About the product
Elecsys Sirolimus (Roche code CPS_000514) is an immunoassay used for the in vitro quantitative determination of sirolimus in human whole blood. According to the Roche product page, the test is defined as an aid in the management of kidney transplant patients receiving sirolimus therapy. The method is specified as electrochemiluminescence immunoassay (ECLIA).
Measured parameter and clinical significance
Sirolimus is an immunosuppressive drug used after organ transplantation. According to the FDA Rapamune drug label, monitoring of sirolimus trough blood levels is recommended for all patients. Monitoring is stated to be especially important in patients whose drug metabolism may be altered, in hepatic impairment, when the dosage form of the drug is changed, and when strong CYP3A4 inducers or inhibitors are used at the same time.
The label recommends monitoring the trough level at least 3 to 4 days after a loading dose. The label states that drug level monitoring should not be the sole basis for treatment adjustment and that clinical findings, biopsy results and other laboratory parameters should also be taken into account. The same document states that sirolimus blood levels are measured by chromatographic and immunoassay methods, that the results of these methods may not be interchangeable, and that the target range must be adjusted according to the method used.
Technical information
- Product: Elecsys Sirolimus (Roche, CPS_000514)
- Method: electrochemiluminescence immunoassay (ECLIA)
- Sample: human whole blood
- Pack size: 100 tests (cobas e 402 and cobas e 801; Roche version 5, catalog 07027834190)
- Pack size: 100 tests (cobas e 411, cobas e 601 and cobas e 602; Roche version 5, catalog 06327974190)
- Sample volume and measuring range are in the Roche method sheet
Use and compatibility
The Roche product page lists these systems:
- cobas e 402 and cobas e 801
- cobas e 411
- cobas e 601 and cobas e 602
System pages: cobas e 411 and cobas e 402. Other reagents are on the test kits page.
Target levels and dose adjustment are the responsibility of the clinical team.
Frequently asked questions
According to the Roche product page, the test is defined for the determination of sirolimus in human whole blood.
According to the Roche product page, the test is used as an aid in the management of kidney transplant patients receiving sirolimus therapy.
According to the FDA Rapamune label, the results of chromatographic and immunoassay methods may not be interchangeable, and the target range must be adjusted according to the method used.
Contact
For product, quotation and technical information requests, use the contact form or write to info@tiliamedical.com.
