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J Antimicrob Chemother. 2017 Sep 1;72(9):2512-2518. doi: 10.1093/jac/dkx189.

Clinical sensitivity and specificity of the Check-Points Check-Direct ESBL Screen for BD MAX, a real-time PCR for direct ESBL detection from rectal swabs.

Author information

1
Department of Epidemiology and Infection Prevention, Regional Public Health Laboratory Kennemerland, Haarlem, The Netherlands.
2
Laboratory for Microbiology and Infection Control, Amphia Hospital, Breda, The Netherlands.
3
University Medical Center, Utrecht, The Netherlands.
4
Department of Medical Microbiology, University of Groningen University Medical Center Groningen, Groningen, The Netherlands.

Abstract

Objectives:

To determine the diagnostic accuracy of the Check-Direct ESBL Screen for BD MAX (ESBL qPCR) and an ESBL culture method to identify ESBLs directly from rectal swabs.

Methods:

Rectal swabs were obtained from clinical patients by performing cross-sectional (point)prevalence measurements in three regional hospitals. Rectal swabs were analysed by direct culture (ChromID ESBL agar) and with the ESBL qPCR. Suspected ESBL-producing isolates were confirmed with the combination disc method and analysed by WGS.

Results:

Out of 354 rectal swabs and 351 patients, 21 rectal swabs and 20 patients were positive for ESBL-producing isolates, resulting in a regional ESBL colonization prevalence of 5.7%. One rectal swab was false negative with the ESBL qPCR (blaTEM-12) and not covered by the ESBL qPCR. Eight ESBL qPCR-positive rectal swabs could not be confirmed by culture and were classified as false ESBL qPCR positive. The sensitivity and specificity of the ESBL qPCR were 95.2% (n = 20) and 97.6% (n = 323), respectively. When an optimal cycle threshold cut-off value of 37 was used, the ESBL qPCR displayed a sensitivity and specificity of 95.2% (n = 20) and 98.8% (n = 327), respectively (AUC = 0.975, 95% CI = 0.922-1).

Conclusions:

This ESBL qPCR offers rapid direct detection of the most prevalent ESBL types (blaCTX-M group and blaSHV group) from rectal swabs. The relatively high false-positive rate renders this test the most suitable as a screening test in high-prevalence regions or in an outbreak setting where a fast result is essential.

PMID:
28633496
DOI:
10.1093/jac/dkx189
[Indexed for MEDLINE]

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