Background:
There is no worldwide recognized reference internal quality control method for therapeutic drug
monitoring (TDM) of voriconazole (VCZ) by liquid chromatography (LC). In this study, we aimed to develop an internal
quality control method for TDM of VCZ, evaluate it by the Westgard Multi-rule Theory, and guarantee the analytical
quality of the assays.
Method:
The plasma concentration of VCZ was detected by two-dimensional liquid chromatography with ultraviolet
detection (2D-LC-UV) method. The internal quality control results accompanying with TDM of VCZ in our laboratory
from July 2019 to January 2020 were collected and retrospectively studied. The Levey-Jennings quality chart and Z-score
quality chart were drawn and Westgard Multi-rules of 12s/13s/22s/R4s/41s/10x were applied to assess the suitable quality
control method for TDM of VCZ.
Results:
The 2D-LC-UV method was well suited to monitor the plasma concentration of VCZ and increase the real-time
capability of TDM for VCZ. Combined with Westgard Multi-rules, the quality control charts of Levery-Jennings and Zscore both can timely discover and judge the systematic errors and random errors for the internal quality control results.
86 batches of quality control products were assessed and 7 times warnings and 6 times out of control were detected.
Conclusion:
The Westgard Multi-rules, with high efficacy in determining detection errors, has important application
value in the internal quality control for TDM of VCZ. The developed quality control method can improve the accuracy
and reliability for VCZ measurement by a 2D-LC-UV method and further promote the clinical rational use of the drug.
Establishing an internal quality control method for the stable extraction of nucleic acids of severe acute respiratory syndrome coronavirus 2 and RT‐PCR‐based detection
