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Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS
Published on: November 8, 2015
Inter-laboratory Variability of Current Immunoassay Methods for Tacrolimus among Japanese Hospitals
Masatomo Miura1, Satohiro Masuda, Hiroto Egawa
1Department of Pharmacy, Akita University Hospital.
Insights
Inter-hospital variability in tacrolimus immunoassay testing was assessed. Chemiluminescent (CLIA) and electro-chemiluminescence (ECLIA) assays showed better precision and accuracy for tacrolimus monitoring than ACMIA and EMIT methods.
Area of Science:
- Clinical Chemistry
- Pharmacology
- Transplantation Medicine
Background:
- Tacrolimus is a critical immunosuppressant for transplant recipients.
- Accurate therapeutic drug monitoring (TDM) of tacrolimus is essential for patient outcomes.
- Inter-laboratory variability in tacrolimus immunoassays may impact clinical decisions.
Purpose of the Study:
- To evaluate the inter-hospital laboratory variability (coefficient of variation) of different immunoassay methods for tacrolimus.
- To compare the accuracy and precision of tacrolimus measurements across various immunoassay platforms.
- To assess the suitability of different assays for therapeutic drug monitoring of tacrolimus.
Main Methods:
- One hundred seven hospital laboratories participated in the study.
- Thirteen spiked samples with known tacrolimus concentrations (0-26.0 ng/mL) were analyzed.
- Immunoassays evaluated included affinity column-mediated immunoassay (ACMIA), enzyme multiplied immunoassay technique (EMIT), chemiluminescent enzyme immunoassay (CLIA), and electro-chemiluminescence immunoassay (ECLIA).
Main Results:
- Electro-chemiluminescence immunoassay (ECLIA) and chemiluminescent enzyme immunoassay (CLIA) demonstrated superior precision (CVs of 0.89 and 1.82 ng/mL, respectively) compared to ACMIA and EMIT.
- CLIA and ECLIA showed adequate precision at the target concentration of 3.0 ng/mL, while ACMIA and EMIT struggled with concentrations between 3.0-5.0 ng/mL.
- Assay biases varied, with CLIA and ECLIA showing positive bias above 12 ng/mL, ACMIA negative bias above 6 ng/mL, and EMIT consistent positive bias across the concentration range.
Conclusions:
- Significant inter-laboratory variability exists for tacrolimus immunoassay methods.
- ECLIA and CLIA assays offer better precision and accuracy for tacrolimus monitoring compared to ACMIA and EMIT.
- Selection of a sensitive, precise, and accurate assay is crucial for optimizing tacrolimus therapy and ensuring long-term transplant recipient survival.
Abstract:
The aim of this study was to assess inter-hospital laboratory variability (coefficient of variation; CV) of immunoassay methods for tacrolimus and the comparability of control samples and results obtained by immunoassay measurements. One hundred seven hospital laboratories routinely performing therapeutic drug monitoring (TDM) of tacrolimus participated in the study. Thirteen spiked samples with known tacrolimus concentrations in the range of 0-26.0 ng/mL were prepared. Each spiked sample was analyzed according to the manufacturer's instructions using an affinity column-mediated immunoassay (ACMIA) on a Dimension(®) analyzer, the enzyme multiplied immunoassay technique (EMIT) on a Viva-E(®) analyzer, a chemiluminescent enzyme immunoassay (CLIA) on the Architect(®) system, and the electro-chemiluminescence immunoassay (ECLIA) on a cobas(®) analyzer. The 20% coefficient of variation values for the CLIA, ACMIA, EMIT, and ECLIA assays in the hospital laboratories were 1.82, 5.36, 4.59, and 0.89 ng/mL, respectively. CLIA and ECLIA had positive biases at concentrations of tacrolimus above 12 ng/mL relative to the spiked concentration, whereas the assay bias for ACMIA tended to be more negative at concentrations of tacrolimus above 6 ng/mL. EMIT had positive biases over the wide concentration range of 0.0-26.0 ng/mL (mean of mean errors 1.224). CLIA and ECLIA provided adequate precision at the target tacrolimus concentration of 3.0 ng/mL, whereas ACMIA and EMIT were unable to respond to target concentrations between 3.0 and 5.0 ng/mL for renal transplant recipients. Appropriate assessment of tacrolimus concentration by an assay having higher sensitivity, precision, and accuracy is necessary to ensure long-term survival of transplant recipients receiving tacrolimus.
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