One Step Morphine Test is a lateral flow, one-step immunoassay for qualitative detection of morphine and their metabolites in human urine at a cut-off of 300ng/ml . This product is used to obtain a visual, qualitative results and is intended for professional use. The assay should not be used without proper supervision and is not intended for over the counter sale to lay persons.
This assay provides only a preliminary analytical test result. A more specific alternative chemical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the National Institute on Drug Abuse. Clinical consideration and professional judgment should be applied to any drug of abuse result, particularly when preliminary results are indicated.
The opiates such as heroin, morphine, and codeine are derived from the resin of opium poppy. Heroin is quickly metabolized to morphine. Thus, morphine and morphine glucuronide both might be found in the urine of a person who has taken only heroin. The body also changes codeine to morphine. Thus, the presence of morphine ( or the metabolite, morphine glucuronide ) in the urine indicates heroin, morphine and/or codeine use.
Urine based screening tests for drugs of abuse range from simple immunoassay tests to complex analytical procedures. The speed and sensitivity of immunoassays have made them the most widely accepted method for screening urine for drugs of abuse. The One-Step Morphine Test is based on the principle of highly specific immunochemical reactions of antigens and antibodies which are use for the analysis of specific compounds in biological fluids. This test is a rapid, visual, competitive immunochemical that can be used for the qualitative detection of morphine in human urine at a 300ng/ml cut-off concentration.
The One-Step Morphine Test is a one-step immunoassay in which a chemically labeled drug (drug-protein conjugate) competes with the drug which may be present in urine for limited antibody binding sites. The test device contains a membrane strip which is precoated with drug-protein conjugate on the test band. The colored anti-morphine antibody-colloidal gold conjugate pad is placed at the end of the membrane. In the absence of drug in the urine, the solution of colored antibody-colloidal gold conjugate and urine moves upward chromatographically by capillary action across the membrane. This solution then migrates to the immobilized drug-protein conjugate zone to form a visible line as the antibody complexes with the drug-protein conjugate. Therefore , the formation of a visible precipitant in the test band region occurs when the test urine is negative for the drug. When the drug is present in the urine, the drug/metabolite antigen competes with the drug-protein conjugate on the test band region (T) for the limited antibody sites on the anti-morphine antibody-colloidal gold conjugate. When a sufficient concentration of drug is present , it will fill the limited antibody binding sites. This will prevent attachment of the colored antibody-colloidal gold conjugate to the drug-protein conjugate zone on the test band region. Therefore, absence of the color band on the test region indicates a positive result. Reaction is also to added to thetest is performed properly. This control line should always appear regardless of the presence of drug or metabolite. This means that negative urine will produce two colored band, and positive urine will produce only one band. The presence of this colored band in the control region also serves as verification that sufficient specimen has been added, and that proper flow was obtained.
MATERIALS REQUIRED BUT NOT PROVIDED
Specimen collection container.
STORAGE AND STABILITY
The test kit should be stored refrigerated or at room temperature 2-30℃(36-86℉). Each device should remain in its sealed pouch for the duration of the shelf life of two years.
FOR IN-VITRO DIAGNOSTIC USE.
For professional use only
Urine specimens may be potentially infectious. Proper handing and disposal methods should be established.
Avoid cross-contamination of urine samples by using a new specimen collection container and specimen pipette for each urine sample.
SPECIMEN COLLECTION AND HANDING
The One-Step Morphine Test is formulated for use with urine specimens. Fresh urine does not require any special handing or pretreatment. Urine samples should be collected such that testing may be performed as soon as possible after the specimen collection, preferably during the same day. The specimen may be refrigerated at 2-8℃ for 3 days or frozen at -20℃ for a longer period of time. Specimens that
Have been refrigerated must be equilibrated to room temperature prior to testing. Specimens previously frozen must be thawed, equilibrated to room temperature ,and mixed thoroughly prior to testing.
1.Review “ Specimen collection ” instructions. Test device, patient’s samples, and controls should be brought to room temperature (20-30 ℃) prior to testing. Do not open pouches until ready to perform the assay.
2.Remove the test device from its protective pouch (bring the device to room temperature before open the pouch to avoid condensation of moisture on the membrane ). Label the device with patient or control number.
3.Hold the dropper vertically and transfer 3 full drops of urine (approx. 150ul) to the specimen well (S) of the test devoice, and then start the time. Use a separate pipette and device for each sample or control.
4.Read result between 3 to 8 minutes after the addition of samples. Do not read result after 10 minutes.
INTERPRETATION OF RESULTS
Positive : Only one pink band appears on test region of the Cassette.
Negative : two pink bands appear on test region of the cassette.
Invalid : if without colored band appears oa test region, this is an indication of a possible error in performing the test should be repeated using a new device.
LIMITATIONS OF PROCEDURE
1.The assay is designed for use with human urine only.
2.a positive result with the tests indicates the presence of a drug/metabolite only and does not indicate or measure intoxication.
3.There is a possibility that technical and/or procedural errors as well as other substances or factors not listed may interfere with the test and cause false results. See SPECIFICITY for lists of substances that will produce positive result, or that do not interfere with test performance.
4.If it is suspected that the samples have been mislabeled or tampered with, a new specimen should be collected and the test should be repeated.
The precision of the One-Step Morphine Test was determined by conducting the test with spiked controls. The control at 150ng/ml gave negative results and the control at
450ng/ml gave positive results.
The specificity for the One-Step Morphine Test was tested by adding various drugs, drug metabolites, and other compounds that are likely to be present in urine. All compounds were prepared in drug-free normal human urine.