Prospective study of the feasibility of point-of-care testing strategy for carbapenem-resistant organism detection
submitted 25 January 2017
accepted after revision 10 October 2017
12 January 2018 (online)
Background/aims In an investigator-initiated, prospective study, we evaluated the feasibility of a five-gene sequence point-of-care (POC) testing strategy (Xpert CARBA-R Assay, Cepheid Inc., Sunnyvale, CA, USA), compared to reference laboratory PCR (48 – 72 hours turnaround time, two gene sequences), in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) and in a hospital outbreak investigation.
Methods After informed consent, patients undergoing ERCP (September 2015 – April 2016, n = 191) at Mayo Clinic and potential hospital contacts (n = 9) of an index carbapenem-resistant organism (CRO)-positive inpatient were included. Two rectal swabs, one each for reference and POC assays were obtained. The Xpert CARBA-R Assay enables qualitative rapid detection of five beta-lactamase gene sequences associated with carbapenem-non-susceptibility in Gram-negative bacteria. Feasibility parameters (specimen processing and assay run time, ease of use) and percent agreement between the tests were calculated using JMP Pro11 (SAS Corp, Cary, NC, USA).
Results Mean age was 62 ± 15 years; 108 (54 %) were male. Both tests were successfully performed in all patients. The POC test was rated by endoscopy nurses as easy/very easy to conduct in 193 patients (97 %); median assay run time and median time for specimen collection and processing were 55 minutes (interquartile range IQR: 53 – 55 minutes) and 3 minutes (IQR: 3 – 6 minutes), respectively. In 200/201 (99.5 %) tests, there was agreement between the POC and reference PCR.
Conclusions The more comprehensive POC CRO testing of patients in the endoscopy suite is feasible and results are available in < 1 hour. This strategy may enable rapid risk stratification of duodenoscope exposure to CRO and potentially improve operational efficiency and decrease costs.
- 1 Centers for Disease Control and Prevention. Facility guidance for carbapenem-resistant enterobacteriaceae (CRE) – November 2015 update – CRE toolkit. Atlanta: GA; 2015
- 2 Yigit H, Queenan AM, Anderson GJ. et al. Novel carbapenem-hydrolyzing beta-lactamase, KPC-1, from a carbapenem-resistant strain of Klebsiella pneumoniae. Antimicrob Agents Chemother 2001; 45: 1151-1161
- 3 Centers for Disease Control and Prevention (CDC). Update: detection of a verona integron-encoded metallo-beta-lactamase in Klebsiella pneumoniae – United States, 2010. MMWR Morb Mortal Wkly Rep 2010; 59: 1212
- 4 Lyman M, Walters M, Lonsway D. et al. Notes from the field: carbapenem-resistant Enterobacteriaceae producing OXA-48-like carbapenemases – United States, 2010–2015. MMWR Morb Mortal Wkly Rep 2015; 64: 1315-1316
- 5 Epstein L, Hunter JC, Arwady MA. et al. New Delhi metallo-beta-lactamase-producing carbapenem-resistant Escherichia coli associated with exposure to duodenoscopes. Jama 2014; 312: 1447-1455
- 6 Centers forDisease Control and Prevention. Notes from the Field: New Delhi metallo-beta-lactamase-producing Escherichia coli associated with endoscopic retrograde cholangiopancreatography – Illinois, 2013. MMWR Morb Mortal Wkly Rep 2014; 62: 1051
- 7 Ross AS, Baliga C, Verma P. et al. A quarantine process for the resolution of duodenoscope-associated transmission of multidrug-resistant Escherichia coli. Gastrointest Endosc 2015; 82: 477-483
- 8 Wendorf KA, Kay M, Baliga C. et al. Endoscopic retrograde cholangiopancreatography-associated AmpC Escherichia coli outbreak. Infect Control Hosp Epidemiol 2015; 36: 634-642
- 9 Verfaillie CJ, Bruno MJ, Voor in ’t Holt AF. et al. Withdrawal of a novel-design duodenoscope ends outbreak of a VIM-2-producing Pseudomonas aeruginosa. Endoscopy 2015; 47: 493-502
- 10 FDA. Design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes may impede effective cleaning: FDA Safety Communication. 2015
- 11 Kim S, Russell D, Mohamadnejad M. et al. Risk factors associated with the transmission of carbapenem-resistant Enterobacteriaceae via contaminated duodenoscopes. Gastrointest Endosc 2016; 83: 1121-1129
- 12 ASGE. Transmission of CRE bacteria through endoscopic retrograde cholangiopancreatography (ERCP) – interim guidance. ASGE; 17.03.2015
- 13 Naryzhny I, Silas D, Chi K. Impact of ethylene oxide gas sterilization of duodenoscopes after a carbapenem-resistant Enterobacteriaceae outbreak. Gastrointest Endosc 2016; 84: 259-262
- 14 Almario CV, May FP, Shaheen NJ. et al. Cost utility of competing strategies to prevent endoscopic transmission of carbapenem-resistant enterobacteriaceae. Am J Gastroenterol 2015; 110: 1666-1674
- 15 Parcell BJ, Phillips G. Use of Xpert(R) MRSA PCR point-of-care testing beyond the laboratory. J Hosp Infect 2014; 87: 119-121
- 16 Goldenberg SD, Bisnauthsing KN, Patel A. et al. Point-of-care testing for clostridium difficile infection: a real-world feasibility study of a rapid molecular test in two hospital settings. Infect Dis Ther 2014; 3: 295-306
- 17 Cepheid. Sunnyvale, CA, USA: Cepheid. http://cepheid.com/administrator/components/com_productcatalog/library-files/93eee8a71f1ef27462a70a0ba22fd8f4-a592a437b2387d232128ea7dda751100-Xpert-Carba-R-Datasheet-US-0561-02.pdf
- 18 Vasoo S, Cunningham SA, Kohner PC. et al. Rapid and direct real-time detection of blaKPC and blaNDM from surveillance samples. J Clin Microbiol 2013; 51: 3609-3615
- 19 Smith ZL, Dua A, Saeian K. et al. A novel protocol obviates endoscope sampling for carbapenem-resistant Enterobacteriaceae: experience of a center with a prior outbreak. Dig Dis Sci 2017; 62: 3100-3109
- 20 Sethi S, Huang RJ, Barakat MT. et al. Adenosine triphosphate bioluminescence for bacteriologic surveillance and reprocessing strategies for minimizing risk of infection transmission by duodenoscopes. Gastrointest Endosc 2017; 85: 1180-1187 e1
- 21 Snyder GM, Wright SB, Smithey A. et al. Randomized comparison of 3 high-level disinfection and sterilization procedures for duodenoscopes. Gastroenterology 2017; 153: 1018-1025
- 22 Olafsdottir LB, Wright SB, Smithey A. et al. Adenosine triphosphate quantification correlates poorly with microbial contamination of duodenoscopes. Infect Control Hosp Epidemiol 2017; 38: 678-684