Impact of toxigenic Clostridium difficile polymerase chain reaction testing on the clinical microbiology laboratory and inpatient epidemiology

Napierala, Maureen; Munson, Erik; Skonieczny, Patrice; Rodriguez, Sonia; Riederer, Nancy; Land, Gayle; Luzinski, Mary; Block, Denise; Hryciuk, Jeanne E.

doi:10.1016/j.diagmicrobio.2013.04.020

Cited by 7 publications

(4 citation statements)

References 25 publications

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“…Our clinical study showed that out of 59 discrepant samples (CCNA negative but PCR positive), 54 (91.5%) were found to be true positives on clinical diagnosis which demonstrates convincingly that PCR results are reliable and accurate for diagnosing CDI, at the same time reducing the need for repeat testing. This was confirmed by Napierala et al [ 37 ] who found that after implementation of PCR, testing volume as well as CDI rates decreased significantly. Increased faith of clinicians in a more accurate testing method not only impacts on CDI-positive patients but also affects CDI-negative patients, who can be assessed for other gastrointestinal problems at an earlier point in time without having to revisit CDI as a cause for diarrhea.…”

Section: Discussionsupporting

confidence: 59%

Cost and Impact on Patient Length of Stay of Rapid Molecular Testing for Clostridium difficile

et al. 2014

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IntroductionA study was performed to assess the cost of a rapid molecular assay (PCR) for diagnosis of Clostridium difficile infection (CDI) and the impact of its routine use on patient length of stay (LOS) in comparison with cell culture cytotoxin neutralization assay (CCNA).MethodsFrom March 2011 to September 2011, Xpert®C. difficile (Cepheid, Sunnyvale, CA, USA) PCR was used on patients with suspicion of CDI in two acute care hospitals in Abertawe Bro Morgannwg University Health Board, Swansea, Wales, UK. Test results were used for patient management. LOS and time to reportable result were compared for negative and positive prospective patients tested by PCR and historic control patients tested by CCNA during March 2010 to September 2010. Tests were priced using micro-costing and a cost comparison analysis was undertaken.ResultsIn total, 506 patients were included. Time to reportable result for PCR samples was 1.53 h compared to 46.54 h for CCNA negatives and 22.45 h for CCNA positives. Patients tested by CCNA stayed 4.88 days longer in hospital compared to PCR patients if they tested positive and 7.03 days if tests were negative. The mean reduction in LOS observed in our study has the potential to generate cost savings of up to £2,292.62 for every patient with suspected CDI, if samples were to be tested routinely with PCR instead of CCNA.ConclusionA rapid molecular test for C. difficile in an acute hospital setting produced quick results that led to a decrease in LOS compared to historic CCNA control patients. This could result in considerable savings through reduced excess inpatient days.Electronic supplementary materialThe online version of this article (doi:10.1007/s40121-014-0034-x) contains supplementary material, which is available to authorized users.

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Section: Discussionsupporting

confidence: 59%

Cost and Impact on Patient Length of Stay of Rapid Molecular Testing for Clostridium difficile

et al. 2014

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“…First, the National Health Safety Network applies a correction factor for institutions that use NAATs to diagnosis CDI, so that institutions using more-sensitive diagnostic methods will not be penalized (18). Second, the greater detection of toxigenic C. difficile by NAATs can facilitate more-effective infection control measures so that institutional infection rates subsequently decline (19)(20)(21). This has been the experience at my own institution, where several years ago our CDI rates fell within a few months of introducing NAATs and have remained low ever since.…”

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confidence: 99%

Point-Counterpoint: What Is the Optimal Approach for Detection of Clostridium difficile Infection?

2017

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INTRODUCTION In 2010, we published an initial Point-Counterpoint on the laboratory diagnosis of Clostridium difficile infection (CDI). At that time, nucleic acid amplification tests (NAATs) were just becoming commercially available, and the idea of algorithmic approaches to CDI was being explored. Now, there are numerous NAATs in the marketplace, and based on recent proficiency test surveys, they have become the predominant method used for CDI diagnosis in the United States. At the same time, there is a body of literature that suggests that NAATs lack clinical specificity and thus inflate CDI rates. Hospital administrators are taking note of institutional CDI rates because they are publicly reported. They have become an important metric impacting hospital safety ratings and value-based purchasing; hospitals may have millions of dollars of reimbursement at risk. In this Point-Counterpoint using a frequently asked question approach, Ferric Fang of the University of Washington, who has been a consistent advocate for a NAAT-only approach for CDI diagnosis, will discuss the value of a NAAT-only approach, while Christopher Polage of the University of California Davis and Mark Wilcox of Leeds University, Leeds, United Kingdom, each of whom has recently written important articles on the value of toxin detection in the diagnosis, will discuss the impact of toxin detection in CDI diagnosis.

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“…In addition, based on our sensitivity analysis, the cost per true positive CDI diagnosed was consistently lower with the NAAT alone pathway, compared to the two-step algorithm. The adoption of NAAT for CDI diagnosis can subsequently facilitate more effective infection control measures, which has shown to reduce institutional CDI infection rates in the United States [ 38 , 39 ]. It is important to note that the costs generated by every true positive CDI are most likely greater than what has been calculated in the current model.…”

Section: Discussionmentioning

confidence: 99%

Budget Impact Analysis of Adopting a One-Step Nucleic Acid Amplification Testing (NAAT) Alone Diagnostic Pathway for Clostridioides difficile in Japan Compared to a Two-Step Algorithm with Glutamate Dehydrogenase/Toxin Followed by NAAT

Lim¹,

Tomaru²,

Chua

et al. 2023

Diagnostics

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Clostridioides difficile infection (CDI) is a major healthcare-associated infection that leads to a significant health economic burden in Japan. Using a decision tree model, we evaluated the budget impact of adopting a one-step nucleic acid amplification test (NAAT) alone pathway compared to a two-step diagnostic algorithm with glutamate dehydrogenase (GDH) and toxin antigen, followed by NAAT. The analysis was conducted from the government payer’s perspective for 100,000 symptomatic, hospitalized adults requiring a CDI diagnostic test. One-way sensitivity analysis was conducted for all data inputs. The NAAT alone strategy costed JPY 225,886,360 (USD 2,424,714) more, but was more effective, resulting in 1749 more patients accurately diagnosed and 91 fewer deaths compared to the two-step algorithm. Additionally, the NAAT alone pathway costed JPY 26,146 (USD 281) less per true positive CDI diagnosed. The total budget impact, and cost per CDI diagnosed was most sensitive to GDH sensitivity in one-way sensitivity analysis, where a lower GDH sensitivity resulted in greater cost savings with the NAAT alone pathway. Findings from this budget impact analysis can guide the adoption of a NAAT alone pathway for CDI diagnosis in Japan.

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Impact of toxigenic Clostridium difficile polymerase chain reaction testing on the clinical microbiology laboratory and inpatient epidemiology

Cited by 7 publications

References 25 publications

Cost and Impact on Patient Length of Stay of Rapid Molecular Testing for Clostridium difficile

Cost and Impact on Patient Length of Stay of Rapid Molecular Testing for Clostridium difficile

Point-Counterpoint: What Is the Optimal Approach for Detection of Clostridium difficile Infection?

Budget Impact Analysis of Adopting a One-Step Nucleic Acid Amplification Testing (NAAT) Alone Diagnostic Pathway for Clostridioides difficile in Japan Compared to a Two-Step Algorithm with Glutamate Dehydrogenase/Toxin Followed by NAAT

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