Urine drug test MDMA Rapid test,4mm dipcard detecting Ecstasy in
urine, Quickly, Gold colloidal method
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:
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
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.
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
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.
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
|MDMA One Step Test Strip||+||-|
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%