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Test ID: TOBPK
Tobramycin, Peak, Serum

Secondary ID A test code used for billing and in test definitions created prior to November 2011

84810

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

Yes

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

Enzyme-Multiplied Immunoassay Technique (EMIT)

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

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 needed for testing

Serum Red

Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.

Collection Container/Tube: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

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

2. Spin down within 2 hours of draw.

Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.

0.25 mL

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

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross reject

Icterus

Mild OK; Gross reject

Other

Serum gel tube

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
Serum RedFrozen14 days

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 <4.0 mcg/mL is considered susceptible for gram-negative bacilli, while a MIC of >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.

5.0-12.0 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 5.0 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 Provides recommendations for further 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

This assay is performed by enzyme-multiplied immunoassay technique (EMIT) using an Olympus analyzer. EMIT offers an alternative to the traditional spectroscopic and chromatographic method for quantitating blood concentrations of drugs. The technique for drugs is based upon an enzymatic assay for glucose-6-phosphate dehydrogenase (G6P-DH), using spectral properties at 340 nm, in which the reduction of nicotinamide adenine dinucleotide (NAD) substrate is monitored. The basis of the drug detection technique is an immunological reaction between the drug and a specific antibody. The reagent contains the enzyme G6P-DH to which the drug is covalently bound and an antibody specific to the drug. The antibody binds most of the drug-bound enzyme, rendering the enzyme inactive. This results in a baseline enzymatic activity. In the presence of free drug, antibody equilibrates between free drug and enzyme-bound drug leaving some of the drug-bound enzyme uncomplexed and able to catalyze the reaction. If more free drug is introduced, either as standard or sample, then competition for the antibody takes place between the drug in the sample and the drug attached to the enzyme. This results in more drug-bound enzyme being left uncomplexed and able to catalyze the enzyme reaction at a greater rate as compared to the baseline activity. The observed enzyme activity increases with the amount of total free drug in the sample.(Package insert: EMIT 2000 Tobramycin Syva Company, Siemens Healthcare Diagnositics, Newwark DE, June 2011)

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

Monday through Sunday; Varies

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

Same day/1 day

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

2 days

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

14 days

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

Rochester

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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.

This test has been cleared or approved by the U.S. 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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

80200

LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.

Result IDReporting NameLOINC Code
6799Tobramycin, Peak, S4057-6