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CLOZAPINE/NORCLOZAPINE

Test Code
CLONOR
 
This test is a lab developed test. For further information, see the Compliance Remarks section below.
Synonyms
Clozaril; Fazaclo
SPECIMEN REQUIREMENTS
Container Type
Red top tube (plain)
Supply Item Number
1372
Specimen Type
Serum
Preferred Volume
0.25 mL
Emergency Minimum Volume
0.1 mL
Patient Prep
Timing of specimen collection: Pre-dose (trough) draw - At steady state concentration.
Specimen Processing
Separate serum from cells and transfer to a standard PAML aliquot tube.
Store and Transport
Refrigerated
Stability
Room Temp 2 weeks  Refrigerated 2 weeks  Frozen (-20 °C) 1 month  
Unacceptable Condition
DO NOT use gel separator tubes (Corvac®, SST or equivalent) for the collection of blood samples for this test.
Alternate Specimens
EDTA, sodium heparinized or sodium fluoride/potassium oxalate plasma (lavender, green or grey top tube)
Reference Laboratory
PAML
CPT Codes
80159, (HCPCS G0480)
Interface Order Code
80299.Z69
Billing Code
CLONOR
Test Schedule
Mon, Wed, Fri
Turnaround Time
1-3 days
Method
Tandem Mass Spectrometry
Reference Ranges
TitleRangesUnits
Clozapine350-650ng/mL
NorclozapineNot Establishedng/mL
Total(Cloz+Norcloz)ng/mL
Patients dosed with 400 mg clozapine daily for 4 weeks were most liekly to exhibit a therapeutic effect whe nteh sum of clozapine and norclozapine concentrations were at least 450 ng/ml.
Compliance Remarks
This test was developed and its performance characteristics determined by PAML. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test. However, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. PAML is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.
Notes
Clozapine is associated with severe neutropenia (absolute neutrophil count (ANC) less than 500/uL). The requirements to prescribe, dispense, and receive clozapine are incorporated into a single, shared program called the Clozapine Risk Evaluation and Mitigation Strategy (REMS). A REMS is a strategy to manage known or potential risks associated with a drug or group of drugs, and is required by the FDA for clozapine to ensure that the benefits of the drug outweigh the risk of severe neutropenia. The Clozapine REMS Program replaces the individual clozapine patient registries and the National Non-Rechallenge Master File (NNRMF). For additional information about the Clozapine REMS Program, please call 844-267-8678.

Interface Codes
typeorder codetest descriptionresult coderesult descriptionunitsdecimal placesloinc code
o80299.Z69Clozapine/Norclozapine
r80299.Z69Clozapine/Norclozapine80299.Z62Clozapineng/mL 6896-5
r80299.Z69Clozapine/Norclozapine80299.Z68Norclozapineng/mL 10992-6

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