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Clinical Chemistry 45: 1449-1458, 1999;
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(Clinical Chemistry. 1999;45:1449-1458.)
© 1999 American Association for Clinical Chemistry, Inc.

Articles

Analytical Validation of the PRO-Trac II ELISA for the Determination of Tacrolimus (FK506) in Whole Blood

Gordon D. MacFarlane1,a, Daniel G. Scheller1, Diana L. Ersfeld1, Leslie M. Shaw2, Raman Venkatarmanan3, Laszlo Sarkozi4, Richard Mullins5 and Bonnie R. Fox1

1 DiaSorin Inc., Stillwater, MN 55082.

2 University of Pennsylvania Medical Center, Philadelphia, PA 19104.

3 University of Pittsburgh Medical Center, Pittsburgh, PA 15261.

4 Mount Sinai Medical Center, New York, NY 10001.

5 Department of Clinical Chemistry, Emory University, Atlanta, GA 30322.
a Address correspondence to this author at: DiaSorin Inc., PO Box 285, 1990 Industrial Blvd., Stillwater, MN 55082. Fax 651-351-5669; e-mail gordon.macfarlane{at}diasorin.com

Background: The analytical validation of multiple lots of the PRO-TracTM II ELISA (DiaSorin) for the determination of tacrolimus in whole blood is described.

Methods: The analytical parameters assessed included analytical sensitivity, dilution linearity, functional sensitivity, values in samples containing no tacrolimus, intra- and interassay precision, supplementation and recovery, metabolite cross-reactivity, interference studies, and method comparisons HPLC-tandem mass spectrometry (HPLC/MS/MS) and the IMx® Tacrolimus II multiparticle enzyme immunoassay. Where appropriate, assessments were performed according to NCCLS guidelines.

Results: The mean analytical detection limit was <0.25 µg/L for all lots, whereas the functional sensitivity was 1.0 µg/L. Excellent linear correlation (r = 0.985) was observed for dilution linearity. The intraassay imprecision was <7%, and the total imprecision by ANOVA was <10%. Recovery was 109% ± 11%. Metabolite cross-reactivity was consistent with previous reports for this antibody. No interference was observed for 35 tested drugs. Method comparison with HPLC/MS/MS showed no statistically significant differences. Samples exhibited stability through four freeze/thaw cycles and for 1 week at room temperature.

Conclusion: These data demonstrate that the PRO-Trac II ELISA is a robust, accurate, and precise tool for the assessment and management of tacrolimus blood concentrations in transplant patients.






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Copyright © 1999 by the American Association for Clinical Chemistry.