2013433
print

Clozapine and Metabolites, Serum or Plasma, Quantitative

CLOZAP SP
Example Reports
High
Normal

Ordering Recommendation

Optimize drug therapy and monitor patient adherence.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation

Timing of specimen collection: Predose(trough) draw - at steady -state concentration.

Collect

Plain red. Also acceptable: Lavender (K2 or K3EDTA) or pink (K2EDTA).

Specimen Preparation

Separate serum or plasma from cells within 2 hours of collection. Transfer 1 mL serum or plasma to an ARUP standard transport tube.(Min: 0.5 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

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

Remarks
Stability

After separation from cells: Ambient: 24 hours; Refrigerated: 1 week; Frozen: 3 months

Methodology

Quantitative Liquid Chromatography-Tandem Mass Spectrometry

Performed

Sun-Sat

Reported

1-5 days

Reference Interval

Test Number
 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.

Compliance Category

Laboratory Developed Test (LDT)

Note

Hotline History

View Hotline History

 

Hotline History

Date of Change
Test Name Change
Methodology
Performance/Reported Schedule
Specimen Requirements
Reference Interval
Interpretive Data
Note
CPT Code
Component Change
Other Interface Change
New Test
Inactive
10/20/2025
X
X
02/20/2024
X
N/A

CPT Codes

80159

Are you an ARUP Client? Click here for your pricing.

Components

Component Test Code* Component Chart Name LOINC
2013458 Clozapine, S/P, Quant 6896-5
2013459 Norclozapine, S/P, Quant 10992-6
2013460 Clozapine-N-Oxide, S/P, Quant 85497-6
2013461 Total Clozapine and Metabolites 12375-2
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • Clopine
  • Clozaril
  • Denzapine
  • FazaClo
  • Versacloz
  • Zaponex
Clozapine and Metabolites, Serum or Plasma, Quantitative