This study aimed to develop a simple,effective,and accurate internal quality control(IQC)method for therapeutic drug monitoring(TDM)of levetiracetam(LEV)in the serum of patients with epilepsy and to evaluate its perfo...This study aimed to develop a simple,effective,and accurate internal quality control(IQC)method for therapeutic drug monitoring(TDM)of levetiracetam(LEV)in the serum of patients with epilepsy and to evaluate its performance using the Westgard multi-rule criteria,thereby ensuring the analytical quality of the assays.A high-performance liquid chromatography method with diode array detection was established and validated for the quantitative determination of LEV in 100μL of human plasma.Quality control(QC)samples at low,medium,and high concentrations(2.5,10,and 50μg/mL)were prepared in-house,and retrospective IQC data associated with routine TDM of LEV in our laboratory were collected for analysis.Levey-Jennings and Z-score charts were generated using Microsoft Excel,and the TDM assays were assessed according to Westgard multi-rules.Calibration curves demonstrated excellent linearity over a LEV concentration range of 180μg/mL,with correlation coefficients≥0.997 and a lower limit of quantification of 0.5μg/mL.Intra-day and inter-day coefficients of variation for the low,medium,and high concentration QC samples ranged from 1.03%to 6.90%and 1.63%to 8.19%,respectively,while extraction recovery rates were 74.20%83.85%and 70.65%83.72%,respectively.The accuracy of the assay ranged from 96.26%to 109.31%.Twenty batches of QC samples were evaluated using Levey-Jennings and Z-score charts in combination with Westgard multi-rules,and none were found to be out of control.Taken together,this internally developed QC method was simple,rapid,reliable,and accurate for routine TDM of LEV.Its application enhanced the reliability and precision of LEV measurement and supported the rational and safe clinical use of this antiepileptic drug.展开更多
Brine shrimp are vital inhabitants of saltwater lakes,contributing significantly to economic and ecological systems.With increasing threats from environmental degradation and overharvesting,effec-tive monitoring is ur...Brine shrimp are vital inhabitants of saltwater lakes,contributing significantly to economic and ecological systems.With increasing threats from environmental degradation and overharvesting,effec-tive monitoring is urgenttly needed.Traditional field sampling meth-ods are limited in scope and efficiency,necessitating a reliable remote sensing-based approach.However,Ebinur Lake's complex spectral environment,characterized by poor water quality and diverse suspended particulates,poses challenges for satellite remote sensing accuracy.To overcome these issues,we developed a novel multi-rule extraction model based on Landsat data,lever-aging the distinct short-wave infrared signatures of brine shrimp to enhance detection accuracy.We evaluated and validated this method using Landsat 8 and Sentinel-2 datasets,achieving a classification accuracy of 94.5%and a kappa coefficient of 0.88,surpassing existing methods.Additionally,our analysis of a decade of Landsat data in Ebinur Lake via Google Earth Engine revealed a correlation between brine shrimp distribution and lake surface area.Our model demonstrates high accuracy and scalability in mapping brine shrimp,making it a valuable tool for long-term,large-scale assessments in saline lakes.This capability holds signifi-cant potential for advancing fisheries research and informing con-servation strategies.展开更多
基金The Support Program Special Grant of Anhui Pharmacist Association(Grant No.SPSG2023001005)the Key Program of Natural Science Research of Higher Education of Anhui Province(Grant No.2023AH052545)。
文摘This study aimed to develop a simple,effective,and accurate internal quality control(IQC)method for therapeutic drug monitoring(TDM)of levetiracetam(LEV)in the serum of patients with epilepsy and to evaluate its performance using the Westgard multi-rule criteria,thereby ensuring the analytical quality of the assays.A high-performance liquid chromatography method with diode array detection was established and validated for the quantitative determination of LEV in 100μL of human plasma.Quality control(QC)samples at low,medium,and high concentrations(2.5,10,and 50μg/mL)were prepared in-house,and retrospective IQC data associated with routine TDM of LEV in our laboratory were collected for analysis.Levey-Jennings and Z-score charts were generated using Microsoft Excel,and the TDM assays were assessed according to Westgard multi-rules.Calibration curves demonstrated excellent linearity over a LEV concentration range of 180μg/mL,with correlation coefficients≥0.997 and a lower limit of quantification of 0.5μg/mL.Intra-day and inter-day coefficients of variation for the low,medium,and high concentration QC samples ranged from 1.03%to 6.90%and 1.63%to 8.19%,respectively,while extraction recovery rates were 74.20%83.85%and 70.65%83.72%,respectively.The accuracy of the assay ranged from 96.26%to 109.31%.Twenty batches of QC samples were evaluated using Levey-Jennings and Z-score charts in combination with Westgard multi-rules,and none were found to be out of control.Taken together,this internally developed QC method was simple,rapid,reliable,and accurate for routine TDM of LEV.Its application enhanced the reliability and precision of LEV measurement and supported the rational and safe clinical use of this antiepileptic drug.
基金supported in part by the National Natural Science Foundation of China(NSFC)under Grant 42471390 and Grant 42425104the Third Comprehensive Scientific Expedition to Xinjiang under Grant 2021xjkk1403.
文摘Brine shrimp are vital inhabitants of saltwater lakes,contributing significantly to economic and ecological systems.With increasing threats from environmental degradation and overharvesting,effec-tive monitoring is urgenttly needed.Traditional field sampling meth-ods are limited in scope and efficiency,necessitating a reliable remote sensing-based approach.However,Ebinur Lake's complex spectral environment,characterized by poor water quality and diverse suspended particulates,poses challenges for satellite remote sensing accuracy.To overcome these issues,we developed a novel multi-rule extraction model based on Landsat data,lever-aging the distinct short-wave infrared signatures of brine shrimp to enhance detection accuracy.We evaluated and validated this method using Landsat 8 and Sentinel-2 datasets,achieving a classification accuracy of 94.5%and a kappa coefficient of 0.88,surpassing existing methods.Additionally,our analysis of a decade of Landsat data in Ebinur Lake via Google Earth Engine revealed a correlation between brine shrimp distribution and lake surface area.Our model demonstrates high accuracy and scalability in mapping brine shrimp,making it a valuable tool for long-term,large-scale assessments in saline lakes.This capability holds signifi-cant potential for advancing fisheries research and informing con-servation strategies.