INDICAID® Fentanyl Drug Detection Test
A rapid, one-step immunoassay for the qualitative detection of fentanyl in human urine.
- CLIA Waived
- For in vitro diagnostic use
- Medical and other professional in vitro diagnostic use
About
The INDICAID Fentanyl Drug Detection Test is a rapid, one-step immunoassay for the qualitative detection of fentanyl in human urine at the cut-off concentration of 1 ng/mL. With the growing need for effective substance use monitoring, this point-of-care test provides quick and reliable results, empowering healthcare professionals to take immediate action and improve patient outcomes.
Who Is It For?
- Healthcare providers → Healthcare providers managing patients with suspected fentanyl use to quickly confirm or rule out exposure.
- Clinicians → Clinicians in addiction recovery programs monitoring fentanyl presence during treatment.
- Law enforcement professionals → Law enforcement professionals conducting investigations or criminal justice cases requiring rapid, on-site confirmation of fentanyl use.
Specifications
| Components | Test devices packaged individually in a foil pouch with desiccant and package insert |
|---|---|
| Test type | Rapid lateral fluid immunoassay for the detection of fentanyl in human urine |
| Tests per kit | 25 |
| Specimen type | Urine sample |
| Result time | 5 Minutes |
| Urine cutoff | 1 ng/mL |
| FDA status | 510(k) cleared |
Intended use
The INDICAID Fentanyl Drug Detection Test is a rapid, one-step immunoassay for the qualitative detection of fentanyl in human urine at a 1 ng/mL cutoff. Designed to meet the growing need for substance use monitoring, this point-of-care test delivers rapid, reliable results to support immediate clinical decisions and improve patient outcomes.
This device provides only preliminary drug test results. To obatin a quantitative result or a confirmation of a presumptive positive result, a more specific alternative method must be used. GC/MS or LC/MS is the preferred confirmatory method.
Professional judgement should be applied to drug test results, particularly when preliminary positive results are indicated.
Fentanyl Drug Detection Test Resources
| INDICAID Fentanyl Drug Detection Test Instructions for use (IFU) |
| INDICAID Fentanyl Drug Detection Test Sales Sheet (coming soon) |
