Electrochemiluminescence immunoassay (ECLIA)
for the in vitro quantitative determination
of tacrolimus in human whole blood
IndicationThe Elecsys Tacrolimus assay is used as an aid in the management of heart, liver and kidney transplant patients receiving tacrolimus therapy. Organ transplant patients are prescribed immunosuppressant drugs (ISD) like e.g. tacrolimus so that the immune system does not reject the newly transplanted organ. ISD assays are used to determine the drug concentration in the patient’s blood as a guide for effective and well-tolerated doses as the desired therapeutic effect is only obtained in a narrow therapeutic range: The dose must be high enough to prevent organ rejection, and the dose must be low enough to avoid drug toxicity and opportunistic infections.
Manual sample pretreatmentThe Elecsys Tacrolimus assay uses human whole blood specimens as sample material. As tacrolimus is largely distributed in red blood cells and bound to proteins, a one-step manual pretreatment is performed to release the analytes from the proteins. The pretreatment reagent is universally used for all Elecsys ISD assays.
1st incubation (9 minutes)35 µL of pretreated sample is incubated with a tacrolimus-specific biotinylated antibody and a ruthenium complex labeled tacrolimus-derivate. Depending on the concentration of the analyte in the sample and the formation of the respective immune complex, the labeled antibody binding site is occupied in part with sample analyte and in part with ruthenylated hapten.
2nd incubation (9 minutes)After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin.
MeasurementThe reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.
Elecsys technologyECL (ElectroChemiLuminescence) is Roche’s technology for immunoassay detection. Based on this technology and combined with well-designed, specific and sensitive immunoassays, Elecsys delivers reliable results. The development of ECL immunoas-says is based on the use of a ruthenium-complex and tripropylamine (TPA). The chemiluminescence reaction for the detection of the reaction complex is initiated by applying a voltage to the sample solution resulting in a precisely controlled reaction. ECL technology can accommodate many immunoassay principles while providing superior performance.
Elecsys® Tacrolimus test characteristicsTesting time
Standardized against reference standards traceable to tacrolimus reference material (USP = United States Pharmacopeia) by weight
Intermediate precision (representative data)
cobas e 601/e 602 modules: 2.4 – 10.4 %Lowest conc. measured:
*LoB = Limit of Blank; LoD = Limit of Detection; LoQ = Limit of Quantitation (20 % total error)
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Roche Diagnostics International LtdCH-6343 RotkreuzSwitzerlandwww.cobas.com
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