Test Catalog

Test Id : GENRA

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Gentamicin, Random, Serum

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Overview

Test Catalog

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

Monitoring adequacy of serum concentration during gentamicin therapy in specimens for which no collection timing information is provided

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

Turbidimetric 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

Gentamicin, Random, S

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 

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.

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. The minimum volume is sufficient for one attempt at testing.

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 14 days
Ambient 72 hours

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

Monitoring adequacy of serum concentration during gentamicin therapy in specimens for which no collection timing information is provided

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

Gentamicin is an antibiotic used to treat life-threatening blood infections caused by gram-negative bacilli, particularly Citrobacter freundii, Acinetobacter species, Enterobacter 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 gentamicin minimal inhibitory concentration (MIC) of less than or equal to 4.0 mcg/mL is considered susceptible for gram-negative bacilli. A MIC of less than or equal to 500 mcg/mL is considered synergistic when combined with appropriate antibiotics for treatment of serious enterococcal infections.

 

Conventional dosing of gentamicin is usually given 2 to 3 times per day by intravenous or intramuscular injections in doses to achieve peak blood concentration between 3.0 to 12.0 mcg/mL depending on the type of infections. Gentamicin also may be administered at higher doses (usually 5-7 mg/kg) once per day to patients with good renal function (known as pulse dosing). Dosing amount or interval must be decreased to accommodate for reduced renal function.

 

Ototoxicity and nephrotoxicity are the primary toxicities associated with gentamicin. This risk is enhanced in presence of other ototoxic or nephrotoxic drugs. Monitoring of serum levels and symptoms consistent with ototoxicity is important. For longer durations of use, audiology/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.

Gentamicin, Peak

Therapeutic: 3.0-12.0 mcg/mL

Toxic: >12.0 mcg/mL

Gentamicin, Trough

Therapeutic: <2.0 mcg/mL

Toxic: >2.0 mcg/mL

Interpretation
Provides information to assist in interpretation of the test results

Goal peak concentrations levels depend on the type of infection being treated. Goal trough levels should be less than 2.0 mcg/mL. Peak targets are generally between 3.0 and 12.0 mcg/mL for conventional dosing. Prolonged exposure to either peak levels exceeding 12.0 mcg/mL or to trough levels exceeding 2.0 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

Patient samples that contain the drug sisomicin will yield falsely elevated values for gentamicin. However, this drug is not usually coadministered with gentamicin.

 

High concentrations of penicillins or cephalosporins have been shown to inactivate gentamicin in vitro. The degree of inactivation is dependent on the particular aminoglycoside being measured, the type and concentration of the penicillin or cephalosporin that is also present and the storage conditions of the sample. For patients receiving additional antibiotics of these types, 5 to 7 samples should be assayed immediately or stored frozen.

 

In very rare cases, patient samples may contain heterophile antibodies, which may produce low results with the QMS Gentamicin assay.

 

Interfering heterophile antibodies occur at low frequency in the general population. These antibodies can cause autoagglutination of the microparticle reagent leading to undetected erroneously low results.

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 Information Healthcare USA, 2008

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

The assay is a homogeneous particle-enhanced turbidimetric immunoassay. The assay is based on competition between drug in the sample and drug coated onto a microparticle for antibody binding sites of the gentamicin antibody reagent. The gentamicin-coated microparticle reagent is rapidly agglutinated in the presence of the antigentamicin antibody reagent and in the absence of any competing drug in the sample. The rate of absorbance change is measured photometrically. When a sample containing gentamicin is added, the agglutination reaction is partially inhibited, slowing down the rate of absorbance change. A concentration-dependent classic agglutination inhibition curve can be obtained with maximum rate of agglutination at the lowest gentamicin concentration and the lowest agglutination rate at the highest gentamicin concentration.(Package insert: Roche Gentamicin reagent, Roche Diagnostic Corp, Indianapolis, IN 01/2018)

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 day

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 account representative. 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.

80170

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
GENRA Gentamicin, Random, S 35668-3
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.
GENRA Gentamicin, Random, S 35668-3

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