Multi-Site Validation of a Newly FDA-Cleared Automated Methotrexate Immunoassay for Therapeutic Drug Monitoring.

Key Points

• The aim is to validate the effectiveness of the Roche ONLINE TDM MTX assay for therapeutic drug monitoring.
• Multi-site validation approach.
• Automated immunoassay technique.
• Measurement of methotrexate levels.
• The assay demonstrated robust quantification of methotrexate.
• Clinically adequate performance was established for therapeutic monitoring.