Test Catalog

Test Id : TOBPA

Tobramycin, Peak, Serum

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

Monitoring adequacy of serum concentration during tobramycin therapy

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

Immunoassay

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

Tobramycin, Peak, S

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

Antibiotic Assay

Antimicrobial Assay, Tobramycin

Nebcin (Tobramycin Sulfate Injection)

Tobramycin, Antimicrobial Assay

Specimen Type
Describes the specimen type validated for testing

Serum

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

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.5 mL

Collection Instructions:

1. Serum for a peak level should be drawn 30 to 60 minutes after last dose.

2. Serum gel tubes should be centrifuged within 2 hours of collection.

3. Red-top tubes should be centrifuged and aliquoted within 2 hours of collection.

Forms

If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.

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

0.25 mL

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

Gross hemolysis 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
Serum Refrigerated (preferred) 7 days
Frozen 28 days
Ambient 72 hours

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

Monitoring adequacy of serum concentration during tobramycin therapy

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

Tobramycin is an antibiotic used to treat life-threatening blood infections caused by gram-negative bacilli, particularly Citrobacter freundii, Enterobacter (all species), Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Providencia stuartii, Pseudomonas aeruginosa, and Serratia species. It is often used in combination with beta-lactam therapy.

 

A tobramycin minimum inhibitory concentration (MIC) of less than 4.0 mcg/mL is considered susceptible for gram-negative bacilli, while a MIC of greater than 8.0 mcg/mL is considered resistant.

 

Toxicities include ototoxicity and nephrotoxicity. This risk is enhanced in presence of other ototoxic or nephrotoxic drugs. Monitoring of serum levels, renal function, and symptoms consistent with ototoxicity is important. For longer durations of use, audiology and vestibular testing should be considered at baseline and periodically during therapy.

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.

Therapeutic: 3.0-12.0 mcg/mL

Toxic: >12.0 mcg/mL

Interpretation
Provides information to assist in interpretation of the test results

Target peak concentrations depend on the type of infection being treated. Peak levels for most infections using conventional dosing are 3.0 to 12.0 mcg/mL. Prolonged exposure to peak concentrations exceeding 12.0 mcg/mL may lead to toxicity.

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

No significant cautionary statements

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

1. Hammett-Stabler CA, Johns T: Laboratory guidelines for monitoring of antimicrobial drugs. Clin Chem 1998;44(5):1129-1140

2. Moyer TP: Therapeutic drug monitoring. In Tietz Textbook of Clinical Chemistry. Fourth edition. Edited by CA Burtis, ER Ashwood, Philadelphia, WB Saunders Company, 2006

3. Wilson JW, Estes LL: Mayo Clinic Antimicrobial Therapy Quick Guide. Mayo Clinic Scientific Press and Informa Healthcare USA, 2008

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

The assay is based on a homogeneous enzyme immunoassay technique used for the quantitative analysis of tobramycin in human serum or plasma. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the sample can be measured in terms of enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD) to NADH (the reduced form of NAD), resulting in an absorbance change that is measured spectrophotometrically. Endogenous serum G6PDH does not interfere because the coenzyme functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.(Package insert: Roche Tobramycin reagent, Roche Diagnostic Corp, Indianapolis, IN)

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.

Same day/1 to 2 days

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

1 week

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 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.

80200 

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