Document Detail

High Proportion of False-Positive Clostridium difficile Enzyme Immunoassays for Toxin A and B in Pediatric Patients.
MedLine Citation:
PMID:  22227987     Owner:  NLM     Status:  In-Data-Review    
Objectives. To determine the frequency of false-positive Clostridium difficile toxin enzyme immunoassay (EIA) results in hospitalized children and to examine potential reasons for this false positivity. Design. Nested case-control. Setting. Two tertiary care pediatric hospitals. Methods. As part of a natural history study, prospectively collected EIA-positive stools were cultured for toxigenic C. difficile, and characteristics of children with false-positive and true-positive EIA results were compared. EIA-positive/culture-negative samples were recultured after dilution and enrichment steps, were evaluated for presence of the tcdB gene by polymerase chain reaction (PCR), and were further cultured for Clostridium sordellii, a cause of false-positive EIA toxin assays. Results. Of 112 EIA-positive stools cultured, 72 grew toxigenic C. difficile and 40 did not, indicating a positive predictive value of 64% in this population. The estimated prevalence of C. difficile infection (CDI) in the study sites among children tested for this pathogen was 5%-7%. Children with false-positive EIA results were significantly younger than those with true-positive tests but did not differ in other characteristics. No false-positive specimens yielded C. difficile when cultured after enrichment or serial dilution, 1 specimen was positive for tcdB by PCR, and none grew C. sordellii. Conclusions. Approximately one-third of EIA tests used to evaluate pediatric inpatients for CDI were falsely positive. This finding was likely due to the low prevalence of CDI in pediatric hospitals, which diminishes the test's positive predictive value. These data raise concerns about the use of EIA assays to diagnosis CDI in children.
Philip Toltzis; Michelle M Nerandzic; Elie Saade; Mary Ann O'Riordan; Sarah Smathers; Theoklis Zaoutis; Jason Kim; Curtis J Donskey
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Publication Detail:
Type:  Journal Article     Date:  2011-12-20
Journal Detail:
Title:  Infection control and hospital epidemiology : the official journal of the Society of Hospital Epidemiologists of America     Volume:  33     ISSN:  1559-6834     ISO Abbreviation:  Infect Control Hosp Epidemiol     Publication Date:  2012 Feb 
Date Detail:
Created Date:  2012-01-09     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8804099     Medline TA:  Infect Control Hosp Epidemiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  175-9     Citation Subset:  IM; N    
Rainbow Babies and Children's Hospital, Cleveland, Ohio.
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