A rapid test for the qualitative detection of Morphine in human
urine. For professional in vitro diagnostic use only.
INTENDED USE
The OPI Rapid Test Cassette is a rapid chromatographic immunoassay
for the detection of Morphine in human urine at the cut-off concentration of 300ng/ml. This test
will detect other compounds, please refer to Analytical Specificity table in this package insert.
This assay provides only a qualitative, preliminary, analytical
test result. A more specific alternate chemical method must be used in order to obtain a confirmed
analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred
confirmatory method. Clinical consideration and professional judgment should be applied to any
drug of abuse test result,particularly when preliminary positive results are used.
SUMMARY
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.
The OPI Rapid Test Cassette 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 Rapid Test Cassette yields a positive
result when Morphine in urine reaches 300ng/mL. This is the suggested screening cut-off for
positive specimens set by the Substance Abuse and Mental Health Services Administration (SAMHSA,
USA).
PRINCIPLE
The OPI Rapid Test Cassette is an 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 300ng/ml, will not saturate the binding sites of the
antibody coated particles in the test device. 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 is at or above 300ng/mL because
it will saturate all the binding sites of anti-Morphine antibodies.
A drug-positive urine specimen will not generate a colored line in
the test line region because of drug competition, while a drug-negative urine specimen or a specimen
containing a drug concentration less than the cut-off will generate a 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.
| Principle | Chromatographic Immunoassay |
| Format | Dipstick, Cassette, Panel, Device |
| Specimen | Urine, Oral Fluid, Powder |
| Certificate | CE/FDA |
| Reading Time | 5 minutes |
| Pack | 25T/40T/50T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
| Sensitivity | 95.00% |
| Specificity | 95.30% |
| Accuracy | 95.20% |
| Cut-Off | 300 ng/mL |
REAGENTS
The test contains mouse monoclonal anti-Morphine antibody-coupled
particles and Morphine-protein conjugate. A goat antibody is employed in the control line system.
PRECAUTIONS
For medical and other professional in vitro diagnostic use only. Do
not use after the expiration date.
The test should remain in the sealed pouch until use.
All specimens should be considered potentially hazardous and
handled in the same manner as an infectious agent.
The used test should be discarded according to local regulations.
DIRECTIONS FOR USE
Allow the test, urine specimen, and/or controls to reach room
temperature (15-30ºC) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove
the test cassette from the sealed pouch and use it within one hour.
2. Place the test cassette on a clean and level surface. Hold the
dropper vertically and transfer 3 full drops of urine (approx. 120 uL) to the specimen well (S) of
the test cassette, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See
the illustration below.
3. Wait for the color line(s) to appear. The result should be read
at 5 minutes. Do not interpret the result after 10 minutes.
| Cat. No. | Product | Specimen | Pack |
| DOP-102 | Opiates (OPI) Rapid Test Cassette | Urine | 25T |
| DOP-114 | Opiates (OPI) Rapid Test Panel | Urine | 25 T/40 T |
| DOP-101 | Opiates (OPI) Rapid Test Dipstick | Urine | 50 T |
