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Test Code GENPA; SQ: GENPA Gentamicin, Peak, Serum

Important Note

This test should be ordered in place of in-house test code GENTPK.

Useful For

Monitoring adequacy of drug clearance during gentamicin therapy

Method Name

Turbidimetric Immunoassay

Reporting Name

Gentamicin, 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  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 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 and 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

Peak: 3.0-12.0 mcg/mL

Toxic peak: >12.0 mcg/mL

Interpretation

Goal levels depend on the type of infection being treated. Peak targets are generally between 5.0 and 8.0 mcg/mL for less severe infections and 8.0 and 10.0 mcg/mL for severe infections. Prolonged exposure to peak levels exceeding 12.0 mcg/mL may lead to toxicity.

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

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
GENPA Gentamicin, Peak, S 3663-2

 

Result ID Test Result Name Result LOINC Value
GENPA Gentamicin, Peak, S 3663-2

Secondary ID

37042

Forms

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