Intended Use
The Fentanyl Test (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
Storage
The product should be stored in a dry place at 2~30°C and not frozen.
Precision
This study is performed by three POC personnel who don't know the sample number system participate in the study, at 3 POC site. Three lots were run in consecutive business days at each concentration for each lot per day. The results as follows:

General Description
Fentanyl, belongs to powerful narcotics analgesics, and is a μ special opiates receptor stimulant. Fentanyl is one of the varieties that been listed in management of United Nations "Single Convention of narcotic drug in 1961". Among the opiates agents that under international control, fentanyl is one of the most commonly used to cure moderate to severe pain. After continuous injection of fentanyl, the sufferer will have the performance of protracted opioid abstinence syndrome, such as ataxia and irritability etc, which presents the addiction after taking fentanyl in a long time. Compared with drug addicts of amphetamine, drug addicts who take fentanyl mainly have got the possibility of higher infection rate of HIV, more dangerous injection behavior and more lifelong medication overdose.
The Fentanyl Test (Urine) is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of Fentanyl in urine. The Fentanyl Test (Urine) yields a positive result when Fentanyl in urine exceeds 1 ng/mL.
Citations
Publication ()
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Evaluation of US Commercial-Off-the-Shelf Hand-Held Assays to Detect Opiate Pain Reliever Compounds in Multiple Biofluids.
Sekowski, Jennifer, and Jennifer Gibbons.
Applications: ELISA
Reactive species: Human
"Abstract: Law enforcement, first responders, and the DOD community require fast, reliable, and inexpensive screening technologies for drugs and other compounds that can pose a threat to safety and health. However, there are gaps in the ability to detect many compounds in the field. For some compounds, the problem may be poor screening tests that can include false positives or impractical limits of detection, and others may have no field tests at all. In this study, we evaluated the potential for several U.S. commercial-off-the-shelf (COTS) hand-held assays (HHAs) to detect members of the opiate pain reliever class of compounds. Each HHA was developed for urine testing, and each came with its own stated claims of sensitivity and specificity. We evaluated the performance of three HHAs and tested for sensitivity and specificity to compounds in buffer conditions and in exposed animal biofluids. All HHAs successfully detected Compounds 1 and 2 in urine to varying degrees, some showed some detection of Compound 1 in saliva, and none detected Compound 3. In collaboration with the leading HHA company from this study, future work will functionalize and improve a COTS HHA platform for enhanced sensitivity of detection of Compound 1 in saliva and plasma."
Article snippet: Creative Diagnostics (Shirley, NY; part no. DTS237).
Figure 1. Creative Diagnostics' hand-held assays (HHAs) to detect members of the opiate pain reliever class of compounds.