| Web: | mayocliniclabs.com |
|---|---|
| Email: | mcl@mayo.edu |
| Telephone: | 800-533-1710 |
| International: | +1 855-379-3115 |
| Values are valid only on day of printing | |
Test Id : OXVRP
Oxacillin-Hydrolyzing Beta-Lactamase (blaOXA-48-like) and Verona integron-encoded metallo-beta-lactamase (blaVIM) in Gram-Negative Bacilli, Molecular Detection, PCR, Varies
Useful For
Suggests clinical disorders or settings where the test may be helpful
Suggests clinical disorders or settings where the test may be helpful
Assessing pure isolates of Gram-negative bacilli for mechanism of carbapenem resistance
Highlights
Rapid molecular test that detects OXA-48-like beta-lactamase and VIM metallo-beta-lactamase DNA associated with antimicrobial resistance in isolates of Gram-negative bacilli.
Special Instructions
Library of PDFs including pertinent information and forms related to the test
Library of PDFs including pertinent information and forms related to the test
Method Name
A short description of the method used to perform the test
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.
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
Lists a shorter or abbreviated version of the Published Name for a test
OXA-48 and VIM PCR
Aliases
Lists additional common names for a test, as an aid in searching
Lists additional common names for a test, as an aid in searching
Carbapenem resistant Enterobacteriaceae
Carbapenem resistant CRE
Carbapenemase producing, carbapenem resistant Enterobacteriaceae
Carbapenemase
CP-CRE
Oxacillinase
OXA
OXA-48
OXA-48-like
VIM
CRE
Specimen Type
Describes the specimen type validated for testing
Describes the specimen type validated for testing
Varies
Ordering Guidance
This assay should be used for testing of isolates of gram-negative bacilli. If testing directly from rectal swabs, perirectal swabs, anal swabs, perianal swabs, or stool is desired, request OVSRP / OXA-48-like (blaOXA-48-like) and VIM (blaVIM) Surveillance, PCR.
Other mechanisms of carbapenem resistance, including other carbapenemase-types, porin mutations, or hyperexpression 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 KPNRP / KPC (blaKPC) and NDM (blaNDM) in Gram-Negative Bacilli, Molecular Detection, PCR.
Additional Testing Requirements
1. Organism identification must be provided. If organism identification is unknown, concomitantly order IDENT / Organism Referred for Identification, Aerobic Bacteria.
2. If susceptibility testing is needed; also order ZMMLS / Antimicrobial Susceptibility, Aerobic Bacteria, MIC.
3. If testing for Klebsiella pneumoniae carbapenemase (KPC) or New Delhi metallo-beta-lactamase (NDM) is also needed; also order KPNRP / KPC (blaKPC) and NDM (blaNDM) in Gram-Negative Bacilli, Molecular Detection, PCR.
Shipping Instructions
1. See Infectious Specimen Shipping Guidelines in Special Instructions for shipping information.
2. Place specimen in a large infectious container (T146) and label as an etiologic agent/infectious substance, if appropriate.
Necessary Information
Organism identification and specimen source are required.
ORDER QUESTIONS AND ANSWERS
| Question ID | Description | Answers |
|---|---|---|
| OXORG | Organism Identified by Client | |
| OXSRC | Specimen Source |
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
The high sensitivity of amplification by PCR requires the specimen to be processed in an environment in which contamination of the specimen by oxacillin-hydrolyzing beta-lactamase (OXA-48-like) or Verona integron-encoded metallo-beta-lactamase (VIM) DNA is unlikely.
Supplies: Infectious Container, Large (T146)
Collection Container/Tube: Slant
Specimen Volume: Isolate
Collection Instructions:
1. Perform isolation of infecting bacteria.
2. Bacterial organism must be submitted in pure culture, actively growing. Do not submit mixed cultures.
Special Instructions
Library of PDFs including pertinent information and forms related to the test
Library of PDFs including pertinent information and forms related to the test
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
Identifies specimen types and conditions that may cause the specimen to be rejected
| Other | Agar plate, mixed culture |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
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 | Ambient (preferred) | ||
| Refrigerated | |||
Useful For
Suggests clinical disorders or settings where the test may be helpful
Suggests clinical disorders or settings where the test may be helpful
Assessing pure isolates of Gram-negative bacilli for mechanism of carbapenem resistance
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
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). OXA-48-like and 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. PCR is a sensitive, specific, and rapid means of identifying these genes. This test detects the genes encoding OXA-48-like (oxacillin-hydrolyzing beta-lactamase) and VIM (Verona integron-encoded metallo-beta-lactamase) types of beta-lactamases in bacterial isolates.
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.
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.
Not applicable
Interpretation
Provides information to assist in interpretation of the test results
Provides information to assist in interpretation of the test results
This PCR detects and differentiates blaOXA-48-like and blaVIM. A positive blaOXA-48-like (oxacillin-hydrolyzing beta-lactamase) PCR indicates that the isolate carries blaOXA-48-like. A positive VIM (Verona integron-encoded metallo-beta-lactamase) PCR indicates the isolate carries blaVIM. 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
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 PCR, 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.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
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. Diagnostic Microbiology and Infectious Disease 2017 July;88(3):252-258 doi.org/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. Annual Review of Microbiology 2011;65:455-478
3. Poirel L, Potron A, Nordmann P: OXA-48-like carbapenemases: the phantom menace. Journal of Antimicrobial Chemotherapy 2012;67:1597-1606
4. Nordmann P, Naas T, Poirel L: Global spread of carbapenemase-producing Enterobacteriaceae. Emerging Infectious Diseases 2011;17:1791-1798
Special Instructions
Library of PDFs including pertinent information and forms related to the test
Library of PDFs including pertinent information and forms related to the test
Method Description
Describes how the test is performed and provides a method-specific reference
Describes how the test is performed and provides a method-specific reference
Isolates are lysed in buffer to release their DNA. This assay amplifies and detects a specific portion of the genes encoding the OXA-48-like (oxacillin-hydrolyzing beta-lactamase) and VIM (Verona integron-encoded metallo- beta-lactamase) 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, et al: 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;51:1269-1271)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
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.
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.
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.
2 to 5 days
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
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.
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.
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.
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.
CPT codes are provided by the performing laboratory.
87150 x 2
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.
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 |
|---|---|---|
| OXVRP | OXA-48 and VIM 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.
|
|---|---|---|
| OXORG | Organism Identified by Client | 43409-2 |
| OXSRC | Specimen Source | 31208-2 |
| 41743 | OXA-48-like PCR | 85503-1 |
| 41744 | 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.
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.
Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.
Normal and Abnormal sample reports are provided as references for report appearance.
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.
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.