Drug test MDMA Rapid test strip,4mm strip detecting Ecstasy in urine, Quickly, Gold colloidal method

Drug test MDMA Rapid test strip,4mm strip detecting Ecstasy in urine, Quickly, Gold colloidal method
 
Specimen: Urine
 
 
Intended Use
 
Methylenedioxymethamphetamine (Ecstasy) is a designer drug first synthesized in 1914 by a German drug company for the treatment of obesity.1 Those who take the drug frequently report adverse effects, such as increased muscle tension and sweating. MDMA is not clearly a stimulant, although it has, in common with amphetamine drugs, a capacity to increase blood pressure and heart rate. MDMA does produce some perceptual changes in the form of increased sensitivity to light, difficulty in focusing, and blurred vision in some users. Its mechanism of action is thought to be via release of the neurotransmitter serotonin. MDMA may also release dopamine, although the general opinion is that this is a secondary effect of the drug (Nichols and Oberlender, 1990). The most pervasive effect of MDMA, occurring in virtually all people who have taken a reasonable dose of the drug, is to produce a clenching of the jaws.
The MDMA One Step Ecstasy Test Strip (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 Ecstasy s in urine. The MDMA One Step Ecstasy Test Strip (Urine) yields a positive result when Methylenedioxymethamphetamine in urine exceeds 500 ng/mL
 

 
 
Test Principle
 
 

The MDMA One Step Ecstasy Test Strip (Urine) is a rapid chromatographic 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. Methylenedioxy-methamphetamine, if present in the urine specimen below 500 ng/mL, will not saturate the binding sites of antibody-coated particles in the test strip. The antibody-coated particles will then be captured by immobilized Methylenedioxymethamphetamine 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 Methylenedioxymethamphetamine level exceeds 500 ng/mL because it will saturate all the binding sites of anti- Methylenedioxymethamphetamine 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 in a concentration less than the cut-off will generate a colored 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
 
(Please refer to the illustration above)
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 line appearing in the control region
(C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.
Control standards are not supplied with this kit. However, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance.
 
Performance characteristics
 
Analytical Sensitivity
A drug-free urine pool was spiked with Ecstasy at the following concentrations: 0 ng/mL, 250 ng/mL, 375 ng/mL, 500 ng/mL, 625 ng/mL, 750 ng/mL and 1,000 ng/mL. The result demonstrates > 99% accuracy at 50% above and 50% below the cut-off concentration. Results are presented in Table 2 below.

Table 2: Analytical Sensitivity Summary

 
Conclusion: As indicated in table above: all specimens with MDMA concentration equal to or lower than 250ng/mL show negative results, all specimens with MDMA concentration of 500ng/mL are identified as “+/-”, and all specimens with MDMA concentration equal to or higher than 750ng/mL showed positive results. Therefore, the cut-off concentration of the MDMA One Step Ecstasy Test Strip (Urine) is determined to be 500ng/mL MDMA.
 
Analytical Specificity
 

Table 3 lists the compounds that are positively detected in urine by the MDMA One Step Ecstasy Test Strip (Urine) at 5 minutes and the concentrations at which they are detected.
 

Table 3: Analytical Specificity