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 |
