Test Catalog

Test Id : OVSRP

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Oxacillin-Hydrolyzing Beta-Lactamase (blaOXA-48-like) and Verona Integron-Encoded Metallo-Beta-Lactamase (blaVIM) DNA Surveillance, PCR, Varies

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Overview

Test Catalog

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

Identifying carriers of Ggram-negative bacilli harboring oxacillin-hydrolyzing beta-lactamase (OXA-48-like) or Verona integron-encoded metallo-beta-lactamase (VIM) genes

Highlights

This test detects oxacillin-hydrolyzing beta-lactamase (blaOXA-48-like) and Verona integron-encoded metallo-beta-lactamase DNA (associated with antimicrobial resistance) in perirectal/rectal/perianal/anal swabs or fecal specimens.

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

Real-Time Polymerase Chain Reaction (PCR) using LightCycler and Fluorescent Resonance Energy Transfer (FRET)

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

OXA-48 and VIM Surveillance PCR

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

Carbapenem resistant Enterobacteriaceae

Carbapenem resistant CRE

Carbapenemase

Carbapenemase producing, carbapenem resistant Enterobacteriaceae

CP-CRE

Oxacillinase

OXA

OXA-48

OXA-48-like

VIM

CRE

Specimen Type
Describes the specimen type validated for testing

Varies

Ordering Guidance

This assay is for surveillance testing on perirectal/rectal/perianal/anal swabs or fecal specimens only. If testing isolates from culture, request OXVRP / Oxacillin-Hydrolyzing Beta-Lactamase (blaOXA-48-like) and Verona integron-encoded metallo-beta-lactamase (blaVIM) in Gram-Negative Bacilli, Molecular Detection, PCR, Varies.

 

Other mechanisms of carbapenem resistance, including other carbapenemase-types, porin mutations, or hyper-expression of drug efflux pumps may result in carbapenem resistance. These are not detected by this assay. If testing for Klebsiella pneumoniae carbapenemase (KPC) or New Delhi metallo-beta-lactamase (NDM) is desired, order KNSRP / Klebsiella pneumoniae Carbapenemase (blaKPC) and New Delhi Metallo-beta-lactamase (blaNDM) Surveillance, PCR, Varies.

Additional Testing Requirements

If testing for Klebsiella pneumoniae carbapenemase (KPC) or New Delhi metallo-beta-lactamase (NDM) is also needed; also order KNSRP / Klebsiella pneumoniae Carbapenemase (blaKPC) and New Delhi Metallo-beta-lactamase (blaNDM) Surveillance, PCR, Varies.

Necessary Information

Specimen source is required.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
OVSRC Specimen source

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

The high sensitivity of amplification by polymerase chain reaction requires the specimen to be processed in an environment in which contamination of the specimen by oxacillin-hydrolyzing beta-lactamase (blaOXA-48-like) or Verona integron-encoded metallo-beta-lactamase (blaVIM) DNA is unlikely.

 

Submit only 1 of the following specimens:

 

Preferred:

Specimen Type: Perianal, perirectal, rectal, anal

Supplies: Culturette (BBL Culture Swab) (T092)

Container/Tube: Culture transport swab (Dacron or rayon swab with aluminum or plastic shaft with either Stuart or Amies liquid medium)

Specimen Volume: Swab

Specimen Stability Information: Refrigerated (preferred)/Frozen

 

Acceptable:

Supplies: Culture and Sensitivity Stool Transport Vial (T058)

Specimen Type: Preserved feces

Container/Tube: Commercially available transport system specific for recovery of enteric pathogens from fecal specimens (15 mL of non-nutritive transport medium containing phenol red as a pH indicator, either Cary-Blair or Para-Pak C and S vial)

Specimen Volume: Representative portion of feces

Collection Instructions:

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

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

Specimen Stability Information: Ambient (preferred)/Refrigerated

Forms

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

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

E-swab
Calcium alginate swab
Cotton-tipped swab
Swab sent in gel transport medium
Swab sent in viral or universal transport medium 		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
Varies Varies

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

Identifying carriers of Ggram-negative bacilli harboring oxacillin-hydrolyzing beta-lactamase (OXA-48-like) or Verona integron-encoded metallo-beta-lactamase (VIM) genes

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

In the United States, Klebsiella pneumoniae carbapenemase (KPC) is the most common carbapenemase, followed by New Delhi metallo-beta-lactamase (NDM). Oxacillin-hydrolyzing beta-lactamase (OXA-48-like) and Verona integron-encoded metallo-beta-lactamase (VIM) carbapenemases predominate in other parts of the globe but do occur in the United States. The genes blaOXA-48-like and blaVIM encode OXA-48-like and VIM enzyme production, respectively. Polymerase chain reaction is a sensitive, specific, and rapid means of identifying these genes.

 

This test detects the genes encoding OXA-48-like and VIM types of beta-lactamases in feces and perirectal/rectal/perianal/anal swabs. It can be used as a tool to find patients who have been colonized. The Centers for Disease Control and Prevention recommends surveillance to detect unrecognized patients who are colonized and who may be a potential source for transmission of carbapenemase-producing Ggram-negative bacilli under certain circumstances. Such surveillance may be focused oin certain high-risk settings or patient groups (eg, intensive care units, long-term care facilities, patients transferred from areas or facilities with a high prevalence of the relevant type of resistance) or may be directed by infection prevention and control to investigate an outbreak.

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

 

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

This polymerase chain- reaction (PCR) assay detects and differentiates blaOXA-48-like and blaVIM in surveillance specimens (perirectal/rectal/perianal/anal swabs or feces). A positive OXA-48-like (oxacillin-hydrolyzing beta-lactamase) and/or VIM (Verona integron-encoded metallo-beta-lactamase) PCR indicates that the patient is colonized by a Gram-negative bacillus (or Gram-negative bacilli) harboring blaOXA-48-like and/or blaVIM, respectively. A negative result indicates the absence of detectable DNA.

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

False-negative results may occur due to inhibition of the polymerase chain reaction, sequence variability underlying primers and probes, or the presence of the blaOXA-48-like or blaVIM genes in quantities lower than the limit of detection of the assay.

Supportive Data

The assay was validated using 46 gram-negative bacilli, including 30 carbapenemase-producers (26 OXA/VIM-type, 1 NMC/IMI, 1 NDM-1, and 2 KPC), and 2 gram-positive organisms. The assay provided 100% sensitivity and specificity for both targets.

 

The assay detects oxacillin-hydrolyzing beta-lactamase (OXA-48-like) and Verona integron-encoded metallo-beta-lactamase (VIM) in surveillance perirectal/rectal/perianal/anal swabs and stool with the following limits of detection: OXA-48-like and VIM, 78 and 75 CFU/mL, respectively. A blinded panel of spiked perirectal/rectal/perianal/anal surveillance swabs and stool was assayed. The assay had 100% sensitivity and specificity, for both targets, in all spiked clinical samples.

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

1. Fernandez J, Cunningham SA, Fernandez-Verdugo A, et al: Evaluation of a real-time PCR assay for rectal screening of OXA-48-producing Enterobacteriaceae in a general intensive care unit of an endemic hospital. Diagn Microbiol Infect Dis. 2017 Jul;88(3):252-258. doi: 10.1016/j.diagmicrobio.2017.04.001

2. Bush K, Fisher JF: Epidemiological expansion, structural studies, and clinical challenges of new beta-lactamases from gram-negative bacteria. Annu Rev Microbiol. 2011;65:455-478

3. Poirel L, Potron A, Nordmann P: OXA-48-like carbapenemases: the phantom menace. J Antimicrob Chemother. 2012 Jul;67(7):1597-1606

4. Nordmann P, Naas T, Poirel L: Global spread of carbapenemase-producing Enterobacteriaceae. Emerg Infect Dis. 2011 Oct;17(10):1791-1798

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

Perirectal, rectal, perianal, and anal swabs are processed in neutralization buffer tubes, and organisms are lysed to release their genomic material. Fecal specimens undergo DNA extraction prior to polymerase chain- reaction (PCR). This assay amplifies and detects a specific portion of the genes encoding the oxacillin-hydrolyzing beta-lactamase (OXA-48-like) and Verona integron-encoded metallo-beta-lactamase (VIM) enzymes. The LightCycler instrument amplifies and monitors target nucleic acid sequences by fluorescence during PCR cycling. This is an automated PCR system that can rapidly detect amplified product development through stringent air-controlled temperature cycling and capillary cuvettes. The detection of amplified products is based on the fluorescent-resonance energy transfer (FRET) principle. For FRET product detection, hybridization probes with a donor fluorophore, fluorescein, on the 3' end are excited by an external light source, which emits light that is absorbed by secondary hybridization probes with acceptor fluorophores, LC-Red 610 (blaOXA-48-like) and LC-Red 670 (blaVIM) on the 5' end. The acceptor fluorophore then emits a light of a different wavelength that can be measured with a signal that is proportional to the amount of specific PCR product. The detection process is completed in less than 1 hour using a closed tube system.(Cunningham SA, Noorie T, Meunier D, Woodford N, Patel R: Rapid and simultaneous detection of genes encoding Klebsiella pneumoniae carbapenemase (blaKPC) and New Delhi metallo-beta-lactamase (blaNDM) in Gram-negative bacilli. J Clin Microbiol. 2013 Apr;519[(4]):1269-1271)

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 Friday

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.

1 to 4 days

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

3 days if received in a swab transport; 7 days if received in C and S vial

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 Regional Manager. 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 was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

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.

87798 x 2

87999 (if appropriate for government payers)

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
OVSRP OXA-48 and VIM Surveillance PCR 85502-3
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.
OVSRC Specimen Source 31208-2
41746 OXA-48-like PCR 85827-4
41747 VIM PCR 85501-5

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 | 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

Test Update Resources

Change Type Effective Date
Test Changes - Specimen Information 2021-08-04
Test Changes - Specimen Information 2021-08-18