Application of the Westgard Multi-Rule Theory to Internal Quality Control Evaluation of Voriconazole for Therapeutic Drug Monitoring

2020 ◽  
Vol 16 ◽  
Author(s):  
Houli Li ◽  
Di Zhang ◽  
Xiaoliang Cheng ◽  
Marwa Fath Abdulqawi Sultan ◽  
Lilong Xiong ◽  
...  
Keyword(s):  
Quality Control ◽  
Liquid Chromatography ◽  
Plasma Concentration ◽  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Control Method ◽  
Internal Quality Control ◽  
Internal Quality ◽  
Therapeutic Drug ◽  
Quality Control Method

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.

An assessment of partial rescreening as an internal quality control method for cervical smears

Cytopathology ◽  
1995 ◽  
Vol 6 (6) ◽  
pp. 376-387 ◽  
Author(s):  
S. J. JOHNSON ◽  
T. HAIR ◽  
L. GIBSON ◽  
B. RIDLEY ◽  
V. WADEHRA
Keyword(s):  
Quality Control ◽  
Control Method ◽  
Internal Quality Control ◽  
Internal Quality ◽  
Cervical Smears ◽  
Quality Control Method

scholarly journals A Novel, Rapid, and Low-Volume Assay for Therapeutic Drug Monitoring of Posaconazole and Other Long-Chain Azole-Class Antifungal Drugs

mSphere ◽  
2018 ◽  
Vol 3 (6) ◽  
Author(s):  
Gregory R. Wiedman ◽  
Yanan Zhao ◽  
David S. Perlin
Keyword(s):  
Liquid Chromatography ◽  
Therapeutic Drug Monitoring ◽  
Human Serum ◽  
Drug Monitoring ◽  
Fungal Infections ◽  
Antifungal Drugs ◽  
Therapeutic Drug ◽  
Serum Samples ◽  
Human Serum Samples ◽  
Long Chain

ABSTRACT Clinicians need a better way to accurately monitor the concentration of antimicrobials in patient samples. In this report, we describe a novel, low-sample-volume method to monitor the azole-class antifungal drug posaconazole, as well as certain other long-chain azole-class antifungal drugs in human serum samples. Posaconazole represents an important target for therapeutic drug monitoring (TDM) due to its widespread use in treating invasive fungal infections and well-recognized variability of pharmacokinetics. The current “gold standard” requires trough and peak monitoring through high-pressure liquid chromatography (HPLC) or liquid chromatography-tandem mass spectroscopy (LC-MS/MS). Other methods include bioassays that use highly susceptible strains of fungi in culture plates or 96-well formats to monitor concentrations. Currently, no method exists that is both highly accurate in detecting free drug concentrations and is also rapid. Herein, we describe a new method using reduced graphene oxide (rGO) and a fluorescently labeled aptamer, which can accurately assess clinically relevant concentrations of posaconazole and other long-chain azole-class drugs in little more than 1 h in a total volume of 100 µl. IMPORTANCE This work describes an effective assay for TDM of long-chain azole-class antifungal drugs that can be used in diluted human serum samples. This assay will provide a quick, cost-effective method for monitoring concentrations of drugs such as posaconazole that exhibit well-documented pharmacokinetic variability. Our rGO-aptamer assay has the potential to improve health care for those struggling to treat fungal infections in rural or resource-limited setting.

scholarly journals Sensitive and Rapid Quantification of Busulfan in Small Plasma Volumes by Liquid Chromatography–Electrospray Mass Spectrometry

2001 ◽  
Vol 47 (8) ◽  
pp. 1437-1442 ◽  
Author(s):  
Thomas E Mürdter ◽  
Janet Coller ◽  
Alexander Claviez ◽  
Frank Schönberger ◽  
Ute Hofmann ◽  
...  
Keyword(s):  
Liquid Chromatography ◽  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Internal Standard ◽  
Therapeutic Drug ◽  
High Dose ◽  
Selected Ion Monitoring ◽  
Hematopoietic Stem ◽  
Adults And Children ◽  
Liquid Chromatographic

Abstract Background: High-dose busulfan is widely used in conditioning regimens before hematopoietic stem cell transplantation in both adults and children. Large interindividual variability in pharmacokinetics after oral administration has been reported; therefore, therapeutic drug monitoring of busulfan may decrease the incidence of drug-related toxicity (for example, hepatic venoocclusive disease) and may also improve therapeutic efficacy. Methods: Busulfan concentrations were quantified using 200 μL of plasma and liquid–liquid extraction with diethyl ether after the addition of [2H8]busulfan as the internal standard. Separation and detection of busulfan and [2H8]busulfan were achieved with a LUNA C8 column (5 μm; 150 × 2 mm i.d.) at 30 °C, a HP 1100 liquid chromatography system, and a HP 1100 single-quadrupole mass spectrometer. Busulfan and [2H8]busulfan were detected as ammonium adducts in selected-ion monitoring mode at m/z 264.2 and 272.2, respectively. Results: The calibration curve was linear at 5–2000 μg/L busulfan. Intra- and interassay imprecision (CV) and bias were both <11%. The limits of detection and quantification were 2 and 5 μg/L, respectively. Extraction recovery of busulfan was >87%. Analysis of pharmacokinetics in four patients receiving high-dose busulfan indicated that minimum busulfan concentrations before the next dose were 405–603 μg/L, with no interference observed. Conclusions: The new rapid and sensitive liquid chromatographic–mass spectrometric assay is an appropriate method for quantification of busulfan in human plasma, making therapeutic drug monitoring of busulfan faster and easier in clinical practice.

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