DOA MDMA rapid Test with CE certificate urine test device
Product Name | MDMA One Step Ecstasy Test |
Formats | Strip(3mm)Device(4mm) Multi panel |
Place of Origen | China |
Specimen | Urine |
Read Time | 5 minutes |
Shelf life | 2 years |
Package | 25 device/box or 50 strip/Box |
Storage | 2℃-30℃ |
For professional in vitro diagnostic use only.
INTENDED USE
The MDMA One Step Ecstasy Test is a lateral flow chromatographic immunoassay for the detection of Methylenedioxymethamphetamine (primary ingredient of Ecstasy) in human urine at the cut-off concentration of 500 ng/mL. .
Accuracy
A side-by-side comparison was conducted using the MDMA One Step Ecstasy Test and a leading commercially available Methylenedioxymeth-amphetamine rapid test. Testing was performed on 253 clinical specimens. Ten percent of the specimens employed were either at -25% or +25% level of the cut-off concentration of 500ng/mL Methylenedioxymeth-amphetamine. Presumptive positive results were confirmed by GC/MS. The following results were tabulated:
Method | Other MDMA Rapid Test | Total Results | ||
One Step MDMA Test | Results | Positive | Negative | |
Positive | 93 | 1 | 94 | |
Negative | 0 | 159 | 159 | |
Total Results | 93 | 160 | 253 | |
% Agreement with this Rapid Test Kit | 100% | 99.4% | 99.6% |
When compared at 500 ng/mL cut-off with GC/MS, the following results were tabulated:
Method | GC/MS | Total Results | ||
MDMA Test | Results | Positive | Negative | |
Positive | 95 | 0 | 95 | |
Negative | 5 | 153 | 139 | |
Total Results | 100 | 153 | 253 | |
% Agreement with GC/MS Analysis | 95.0% | 100% | 98.0% |
Analytical Sensitivity
A drug-free urine pool was spiked with Methylenedioxy-methamphetamine at the following concentrations: 0 ng/mL, 250 ng/mL, 375 ng/mL, 500 ng/mL, 625 ng/mL and 750 ng/mL. The result demonstrates >99% accuracy at 50% above and 50% below the cut-off concentration. The data are summarized below:
MDMA Concentration (ng/mL) | Percent of Cut-off | n | Visual Result | |||||||
Negative | Positive | |||||||||
0 | 0% | 20 | 20 | 0 | ||||||
250 | -50% | 20 | 20 | 0 | ||||||
375 | -25% | 20 | 15 | 5 | ||||||
500 | Cut-off | 20 | 10 | 10 | ||||||
625 | +25% | 20 | 4 | 16 | ||||||
750 | +50% | 20 | 0 | 20 |
SUMMARY
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 yields a positive result when Methylenedioxymethamphetamine in urine exceeds 500 ng/mL.