Feasibility Analysis of Different Bovine Serum Replacing Human Serum in Therapeutic Drug Monitoring of Vancomycin
Objective To analyze the feasibility of different bovine serum replacing human serum as blank substrate in the therapeutic drug monitoring(TDM)of vancomycin.Methods The high-performance liquid chromatography(HPLC)method for determining the plasma concentration of vancomycin was established.A total of 105 serum samples(plasma concentration had been tested)from patients receiving vancomycin treatment in a hospital from January 2022 to January 2023 were collected,the vancomycin plasma concentration of human serum and different bovine serum(calf serum,newborn calf serum,fetal calf serum)from manufacturers 1 and 2 was obtained through the correlation of the vancomycin plasma concentration of above serum samples and the standard curves of human serum and bovine serum as the blank substrate.The Passing-Bablock regression analysis and the Bland-Altman method were used to explore the correlation and consistency of the measurement results.Results When human serum and different bovine serum as the blank substrate,the linear range of vancomycin was 1-100 mg/L(R2>0.999).The RSDs of intra-day precision and inter-day precision were lower than 15%,and the relative recovery rate of vancomycin was in the range of 85%to 115%.The correlation of human serum with different bovine serum as blank substrate was good(r>0.999),but with systematic and proportional errors.The relative average deviations and 95%limits of agreement(95%LoA)of the detection values of three bovine serum from manufacturer 1(calf serum 1,newborn calf serum 1,fetal calf serum 1)compared to human serum as the blank substrate were all lower than the 50%of total allowable error(±15%),while the relative average deviations or 95%LoA of the detection values of three bovine serum from manufacturer 2(calf serum 2,newborn calf serum 2,fetal calf serum 2)compared to human serum as the blank substrate were over±15%.Conclusion In the TDM of vancomycin by HPLC,the bovine serum produced by some manufacturers can replace human serum as the blank substrate for detection.
vancomycintherapeutic drug monitoringhuman serumcalf serumnewborn calf serumfetal calf serumblank substrateHPLC
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维普
