Test Directory

Test Code
CLOZM
Test Name
Clozapine and Metabolites
CPT Codes
80159
Included Tests
  • Clozapine, Serum or Plasma
  • Norclozapine, Serum or Plasma
  • Total (Clozapine and Norclozapine)
Expected Turnaround Time
2 - 4 days
Clinical Utility

Evaluate toxicity; monitor therapeutic levels

Specimen and Container Info

Preferred Specimen Type: Serum

Alternate Specimen Type: Plasma

Preferred Collection Container: Red Top, Plain

Alternate Collection Container: Lavender Top (EDTA)

Desired Specimen Volume: 1 mL

Collection Instructions
  1. Collect red top, plain or lavender top (EDTA) tube via venipuncture.
  2. Separate serum or plasma from cells.
  3. Transfer 1 mL of serum or plasma to a clear aliquot tube.
Transport Instructions

Transport to the laboratory refrigerated. 

Stability Requirements

Room Temperature

14 days

Refrigerated

14 days

Frozen

14 days

Freeze/Thaw Cycles

 Stable x3

Causes for Rejection

Gel-barrier tube

Methodology
Liquid Chromatography - Tandem Mass Spectrometry (LC-MS/MS)
Reference Intervals

ng/mL

Limitations

Clozapine is absorbed rapidly, with peak plasma concentrations occurring within 30 minutes to six hours. Terminal half-life in humans is in the range of 5.5 to 33 hours. Determination of clozapine in plasma is needed to correlate efficacy with plasma concentration. However, pharmacogenomics and coadministration of other agents can complicate the correlation between dose and plasma concentration. Changes in the activity of the cytochrome P450 mixed-function oxidases, especially CYP1A2 and CYP3A4 can affect clozapine levels. These oxidases can be induced by drugs such as carbamazepine, with the resulting increase in activity causing 50% decrease in clozapine concentration. An additional report has indicated some patients may be ultrarapid metabolizers of clozapine due to genetically induced CYP1A2 activity levels. Conversely, clozapine plasma (serum) concentrations may be increased by inhibitors of the P450 oxidases. Amiodarone, cimetidine, ciprofloxacin, fluoxetine, fluvoxamine, indinavir, paroxetine, quinidine, ritonavir, and saquinavir are examples of inhibiting drugs which may cause increases in clozapine levels when coadministered.

A review of adverse metabolic effects has indicated clozapine can significantly increase mean levels of glucose and C-peptide, as well as increase in triglyceride levels. Additionally, the Federal Drug Administration and drug provider have issued the following: Patients being treated with clozapine must have a baseline white blood cell (WBC) count and absolute neutrophil count (ANC) before initiation of treatment as well as regular WBC counts and ANCs during treatment and for at least four weeks after discontinuation of treatment.

Alternate Names
  • FazaClo
  • Clozaril
  • Total Clozapine and Metabolites
Reference Lab
Labcorp Of America Holdings
Testing Schedule
Varies