One Step Rapid Mop Morphine Test

INTENDED USE

The MOP One Step Opiate Test Device is a lateral flow chromatographic immunoassay for the detection of opiates in urine at a cut-off concentration of 300 ng/mL. This test will detect other opiates, please refer to analytical specificity table in this package insert.
This assay provides only a 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

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 substance which control pain by depressing the central nervous system. Large doses of morphine can produce higher tolerance level 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 MOP One Step Opiate Test Device 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 opiates in urine. The MOP One Step Opiate Test Device yields a positive result when the concentration of opiates in urine exceeds the cutoff level.



PRINCIPLE
 
 The MOP One Step Opiate Test Device 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. Opiates, if present in the urine specimen below the cutoff level, will not saturate the binding sites of the antibody in the test device. The morphine conjugate will be captured by antibody 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 opiates level exceeds the cutoff concentration 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 will generate a line in the test line region because of the absence of drug competition.
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. 



PRECAUTIONS

·     For healthcare professionals including professionals at point of care sites.
·     For professional in vitro diagnostic use only. Do not use after the expiration date The test device 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 test device should be discarded according to federal, state and local regulations.
 
STORAGE AND STABILITY

Store as packaged in the sealed pouch at 2-30°C. The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.


DIRECTIONS FOR USE

Allow the test device, urine specimen and/or controls to reach room temperature (15-30°C) prior to testing.
 
1.     Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible. 
2.     Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 100ml) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See the illustration below.
3.     Wait for the colored line(s) to appear. The result should be read at 5 minutes.  Do not interpret the result after 10 minutes.



INTERPRETATION OF RESULTS

(Please refer to illustration above)
 
NEGATIVE:* Two lines appear. One colored line should be in the control region (C), and another colored line should be in the test region (T). This negative result indicates that the morphine concentration is below the detectable level (300 ng/mL).
* NOTE: The shade of the color in the test region (T) may vary, but it should be considered negative whenever there is even a faint line.
 
POSITIVE: One colored line appears in the control region (C). No line appears in the test region (T).  This positive result indicates that the morphine concentration exceeds the detectable level (300 ng/mL).
 
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.


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