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Therapeutic Drug Monitoring

The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practices.

The Biorex Diagnostics Therapeutic Drug Monitoring Control (TDM) kit is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for a range of analytes.

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Description

Product Name CAT.No Size
Therapeutic Drug Monitoring Level 1 BXC0781A 5 x 5ml
Therapeutic Drug Monitoring Level 2 BXC0782A 5 x 5ml
Therapeutic Drug Monitoring Level 3 BXC0783A 5 x 5ml

 

 

Product Description

The Biorex Diagnostics Therapeutic Drug Monitoring (TDM) Control provides human serum–based, assayed, ready-to-use materials designed for accurate quality control of TDM assays. TDM is a critical component of clinical practice, ensuring that patients receive safe and effective dosing of medications with narrow therapeutic windows, such as antiepileptics, immunosuppressants, and cardiac drugs. Accurate quality control is essential to validate assay performance, maintain reproducibility, and deliver clinically reliable results for informed patient management.

These controls are formulated from human serum to closely replicate patient samples, offering a matrix that reflects real-world testing conditions. The Biorex TDM Control supports multiple analytes, covering a broad range of commonly monitored therapeutic drugs, making it suitable for diverse laboratory applications. The controls are assayed and ready-to-use, streamlining workflow, reducing handling errors, and saving laboratory time.

Key Features

  • Human serum–based materials: Closely mimics patient samples for clinically relevant quality control.
  • Multi-analyte coverage: Supports a wide range of commonly monitored therapeutic drugs.
  • Assayed and ready-to-use: Minimises preparation errors and ensures consistent application.
  • Precision and accuracy assessment: Monitors assay reproducibility across runs and instruments.
  • Broad compatibility: Suitable for immunoassays, HPLC, and automated analyser platforms.

Benefits
Routine use of the Biorex TDM Control allows laboratories to maintain high standards in therapeutic drug monitoring. By providing reproducible and reliable quality control, these materials help detect assay deviations early, ensuring accurate drug concentration measurement. This supports safe dosing decisions, reduces the risk of toxicity or subtherapeutic exposure, and enhances overall patient safety. Additionally, the controls assist laboratories in maintaining compliance with ISO 15189, CAP, and CLIA standards, strengthening quality assurance programs. With the Biorex TDM Control, clinical laboratories can confidently monitor therapeutic drug levels, improve clinical decision-making, and provide reliable support for patient management and clinical research in pharmacology and toxicology.

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Additional information

Storage

2-8°C