Real-Time Polymerase Chain Reaction Detection of Asymptomatic <i>Clostridium difficile</i> Colonization and Rising <i>C. difficile</i>–Associated Disease Rates

Koo, Hoonmo L.; Van, John; Zhao, Meina; Ye, Xunyan; Revell, Paula A.; Jiang, Zhi; Grimes, Carolyn Z.; Koo, Diana C.; Lasco, Todd M.; Kozinetz, Claudia A.; Garey, Kevin W.; DuPont, Herbert L.

doi:10.1086/676433

Cited by 101 publications

(88 citation statements)

References 33 publications

(34 reference statements)

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“…38,39 Notably, PCR diagnostics for symptomatic CDI may result in over diagnosis compared with toxin enzyme immunoassay (EIA) tests, though in the case of screening, this is likely an acceptable bias. 40,41 Offlabel rectal swab PCR testing for asymptomatic carriers has been used in at least one study. 37 However, further clinical validation of C. difficile PCR testing is urgently needed to evaluate its use for screening of asymptomatic individuals.…”

Section: Limitations Of Screening Asymptomatic Donorsmentioning

confidence: 99%

Challenges in fecal donor selection and screening for fecal microbiota transplantation: A review

et al. 2017

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Fecal microbiota transplantation is best understood as an effective and inexpensive therapy for recurrent Clostridium difficile infection but fecal donor selection and screening should be periodically revised. Here, we review current recommendations for selection and screening of fecal donors for fecal microbiota transplantation. We recommend considering diabetes mellitus, prior cardiovascular events, and clinical healthcare exposure as fecal donor exclusion criteria until more is known about the association of these conditions with the human gut microbiome. We review the non-bacterial members of the human gut microbiome, associations of the gut microbiome with colorectal malignancies, the human gut resistome and how these may impact future donor screening recommendations. Collaboration between clinicians, clinical laboratory scientists, industry and regulatory agencies will be critically important for continued improvement in donor selection and screening.

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Section: Limitations Of Screening Asymptomatic Donorsmentioning

confidence: 99%

Challenges in fecal donor selection and screening for fecal microbiota transplantation: A review

et al. 2017

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“…In such cases, if the organism identified is not on the NHSN list of common commensals, but the genus is included in the "all organisms" list, the episode counts as a CLABSI (8). In scenario 2 above, the increased sensitivity of the C. difficile NAAT results in a predictable increase in CDI rates of 50% or more (9,10). Although the NHSN includes a "test method" variable in the risk adjustment formula for HO-CDI rate calculations (11), the risk adjustment is clearly not adequate to fully account for the increased sensitivity of the NAAT.…”

Section: Unintended Consequences For Cmlsmentioning

confidence: 99%

Rising Stakes for Health Care-Associated Infection Prevention: Implications for the Clinical Microbiology Laboratory

Diekema

2017

J Clin Microbiol

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Health care-associated infection (HAI) rates are subject to public reporting and are linked to hospital reimbursement from the Centers for Medicare and Medicaid Services (CMS). The increasing pressure to lower HAI rates comes at a time when advances in the clinical microbiology laboratory (CML) provide more-precise and -sensitive tests, altering HAI detection in ways that may increase reported HAI rates. I review how changing CML practices can impact HAI rates and how the financial implications of HAI metrics may produce pressure to change diagnostic testing practices. Finally, I provide suggestions for how to respond to this rapidly changing environment.KEYWORDS clinical microbiology, infection prevention, nosocomial, pay for performance, health care-associated infections C onsider the following three scenarios related to the role of the clinical microbiology laboratory (CML) in health care-associated infection (HAI) surveillance and prevention. In scenario 1, during an investigation of rising rates of central-line-associated bloodstream infection (CLABSI), the infection prevention program (IPP) notes that some CLABSIs were due to organisms that grew in only one of several blood cultures and which, prior to the institution of matrix-assisted laser desorption-ionization time of flight (MALDI-TOF) mass spectrometry for organism identification, would have been classified as contaminants. An example included a CLABSI attributed to an unusual species of Actinomyces that previously would have been categorized as a "diphtheroid." Your hospital leadership requests that you either revert to former identification methods or change your reporting in a way that prevents these events from being classified as CLABSIs.In scenario 2, since you changed to a nucleic acid amplification test (NAAT) for Clostridium difficile detection, your positivity rate has increased by over 100%. The rate of hospital-onset C. difficile infection (HO-CDI) has increased similarly. During an investigation of the increase in CDI, you find that many samples positive by NAAT are toxin negative by enzyme immunoassay (EIA) and that many patients with a low pretest probability of disease are being tested. However, after an initiative to improve testing practices, your HO-CDI lab identification (LabID) event rate remains high (standardized infection ratio [SIR], Ͼ1). Concerned about how this rate will impact the value-based purchasing (VBP) and health care-associated condition (HAC) scores, your hospital leadership asks you to consider a change back to EIA for CDI diagnosis.In scenario 3, even after a campaign to reduce your hospital's rate of catheterassociated urinary tract infection (CAUTI) through a reduction in catheter use and improvement in catheter placement and care, the CAUTI rate remains unacceptably high. Your hospital epidemiologist sets up a meeting with you to discuss how to reduce the number of urine cultures ordered or performed by the laboratory as another way to reduce both the CAUTI rate and unnecessary antibiotic use. She is...

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“…The excellent sensitivity and analytical specificity, low labor requirements, and quick turnaround time of NAATs have prompted the widespread adoption of NAATs as the preferred method of CDI diagnosis (2,6). The exquisite sensitivity of NAATs is supported by the substantial increases in CDI rates across medical centers after the transition from toxin EIAs to NAATs for CDI diagnosis (2,6,9).…”

mentioning

confidence: 99%

“…Two large clinical research studies in the United States (10) and the United Kingdom (11) questioned the clinical significance of a positive PCR test (10) (or toxigenic culture [11]) when the patient also tests negative by toxin EIA because these patients have benign clinical outcomes that are similar to those seen with patients who do not have CDI. Furthermore, several studies have demonstrated the high rate of NAAT (or toxigenic culture) positivity in patients without diarrhea, including hospitalized children (12) and adults (9) as well as children with cancer (13). In addition, even among patients with diarrhea, a high proportion test positive by NAAT who have a likely alternate diarrheal etiology, such as recent laxative use (2) or a concomitant viral illness (14).…”

mentioning

confidence: 99%

“…This is exceedingly important in particular patient populations, such as hospitalized children (12) and adults (9), in whom the prevalence of C. difficile carriage exceeds 10 to 20%, and children with cancer, in whom carriage rates may be as high as 30 to 50% (13). However, because hospitalization and malignancy, for example, can be risk factors for both CDI and C. difficile carriage, C. difficile testing decisions can be quite difficult in practice.…”

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confidence: 99%

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Strategies for Optimizing the Diagnostic Predictive Value of Clostridium difficile Molecular Diagnostics

Kociolek

2017

J Clin Microbiol

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Because nucleic acid amplification tests (NAATs) do not distinguish Clostridium difficile infection (CDI) and asymptomatic C. difficile carriage, the diagnostic predictive value of NAATs is limited when used in patients with a low probability of CDI. In this issue of the Journal of Clinical Microbiology, Truong et al. (J. Clin. Microbiol., 55:1276 -1284, 2017, https://doi.org/10.1128/JCM.02319-16) report significant reductions in hospital-onset CDI and oral vancomycin utilization at their institution following implementation of a novel intervention that leveraged their clinical bioinformatics resources to prevent C. difficile testing of stools from patients without clinically significant diarrhea and in patients with recent laxative use.

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Real-Time Polymerase Chain Reaction Detection of Asymptomatic Clostridium difficile Colonization and Rising C. difficile–Associated Disease Rates

Cited by 101 publications

References 33 publications

Challenges in fecal donor selection and screening for fecal microbiota transplantation: A review

Challenges in fecal donor selection and screening for fecal microbiota transplantation: A review

Rising Stakes for Health Care-Associated Infection Prevention: Implications for the Clinical Microbiology Laboratory

Strategies for Optimizing the Diagnostic Predictive Value of Clostridium difficile Molecular Diagnostics

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