Ann Lab Med.  2018 Mar;38(2):85-94. 10.3343/alm.2018.38.2.85.

Multi-center Performance Evaluations of Tacrolimus and Cyclosporine Electrochemiluminescence Immunoassays in the Asia-Pacific Region

• Qin X
• Rui J
• Xia Y
• Mu H
• Song SH
• Raja Aziddin RE
• Miles G
• Sun Y
• Chun S

• KMID: 2403352
• DOI: http://doi.org/10.3343/alm.2018.38.2.85

Abstract

BACKGROUND
The immunosuppressant drugs (ISDs), tacrolimus and cyclosporine, are vital for solid organ transplant patients to prevent rejection. However, toxicity is a concern, and absorption is highly variable across patients; therefore, ISD levels need to be precisely monitored. In the Asia-Pacific (APAC) region, tacrolimus and cyclosporine concentrations are typically measured using immunoassays. The objective of this study was to assess the analytical performance of Roche Elecsystacrolimus and cyclosporinee electrochemiluminescence immunoassays (ECLIAs).
METHODS
This evaluation was performed in seven centers across China, South Korea, and Malaysia. Imprecision (repeatability and reproducibility), assay accuracy, and lot-to-lot reagent variability were tested. The Elecsys ECLIAs were compared with commercially available immunoassays (Architect, Dimension, and Viva-E systems) using whole blood samples from patients with various transplant types (kidney, liver, heart, and bone marrow).
RESULTS
Coefficients of variation for repeatability and reproducibility were ≤5.4% and ≤12.4%, respectively, for the tacrolimus ECLIA, and ≤5.1% and ≤7.3%, respectively, for the cyclosporine ECLIA. Method comparisons of the tacrolimus ECLIA with Architect, Dimension, and Viva-E systems yielded slope values of 1.01, 1.14, and 0.897, respectively. The cyclosporine ECLIA showed even closer agreements with the Architect, Dimension, and Viva-E systems (slope values of 1.04, 1.04, and 1.09, respectively). No major differences were observed among the different transplant types.
CONCLUSIONS
The tacrolimus and cyclosporine ECLIAs demonstrated excellent precision and close agreement with other immunoassays tested. These results show that both assays are suitable for ISD monitoring in an APAC population across a range of different transplant types.

Keyword

Cyclosporine; Tacrolimus; Immunosuppressant drugs; Immunoassay; Therapeutic drug monitoring; Asia-Pacific

MeSH Terms

Absorption
China
Cyclosporine*
Drug Monitoring
Heart
Humans
Immunoassay*
Korea
Liver
Malaysia
Methods
Tacrolimus*
Transplants
Cyclosporine
Tacrolimus

Figure

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  Fig. 1 Accuracy of the (A) tacrolimus and (B) cyclosporine immunoassays.Abbreviations: AMC, Asan Medical Center; SNUH, Seoul National University Hospital; HKL, Hospital Kuala Lumpur Drug and Research Laboratory.

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  Fig. 2 Lot-to-lot variability of reagents in each assay. Comparison of (A) reagent Lot 18285901 (x axis) and Lot 18542901 (y axis) for the tacrolimus ECLIA using samples from patients with kidney transplants and (B) Lot 18286001 (x axis) and Lot 18555801 (y axis) for the cyclosporine ECLIA using samples from patients with kidney or bone marrow transplants.

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  Fig. 3 Method comparisons of tacrolimus immunoassays using samples from patients with liver, kidney, or heart transplants on: (A) cobas e 411 or cobas e 601 vs Architect; (B) cobas e 411 vs Dimension; and (C) cobas e411 or cobas e601 vs Viva-E.

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  Fig. 4 Method comparisons of cyclosporine immunoassays on: (A) cobas e 411 or cobas e 601 vs Architect using samples from kidney or liver transplant patients; (B) cobas e 411 vs Dimension using samples from kidney, liver, or heart transplant patients; (C) cobas e 411 or cobas e 601 vs Viva-E using samples from patients with kidney or bone marrow transplants.

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