Active Member
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[China]
Address: 3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, 310018 Hangzhou, Zhejiang, P.R. China
Contact name:Edward YU
Hangzhou Aichek Medical Technology Co.,Ltd |
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DOA MDMA rapid Test with CE certificate urine uncut sheet
| Product Name | MDMA One Step Ecstasy Test |
| Formats | Strip(3mm)Device(4mm) uncut sheet |
| Place of Origen | China |
| Specimen | Urine |
| Read Time | 5 minutes |
| Shelf life | 2 years |
| Package | uncut sheet |
| 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 | ||||||
Analytical Specificity
The following table lists compounds that are positively detected in urine by the MDMA One Step Ecstasy Test at 5 minutes.
| Compound | Concentration (ng/mL) |
| (±) 3,4-Methylenedioxymethamphetamine HCl | 500 |
| (±) 3,4-Methylenedioxyamphetamine HCl | 3,000 |
| 3,4-Methylenedioxyethylamphetamine | 300 |
Effect of Urinary Specific Gravity
Fifteen (15) urine specimens with specific gravity ranging from 1.001 to 1.032 were spiked with 250 ng/mL and 750 ng/mL of Methylenedioxymethamphetamine. The MDMA One Step Ecstasy Test was tested in duplicate using the fifteen neat and spiked urine specimens. The results demonstrate that varying ranges of urinary specific gravity do not affect the test results.
Effect of Urinary pH
The pH of an aliquoted negative urine pool was adjusted to a pH range of 5 to 9 in 1 pH unit increments and spiked with Methylenedioxymethamphetamine to 250ng/mL and 750ng/mL. The spiked, pH-adjusted urine was tested with the MDMA One Step Ecstasy Test in duplicate. The results demonstrate that varying ranges of pH do not interfere with the performance of the test.
