Clozapine Drug Level

Label Mnemonic: CLOZ
Epic code: LAB2886
Downtime form: Doctor/Provider Orders - Pathology Core and Specialty Care Nursery
Commercial Mailout Laboratory
6240-8 RCP
356-8593
Specimen(s):
Serum
Specimen Instructions:

Separate serum from cells as soon as possible.

Patient Prep: Timing of specimen collection: Pre-dose (trough) draw - At steady state concentration.

Collection Medium:
Red top tube 5 mL (Clot Activator)
Minimum:

Preferred Minimum: 1.0 mL serum

Rejection Criteria:

Whole blood. Gel separator tubes, light blue (citrate), or yellow (SPS or ACD solution).

Delivery Instructions:
Submit specimen to laboratory as soon as possible after collection.
Turn Around Time:

1-5 days upon receipt at reference laboratory

Reference Range:
Components Reference Interval
Clozapine-N-Oxide, S/P, Quant Therapeutic and toxic ranges are not well established
Norclozapine, S/P, Quant Therapeutic and toxic ranges are not well established
Clozapine, S/P, Quant Therapeutic Range: 350-600 ng/mL
Toxic: Greater than or equal to 1000 ng/mL
Interpretive Data:

The therapeutic range is based on serum pre-dose (trough) draw at steady-state concentration. Adverse effects to clozapine therapy may include tachycardia, hematologic disorders, neuroleptic malignant syndrome, elevation of liver enzymes, seizures, and tardive dyskinesia. Therapeutic and toxic ranges are not well established in children.


This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA-certified laboratory and is intended for clinical purposes.

Comments:

Gel separator tubes are not recommended.

Methodology:

Quantitative Liquid Chromatography-Tandem Mass Spectrometry

CPT Code:
80159