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Dimension Clinical Chemistry Systems - Everolimus Assay

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The Dimension® Everolimus* assay is for in vitro diagnostic use in the quantitative measurement of everolimus in human whole blood (EDTA) using the Dimension Clinical Chemistry System. The Dimension Everolimus assay is intended for use as an aid in the management of everolimus therapy in kidney, liver, and heart transplant patients.

Transplant medicine depends on reliable results. At Siemens Healthineers, we value the trust of our physicians and laboratories and are committed to providing comprehensive, high-quality testing solutions for transplant patients around the world.

Assay Benefits

  • Provides reliable results with a proprietary automated pretreatment that reduces the risk of matrix effect.
  • Delivers sensitive results with a limit of quantitation (1 ng/mL) specified by the Therapeutic Drug Monitoring of Everolimus Consensus Report1, which recommends this to ensure reliable assessment of low concentration dosing.
  • Offers good agreement with the LC-MS/MS reference method.
  • Helps avoid errors with built-in repeat testing if calculated results exceed 10 ng/mL.

Assay Specifications2

Parameter

Description

Assay principle
Affinity chrome mediated immunoassay (ACMIA)
Sample type
Whole blood
Sample pretreatment

No manual pretreatment by user; performed automatically onboard instrument

Sample volume

12 µL

Measuring interval

1.0–25.0 ng/mL (1.0–26.1 nmol/L)

Reagent shelf life

2–8°C until expiration date on product

Reagent onboard stability

30 days

Reagent open stability

4 days for liquid reagents/2 days for tablet wells

Turnaround time (TAT)

19 minutes

Calibration interval

30 days

Limit of quantitation (LOQ)

1.0 ng/mL (1.0 nmol/L)

Limit of detection (LOD)

0.6 ng/mL (0.6 nmol/L)

Limit of blank (LOB)

0.1 ng/mL (0.1 nmol/L)

Dilutions

Manual, not to exceed dilution factor of 2

1

Therapeutic Drug Monitoring of Everolimus: A Consensus Report. 2016 Apr;38(2):143-69.doi: 10.1097/FTD.0000000000000260.

2

Dimension Everolimus Assay Instructions for Use (IFU) 11417409_EN Rev. 01, 2021-05

* Not available for sale in the U.S.