Performance characteristics of four free phenytoin immunoassays

William L. Roberts, Thomas M. Annesley, Barun K. De, Linda Moulton, Jo Etta M. Juenke, Thomas P. Moyer

Research output: Contribution to journalArticlepeer-review

14 Scopus citations

Abstract

The measurement of the unbound or free phenytoin concentration is indicated in several situations, including uremia. In patients with uremia, metabolites of phenytoin and other substances accumulate and can displace phenytoin from its protein binding sites, with a consequent increase in the free fraction of drug. Some of the phenytoin metabolites that accumulate in uremia can cross-react with phenytoin immunoassays. In this study the authors evaluated four free phenytoin immunoassays compared with a high-performance liquid chromatography (HPLC) method: the Roche COBAS Integra, the Syva EMIT 2000, the Opus INNOFLUOR, and the Abbott TDx. All four methods demonstrated good precision, with interday coefficients of variation of ≤5% and comparable recoveries using quality control material. Two of the methods, the EMIT 2000 and COBAS Integra, showed excellent agreement with the HPLC method using samples from patients both with normal renal function and with renal insufficiency. The other two methods, the INNOFLUOR and TDx, showed average positive biases for the therapeutic range of 3-7% and 21-22%, respectively, compared with the HPLC method for samples from patients with normal renal function, and average positive biases of 24-32% and 75-81%, respectively, with samples from patients with uremia.

Original languageEnglish (US)
Pages (from-to)148-154
Number of pages7
JournalTherapeutic Drug Monitoring
Volume23
Issue number2
DOIs
StatePublished - Apr 5 2001
Externally publishedYes

Keywords

  • Fluorescence polarization immunoassay
  • Free phenytoin
  • Immunoassay
  • Metabolite interference
  • Uremia

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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