CC BY-NC-ND 4.0 · Endosc Int Open 2018; 06(01): E58-E63
DOI: 10.1055/s-0043-122141
Original article
Eigentümer und Copyright ©Georg Thieme Verlag KG 2018

Prospective study of the feasibility of point-of-care testing strategy for carbapenem-resistant organism detection

Rahul Pannala1, Bruce Baldwin1, Vijay Aluru1, Thomas E. Grys2, Jordan Holmes1, Laurence J. Miller1, M. Edwyn Harrison1, Cuong C. Nguyen1, Fred C. Tenover3, David Persing3, Douglas O. Faigel1
  • 1Division of Gastroenterology and Hepatology, Mayo Clinic, Scottsdale, AZ, USA
  • 2Division of Laboratory Medicine, Mayo Clinic, Scottsdale, AZ, USA
  • 3Cepheid, Sunnyvale, CA, USA
Further Information

Publication History

submitted 25 January 2017

accepted after revision 10 October 2017

Publication Date:
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.