| Synonyms | Risperdal; Risperidone Metabolite; Total Active Moiety; 9-Hydroxyrisperidone; 9-OH-Risperidone |
| 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 | Optimal time to collect sample: 0.5-1 hour before next oral dose at steady state. (Time to steady state: 3-5 days) |
| 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 | Plasma (EDTA or heparinized) |
| Reference Laboratory | PAML |
| CPT Codes | 80342, (HCPCS G0480) |
| Interface Order Code | 82542.Z17 |
| Billing Code | RIS |
| Test Schedule | Mon, Wed, Fri |
| Turnaround Time | 1-3 days |
| Method | Tandem Mass Spectrometry |
| Reference Ranges | | Title | Descriptor | Ranges | Units | | Risperidone | | Not established | ng/mL | | 9-Hydroxyrisperidone | | Not established | ng/mL | | Total (Risperidone and Metabolite) | | 20-60 | ng/mL | |
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| 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 | Adverse effects to risperidone therapy may include headache, nausea, dizziness, tachycardia, orthostatic hypotension and dyskinesia. |
