Clozapine
Test Summary
Clozapine is an atypical antipsychotic agent. Norclozapine has minimal therapeutic activity.
Aliases
- Clozaril
Specimen Collection
Special Instructions
N/A
Preferred Specimen
2 mL serum collected in a red-top tube (no gel)
Minimum Volume
1 mL
Instructions
N/A
Patient Preparation
N/A
Storage
Plastic screw-cap vial
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
- Room temperature: 24 hours
- Refrigerated: 5 days
- Frozen: 30 days
Limitations
N/A
Other Acceptable Specimens
Plasma collected in an: EDTA (lavender-top), or sodium or lithium heparin (green-top) tube
Unacceptable Specimens
Gross hemolysis • Gel barrier/Serum Separator Tube (SST®)
Order Code
CLOZPN
EPIC (Premier) Code
LAB804
Includes
Clozapine and Norclozapine
CPT Code
- 80159
Billing Code
- 670214
CPT Statement
Methodology
Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS)
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Physician Attestation of Informed Consent
N/A
Testing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly VA, 20153
14225 Newbrook Drive
Chantilly VA, 20153
Department
Reference Testing
Reference Range
| Norclozapine | 25-400 mcg/L |
The therapeutic response begins to appear at 100 mcg/L
Refractory schizophrenia appears to require a therapeutic concentration of at least 350 mcg/L (trough, at steady state).
Toxic range: >900 mcg/L
Setup Schedule / Expected Turnaround Time
Monday - Saturday morning; Report available: 2 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
2 mL serum collected in a red-top tube (no gel)
Minimum Volume
1 mL
Instructions
N/A
Patient Preparation
N/A
Storage
Plastic screw-cap vial
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
- Room temperature: 24 hours
- Refrigerated: 5 days
- Frozen: 30 days
Limitations
N/A
Other Acceptable Specimens
Plasma collected in an: EDTA (lavender-top), or sodium or lithium heparin (green-top) tube
Unacceptable Specimens
Gross hemolysis • Gel barrier/Serum Separator Tube (SST®)
Result Information
Methodology
Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS)
Testing Laboratory
N/A
Reference Range
| Norclozapine | 25-400 mcg/L |
The therapeutic response begins to appear at 100 mcg/L
Refractory schizophrenia appears to require a therapeutic concentration of at least 350 mcg/L (trough, at steady state).
Toxic range: >900 mcg/L
Setup Schedule / Expected Turnaround Time
Monday - Saturday morning; Report available: 2 days