The Opiates (OPI) Rapid Test (Urine) is a rapid chromatographic immunoassay for the qualitative presumptive detection of Morphine/Heroin in human urine specimen.
INTRODUCTION
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.
TEST PROCEDURE
Bring tests, specimens, buffer and/or controls to room temperature (1530°C) before use.
- 1. Remove the test from its sealed pouch, or remove one strip from the canister, and use it as soon as possible. For best results, the assay should be performed within one hour. Canisters should be closed tightly after removing strips.
- 2. Hold the strip by the end, where the product name is printed. To avoid contamination, do not touch the strip membrane.
- 3. Holding the strip vertically, dip the test strip in the urine specimen for at least 10-15 seconds. Do not immerse past the maximum line (MAX) on the test strip.
- 4. After the test has finished running, remove the strip from the specimen and place it on a non-absorbent flat surface. Start the timer and wait for the colored band(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 8 minutes.
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INTERPRETATION OF RESULTS
POSITIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).
NEGATIVE: Two colored bands appear on the membrane.One band appears in the control region (C) and another band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
NOTE:
- The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
- Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.
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LIMITATIONS OF THE TEST
- 1. The Opiates (OPI) Rapid Test(Urine) is for professional in vitro diagnostic use, and should be only used for the qualitative detection of Morphine/Heroin.
- 2. This assay provides a preliminary analytical test result only. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the National Institute on Drug Abuse (NIDA). Clinical consideration and professional judgment should be applied to any test result, particularly when preliminary positive results are indicated.
- 3. There is a possibility that technical or procedural errors as well as other substances and factors may interfere with the test and cause false results.
- 4. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. Therefore, please preclude the possibility of urine adulteration prior to testing.
- 5. A positive result indicates the presence of a Morphine/Heroin only, and does not indicate or measure intoxication.
- 6. A negative result does not at any time rule out the presence of Morphine/Heroin in urine, as they may be present below the minimum detection level of the test.
- 7. This test does not distinguish between Morphine/Heroin and certain medications.
- 8. The test results can be used to provide evidence and basis for therapy and treatment plans of drug dependence and toxic psychosis. For laboratory professional in vitro diagnostic use only.
- 9. The test should only be performed by health professionals in a clinical/hospital setting to aid in screening of drug of abuse to determine the follow-up treatment measures in combination of clinical symptoms.