Is Repeat PCR Needed for Diagnosis of
            <i>Clostridium difficile</i>
            Infection?

Luo, Robert; Banaei, Niaz

doi:10.1128/jcm.00722-10

Cited by 64 publications

(35 citation statements)

References 21 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: 80%

“…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: 80%

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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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“…(Conditional recommendation, moderate-quality evidence) 31. Routine screening for C. diffi cile in hospitalized patients without diarrhea is not recommended and asymptomatic carriers should not be treated.…”

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Guidelines for Diagnosis, Treatment, and Prevention of Clostridium difficile Infections

Surawicz

Brandt

Binion

et al. 2013

American Journal of Gastroenterology

1,478

1,408

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Clostridium diffi cile infection (CDI) is a leading cause of hospital-associated gastrointestinal illness and places a high burden on our health-care system. Patients with CDI typically have extended lengths-of-stay in hospitals, and CDI is a frequent cause of large hospital outbreaks of disease. This guideline provides recommendations for the diagnosis and management of patients with CDI as well as for the prevention and control of outbreaks while supplementing previously published guidelines. New molecular diagnostic stool tests will likely replace current enzyme immunoassay tests. We suggest treatment of patients be stratifi ed depending on whether they have mild-to-moderate, severe, or complicated disease. Therapy with metronidazole remains the choice for mildto-moderate disease but may not be adequate for patients with severe or complicated disease. We propose a classifi cation of disease severity to guide therapy that is useful for clinicians. We review current treatment options for patients with recurrent CDI and recommendations for the control and prevention of outbreaks of CDI. Am J Gastroenterol 2013; 108:478-498; doi: 10.1038/ajg.2013 12. In patients in whom oral antibiotics cannot reach a segment of the colon, such as with Hartman's pouch, ileostomy, or colon diversion, vancomycin therapy delivered via enema should be added to treatments above until the patient improves. (Conditional recommendation, low-quality evidence)13. The use of anti-peristaltic agents to control diarrhea from confi rmed or suspected CDI should be limited or avoided, as they may obscure symptoms and precipitate complicated disease. Use of anti-peristaltic agents in the setting of CDI must always be accompanied by medical therapy for CDI. (Strong recommendation, low-quality evidence) Management of severe and complicated CDI14. Supportive care should be delivered to all patients and includes intravenous fl uid resuscitation, electrolyte replacement, and pharmacological venous thromboembolism prophylaxis. Furthermore, in the absence of ileus or signifi cant abdominal distention, oral or enteral feeding should be continued. 17. Vancomycin delivered orally (500 mg four times per day) and per rectum (500 mg in a volume of 500 ml four times a day) plus intravenous metronidazole (500 mg three times a day) is the treatment of choice for patients with complicated CDI with ileus or toxic colon and / or signifi cant abdominal distention. (Strong recommendation, low-quality evidence)18. Surgical consult should be obtained in all patients with complicated CDI. Surgical therapy should be considered in patients with any one of the following attributed to CDI: hypotension requiring vasopressor therapy; clinical signs of sepsis and organ dysfunction (renal and pulmonary); mental status changes; white blood cell count ≥ 50,000 cells / μ l, lactate ≥ 5 mmol / l; or failure to improve on medical therapy after 5 days. (Strong recommendation, moderate-quality evidence) Management of recurrent CDI (RCDI)19. The fi rst recurrence of CDI can be treated ...

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Is Repeat PCR Needed for Diagnosis of Clostridium difficile Infection?

Cited by 64 publications

References 21 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

Guidelines for Diagnosis, Treatment, and Prevention of Clostridium difficile Infections

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