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ISO13485 MDMA Test Kit RTK Antigen Test Over The Counter

Categories DOA Rapid Test
Brand Name: Aichek
Model Number: MOP-A01
Certification: CE
Place of Origin: China
MOQ: 5000 Test
Price: 0.2 USD
Payment Terms: T/T
Supply Ability: negotiable
Packaging Details: 40box/carton
Storage: 2℃-30℃
Sample Type: Urine
User: Professional
Accuracy: 99.9%
Certificate: CE ISO 13485
OEM: OEM customized packing avaliable
Formats: 25T/box 1T/box
After-sales Service: Available
Key words: MDMA rapid Test with CE certificate urine test device
Combo Device: Any 2 To 12 Of The Products Can Be Integrated Into A Combo Cassette
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ISO13485 MDMA Test Kit RTK Antigen Test Over The Counter

DOA MDMA rapid Test with CE certificate urine test device


Product NameMDMA One Step Ecstasy Test
FormatsStrip(3mm)Device(4mm) Multi panel
Place of OrigenChina
SpecimenUrine
Read Time5 minutes
Shelf life2 years
Package25 device/box or 50 strip/Box
Storage2℃-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:


MethodOther MDMA Rapid TestTotal Results

One Step MDMA

Test

ResultsPositiveNegative
Positive93194
Negative0159159
Total Results93160253

% 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:


MethodGC/MSTotal Results

MDMA

Test

ResultsPositiveNegative
Positive95095
Negative5153139
Total Results100153253

% 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-offnVisual Result
NegativePositive
00%20200
250-50%20200
375-25%20155
500Cut-off201010
625+25%20416
750+50%20020

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.


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