Test Catalog

Test Id : ESBLS

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Extended-Spectrum Beta-Lactamase-Producing Gram-Negative Bacteria Surveillance Culture, Feces

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Screening for colonization of extended-spectrum beta-lactamase (ESBL)-producing organisms in stool

 

Screening fecal microbiota transplant donor feces for ESBL-producing organisms.

 

This test is not intended for medicolegal use.

Highlights

This test screens fecal microbiota transplant donor stool for extended-spectrum beta-lactamase-producing organisms.

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
RMALD Ident by MALDI-TOF mass spec No, (Bill Only) No
CHESB ESBL SUS Test Charge No, (Bill Only) No

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

When this test is ordered, the reflex tests may be performed at an additional charge. All bacterial isolates tested, to rule in or out as a potential extended-spectrum beta-lactamase (ESBL)-producing pathogen, will be billed for work performed and resources consumed. The following Enterobacterales will be tested for ESBL production: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, and Proteus mirabilis.

Method Name
A short description of the method used to perform the test

Conventional Culture Technique

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

ESBL GNB Surveillance Culture, F

Aliases
Lists additional common names for a test, as an aid in searching

Fecal Microbiota Transplant donors

FMT

ESBL

Extended spectrum Beta-lactamase-producing organisms

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

When this test is ordered, the reflex tests may be performed at an additional charge. All bacterial isolates tested, to rule in or out as a potential extended-spectrum beta-lactamase (ESBL)-producing pathogen, will be billed for work performed and resources consumed. The following Enterobacterales will be tested for ESBL production: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, and Proteus mirabilis.

Specimen Type
Describes the specimen type validated for testing

Fecal

Shipping Instructions

Specimen must arrive within 96 hours of collection.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Patient Preparation: Do not use barium or bismuth before specimen collection.

Supplies: Culture and Sensitivity Stool Transport Vial (T058)

Specimen Type: Preserved feces

Container/Tube: Cary-Blair or modified Cary-Blair transport system is required.

Commercially available transport system specific for recovery of enteric pathogens from fecal specimens (15 mL of nonnutritive transport medium containing phenol red as a pH indicator. Submit sample in original Cary Blair medium container (not an aliquot of Cary Blair medium).

Specimen Volume: Representative portion of feces; 1 gram or 5 mL

Collection Instructions:

1. Collect fresh fecal specimen and place 1 gram or 5 mL in container with transport medium.

2. Place feces in preservative within 2 hours of collection.

3. Place vial in a sealed plastic bag.

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

See Specimen Required

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Products containing formalin
SAF fixative
PVA fixative
EcoFix preservative
Endoscopy specimen
Processed stool 		Reject
 

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Fecal Ambient (preferred) 4 days
Refrigerated 4 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Screening for colonization of extended-spectrum beta-lactamase (ESBL)-producing organisms in stool

 

Screening fecal microbiota transplant donor feces for ESBL-producing organisms.

 

This test is not intended for medicolegal use.

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

When this test is ordered, the reflex tests may be performed at an additional charge. All bacterial isolates tested, to rule in or out as a potential extended-spectrum beta-lactamase (ESBL)-producing pathogen, will be billed for work performed and resources consumed. The following Enterobacterales will be tested for ESBL production: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, and Proteus mirabilis.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

In June 2019, the US Food and Drug Administration recommended stool testing of fecal microbiota transplant (FMT) donors to assess for the presence of certain infectious agents.(1) FMT donor feces should be screened for extended-spectrum beta-lactamase (ESBL)-producing organisms. ESBLs are enzymes that confer variable resistance to third- and fourth-generation cephalosporins as well as aztreonam. Because these resistance genes are encoded on plasmids, which are easily transmissible, ESBL-producing organisms raise important infection control issues.

 

FMT donor feces may be screened on a regularly scheduled basis for ESBL-producers. Screening will be performed via culture of stool samples using vancomycin, amphotericin B, ceftazidime, and clindamycin (VACC) agar. Remel VACC agar is a primary selective medium for the isolation of ESBL-producing Enterobacterales. In addition to multiple substrates necessary for bacterial growth, this medium also contains multiple antimicrobials which inhibit normal intestinal microbiota. Possible ESBL-producers isolated on VACC agar will be confirmed by the Clinical and Laboratory Standards Institute ESBL disk diffusion test.(2)

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative for extended-spectrum beta-lactamase-producing organisms

 

Positive for extended-spectrum beta-lactamase-producing organisms

Interpretation
Provides information to assist in interpretation of the test results

Exclusion of feces from use in fecal microbiota transplantation is recommended if extended-spectrum beta-lactamase -producing bacteria are detected. Refer to US Food and Drug Administration guidance for details.(3)

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Not all extended-spectrum beta-lactamase-producing organisms may be detected by this method.

Supportive Data

Thiry-two gram-negative bacilli (22 confirmed extended-spectrum beta-lactamase [ESBL]-producing isolates and 10 non ESBL-producing isolates with resistance to either ceftriaxone or ceftazidime) were evaluated. Recovery of ESBL-producing isolates with vancomycin, amphotericin B, ceftazidime, and clindamycin (VACC) media was 100%. Of the non ESBL-producing isolates, 70% (7/10) were inhibited while 30% grew on VACC but tested negative with ESBL confirmatory disk testing. This finding aligns with the package insert information for VACC media.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Food and Drug Administration (FDA) Safety and Availability (Biologics) Communication. Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation - Screening and Testing of Stool Donors for Multi-drug Resistant Organisms. FDA; June 18, 2019. Accessed November 17, 2023. Available at www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/information-pertaining-additional-safety-protections-regarding-use-fecal-microbiota-transplantation

2. Clinical and Laboratory Standards Institute [CLSI]. Performance Standards for Antimicrobial Susceptibility Testing. 31st ed. CLSI supplement M100. CLSI; 2021.

3. Food and Drug Administration (FDA) Safety and Availability (Biologics) Communication. Important Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms. FDA; June 13, 2019. Updated December 04, 2020. Accessed November 17, 2023. Available at www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/important-safety-alert-regarding-use-fecal-microbiota-transplantation-and-risk-serious-adverse

Method Description
Describes how the test is performed and provides a method-specific reference

Remel vancomycin, amphotericin B, ceftazidime, and clindamycin (VACC) primary selective media is used to isolate extended-spectrum beta-lactamase (ESBL)-producing Enterobacterales from stool. This media contains antimicrobials which inhibit normal intestinal microbiota. Colonial morphologies consistent with Gram-negative bacilli are screened with oxidase reagent and matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) is utilized to identify oxidase negative gram-negative bacilli. ESBL confirmatory disk testing is performed on any isolate identified as Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, or Proteus mirabilis. Confirmatory disk diffusion testing is performed using cefotaxime and ceftazidime with and without the addition of clavulanic acid. ESBLs show an increased zone of inhibition in the presence of clavulanate.(Clinical and Laboratory Standards Institute [CLSI]. Performance Standards for Antimicrobial Susceptibility Testing. 31st ed. CLSI supplement M100.CLSI; 2021)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Sunday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

4 to 6 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87081-ESBL GNB surveillance culture

87077-Ident by MALDI-TOF mass spec (if appropriate)

87184-ESBL SUS test charge (if appropriate)

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
ESBLS ESBL GNB Surveillance Culture, F 102121-1
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
ESBLS ESBL GNB Surveillance Culture, F 102121-1

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | PHP Pdf | CMS Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports