Clozapine and N-Desmethylclozapine (Norclozapine) Proficiency Testing Data, 2012-2024
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View abstract on PubMed
Summary
This summary is machine-generated.Serum clozapine proficiency testing shows increased liquid chromatography-mass spectrometry use did not improve analytical performance. Method validation should address potential interferences and unexpected results require repeat analysis.
Area Of Science
- Clinical Chemistry
- Pharmacology
- Analytical Chemistry
Background
- Proficiency testing schemes are crucial for monitoring laboratory performance in therapeutic drug monitoring.
- Clozapine and norclozapine are essential antipsychotic medications requiring accurate quantification.
- Assessing analytical methods used in clozapine and norclozapine testing is vital for patient safety.
Purpose Of The Study
- To summarize data from a serum clozapine and norclozapine proficiency testing scheme.
- To evaluate the impact of analytical methods on quantitative performance over time.
- To identify potential issues in clozapine and norclozapine measurement.
Main Methods
- Analysis of monthly returns from a clozapine and norclozapine proficiency testing scheme (2012-2024).
- Tracking the proportion of laboratories using different analytical techniques, including liquid chromatography-mass spectrometry (LC-MS) and high-performance liquid chromatography (HPLC).
- Assessment of quantitative performance using z-scores and analysis of reported clozapine and norclozapine concentrations.
Main Results
- 191 laboratories participated, with 164 reporting norclozapine results.
- The use of LC-MS increased to 74% by 2024, while HPLC use decreased.
- Detectable clozapine concentrations were reported in 6.8% of returns, with some high concentrations reported as "0" or below the limit of quantification.
- No significant temporal differences in quantitative performance (z-scores) were observed between analytical methods.
- Median clozapine z-scores were further from zero when clozapine alone was measured compared to when both clozapine and norclozapine were measured.
Conclusions
- Increased adoption of LC-MS did not correlate with improved analytical performance for clozapine or norclozapine.
- Method validation should incorporate assessment of interference from metabolites and co-administered drugs.
- Unexpected quantitative results necessitate repeat analysis or, when feasible, repeat sampling for clinical confirmation.
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