One Step Saliva Morphine/Metamphtamine Test is a lateral flow, one-step immunoassay for qualitative detection of Morphine/Metamphtamine and their metabolites in human saliva, Morphine at a cut-off of 15ng/ml, Metamphtamine at a cut-off of 50ng/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.
Saliva 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 saliva for drugs of abuse. The One-Step Saliva Test is based on the principle of highly specific immunochemical reactions of antigens and antibodies which are used 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 Metamphtamine in human urine at a 50ng/ml cut-off concentration,and morphine in human saliva at a 15ng/ml cut-off concentration.
The One-Step Saliva Test is a one-step immunoassay in which a chemically labeled drug (drug-protein conjugate) competes with the drug which may be present in saliva for limited antibody binding sites. The test device contains a membrane strip which is pre-coated with drug-protein conjugate on the test band. The colored antibody-colloidal gold conjugate pad is placed at the end of the membrane. In the absence of drug in the saliva, the solution of colored antibody-colloidal gold conjugate and saliva 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 saliva, the drug/metabolite antigen competes with the drug-protein conjugate on the test band region (T) for the limited antibody sites on the 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. 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, andthat proper flow was obtained.
MATERIALS REQUIRED BUT NOT PROVIDED
Saliva collection container. Timer
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 one and a half years.
FOR IN-VITRO DIAGNOSTIC USE.
For professional use only
Saliva specimens may be potentially infectious. Proper handle and disposal methods should be established.
Avoid cross-contamination of urine samples by using a new specimen collection container and specimen pipette for each saliva sample.
SPECIMEN COLLECTION AND HANDING
Collect sublingualfreshsecretion ofsaliva.
Secretionofsputum might affect chromatography or could not chromatography due to viscous.
If thirst or dry will not secret saliva or secret sticky saliva,drink and wash mouth then collect saliva after 10 minutes.
Review “ Specimen collection ” instructions. Test device, samples, and controls should be brought to room temperature (20-30 ℃) prior to testing. Do not open pouches until ready to perform the assay.
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.
Collect fresh saliva in saliva collection container .Hold the dropper vertically and transfer one drop of no bubbles saliva to the specimen well (S) of the test device.
Transfer one drop of diluent to the specimen well (S) and then start the time. Use a separate pipette and device for each sample or control.
Read result between 3 to 5 minutes after the addition of samples. Do not read result after 10 minutes.
INTERPRETATION OF RESULTS
Positive: Only one pink band appears on control region of the Cassette.
Negative: Two pink bands appear on the membrane of the cassette.
Invalid: If without colored band appears on control 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 saliva only.
A positive result with the tests indicates the presence of
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 Saliva Metamphtamine Test was determined by conducting the test with spiked controls. The control is at 50ng/ml.
The precision of the One-Step Saliva Morphine Test was determined by conducting the test with spiked controls. The control is at 15ng/ml.
The specificity for the One-Step Saliva Test was tested by adding various drugs, drug metabolites, and other compounds that are likely to be present in saliva. All compounds were prepared in drug-free normal human saliva.