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

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 sequence...

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Autores principales: Pannala, Rahul, Baldwin, Bruce, Aluru, Vijay, Grys, Thomas E., Holmes, Jordan, Miller, Laurence J., Harrison, M. Edwyn, Nguyen, Cuong C., Tenover, Fred C., Persing, David, Faigel, Douglas O.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: © Georg Thieme Verlag KG 2018
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5766332/
https://www.ncbi.nlm.nih.gov/pubmed/29340299
http://dx.doi.org/10.1055/s-0043-122141
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author Pannala, Rahul
Baldwin, Bruce
Aluru, Vijay
Grys, Thomas E.
Holmes, Jordan
Miller, Laurence J.
Harrison, M. Edwyn
Nguyen, Cuong C.
Tenover, Fred C.
Persing, David
Faigel, Douglas O.
author_facet Pannala, Rahul
Baldwin, Bruce
Aluru, Vijay
Grys, Thomas E.
Holmes, Jordan
Miller, Laurence J.
Harrison, M. Edwyn
Nguyen, Cuong C.
Tenover, Fred C.
Persing, David
Faigel, Douglas O.
author_sort Pannala, Rahul
collection PubMed
description 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.
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spelling pubmed-57663322018-01-16 Prospective study of the feasibility of point-of-care testing strategy for carbapenem-resistant organism detection Pannala, Rahul Baldwin, Bruce Aluru, Vijay Grys, Thomas E. Holmes, Jordan Miller, Laurence J. Harrison, M. Edwyn Nguyen, Cuong C. Tenover, Fred C. Persing, David Faigel, Douglas O. Endosc Int Open 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. © Georg Thieme Verlag KG 2018-01 2018-01-12 /pmc/articles/PMC5766332/ /pubmed/29340299 http://dx.doi.org/10.1055/s-0043-122141 Text en https://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License, which permits unrestricted reproduction and distribution, for non-commercial purposes only; and use and reproduction, but not distribution, of adapted material for non-commercial purposes only, provided the original work is properly cited.
spellingShingle Pannala, Rahul
Baldwin, Bruce
Aluru, Vijay
Grys, Thomas E.
Holmes, Jordan
Miller, Laurence J.
Harrison, M. Edwyn
Nguyen, Cuong C.
Tenover, Fred C.
Persing, David
Faigel, Douglas O.
Prospective study of the feasibility of point-of-care testing strategy for carbapenem-resistant organism detection
title Prospective study of the feasibility of point-of-care testing strategy for carbapenem-resistant organism detection
title_full Prospective study of the feasibility of point-of-care testing strategy for carbapenem-resistant organism detection
title_fullStr Prospective study of the feasibility of point-of-care testing strategy for carbapenem-resistant organism detection
title_full_unstemmed Prospective study of the feasibility of point-of-care testing strategy for carbapenem-resistant organism detection
title_short Prospective study of the feasibility of point-of-care testing strategy for carbapenem-resistant organism detection
title_sort prospective study of the feasibility of point-of-care testing strategy for carbapenem-resistant organism detection
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5766332/
https://www.ncbi.nlm.nih.gov/pubmed/29340299
http://dx.doi.org/10.1055/s-0043-122141
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