Accuracy evaluation of automated electrochemiluminescence immunoassay for everolimus and sirolimus compared to liquid chromatography‐tandem mass spectrometry. Issue 7 (14th June 2019)

• Record Type: Journal Article
• Authors: Lee, Eun Jin; Kim, Hyun‐Ki; Ahn, Sunyoung; Lee, Woochang; Kim, Hyun Soo; Chun, Sail; Min, Won‐Ki
• Is Part Of: Journal of clinical laboratory analysis. Volume 33:Issue 7(2019)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2019-06-14
• Subjects: everolimus -- immunoassay -- liquid chromatography‐tandem mass spectrometry -- sirolimus -- therapeutic drug monitoring; Diagnosis, Laboratory -- Periodicals; Medical laboratory technology -- Periodicals; 616
• DOI: 10.1002/jcla.22941
• Languages: English
• ISSNs: 0887-8013

Abstract

Abstract: Background: We evaluated the analytical performance of a newly developed electrochemiluminescence immunoassay for everolimus and sirolimus compared to that of liquid chromatography‐tandem mass spectrometry (LC‐MS/MS). Methods: According to Clinical and Laboratory Standards Institute guidelines, the analytical performance including precision, recovery, linearity, and carryover was evaluated. For correlation evaluation, the results of Elecsys ® analysis of everolimus and sirolimus were compared with those of LC‐MS/MS using 120 samples from patients treated with everolimus or sirolimus. Results: The within‐run and total imprecision values were as follows: 2.3%‐4.5% and 4.5%‐6.4% for the everolimus assay; 3.3%‐4.8% and 4.7%‐8.1% for the sirolimus assay, respectively. The measured concentration was linear over the range of 0.718‐27.585 ng/mL for everolimus analysis and 0.789‐26.880 ng/mL for sirolimus analysis (all R 2 > 0.99). Recovery was 93.5%‐105.5% for the everolimus assay and 99.2%‐109.1% for the sirolimus assay (except lowest levels). Carryover was −1.09% for the everolimus assay and −0.12% for the sirolimus assay. The results of the two chemiluminescence immunoassays showed acceptable correlations with those of LC‐MS/MS ( R = 0.9585 and R = 0.9799, respectively). The two immunoassays showed slightly proportional biases compared to LC‐MS/MS. Conclusion: Elecsys ® Everolimus and Sirolimus assays showed acceptable analytical performance in precision, linearity, and correlation compared to LC‐MS/MS These methods can be adopted in the clinical laboratory for rapid therapeutic drug monitoring of patients who require treatment with immunosuppressants.