OVERVIEW

Purpose: Detection and quantification of Pregabalin in urine.

CLINICAL INFORMATION

Pregabalin (Lyrica) is an anticonvulsant drug used to treat partial seizures in patients and is a more potent successor to gabapentin. Pregabalin is commonly used for generalized anxiety disorder, neuropathic pain and fibromyalgia. The test is a definitive assay using liquid chromatography mass spectroscopy (LC/MS/MS) methodology.

SPECIMEN COLLECTION

Specimen Type: Random urine
Preferred Collection Container: Non-sterile specimen container
Specimen Required: 3 mL urine; minimum 1 mL

TEST DETAILS

Methodology: Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)
Compliance Category: Laboratory Developed Test (LDT)
This test was developed and assessed by DMD in compliance with CLIA requirements for its analytical performance characteristics and clinical application. This test has not been cleared or approved by the U.S. Food and Drug Administration.
Reference Interval: Negative
Drug/Metabolite Tested:
Drug/Metabolite Cutoff concentration 500 ng/mL
Pregabalin 500 ng/mL
CPT code(s): 80366
Turnaround Time: 90% < 48 hours, 50% < 24 hours

SPECIMEN PROCESSING

Transport Temperature: Refrigerated (preferred) or room temperature overnight shipping.
Specimen Stability: 3 days at room temperature and 14 days at refrigerated and frozen temperatures (to be further confirmed with our validation).
Rejection Criteria: Stability limits exceeded.

Director: Cheryl Hanau, MD; Donald Hall Jr., PhD; Garth Ehrlich, PhD; Yinghua Qiu, PhD, DABCC

Review Date: 08/28/2023

Note: The billing party has sole responsibility for CPT coding. Any questions regarding coding should be directed to the payer being billed. The CPT codes provided by GML are based on AMA guidelines and are for informational purposes only.

The information on these pages is provided for general information only and should not be used for diagnosis or treatment, or as a substitute for consultation with a physician or health care professional. If you have specific questions or concerns about your health, you should consult your health care professional.

 
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