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Test Code GENRA Gentamicin, Random, Serum

Useful For

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

Method Name

Turbidimetric Immunoassay

Reporting Name

Gentamicin, Random, 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  14 days
  Ambient  72 hours

Reject Due To

Gross hemolysis Reject

Clinical Information

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

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

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

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.

Method Description

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)

Day(s) Performed

Monday through Sunday

Report Available

Same day/1 day

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.

CPT Code Information

80170

LOINC Code Information

Test ID Test Order Name Order LOINC Value
GENRA Gentamicin, Random, S 35668-3

 

Result ID Test Result Name Result LOINC Value
GENRA Gentamicin, Random, S 35668-3