PMID: 8946659Dec 1, 1996Paper

Evaluation of the Pro-Trac tacrolimus monoclonal whole-blood enzyme-linked immunosorbent assay for monitoring of tacrolimus levels in patients after kidney, heart, and liver transplantation

Therapeutic Drug Monitoring
M WinklerR Pichlmayr

Abstract

In a prospective study, we evaluated a novel enzyme-linked immunosorbent assay (ELISA) (Pro-Trac) for determining tacrolimus (FK 506) concentrations in whole blood. Results obtained by the ELISA were compared with those obtained either by microparticle enzyme immunoassay (MEIA) or by high-performance liquid chromatography/mass spectrometry (HPLC-MS). The lower limit of quantitation of the ELISA was 0.5 microgram/L. The within-series coefficient of variation (CV) was < 11%. For spiked blood samples containing different concentrations of tacrolimus, interassay CV was 23.6% at 2.5 micrograms/L; however, at 15 and 60 micrograms/L, interassay CV was 44.9 and 50.8%, respectively. In crossover studies including blood samples from patients after liver, heart, or kidney transplantation, ELISA results correlated with those of the HPLC-MS (r = 0.73) as well as with those generated by MEIA (r = 0.82). The ELISA and MEIA showed 52.3 and 56.2% cross-reactivity with 15-O-demethyltacrolimus, respectively, but only 5.0 and 5.4% cross-reactivity with 13-O-demethyltacrolimus. We conclude that if assay precision in the upper range is improved, the Pro-Trac ELISA might be a valuable alternative to the MEIA for therapeutic drug monitoring of tacroli...Continue Reading

References

Sep 1, 1990·Annals of Surgery·S TodoR Shapiro
Oct 28, 1989·Lancet·T E StarzlA Jain
Jun 1, 1994·Therapeutic Drug Monitoring·M WinklerR Pichlmayr
Dec 1, 1995·Therapeutic Drug Monitoring·W J JuskoR Lieberman
Jan 1, 1994·Transplant International : Official Journal of the European Society for Organ Transplantation·M WinklerC Groth

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Citations

Aug 14, 2002·Veterinary Dermatology·Rosanna Marsella, Constance F Nicklin
Feb 19, 2011·European Journal of Clinical Pharmacology·Liang LiZhong-Hai Li
Apr 21, 1998·Annals of Clinical Biochemistry·A K Trull

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