CE Mark Carfentanyl (CFYL) One Step 500ng/ml Fast Reading Drug of Abuse Diagnosis Test Kit Test Panel Powder
Application:
The Carfentanyl (CFYL) Rapid Test Panel (Powder) is a rapid immunochromatographic assay for the qualitative detection of carfentanyl. This test will detect other compounds, please refer to Analytical Specificity table in this package insert.
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Description:
Carfentanyl is an analog of the synthetic opioid analgesic fentanyl. It is 10,000 times more potent than morphine, making it among the most potent commercially used opioids. Carfentanyl was first synthesized in 1974. It is marketed under the trade name Wildnil as a general anaesthetic agent for large animals. Side effects of carfentanyl are similar to those of fentanyl, which include itching, nausea and respiratory depression, which can be life-threatening. Carfentanyl is classified as Schedule II under the Controlled Substances Act in the United States with a DEA ACSCN of 9743.
The Carfentanyl (CFYL) Rapid Test Panel (Powder) is a rapid Powder screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of Carfentanyl. The Carfentanyl (CFYL) Rapid Test Panel (Powder) yields a positive result when the concentration of Carfentanyl exceeds 500 ng/ml.
How to use?
Test device (in closed pouches), samples, and controls should be brought to room temperature (15-30°C) prior to testing. Do not open pouches until ready to perform the assay. Remove the test device from its protective pouch and label the device with patient’s identification or control label.
FOR SURFACES
1. Wipe with the Sample marked side of strip in the panel over the surface on which the drugs are suspected.
2. Take off the cap of buffer vial.
3. Fill all buffer from the buffer vial into the protection cover.
4. Insert the Test slowly and carefully into the protection cover with buffer.
5. Wait for control line to appear on the membrane and read the results after 5 minutes and do not interpret the result after 10 minutes.
FOR SOLIDS WITHOUT SWAB
1. Open the buffer vial and put a pinch of suspected solid in to the buffer.
2. Close the vial with dropper and cap. Shake it vigorously for a short time. Wait for 30sec.
3. Take off the cap of dropper cap.
4. Fill all the buffer with dissolved substances into the protection cover.
5. Insert the Test slowly and carefully into the protection cover with buffer.
6. Wait for control line to appear on the membrane and read the results after 5 minutes and do not interpret the result after 10 minutes.
FOR SOLIDS WITH SWAB
1. Take out the buffer vial and open the lid. Place the swab into the tube for 5-10 seconds to allow swab head to be thoroughly soaked in the buffer.
2. Take out the swab and wipe the surface solids gently at least 3 times, and then insert the swab intobuffer vial and mix well for at least 1 minute. Squeeze the swab several times by compressing the outside walls of the vial against the swab to mix well. Finally squeeze the swab to make most of the solution stay in the buffer vial and remove the swab. Use solution thus obtained as specimen.
3. Take off the cap of dropper cap.
4. Fill the solution with dissolved substances into the protection cover.
5. Insert the Test Panel slowly and carefully into the protection cover with buffer.
6. Wait for control line to appear on the membrane and read the results after 5 minutes and do not interpret the result after 10 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
NEGATIVE:* A colored line appears in the Control region (C) and colored lines appear in the Test region (T). This negative result means that the concentrations in the sample are below the designated cut-off levels for a particular drug tested.
*NOTE: The shade of the colored lines(s) in the Test region (T) may vary. The result should be considered negative whenever there is even a faint line.
POSITIVE: A colored line appears in the Control region (C) and NO line appears in the Test region (T). The positive result means that the drug concentration in the sample is greater than the designated cut-off for a specific drug.
INVALID: No line appears in the Control region (C). Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for Control line failure. Read the directions again and repeat the test with a new test card. If the result is still invalid, contact your manufacturer.
