Determination of cyclosporine and everolimus blood levels compared between the cobas e411 and Indiko Plus automated chemistry analyzers

Main Article Content

Tippanate Keawvijit
Supawadee Pakdeenukoolkijja
Rasda Boonprasert
Teera Kolladarungkri

Abstract

To compare the efficacy of electrochemiluminescence immunoassay (ECLIA) to measure cyclosporin (CsA) and everolimus (EVL) blood levels on the cobas e411 automated chemistry analyzer (Roche Diagnostics) versus the efficacy of cloned enzyme donor immunoassay (CEDIA) to measure CsA blood level and the Quantitative Microsphere System (QMS) to measure EVL blood level on the Indiko Plus automated chemistry analyzer (Thermo Fisher Scientific). This comparative study included 40 blood samples that were collected for measurement of CsA and 40 blood samples that were collected for measurement of EVL that were analyzed at the Clinical Toxicology Laboratory of the Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. CsA and EVL blood level results were statistically analyzed and compared between the two automated analyzer. The precision of internal quality control for CsA and EVL measurement using the automated cobas e411 analyzer ranged from 1.51 to 5.05 %CV. The Pearsons correlation coefficient (r > 0.95, p-value <0.01) indicates a strong positive correlation. The results of linear regression revealed good correlation between the two compared systems (r2 ≥ 0.90). The percentages of bias ranged from 2.11% to 2.69% for CsA, and from 12.29% to 12.61% for EVL. Statistically significant differences were observed between group means, as determined by ANOVA (p<0.01). Calculated total errors were within acceptable range for all evaluated parameters. The results of this study revealed that ECLIA on the cobas e411 system demonstrated good analytical performance that correlated well with the results of the CEDIA and QMS assays on the Indiko Plus system. Accordingly, the cobas e411 system should be introduced into routine practice for determination of CsA and EVL blood levels.

Article Details

How to Cite
1.
Keawvijit T, Pakdeenukoolkijja S, Boonprasert R, Kolladarungkri T. Determination of cyclosporine and everolimus blood levels compared between the cobas e411 and Indiko Plus automated chemistry analyzers. Arch AHS [Internet]. 2019 May 3 [cited 2024 Mar. 28];31(1):43-5. Available from: https://he01.tci-thaijo.org/index.php/ams/article/view/187369
Section
Original article

References

Kahan BD. Cyclosporine. N Engl J Med. 1989 Dec 21; 321(25): 1725-38.

Shipkova M, Hesselink DA, Holt DW, Billaud EM, van Gelder T, Kunicki PK, et al. Therapeutic Drug Monitoring of Everolimus: A Consensus Report. Ther Drug Monit. 2016 Apr; 38(2):143-69. A

Lindholm A. Therapeutic monitoring of cyclosporin--an update. Eur J Clin Pharmacol. 1991; 41(4): 273-83.

Mabasa VH, Ensom MH. The role of therapeutic monitoring of everolimus in solid organ transplantation. Ther Drug Monit. 2005 Oct; 27(5): 666-76.

Verstraete AG, Rigo-Bonnin R, Wallemacq P, Vogeser M, Schuetzenmeister A, Schmiedel C, et al. Multicenter Evaluation of a New Electrochemiluminescence Immunoassay for Everolimus Concentrations in Whole Blood. Ther Drug Monit. 2018 Feb; 40(1): 59-68. A

Buthiau D, Bargnoux AS, Badiou S, Sutra T, Dupuy AM, Pageaux GP, et al. Evaluation of QMS everolimus assay using Indiko analyzer: comparison with an ultra-performance liquid chromatography-tandem mass spectrometry method. Ther Drug Monit. 2015 Apr; 37(2):275-8.

Seger C, Shipkova M, Christians U, Billaud EM, Wang P, Holt DW, et al. Assuring the Proper Analytical Performance of Measurement Procedures for Immunosuppressive Drug Concentrations in Clinical Practice: Recommendations of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology Immunosuppressive Drug Scientific Committee. Ther Drug Monit. 2016 Apr; 38(2): 170-89.

Vogeser M, Shipkova M, Rigo-Bonnin R, Wallemacq P, Orth M, Widmann M, et al. Multicenter analytical evaluation of the automated electrochemiluminescence immunoassay for cyclosporine. Ther Drug Monit. 2014 Oct; 36(5): 640-50.

Henderson DR, Friedman SB, Harris JD, Manning WB, Zoccoli MA. CEDIA, a new homogeneous immunoassay system. Clin Chem. 1986 Sep; 32(9): 1637-41.

CEDIA Cyclosporine PLUS [package insert]. Fremont, CA: Microgenics Corporation. 2017.

QMS EVEROLIMUS [package insert]. Fremont, CA: Microgenics Corporation. 2016.

Leland JK, Powell MJ. Electrogenerated chemiluminescence: an oxidative-reduction type ECL reaction sequence using tripropyl amine. J Electrochem Soc. 1990 Oct; 137 (10): 3127-31.

Cobas Cyclosporine; Revision 2 [package insert]. Mannheim, Germany: Roche Diagnos-tics GmbH. 2016.

Cobas Everolimus; Revision 1 [package insert]. Mannheim, Germany: Roche Diagnostics GmbH. 2017.

Shu I, Wright AM, Chandler WL, Bernard DW, Wang P. Analytical performance of QMS everolimus assay on ortho Vitros 5,1 FS fusion analyzer: measuring everolimus trough levels for solid organ transplant recipients. Ther Drug Monit. 2014 Apr; 36(2): 264-8.

B u t c h AW , Fukuchi AM. Analytical performance of the CEDIA cyclosporine PLUS whole blood immunoassay. J Anal Toxicol. 2004 Apr; 28(3): 204-10.

NCCLS EP9-A: Method comparison and bias estimation using patient samples. National Committee for Clinical Laboratory Standards, Wayne, PA. 1995.

Westgard JO, Hunt MR. Use and interpretation of common statistical tests in method-comparison studies Clin Chem. 1973; 19:49-57.

Taylor PJ, Franklin ME, Graham KS, Pillans PI. A HPLC-mass spectrometric method suitable for the therapeutic drug monitoring of everolimus. J Chromatogr B Analyt Technol Biomed Life Sci. 2007 Apr 1; 848(2): 208-14.

Wong SH, Johnson-Davis KL, Garrison K, Rankin JD, Muhammad CS. Everolimus TDM using Thermo Fisher QMS immunoassay on Indiko, Beckman DxC, AU680, and AU5800 analyzers. Clin Biochem. 2017 May; 50(7-8): 425-30.

Shipkova M, Rapp S, Rigo-Bonnin R, Wieland E, Peter A. Therapeutic Drug Monitoring of Everolimus: Comparability of Concentrations Determined by 2 Immunoassays and a Liquid Chromatography Tandem Mass Spectrometry Method. Ther Drug Monit. 2017 Apr; 39(2):102-8.

Hamwi A, Veitl M, Manner G, Ruzicka K, Schweiger C, Szekeres T. Evaluation of four automated methods for determination of whole blood cyclosporine concentrations. Am J Clin Pathol. 1999 Sep; 112(3): 358-65.

Schutz E, Svinarov D, Shipkova M, Niedmann PD, Armstrong VW, Wieland E, et al. Cyclosporin whole blood immunoassays (AxSYM, CEDIA, and Emit): a critical overview of performance characteristics and comparison with HPLC. Clin Chem. 1998 Oct; 44(10): 2158-64.

Fung AWS, Knauer MJ, Blasutig IM, Colantonio DA, Kulasingam V. Evaluation of electroche-miluminescence immunoassays for immuno-suppressive drugs on the Roche cobas e411 analyzer. F1000Res. 2017; 6: 1832.

Tate J, Ward G. Interferences in immunoassay. Clin Biochem Rev. 2004 May; 25(2): 105-20.