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Test Code TOBPA Tobramycin, Peak, Serum

Useful For

Monitoring adequacy of serum concentration during tobramycin therapy

Method Name

Immunoassay

Reporting Name

Tobramycin, Peak, S

Specimen Type

Serum


Specimen Required


Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions:

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

2. Red-top tubes should be centrifuged, and the serum aliquoted into a plastic vial within 2 hours of collection.


Specimen Minimum Volume

0.25 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 7 days
  Frozen  28 days
  Ambient  72 hours

Reject Due To

Gross hemolysis Reject

Clinical Information

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

Therapeutic: 3.0-12.0 mcg/mL

Toxic: >12.0 mcg/mL

Interpretation

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

No significant cautionary statements

Clinical Reference

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

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)

Day(s) Performed

Monday through Sunday

Report Available

Same day/1 to 2 days

Specimen Retention Time

1 week

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

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.

LOINC Code Information

Test ID Test Order Name Order LOINC Value
TOBPA Tobramycin, Peak, S 4057-6

 

Result ID Test Result Name Result LOINC Value
TOBPA Tobramycin, Peak, S 4057-6

CPT Code Information

80200 

Forms

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