Operator Error: A Critical Determinant of False Amikacin and Tobramycin Concentrations Using Fluorescence Polarization Immunoassay Kits and TDX Analyzer

Abstract

Amikacin and tobramycin are aminoglycosides used to treat severe Gram-negative infections. Therapeutic monitoring of both drugs is essential to avoid drug toxicity. Fluorescence polarization immunoassay kits for both amikacin and tobramycin are available from Abbott Laboratories, and assays can be run using the TDx analyzer. The test code for amikacin is 3, whereas the test code for tobramycin is 2. Here the authors report that when the operator mistakenly programmed test code 3 (amikacin code) while using the tobramycin kit, the tobramycin values were falsely elevated. The instrument software does not have any mechanism to detect this error. Similarly, when the amikacin kit was used and the operator mistakenly programmed test code 2 (tobramycin code), the amikacin values were falsely lowered. For example, in a serum sample taken from a patient the true amikacin concentration was 20.9 microg/mL. When the amikacin kit was used correctly but test code 2 was programmed, the observed concentration was falsely lowered to 6.1 microg/mL. Similarly, in another specimen the true tobramycin concentration was 3.1 microg/mL. However, when the tobramycin kit was used correctly but test code 3 was used, the observed concentration was falsely elevated to 14.3 microg/mL. The authors also observed a similar effect with controls and spiked specimens containing either amikacin or tobramycin. They conclude that correct programming of the test code is vital to obtaining useful results in amikacin and tobramycin analysis using the TDx analyzer.