Drug Test kits OPI Rapid Test strip ,4mm test strip. Urine Specimen
for Opiates, Gold colloidal method
Opiate refers to any drug that is derived from the opium poppy,
including the natural products, Morphine and Codeine, and the
semi-synthetic drugs such as heroin. Opioid is more general,
referring to any drug that acts on the opioid receptor.
Opioid analgesics comprise a large group of substances which
control pain by depressing the central nervous system. Large doses
of Morphine can produce higher tolerance levels and physiological
dependency in users, and may lead to substance abuse. Morphine is
excreted unmetabolized, and is also the major metabolic product of
codeine and heroin. Morphine is detectable in the urine for several
days after an opiate dose.1
The OPI One Step Opiate 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 Morphine in urine. The OPI One Step
Opiate Test Strip (Urine) yields a positive result when the
Morphine in urine exceeds 2,000 ng/mL. This is the suggested
screening cut-off for positive specimens set by the Substance Abuse
and Mental Health Services Administration (SAMHSA, USA).
|OPI 2000 (Opiates)||Opiates||2000|
The OPI One Step Opiate 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. Morphine, if present in the urine specimen below 2,000
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 Morphine 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 Morphine level exceeds
2,000 ng/mL because it will saturate all the binding sites of anti-
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.
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.
A drug-free urine pool was spiked with Opiate at the following
concentrations: 0 ng/mL, 1,000 ng/mL, 1,500 ng/mL, 2,000 ng/mL,
2,500 ng/mL, 3,000 ng/mL and 4,000 ng/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
|OPI Concentration (ng/mL)||Percent of Cut-off||n||Visual Result|
Conclusion: As indicated in table above: all specimens with OPI concentration
equal to or lower than 1,000ng/mL show negative results, all
specimens with OPI concentration of 2,000ng/mL are identified as
“+/-”, and all specimens with OPI concentration equal to or higher
than 3,000ng/mL showed positive results. Therefore, the cut-off
concentration of the OPI One Step Opiate Test Strip (Urine) is
determined to be 2,000ng/mL OPI.
Table 3 lists the compounds that are positively detected in urine
by the OPI One Step Opiate Test Strip (Urine) at 5 minutes and the
concentrations at which they are detected.
Table 3: Analytical Specificity
|Compound||Concentration (ng/mL)||Compound||Concentration (ng/mL)|
|ORIENT NEW LIFE MEDICAL CO., LTD.|
|Email:||Jerry @ newlifebiotest .com|