; Akerlund, Thomas; Weissfeld, Alice S.; Baron, Ellen Jo; Wong, Edith; Marlowe, Elizabeth M.; Whitmore, Joseph; Persing, David H.

In: Journal of Clinical Microbiology, Vol. 48, No. 10, 10.2010, p. 3719-3724.

Research output: Contribution to journalArticle

Tenover, FC, Novak-Weekley, S, Woods, CW, Peterson, LR, Davis, T, Schreckenberger, P, Fang, FC, Dascal, A, Gerding, DN, Nomura, JH, Goering, RV, Akerlund, T, Weissfeld, AS, Baron, EJ, Wong, E, Marlowe, EM, Whitmore, J & Persing, DH 2010, 'Impact of strain type on detection of toxigenic Clostridium difficile: Comparison of molecular diagnostic and enzyme immunoassay approaches', Journal of Clinical Microbiology, vol. 48, no. 10, pp. 3719-3724. https://doi.org/10.1128/JCM.00427-10
Tenover, Fred C. ; Novak-Weekley, Susan ; Woods, Christopher W. ; Peterson, Lance R. ; Davis, Thomas ; Schreckenberger, Paul ; Fang, Ferric C. ; Dascal, Andre ; Gerding, Dale N. ; Nomura, Jim H. ; Goering, Richard V. ; Akerlund, Thomas ; Weissfeld, Alice S. ; Baron, Ellen Jo ; Wong, Edith ; Marlowe, Elizabeth M. ; Whitmore, Joseph ; Persing, David H. / Impact of strain type on detection of toxigenic Clostridium difficile : Comparison of molecular diagnostic and enzyme immunoassay approaches. In: Journal of Clinical Microbiology. 2010 ; Vol. 48, No. 10. pp. 3719-3724.
@article{f2dfdf3f8cfd4dcd9555899d1a603604,
title = "Impact of strain type on detection of toxigenic Clostridium difficile: Comparison of molecular diagnostic and enzyme immunoassay approaches",
abstract = "A multicenter clinical trial assessed the performance of the Cepheid Xpert C. difficile assay on stool specimens collected from patients suspected of having Clostridium difficile infection (CDI). A total of 2,296 unformed stool specimens, collected from seven study sites, were tested by Xpert C. difficile enrichment culture followed by cell culture cytotoxicity testing of the isolates (i.e., toxigenic culture with enrichment) and the study sites' standard C. difficile test methods. The methods included enzyme immunoassay (EIA), direct cytotoxin testing, and two- and three-step algorithms using glutamate dehydrogenase (GDH) screening followed by either EIA or EIA and an in-house PCR assay. All C. difficile strains were typed by PCR-ribotyping. Compared to results for toxigenic culture with enrichment, the sensitivity, specificity, and positive and negative predictive values of the Xpert assay were 93.5, 94.0, 73.0, and 98.8{\%}, respectively. The overall sensitivity of the EIAs compared to that of enrichment culture was 60.0{\%}, and the sensitivity of combined GDH algorithms was 72.9{\%}; both were significantly lower than that of Xpert C. difficile (P <0.001 and P = 0.03, respectively). The sensitivity of the EIA was significantly lower than that of the Xpert C. difficile assay for detection of ribotypes 002, 027, and 106 (P <0.0001, P <0.0001, and P = 0.004, respectively, Fisher's exact test), and the sensitivity of GDH algorithms for ribotypes other than 027 was lower than that for Xpert C. difficile (P <0.001). The Xpert C. difficile assay is a simple, rapid, and accurate method for detection of toxigenic C. difficile in unformed stool specimens and is minimally affected by strain type compared to EIA and GDH-based methods.",
author = "Tenover, {Fred C.} and Susan Novak-Weekley and Woods, {Christopher W.} and Peterson, {Lance R.} and Thomas Davis and Paul Schreckenberger and Fang, {Ferric C.} and Andre Dascal and Gerding, {Dale N.} and Nomura, {Jim H.} and Goering, {Richard V.} and Thomas Akerlund and Weissfeld, {Alice S.} and Baron, {Ellen Jo} and Edith Wong and Marlowe, {Elizabeth M.} and Joseph Whitmore and Persing, {David H.}",
year = "2010",
month = "10",
doi = "10.1128/JCM.00427-10",
language = "English",
volume = "48",
pages = "3719--3724",
journal = "Journal of Clinical Microbiology",
issn = "0095-1137",
publisher = "American Society for Microbiology",
number = "10",

}

TY - JOUR

T1 - Impact of strain type on detection of toxigenic Clostridium difficile

T2 - Comparison of molecular diagnostic and enzyme immunoassay approaches

AU - Tenover, Fred C.

AU - Novak-Weekley, Susan

AU - Woods, Christopher W.

AU - Peterson, Lance R.

AU - Davis, Thomas

AU - Schreckenberger, Paul

AU - Fang, Ferric C.

AU - Dascal, Andre

AU - Gerding, Dale N.

AU - Nomura, Jim H.

AU - Goering, Richard V.

AU - Akerlund, Thomas

AU - Weissfeld, Alice S.

AU - Baron, Ellen Jo

AU - Wong, Edith

AU - Marlowe, Elizabeth M.

AU - Whitmore, Joseph

AU - Persing, David H.

PY - 2010/10

Y1 - 2010/10

N2 - A multicenter clinical trial assessed the performance of the Cepheid Xpert C. difficile assay on stool specimens collected from patients suspected of having Clostridium difficile infection (CDI). A total of 2,296 unformed stool specimens, collected from seven study sites, were tested by Xpert C. difficile enrichment culture followed by cell culture cytotoxicity testing of the isolates (i.e., toxigenic culture with enrichment) and the study sites' standard C. difficile test methods. The methods included enzyme immunoassay (EIA), direct cytotoxin testing, and two- and three-step algorithms using glutamate dehydrogenase (GDH) screening followed by either EIA or EIA and an in-house PCR assay. All C. difficile strains were typed by PCR-ribotyping. Compared to results for toxigenic culture with enrichment, the sensitivity, specificity, and positive and negative predictive values of the Xpert assay were 93.5, 94.0, 73.0, and 98.8%, respectively. The overall sensitivity of the EIAs compared to that of enrichment culture was 60.0%, and the sensitivity of combined GDH algorithms was 72.9%; both were significantly lower than that of Xpert C. difficile (P <0.001 and P = 0.03, respectively). The sensitivity of the EIA was significantly lower than that of the Xpert C. difficile assay for detection of ribotypes 002, 027, and 106 (P <0.0001, P <0.0001, and P = 0.004, respectively, Fisher's exact test), and the sensitivity of GDH algorithms for ribotypes other than 027 was lower than that for Xpert C. difficile (P <0.001). The Xpert C. difficile assay is a simple, rapid, and accurate method for detection of toxigenic C. difficile in unformed stool specimens and is minimally affected by strain type compared to EIA and GDH-based methods.

AB - A multicenter clinical trial assessed the performance of the Cepheid Xpert C. difficile assay on stool specimens collected from patients suspected of having Clostridium difficile infection (CDI). A total of 2,296 unformed stool specimens, collected from seven study sites, were tested by Xpert C. difficile enrichment culture followed by cell culture cytotoxicity testing of the isolates (i.e., toxigenic culture with enrichment) and the study sites' standard C. difficile test methods. The methods included enzyme immunoassay (EIA), direct cytotoxin testing, and two- and three-step algorithms using glutamate dehydrogenase (GDH) screening followed by either EIA or EIA and an in-house PCR assay. All C. difficile strains were typed by PCR-ribotyping. Compared to results for toxigenic culture with enrichment, the sensitivity, specificity, and positive and negative predictive values of the Xpert assay were 93.5, 94.0, 73.0, and 98.8%, respectively. The overall sensitivity of the EIAs compared to that of enrichment culture was 60.0%, and the sensitivity of combined GDH algorithms was 72.9%; both were significantly lower than that of Xpert C. difficile (P <0.001 and P = 0.03, respectively). The sensitivity of the EIA was significantly lower than that of the Xpert C. difficile assay for detection of ribotypes 002, 027, and 106 (P <0.0001, P <0.0001, and P = 0.004, respectively, Fisher's exact test), and the sensitivity of GDH algorithms for ribotypes other than 027 was lower than that for Xpert C. difficile (P <0.001). The Xpert C. difficile assay is a simple, rapid, and accurate method for detection of toxigenic C. difficile in unformed stool specimens and is minimally affected by strain type compared to EIA and GDH-based methods.

UR - http://www.scopus.com/inward/record.url?scp=77957773862&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=77957773862&partnerID=8YFLogxK

U2 - 10.1128/JCM.00427-10

DO - 10.1128/JCM.00427-10

M3 - Article

C2 - 20702676

AN - SCOPUS:77957773862

VL - 48

SP - 3719

EP - 3724

JO - Journal of Clinical Microbiology

JF - Journal of Clinical Microbiology

SN - 0095-1137

IS - 10

ER -