DOSIMMUNE™ immunosuppressants in whole blood using LC-MS/MS

Medical device CE/IVD marked

  • Available for 500 or 1 000 analysis
  • The set is ready-to-use with all consumables
  • Internal standard with isotope labeled analytes
  • For LC-MS/MS application
  • Analysis time: < 2 min.

DOSIMMUNE™ is registered as a CE/IVD device in the EEA. In other case, DOSIMMUNE™ is intendent for research use only, not for diagnostic.

Ask for a quote
Number of analysis
Qty

Description

Therapeutic drug monitoring (TDM) of the main immunosuppressant drugs, Tacrolimus, Sirolimus, Everolimus and Cyclosporin A, is essential to allow regulating of the dosage according to drug concentration of each patients’ whole blood after organ transplantation. Recently, LC-MS/MS has been introduced in many laboratories as an alternative technology for TDM (besides Immunoassays).

Alsachim developed a reagent kit based on LC-MS/MS analytical method for the quantification of immunosuppressants drugs in whole blood: Cyclosporin A, Sirolimus, Everolimus and Tacrolimus. The DOSIMMUNE™ kit is an in vitro diagnostic device for the rapid and multiplex assay of immunosuppressants drugs for LC-MS, thanks to in-house production of stable isotope-labeled internal standards with deuterium, carbon-13. This ready-to-use kit is also for routine LC-MS/MS analysis of these immunosuppressants in whole blood sample.

DOSIMMUNE™ is available for 500 analysis (CE/IVD 227-40101-55 or RUO 227-40101-58 (Europe) / 227-40101-91 (Japan)) or 1 000 analyses (227-40100-55 CE/IVD or 227-40100-58 (Europe) / 227-40100-91 (Japan)).

Technical Data

Method of analysis: LC-MS/MS
Parameter: Cyclosporin A, Sirolimus, Everolimus, Tacrolimus
Analysis time: 1.4 min 
Limit of quantification: 
- Cyclosporin A: ≤5.0 µg/L 
- Everolimus: ≤0.5 µg/L
- Sirolimus: ≤0.5 µg/L
- Tacrolimus: ≤0.5 µg/L
Linearity: 
- Cyclosporin A: up to 3000 µg/L
- Everolimus: up to 100 µg/L
- Sirolimus: up to 100 µg/L
- Tacrolimus: up to 100 µg/L
Specimen: in wole blood 
Storage: Samples can be stored for up to 7 days at +4°C +/-2°C. For longer storage, it is recommended to freeze the sample at -20°C +/-5°C after collection.
Sample preparation: 
- Transfer calibrator or control or human blood sample into a microtube
- Add reconstituted Internal standards pool
- Add extraction buffer
- Shake and centrifuge
- Extract the supernatant
- Insert in LC-MS/MS and analyze
Injection volume: 1–50 µL
Ionisation: ESI positive
MS/MS-Mode: MRM
Comment: DOSIMMUNE™ reagent kit is delivered with all documentation required to use properly the product (complete instructions Manual, safety data sheets, quality an analysis certificates, etc.)

Kit Composition

  • Mobile Phase A
  • Mobile Phase B
  • System Cleaning Phase
  • Extraction Buffer
  • Internal Standard Set
  • Calibrator Set
  • Control Set
  • Analytical & Trap Columns
  • Microtubes
  • LC Vials with low volume glass insert & caps

  • Tuning Mix labeled and unlabeled (optional)

Chromatograms

  • Sample Text
  • Sample Text
  • Sample Text
  • Sample Text

Kit components & accessories