Nonutility of Repeat Laboratory Testing for Detection of
            <i>Clostridium difficile</i>
            by Use of PCR or Enzyme Immunoassay

Aichinger, Elisabeth; Schleck, Cathy D.; Harmsen, William S.; Nyre, Lisa M.; Patel, Robin

doi:10.1128/jcm.00684-08

Cited by 112 publications

(72 citation statements)

References 15 publications

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“…It has been previously shown that repeating C. difficile PCR in patients with a prior negative result rarely yields new information (3,4). In this study, this observation was extended to a panel of pathogens detected by the FilmArray GI panel.…”

Section: Discussionmentioning

confidence: 81%

“…What remains to be determined is the utility of follow-up testing with the FilmArray GI panel when the initial result is negative. Prior studies on Clostridium difficile have shown that follow-up testing within 7 days of a negative result rarely yields new information (3,4), and it was hypothesized that, in a similar fashion, repetition of the FilmArray GI panel following an initial negative result would be of limited clinical utility. The main aim of this retrospective study was to investigate the value of follow-up testing with FilmArray GI panel within 4 weeks when the initial result is negative, although the yield of follow-up testing after an initial positive result was also investigated.…”

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confidence: 99%

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Is Follow-Up Testing with the FilmArray Gastrointestinal Multiplex PCR Panel Necessary?

et al. 2017

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The FilmArray gastrointestinal (GI) panel (BioFire Diagnostics, Salt Lake City, UT) is a simple, sample-to-answer, on-demand, multiplex, nucleic acid amplification test for syndromic diagnosis of infectious gastroenteritis. The aim of this study was to measure the yield of follow-up testing with FilmArray GI panel within 4 weeks of an initial test. Consecutive adult and pediatric patients tested at an academic institution between August 2015 and June 2016 were included in this study. Of 145 follow-up tests in 106 unique patients with an initial negative result, 134 (92.4%) tests and 98 (92.5%) patients remained negative upon follow-up testing. Excluding targets that are not reported at this institution (Clostridium difficile, enteroaggregative Escherichia coli, enteropathogenic E. coli, and enterotoxigenic E. coli), 137 (94.5%) follow-up tests and 101 (95.3%) patients remained negative. Weekly conversion rates were not significantly different across the 4-week follow-up interval. No epidemiological or clinical factors were significantly associated with a negative to positive conversion. Of 80 follow-up tests in patients with an initial positive result, 43 (53.8%) remained positive for the same target, 34 (42.5%) were negative, and 3 were positive for a different target (3.8%). Follow-up testing with FilmArray GI panel within 4 weeks of a negative result rarely changed the initial result, and the follow-up test reverted to negative less than half the time after an initial positive result. In the absence of clinical or epidemiological evidence for a new infection, follow-up testing should be limited and FilmArray GI panel should not be used as a test of cure.

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Section: Discussionmentioning

confidence: 81%

mentioning

confidence: 99%

Is Follow-Up Testing with the FilmArray Gastrointestinal Multiplex PCR Panel Necessary?

et al. 2017

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“…However, in our analysis, no correlation was found between the number of stools per day and the EIA result (Table 3). Furthermore, repeat testing in two or more additional stool specimens by EIA does not result in an appreciable improvement in this test's sensitivity (17)(18)(19), suggesting that intermittent toxin shedding is not the basis for false-negative results. We evaluated specimens for postzone effect as a third possible cause of false-negative EIA results, but dilution and retesting of EIA-negative/NAAT-positive specimens did not yield any increase in EIA sensitivity.…”

Section: Discussionmentioning

confidence: 99%

Performance of Clostridium difficile Toxin Enzyme Immunoassay and Nucleic Acid Amplification Tests Stratified by Patient Disease Severity

2013

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bMany clinical laboratories in the United States are transitioning from toxin enzyme immunoassays (EIA) to nucleic acid amplification tests (NAATs) as the primary diagnostic test for Clostridium difficile infection (CDI). While it is known that the analytical sensitivity of the toxin EIA is poor, there are limited clinical data on the performance of these assays for patients with mild or severe CDI. Two hundred ninety-six hospital inpatients with diarrhea and clinical suspicion for CDI were tested prospectively by toxin EIA, by C. difficile NAAT, and with a reference standard toxigenic culture. Following completion of laboratory testing, retrospective chart reviews were performed to stratify patients into mild and severe disease groups based on clinical criteria using a standard point-based system. One hundred forty-three patients with CDI confirmed by toxigenic culture were evaluated in this study. Among the patients with mild CDI, 49% tested positive by toxin EIA and 98% tested positive by NAAT. Among patients with severe CDI, 58% tested positive by toxin EIA and 98% tested positive by NAAT. Increased CDI disease severity was not associated with an increased sensitivity of EIA (P ‫؍‬ 0.31). These data demonstrate that toxin EIA performs poorly both for patients with severe CDI and for those with mild CDI and support the routine use of NAAT for the diagnosis of CDI. The presence of stool toxin measured by EIA does not correlate with disease severity.

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“…However, Renshaw et al [73] suggested that repeated assays accounted for 36% of all toxin assays ordered, but provided clinically useful information in only 1% of the cases and significantly increased cost. Aichinger et al [74] found that repeat testing within 7 d by EIA for toxin A/B or by PCR for C. difficile toxin resulted in < 2% positive tests. In another study, repeat testing accounted for 17% of all tests ordered, but only 1% were positive [75] .…”

Section: Laboratory Diagnosis Of CDImentioning

confidence: 99%

Clinical update for the diagnosis and treatment ofClostridium difficileinfection

Oldfield

Johnson

2014

WJGPT

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Clostridium difficile infection (CDI) presents a rapidly evolving challenge in the battle against hospitalacquired infections. Recent advances in CDI diagnosis and management include rapid changes in diagnostic approach with the introduction of newer tests, such as detection of glutamate dehydrogenase in stool and polymerase chain reaction to detect the gene for toxin production, which will soon revolutionize the diagnostic approach to CDI. New medications and multiple medical society guidelines have introduced changing concepts in the definitions of severity of CDI and the choice of therapeutic agents, while rapid expansion of data on the efficacy of fecal microbiota transplantation heralds a revolutionary change in the management of patients suffering multiple relapses of CDI. Through a comprehensive review of current medical literature, this article aims to offer an intensive review of the current state of CDI diagnosis, discuss the strengths and limitations of available laboratory tests, compare both current and future treatments options and offer recommendations for best practice strategies.

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Nonutility of Repeat Laboratory Testing for Detection of Clostridium difficile by Use of PCR or Enzyme Immunoassay

Cited by 112 publications

References 15 publications

Is Follow-Up Testing with the FilmArray Gastrointestinal Multiplex PCR Panel Necessary?

Is Follow-Up Testing with the FilmArray Gastrointestinal Multiplex PCR Panel Necessary?

Performance of Clostridium difficile Toxin Enzyme Immunoassay and Nucleic Acid Amplification Tests Stratified by Patient Disease Severity

Clinical update for the diagnosis and treatment ofClostridium difficileinfection

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