Becker's Clinical Quality & Infection Control

40 Executive Briefing method (Figure 1). 8 Although PCR-based tests may be more expensive than other methods, these costs are minimal relative to reduced cost of transmission and extended stays that associated with testing by other methods, such as stand-alone EIAs. 6 There has been concern that increased C. diff rates potentially resulting from using sensitive PCR testing could lead to penalties imposed by CMS once CDI rates become part of the CMS value-based purchasing program in 2017. It is important to note, however, that the CDC performs risk-adjusted calculations to control for testing modality (EIA, PCR, etc.) and its inherent sensitivity and specificity before submitting rates to CMS. 12 Facilities, therefore, will not incur penalties for using more sensitive testing modalities simply on the basis of their test of choice. Looking Forward In recent years, there has been an emergence of a new strain of C. diff, bearing one of several different names dependent on the testing method used to type it: PCR ribotype 027, North American pulsed-field gel electrophoresis type 1, or restriction endonuclease analysis type B1. A study published in July of 2015 demonstrated that infection with this strain independently predicted CDI disease severity and mortality. 13 As the landscape of CDI evolves, it may become even more critical to employ a rapid and sensitive means of testing for C. diff like PCR. n References Bamberg WM, et al. Multistate point prevalence survey of health care-associated infections. N Engl J Med. 2014;(370):1198-208. Bamberg WM, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015;(372):825-34. Berry N, et al. Real-time polymerase chain reaction correlates well with clinical diagnosis of Clostridium difficile infection. J Hosp Infect. 2014;(87):109-14. Cumpio J, et al. Clostridium difficile testing in the clinical laboratory by use of multiple testing algorithms. J Clin Microbiol. 2010;(48):889-93. Davis T, et al. Impact of strain type on detection of toxigenic Clostridium difficile- comparison of molecular diagnostic and enzyme immunoassay approaches. J Clin Microbiol. 2010;(48):3719-24. Balada-llasat JM, et al. Detection of toxigenic Clostridium difficile: comparison of the cell culture neutralization, Xpert C. difficile, Xpert C. difficile/Epi, and Illumigene C. difficile assays. J Clin Microbiol 2012; 50:1331-1335. Humphries RM, et al. Performance of Clostridium difficile toxin enzyme immunoassay and nucleic acid amplification tests stratified by patient disease severity. J Clin Microbiol 2013; 51(3):869-873. Banaei N, et al. Economic evaluation of laboratory testing strategies for hospital- associated Clostridium difficile infection. J Clin Microbiol. 2014;(52):489-96. Donskey CJ, et al. Easily modified factors contribute to delays in diagnosis of Clostridium difficile infection: a cohort study and intervention. J Clin Microbiol. 2013;51(7):2365-70. Catanzaro M, et al. Real-time polymerase chain reaction testing for Clostridium difficile reduces isolation time and improves patient management in a small community hospital. Am J Infect Control. 2012;(40):663-666. Chiarello L, et al. 2007 guideline for isolation precautions: preventing transmission of infectious agents in health care settings. Am J Infect Control 2001;35(10)2:S65-S164. Dudeck MA, et al. Risk adjustment for healthcare facility-onset C. difficile and MRSA bacteremia laboratory-identified event reporting in NHSN. 12 March 2013. Available from: http://www.cdc.gov/nhsn/pdfs/mrsa-cdi/Risk/Adjustment-MRSA- CDI.pdf. Accessed 29 October 2015. Kiel MJ, et al. Clostridium difficile ribotype 027: relationship to age, detectability of toxins A or B in stool with rapid testing, severe infection, and mortality. Clin Infect Dis 2015;61(2):233-241. Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by devel- oping, manufacturing, and marketing accurate yet easy to use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to access the full power of molecular diagnostics. The company's systems enable rapid, sophisticated genetic testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit: www.cepheid.com. Isolation room Isolation material Isolation labor CDI tx Transmission (missed cases) Extended stay Eventual diagnosis Laboratory labor Laboratory reagents Treat none Treat all EIA toxin Direct-tissue culture cytotoxicity Batch PCR Lateral-ow GDH/odPCR Lateral-ow GDH-Tox/odPCR Stand-alone odPCR Average cost per-patient tested $0 $200 $400 $600 $800 $1,000 $1,200 $1,400 $1,600 Figure 1. Categorization of costs in the cost-benet model Figure 1. Despite a higher cost per test, when compared with other testing methodologies stand-alone PCR testing was associated with the lowest average cost per patient. EIA = enzyme immunoassay; PCR = polymerase chain reaction; GDH = glutamate dehydrogenase; OD = on demand. Reprinted with permission from the Journal Clinical Microbiology. 8 Sponsored by:

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