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CE Approved Portable Drug Test Kits 4mm Dipcard 500ng/ML Cut - Off For Ecstasy

Categories Drug Abuse Test Kit
Brand Name: New Life
Model Number: Dipcard/cassette/strip
Certification: ISO13485, CE
Place of Origin: China
MOQ: 5000pcs
Payment Terms: T/T, Western Union, MoneyGram
Supply Ability: 2000000pcs/month
Delivery Time: 20-30days
Packaging Details: 1pc/pouch, 25pcs/box
Method: Gold Colloidal
Format: 4mm DIPCARD
Specimen: Urine
Testing time: 5-15 minutes
Shelf Life: 24 Months
Application: Ecstasy
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CE Approved Portable Drug Test Kits 4mm Dipcard 500ng/ML Cut - Off For Ecstasy

Urine drug test MDMA Rapid test,4mm dipcard detecting Ecstasy in urine, Quickly, Gold colloidal method


Intended Use


The MDMA Rapid Test Device (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of Ecstasy in human urine specimens at the cut-off concentrations listed below:

ParameterCalibratorCut-off (ng/mL)
MDMA (Ecstasy)3,4-Methylenedioxymethamphetamine500

Test Principle


The MDMA Rapid Test Device (Urine) detects Ecstasy through visual interpretation of color development on the Device. Drug conjugates are immobilized on the test region of the membrane. During testing, the specimen reacts with antibodies conjugated to colored particles and precoated on the sample pad. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there are insufficient drug molecules in the specimen, the antibody-colored particle conjugate will bind to the drug conjugates, forming a colored band at the test region of the membrane. Therefore, a colored band appears in the test region when the urine is negative for the drug. If drug molecules are present in the urine above the cut-off concentration of the test, they compete with the immobilized drug conjugate on the test region for limited antibody binding sites. This will prevent attachment of the antibody-colored particle conjugate to the test region. Therefore, the absence of a colored band at the test region indicates a positive result. The appearance of a colored band at the control region serves as a procedural control, indicating that the 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


The specimen correlation study was performed on 240 urine specimens. 88 positive urine specimens and 152 negative urine specimens were confirmed by GC/MS. These specimens were randomized and tested using the MDMA One Step Ecstasy Test Strip (Urine). Specimens were rated as either positive or negative at 5minutes. The test results are shown in Table 1.


Table 1: Specimen Correlation

GC/MS
MDMA One Step Test Strip+-
+883
-0149

Positive agreement with GC/MS: 88/(88+0) >99%

Negative agreement with GC/MS: 149/(149+3) = 98%

Total agreement with GC/MS: (88+149)/(88+0+3+149) = 99%


Quality CE Approved Portable Drug Test Kits 4mm Dipcard 500ng/ML Cut - Off For Ecstasy for sale
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