Description

Intended use

Fentanyl (FYL) Test strip is a lateral flow chromatographic immunoassay for the qualitative detection of Fentanyl in liquid and powder substances at the cut-off concentration of 10 ng/mL.

Non-IVD test.

Introduction

Fentanyl belongs to powerful narcotic analgesics and is a special opiates receptor stimulant. Fentanyl is one of the varieties that have been listed in management of United Nations “Single Convention of Narcotic Drug in 1961”.

Among the opiates agents that are under international control, Fentanyl is one of the most commonly used to cure moderate to severe pain. After continuous injection of fentanyl, the sufferer may experience protracted opioid abstinence syndromes, such as ataxia and irritability etc. after prolonged use of the drug. Compared with drug addicts of amphetamine, drug addicts who take fentanyl mainly have the possibility of higher infection rate of HIV, more dangerous injection behavior, and more lifelong medication overdose.

Descriptions

Product Name	Fentanyl Powder test strips
Brand Name	CIBIO® or OEM
Format	Strip
Cutoff level	10ng/mL
Methodology	Colloidal Gold
Kit Contents	1. Test Strip
	2. Desiccant
	3. Instruction for use
Assay Type	Qualitative Detection
Specimen	Pills Powder/Liquid
Specification	Strip:  3.0 mm; 3.5 mm; 4.0 mm
Certificates	ISO 13485
Accuracy	Over 99%
Storage Temperature	4-30 degree centigrade
Shelf Life	2 years ( 24 months )
Delivery time	15-30 days
OEM Services	Pouch, Box, Insert, Private label
Loading Port	Guangzhou or Shenzhen

Testing Procedure

Test must be in room temperature (15ºC to 30ºC)
1. Mix your drug sample thoroughly before testing. Dilute the drug to be tested in water. Five scoop (50mg) of drug sample should be diluted in 5mL of water.
2. Open the sealed pouch by tearing along the notch. Remove the test strip from the pouch.
3. Immerse the strip into the liquid with the arrow pointing towards the liquid. Take the strip out after 10 seconds.
IMPORTANT： Do not allow the liquid level to exceed the MAX (marker line), otherwise the test will not perform correctly.
4. Lay the test strip on a clean, dry, non-absorbent surface.
5. Read the results at 5 minutes. The drug test results remain stable for up to thirty minutes. See the illustration.

Reading The Results

Positive (+) — Fentanyl Detected
A rose-pink band is visible in the control region. No color band appears in the appropriate test “T” region.

Negative (-)– Fentanyl Could Not be Detected
Two rose-pink band are visible in the control region and the appropriate test “T” region. Even faint lines are considered negative.

Invalid
If a color band is not visible in the control “C” region or a color band is only visible in the test “T” region, the test is invalid. Another test should opened and run to re-evaluate the specimen. If test still provides an invalid result, please contact the distributor from whom you purchased the product. When calling, be sure to provide the lot number for the test.

Note: There is no meaning attributed to line color intensity or width. Any visible line is considered to be a line.