PMID: 8946668Dec 1, 1996Paper

A simplified whole blood enzyme-linked immunosorbent assay (ProTrac II) for tacrolimus (FK506) using proteolytic extraction in place of organic solvents

Therapeutic Drug Monitoring
G MacFarlaneM Kobayashi

Abstract

Tacrolimus (FK506) is a macrolide antibiotic with potent immunosuppressive properties. FK506 is 10- to 100-fold more potent than cyclosporin A in preventing organ rejection and in toxicity. Extreme inter- and intrapatient variability and lack of correlation between drug dosage and drug blood levels necessitate consistent and reliable therapeutic drug monitoring. Previous methods for monitoring drug levels have been lengthy and labor intensive and have required organic solvents for sample extraction. We have developed a manual enzyme-linked immunosorbent assay (ProTrac II ELISA) that employs standardized reagents and a nonorganic solvent extraction and yields good assay sensitivity and precision. The calculated mean sensitivity of the assay was 0.18 ng/ml. Interassay precision ranged from 6.3% to 13.1% (coefficient of variation) for FK506 in whole blood (concentration range, 1.0-25.0 ng/ml). Recovery of the drug from spiked EDTA whole blood was 91-98% over the same concentration range. Mean recovery of the drug from clinical samples spiked with kit standards was 99.5%. Dilutions of high-concentration spiked EDTA whole blood samples and high-concentration samples from patients exhibited linearity of observed versus expected value...Continue Reading

References

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Citations

May 1, 2001·Pediatric Transplantation·G D MacFarlaneW E Fitzsimmons
Aug 19, 2000·The New England Journal of Medicine·J W JonesW C Breidenbach
May 22, 2001·Journal of Clinical Pharmacology·R VenkataramananA Shaked
Jan 1, 1997·Drug Metabolism and Drug Interactions·D W Holt, A Johnston
May 23, 2001·Clinical Pharmacokinetics·P E Wallemacq, R K Verbeeck
May 18, 2007·British Journal of Clinical Pharmacology·Hua-Wen XinLei Xiong
Oct 7, 2004·Analytical Biochemistry·Yoshihiro MurakamiEiichi Tamiya
Nov 5, 2013·Journal of Pharmaceutical and Biomedical Analysis·Lies De BockJan Van Bocxlaer
Jul 27, 2002·Therapeutic Drug Monitoring·Takafumi KuzuyaToshitaka Nabeshima
Oct 30, 2001·Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association·J DietemannF Berthoux
Apr 21, 1998·Annals of Clinical Biochemistry·A K Trull
Oct 3, 1999·Archives of Pathology & Laboratory Medicine·M W Linder, R J Elin

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