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Interlaboratory analysis of teicoplanin plasma concentration assays among Chinese laboratories
- Source :
- Journal of Clinical Pharmacy and Therapeutics. 45:983-990
- Publication Year :
- 2020
- Publisher :
- Hindawi Limited, 2020.
-
Abstract
- What is known and objective Teicoplanin is widely used for the treatment of infections caused by drug-resistant Gram-positive bacteria. Since there is a good correlation between trough levels and clinical outcome, therapeutic drug monitoring (TDM) is recommended to achieve better clinical curative effects. However, TDM of teicoplanin is not routine in China. So, a programme was initiated in 2017, including both HPLC method establishment and interlaboratory quality assessment, for the measurement of teicoplanin. Methods A main centre and a quality control centre were set up in the study. An HPLC-based method of teicoplanin determination in plasma was developed by the main centre. Analysis was performed using a Waters Symmetry C18 column (250 mm × 4.6 mm, 5 µm). The mobile phase was NaH2 PO4 (0.01 mol/L) and acetonitrile (75:25 v/v; pH 3.3), with a flow rate of 1.0 mL/min and a detection wavelength of 215 nm. Piperacillin sodium was selected as an internal standard (IS). Twenty-six additional TDM centres were then recruited to adopt this method. Then, all the centres were asked to take part in a quality control assessment evaluated by the quality control centre. Results For all TDM centres, linearity of teicoplanin concentration ranges was between 3.125 and 100 µg/mL. Intraday and interday accuracies ranged from 87.1% to 118.4%. Intraday and interday precision ranged from 0.3% to 13.8%. Therapeutic drug monitoring centres all passed inter-room quality assessment. All samples tested met the acceptance criteria. Then, 542 samples were collected. Patients with sub-optimal (≤10 mg/L) plasma teicoplanin concentrations constituted 42% of the total study population. What is new and conclusions For the first time, a simple, rapid and accurate HPLC method for determining teicoplanin levels was successfully applied to therapeutic drug monitoring in clinical practice for twenty-seven TDM centres in China. The results demonstrated excellent interlaboratory agreement for teicoplanin testing and provide support for clinical laboratory quality management and results inter-accreditation.
- Subjects :
- Adult
Quality Control
China
Adolescent
030226 pharmacology & pharmacy
High-performance liquid chromatography
Young Adult
03 medical and health sciences
0302 clinical medicine
medicine
Humans
Pharmacology (medical)
030212 general & internal medicine
Hplc method
Chromatography, High Pressure Liquid
Aged
Aged, 80 and over
Pharmacology
Chromatography
medicine.diagnostic_test
business.industry
Teicoplanin
Quality assessment
Reproducibility of Results
Middle Aged
Anti-Bacterial Agents
Clinical Practice
Therapeutic drug monitoring
Plasma concentration
Drug Monitoring
Laboratories
business
medicine.drug
Subjects
Details
- ISSN :
- 13652710 and 02694727
- Volume :
- 45
- Database :
- OpenAIRE
- Journal :
- Journal of Clinical Pharmacy and Therapeutics
- Accession number :
- edsair.doi.dedup.....8d2bf99d091328b1b45f9a2522b4fe73