Orient New Life Medical Co.,Ltd. |
|
Drug test MDMA Rapid test strip,4mm strip detecting Ecstasy in
urine, Quickly, Gold colloidal method
Intended Use
Cocaine, is a potent central nervous system (CNS) stimulant and a
local anesthetic. Initially, it brings about extreme energy and
restlessness while gradually resulting in tremors, over-sensitivity
and spasms. In large amounts, Cocaine causes fever,
unresponsiveness, and difficulty in breathing and unconsciousness.
Cocaine is often self-administered by nasal inhalation, intravenous
injection and free-base smoking. It is excreted in the urine in a
short time primarily as Benzoylecgonine.1,2 Benzoylecgonine, a
major metabolite of Cocaine, has a longer biological half-life (5 -
8 hours) than Cocaine (0.5 - 1.5 hours), and can generally be
detected for 24-48 hours after Cocaine exposure.2
The COC One Step Cocaine Test Strip (Urine) is a rapid urine
screening test that can be performed without the use of an
instrument. The test utilizes a monoclonal antibody to selectively
detect elevated levels of Cocaine metabolite in urine. The COC One
Step Cocaine Test Strip (Urine) yields a positive result when the
Cocaine metabolite in urine exceeds 300 ng/mL.
Parameter | Calibrator | Cut-off(ng/mL) |
COC (Cocaine) | Benzoylecgonine | 300 |
Test Principle
The COC One Step Cocaine Test Strip (Urine) is a rapid
chromatographic immunoassay based on the principle of competitive
binding. Drugs which may be present in the urine specimen compete
against the drug conjugate for binding sites on the antibody.
During testing, a urine specimen migrates upward by capillary
action. Benzoylecgonine, if present in the urine specimen below 300
ng/mL, will not saturate the binding sites of antibody-coated
particles in the test strip. The antibody-coated particles will
then be captured by immobilized Benzoylecgonine conjugate and a
visible colored line will show up in the test line region. The
colored line will not form in the test line region if the
Benzoylecgonine level exceeds 300ng/mL because it will saturate all
the binding sites of antibodies.
A drug-positive urine specimen will not generate a colored line in
the test line region, while a drug-negative urine specimen or a
specimen containing a drug in a concentration less than the cut-off
will generate a colored line in the test line region. To serve as a
procedural control, a colored line will always appear at the
control line region, indicating that 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
Analytical Sensitivity
A drug-free urine pool was spiked with Cocaine at the following
concentrations: 0ng/mL, 150ng/mL, 225ng/mL, 300ng/mL, 375ng/mL,
450ng/mL and 600mg/ml. The result demonstrates > 99% accuracy at
50% above and 50% below the cut-off concentration. Results are
presented in Table 2 below.
Table 2: Analytical Sensitivity Summary
COC Concentration (ng/mL) | Percent of Cut-off | n | Visual Result | |
Negative | Positive | |||
0 | 0 | 30 | 30 | 0 |
150 | -50% | 30 | 30 | 0 |
225 | -25% | 30 | 30 | 0 |
300 | Cut-off | 30 | 4 | 26 |
375 | +25% | 30 | 0 | 30 |
450 | +50% | 30 | 0 | 30 |
600 | +100% | 30 | 0 | 30 |
Conclusion: As indicated in table above: all specimens with COC concentration
equal to or lower than 150ng/mL show negative results, all
specimens with COC concentration of 300ng/mL are identified as
“+/-”, and all specimens with COC concentration equal to or higher
than 450ng/mL showed positive results. Therefore, the cut-off
concentration of the COC One Step Test Strip (Urine) is determined
to be 300ng/mL COC.
Analytical Specificity
Table 3 lists the compounds that are positively detected in urine by the COC One Step Cocaine Test Strip (Urine) at 5 minutes and the concentrations at which they are detected.
Table 3: Analytical Specificity
Compound | Concentration (ng/mL) |
Benzoylecgonine | 300 |
Cocaine HCl | 780 |
Cocaethylene | 12,500 |
Ecgonine HCl | 32,000 |
ORIENT NEW LIFE MEDICAL CO., LTD. | |
Contact: | Jerry Meng |
Email: | Jerry @ newlifebiotest .com |
Tel. | +86 18657312116 |
SKYPE | enetjerry |