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High Proportion of False-Positive Clostridium difficile Enzyme Immunoassays for Toxin A and B in Pediatric Patients

Published online by Cambridge University Press:  02 January 2015

Philip Toltzis ,
Michelle M. Nerandzic ,
Elie Saade ,
Mary Ann O'Riordan ,
Sarah Smathers ,
Theoklis Zaoutis ,
Jason Kim  and
Curtis J. Donskey
Philip Toltzis*
Affiliation:
Rainbow Babies and Children's Hospital, Cleveland, Ohio
Michelle M. Nerandzic
Affiliation:
Research Service, Cleveland VA Medical Center, Cleveland, Ohio
Elie Saade
Affiliation:
Research Service, Cleveland VA Medical Center, Cleveland, Ohio
Mary Ann O'Riordan
Affiliation:
Rainbow Babies and Children's Hospital, Cleveland, Ohio
Sarah Smathers
Affiliation:
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
Theoklis Zaoutis
Affiliation:
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
Jason Kim
Affiliation:
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
Curtis J. Donskey
Affiliation:
Geriatric Research, Education and Clinical Center, Cleveland, Ohio
*
Division of Pharmacology and Critical Care, Rainbow Babies and Children's Hospital, 11100 Euclid Avenue, Cleveland, OH 44106 (pxt2@case.edu)
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Abstract

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.

Infect Control Hosp Epidemiol 2012;33(2):175-179

Type
Original Articles
Information
Infection Control & Hospital Epidemiology , Volume 33 , Issue 2 , February 2012 , pp. 175 - 179
Copyright
Copyright © The Society for Healthcare Epidemiology of America 2012

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