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| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
Fentanyl
Message“This is a screening assay. Fentanyl is detected in concentrations at or above 1.0 ng/mL.”.
Test Code
UFENT
Preferred Specimen
Urine
Preferred method is the Urine Collection Kit with specimen transferred to Urine Chemistry Collection Tube (yellow top).
Preferred method is the Urine Collection Kit with specimen transferred to Urine Chemistry Collection Tube (yellow top).
Patient Preparation
Freshly voided urine specimens should be used for testing.
Minimum Volume
Optimal: 15 mL
Minimum 2 mL
Minimum 2 mL
Other Acceptable Specimens
None
Instructions
No additives or preservatives are needed. Adulteration of the urine specimen may cause erroneous results. If adulteration is suspected, obtain a fresh specimen. Urine specimens should be handled and treated as if they are potentially infected. Preferred method is the Urine Collection Kit with specimen transferred to Urine Chemistry Collection Tube (yellow top).
Transport Container
Urine Chemistry Collection Tube (yellow top)
Transport Temperature
Room temperature
Specimen Stability
When collected and transferred to a Urine Chemistry Collection Tube within 2 hours:
Room Temperature: 24 hours
Refrigerated: 7 days
If a Urine Colection Kit is not used, submit to lab within 2 hours
Room Temperature: 24 hours
Refrigerated: 7 days
If a Urine Colection Kit is not used, submit to lab within 2 hours
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Samples in Urine Analysis Preservative Tube are NOT acceptable.
Methodology
The ARK Fentanyl II Assay is an immunoassay intended for the qualitative detection of fentanyl in human urine at a minimal concentration of 1.0 ng/mL.The ARK Fentanyl II Assay is a homogeneous enzyme immunoassay technique used for the analysis of a specific compound in human urine. The assay is based on competition between drug in the specimen and drug labeled with recombinant glucose-6-phosphate dehydrogenase for antibody binding sites. As the latter binds antibody, enzyme activity decreases. In the presence of drug from the specimen, enzyme activity increases and is directly related to the drug concentration. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH in the presence of glucose-6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically. Endogenous G6PDH does not interfere because the coenzyme NAD functions only with the bacterial enzyme used in the assay.
FDA Status
FDA Approved/Modified• Validated Test Modifications: Specimen stabilities have been modified from the package insert based on in-house stability studies performed at Quest Diagnostics.
Setup Schedule
Daily
Report Available
Daily
Reference Range
None Detected
Clinical Significance
Fentanyl is a synthetic opioid narcotic analgesic similar to morphine. Fentanyl is 50-100 times more potent than morphine. It is prescribed for patients with chronic pain and is used to manage pain after surgery or for treatment of breakthrough pain in cancer patients. Fentanyl is prescribed in various forms: by injection, transdermal patch, and orally. Fentanyl such as the transdermal system can be abused in a manner similar to other opioid agonists, legal or illicit. All patients receiving opioids should be routinely monitored for signs of misuse, abuse and addiction. Fentanyl has high potency and short duration of action, and it is abused for its intense euphoric effects. It is very dangerous when substituted illicitly for other opioids because of its potency and overdoses can lead to respiratory depression and death.
The ARK Fentanyl II Assay detects fentanyl in human urine. The test is not intended to
differentiate between drugs of abuse and prescription use of fentanyl. There are no uniformly
recognized drug levels for fentanyl in urine. The primary metabolism of fentanyl leads to the time-dependent urinary excretion of fentanyl and norfentanyl. The half-life of fentanyl may range 3 - 12 hours. Fentanyl is exclusively metabolized by N-dealkylation and hydroxylation. More than 90% of the dose is eliminated as norfentanyl and hydroxylated metabolites. Less than 7% of the dose is excreted unchanged in the urine.
The ARK Fentanyl II Assay detects fentanyl in human urine. The test is not intended to
differentiate between drugs of abuse and prescription use of fentanyl. There are no uniformly
recognized drug levels for fentanyl in urine. The primary metabolism of fentanyl leads to the time-dependent urinary excretion of fentanyl and norfentanyl. The half-life of fentanyl may range 3 - 12 hours. Fentanyl is exclusively metabolized by N-dealkylation and hydroxylation. More than 90% of the dose is eliminated as norfentanyl and hydroxylated metabolites. Less than 7% of the dose is excreted unchanged in the urine.
Performing Laboratory
Shady Grove Medical Center and White Oak Medical Center
