Lab Med Online.  2020 Oct;10(4):265-275. 10.47429/lmo.2020.10.4.265.

Vancomycin and Aminoglycoside Antibiotic Drug Concentration Measurement: Current Status in Clinical Laboratories in Korea

Affiliations
  • 1Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

Abstract

Background
Therapeutic drug monitoring (TDM) is clinically recommended for vancomycin and aminoglycoside antibiotics owing to their narrow therapeutic range and nephrotoxicity at high concentrations in the blood. This study was conducted to investigate the current status of TDM of vancomycin and aminoglycosides in Korean clinical laboratories.
Methods
Ten organizations participated in this survey. Vancomycin, amikacin, gentamicin, and tobramycin were prepared in three samples of five or six different concentrations. Data from each institution were calculated for the mean, standard deviation, within-day, between-day, and within-laboratory precision. The results from each institution were compared in various ways.
Results
Six instruments from three manufacturers were used. Samples with the lowest drug concentration were reported as below the lower limit of quantitation in most laboratories. Coefficients of variation for within-laboratory values ranged from 1.1% to 10.9% for vancomycin, 0.8% to 18.2% for amikacin, 1.2% to 7.8% for gentamicin, and 1.3% to 6.1% for tobramycin. Based on the overall results of the participants, only one institution’s vancomycin samples standard deviation index exceeded 3, with all other values below 2. The College of American Pathologist criteria were met by all institutions; however, measurement of vancomycin in one laboratory and of gentamycin in three laboratories failed to meet the Royal College of Pathologists of Australasia acceptance criteria.
Conclusions
Although the precision of the antibiotic test in individual institutions was excellent, there was a difference in the measured values between laboratories. Harmonization of antibiotic TDM is needed to reduce inconsistencies in results.

Keyword

Amikacin; Gentamicin; Therapeutic drug monitoring; Tobramycin; Vancomycin

Figure

  • Fig. 1 Box-and-whisker plots of instrument test values for vancomycin (A), amikacin (B), gentamicin (C), and tobramycin (D). The vertical dashed line across each plot represents the median of all participating institutions.

  • Fig. 2 Mean, standard deviation (SD), and coefficient of variation (CV) of measurements from different instruments. The mean (A), SD (B), and CV (%) (C) for vancomycin. The mean (D), SD (E), and CV (%) (F) for amikacin. The mean (G), SD (H), and CV (%) (I) for gentamicin. The mean (J), SD (K), and CV (%) (L) for tobramycin.

  • Fig. 3 Box-and-whisker plots for concentration measured on the same instrument. Cobas c501, c702 (A), Architect i2000 (B), ADVIA Centaur XP (C), and Integra 800 (D). The horizontal line inside the box indicates the median value of the measured concentrations in each group.

  • Fig. 4 Measured concentration of antibiotics in all participating institutions. Vancomycin (A), amikacin (B), gentamicin (C), and tobramycin (D) at each institution. Horizontal dashed lines represent the Royal College of Pathologists of Australasia (RCPA) allowable limits of performance. Asterisks indicate values that exceed the RCPA allowable limits of performance, daggers indicate values below the RCPA allowable limits of performance, and double asterisks indicate values that exceed the RCPA and Korean Association of External Quality Assessment Service (KEQAS) allowable limits of performance.


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