Test Catalog

Test Id : PARO

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Paroxetine, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Monitoring paroxetine therapy

 

Identifying noncompliance, although regular blood level monitoring is not indicated in most patients

 

Identifying states of altered drug metabolism when used in conjunction with CYP2D6 genotyping

Method Name
A short description of the method used to perform the test

Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Paroxetine, S

Aliases
Lists additional common names for a test, as an aid in searching

Paroxetine (Paxil)

Paxil (Paroxetine)

Seroxat

PERO

Specimen Type
Describes the specimen type validated for testing

Serum Red

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Collection Container/Tube: Red top (serum gel/SST are not acceptable)

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions:

1. Draw blood before next scheduled dose.

2. Centrifuge and aliquot serum into plastic vial within 2 hours of collection.

Forms

If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.4 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Red Refrigerated (preferred) 28 days
Ambient 28 days
Frozen 28 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Monitoring paroxetine therapy

 

Identifying noncompliance, although regular blood level monitoring is not indicated in most patients

 

Identifying states of altered drug metabolism when used in conjunction with CYP2D6 genotyping

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Paroxetine (Paxil and Paxil CR) is approved for treatment of depression. Paroxetine is completely absorbed. Metabolites of paroxetine are inactive. Paroxetine metabolism is carried out by cytochrome P450 (CYP) 2D6. Paroxetine can saturate CYP2D6 resulting in a nonlinear relationship between dose and serum concentration. Paroxetine clearance is significantly affected by reduced hepatic function but only slightly by reduced kidney function.

 

A typical adult paroxetine dose is 20 mg per day. Paroxetine is 100% bioavailable, 95% protein bound, and the apparent volume of distribution is 17 L/kg. Time to peak serum concentration is 5 hours for the regular product and 8 hours for the controlled release product. The elimination half-life is 20 hours. Half-life is prolonged in the elderly and with cirrhosis.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

20-65 ng/mL

Interpretation
Provides information to assist in interpretation of the test results

Steady-state serum concentrations associated with optimal response to paroxetine are in the range of 30 to 120 ng/mL and in the narrower range of 20 to 65 ng/mL.

 

The most common toxicities associated with excessive serum concentration are asthenia, anticholinergic effects, anxiety, blurred vision, and changes in sexual function. The toxic range for paroxetine is greater than 120 ng/mL.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Specimens that are obtained from gel tubes are not acceptable as the drug can absorb on the gel and lead to falsely decreased concentrations.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Hiemke C, Baumann P, Bergemann N, et al: AGNP consensus guidelines for therapeutic drug monitoring in psychiatry: update 2011. Pharmacopsychiatry. 2011 Sept;44(6):195-235

2. Rifai N, Horvath AR, Wittwer CT, eds: Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 6th ed. Elsevier; 2018

3. Hiemke C, Bergemann N, Clement HW, et al: Consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology: Update 2017. Pharmacopsychiatry. 2018 Jan;51(1-02):9-62

Method Description
Describes how the test is performed and provides a method-specific reference

Paroxetine, citalopram, venlafaxine, and venlafaxine metabolite are extracted from serum by precipitation with acetonitrile. Dilute methanolic hydrochloric acid is added to form a salt to protect analytes from volatilization during the evaporation of the acetonitrile. High-performance liquid chromatography with detection by tandem mass spectrometer is used to measure concentration.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Thursday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 4 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

2 weeks

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

80299

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
PARO Paroxetine, S 9699-0
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
83731 Paroxetine, S 9699-0

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports

Test Update Resources

Change Type Effective Date
Test Changes - Reference Value 2022-10-31