Development and Validation of a Free Carbamazepine Assay on an Automated Chemistry Analyzer
© American Association for Clinical Chemistry 2020. All rights reserved. For permissions, please email: journals.permissionsoup.com..
BACKGROUND: Carbamazepine is an effective drug for treating seizures and trigeminal neuralgia. Therapeutic drug monitoring of free carbamazepine in serum can be useful in situations that drug--protein binding is altered to guide regimen adjustment and to aid in the diagnosis of clinical toxicity.
METHODS: Separation of the nonprotein bound carbamazepine was achieved via ultrafiltration through a molecular weight cut-off filter. A method for free carbamazepine measurement was developed on the automated cobas chemistry analyzers (Roche Diagnostics) by modifying the Carbamazepine Gen 4 assay (Roche Diagnostics). Assay performance characteristics were established including precision, accuracy, reportable range, analytical specificity, and stability.
RESULTS: The intra- and inter-assay imprecision was 0%-1.4% and 2.4%-5.1%, respectively. The lower limit of quantitation was 0.3 µg/mL, and the assay was linear up to 10.0 µg/mL. A spike recovery study, using reference standard material, showed recovery was 93.5%--101.3% across the analytical measurement range. Method comparison with a reference laboratory method demonstrated equivalent performance with a slope of 1.01, intercept of 0.09, and correlation coefficient of 0.9948.
CONCLUSION: This assay provides a simple and accurate method for monitoring free carbamazepine with a fast turnaround time.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:5 |
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| Enthalten in: |
The journal of applied laboratory medicine - 5(2020), 2 vom: 01. März, Seite 357-362 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Zhang, Xiaochun [VerfasserIn] |
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| Links: |
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| Themen: |
33CM23913M |
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| Anmerkungen: |
Date Completed 09.06.2021 Date Revised 09.06.2021 published: Print Citation Status MEDLINE |
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| doi: |
10.1093/jalm/jfz003 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM310275741 |
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| 500 | |a Date Revised 09.06.2021 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © American Association for Clinical Chemistry 2020. All rights reserved. For permissions, please email: journals.permissionsoup.com. | ||
| 520 | |a BACKGROUND: Carbamazepine is an effective drug for treating seizures and trigeminal neuralgia. Therapeutic drug monitoring of free carbamazepine in serum can be useful in situations that drug--protein binding is altered to guide regimen adjustment and to aid in the diagnosis of clinical toxicity | ||
| 520 | |a METHODS: Separation of the nonprotein bound carbamazepine was achieved via ultrafiltration through a molecular weight cut-off filter. A method for free carbamazepine measurement was developed on the automated cobas chemistry analyzers (Roche Diagnostics) by modifying the Carbamazepine Gen 4 assay (Roche Diagnostics). Assay performance characteristics were established including precision, accuracy, reportable range, analytical specificity, and stability | ||
| 520 | |a RESULTS: The intra- and inter-assay imprecision was 0%-1.4% and 2.4%-5.1%, respectively. The lower limit of quantitation was 0.3 µg/mL, and the assay was linear up to 10.0 µg/mL. A spike recovery study, using reference standard material, showed recovery was 93.5%--101.3% across the analytical measurement range. Method comparison with a reference laboratory method demonstrated equivalent performance with a slope of 1.01, intercept of 0.09, and correlation coefficient of 0.9948 | ||
| 520 | |a CONCLUSION: This assay provides a simple and accurate method for monitoring free carbamazepine with a fast turnaround time | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Free carbamazepine | |
| 650 | 4 | |a and anticonvulsant medication | |
| 650 | 4 | |a chemistry analyzer | |
| 650 | 4 | |a therapeutic drug monitoring | |
| 650 | 7 | |a Anticonvulsants |2 NLM | |
| 650 | 7 | |a Carbamazepine |2 NLM | |
| 650 | 7 | |a 33CM23913M |2 NLM | |
| 700 | 1 | |a Boyert, Nicole |e verfasserin |4 aut | |
| 700 | 1 | |a Mitro, Matthew |e verfasserin |4 aut | |
| 700 | 1 | |a Tang, Xiaoying |e verfasserin |4 aut | |
| 700 | 1 | |a Bowers, Kathleen |e verfasserin |4 aut | |
| 700 | 1 | |a McShane, Adam J |e verfasserin |4 aut | |
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