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DOSIMMUNE™ LC-MS/MS Immunosuppressant Analysis Kit

Shimadzu Corporation’s subsidiary, Shimadzu Chemistry & Diagnostics SAS (France, hereinafter SCHD), has obtained class C certification under the European Union (EU) In Vitro Diagnostic Medical Devices Regulation (IVDR) Class C certification (CE marking) for its DOSIMMUNE™ immunosuppressant analysis kit for use with liquid chromatography with tandem mass spectrometry  (LC-MS/MS) systems. The kit is used as measurement of immunosuppressants used to prevent rejection reactions after organ transplants. The kit includes all necessary reagents (Calibrators, Quality controls and Internal Standards), mobile phases, columns, and other components for measuring the concentration of four immunosuppressant drugs in whole blood using LC-MS/MS.

In recent years, clinical laboratories and university hospitals have seen a growing demand for therapeutic drug monitoring*1 of immunosuppressants used to prevent rejection reactions after organ transplants. This product was previously sold in compliance with the European Union's former In Vitro Diagnostic Medical Devices Directive (IVDD). The new In Vitro Diagnostic Medical Devices Regulation (IVDR) came into effect in May 2017, with implementation starting in May 2022. The IVDR imposes stricter requirements for safety and performance, requiring many products to be reviewed and certified by a third-party Notified Body*2for compliance. SCHD completed the required review process and obtained CE certification based on the IVDR in November 2025.
This certification is a recognition of SCHD’s commitment, as a manufacturer of in vitro diagnostic kits, to providing quality products and services that comply with regulatory requirements and align with Shimadzu’s vision and values.

SCHD was established in 2025 through the merger of Alsachim SAS and Biomaneo SAS, both reagent companies within the Shimadzu Corporation Group. Aiming for further growth in the in vitro diagnostics field, SCHD is expanding its clinical testing solutions.

Features

1. Workload Reduction

This ready-to-use analysis kit includes all necessary components, including internal standards, and a validated analytical method, allowing for immediate use after purchase. The kit can be used with programmable LC-MS/MS systems under conditions specified in the Instructions for Use (IFU).

2. Simultaneous quantification of four immunosuppressants

By simultaneously measuring the blood concentrations of Tacrolimus, Cyclosporine A, Everolimus, and Sirolimus in patient samples quickly and accurately, this method contributes to evaluating treatment efficacy and reducing risks. It covers typical blood concentration ranges and minimizes noise from non-target components, thereby achieving stable and reliable quantitation.

3. Rapid Acquisition of Analytical Results

Under optimal conditions, analytical results can be obtained less than 2 minutes per sample (excluding pretreatment).

• *1 To determine the appropriate dose of a drug by measuring its level in the blood so that the drug remains effective and side effects are minimized
• *2 An independent organization that evaluates and certifies products as a third party, based on EU directives and regulations, to confirm that they meet safety and quality standards.

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DOSIMMUNE™