Urine Carfentanyl Rapid Test Cassette CFYL Rapid Diagnostic Test Cut - Off 500ng/Ml

Drug Abuse Test Kit CFYL(Carfentanyl) Rapid Test 4mm card , cut-off 500ng/ml, urine drug test

Product Name

CFYL Rapid Diagnostic Test/ Carfentanyl Rapid Diagnostic Test

Specimen: Urine

Background

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. Carfentanil was first synthesized in 1974. 1 It is marketed under the trade name Wildnil as a general anaesthetic agent for large animals. 2 Side effects of carfentanil are similar to those of fentanyl, which include itching, nausea and respiratory depression, which can be life-threatening3. Carfentanil is classified as Schedule II under the Controlled Substances Act in the United States with a DEA ACSCN of 9743. 4 The Carfentanyl Rapid Test Cassette (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 Carfentanyl in urine. The Carfentanyl Rapid Test Cassette (Urine) yields a positive result when Carfentanyl in urine exceeds 500 ng/ml.

Test Principle

The Carfentanyl Rapid Test Cassette (Urine) is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody. During testing, a urine specimen migrates upward by capillary action. Carfentanyl, if present in the urine specimen below 500 ng/ml, will not saturate the binding sites of antibody-coated particles in the test device. The antibody-coated particles will then be captured by immobilized Carfentanyl conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the Carfentanyl level exceeds 500 ng/ml because it will saturate all the binding sites of anti- Carfentanyl antibodies. A drug-positive urine specimen will not generate a colored line in the test line region, while a drug-negative urine specimen or a specimen containing a drug concentration less than the cut-off will generate a line in the test line region. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

DIRECTIONS FOR USE

Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.

Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. For best results, the assay should be performed within one hour.

Using the provided disposable pipette, transfer 3 drops of specimen (approximately 120 µL) to the specimen well (S) of the device and start the timer.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

As the test begins to work, color will migrate across the membrane.

Wait for the colored band(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 8 minutes

INTERPRETATION OF RESULTS

NEGATIVE:* A colored line appears in the Control region (C) and colored lines appears in the Test region (T). This negative result means that the concentrations in the urine 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 urine 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.

QUALITY CONTROL

A procedural control is included in the test. A colored line appearing in the control line region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

.

Analytical Sensitivity

A drug-free urine pool was spiked with Carfentanyl at the following concentrations: 0ng/mL, 250ng/mL, 375ng/mL, 500ng/ml, 625ng/mL, 750ng/mL and 1500ng/mL.The results demonstrate >99% accuracy at 50% above and 50% below the cut-off concentration. The data are summarized below:

Carfentanyl	Percent of	n	Visual Result
Concentration (ng/mL)	Cut-off		Negative	Positive
0	0%	30	30	0
250	-50%	30	30	0
375	-25%	30	25	5
500	Cut-off	30	14	16
625	+25%	30	6	24
750	+50%	30	0	30
1500	+300%	30	0	30