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Homogeneous Immunoassays—Therapeutic Drug Monitoring
QMS®—Latex Enhanced Immunoturbidimetric Assays
Amikacin Assay System
The AMIKACIN Assay System is intended for the quantitative determination of total amikacin in serum for therapeutic drug monitoring.
Amikacin is one of the class of aminoglycoside drugs which are used in the treatment of serious enterococcal and gram-negative bacillary infections.1,2 The aminoglycosides inhibit bacterial protein synthesis by specifically binding to the 30 S ribosomal subunit.1,3,4 Amikacin is the aminoglycoside of choice for the treatment of infections caused by microorganisms resistant to other aminoglycosides, primarily gentamicin or tobramycin, due to its unique resistance to aminoglycoside-inactivating enzymes.1,4 Amikacin is routinely administered intravenously or intramuscularly, is rapidly dispersed into extracellular fluid, does not cross most cell membranes, and is essentially unbound to serum proteins.1,4,5 As with other aminoglycosides, amikacin is potentially ototoxic and nephrotoxic.1-6 In patients with normal renal function, amikacin is rapidly excreted, primarily by glomerular filtration, with an elimination half-life of approximately two hours.1-6 The use of amikacin in renal patients must be carefully monitored.1,3-6
Measurement of serum levels is necessary to prevent toxicity and inadequate dosing, due to wide individual variation in the elimination and distribution of amikacin.1,2,5,6
Suggested therapeutic amikacin levels for the peak specimen range from 20-25 µg/mL,3 however, recent literature cites a range for therapeutic peak levels of 20-30 µg/mL.1 Peak serum levels at concentrations greater than 30-35 µg/mL have been associated with nephrotoxicity, mainly tubular necrosis, and otoxicity, which includes damage to the vestibular and auditory branches of the eighth cranial nerve.3 Trough serum concentrations range from 5-10 µg/mL, and trough levels greater than 10 µg/mL have been associated with toxicity, 250 including renal failure, in some patients.1,13
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