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ACCU-TELL MDMA URINE TEST (CE)
Declaration: As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
Catalog No. Product Name Note ABT-DOA-A55 MDMA Urine Strip CE ABT-DOA-B55 MDMA Urine Cassette CE
Accu-Tell ® Rapid MDMA Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of (±)-3,4-Methylene-dioxymethamphetamine (MDMA) in human urine. The detection limit (cut-off) is 1000 ng/ml and provides a visual, qualitative result.
It is a competitive immuno-assay and in case there is no methamphetamine (non-consumer) in the urine two red lines (test- and control-line) appear at the strips of the device. If there is methamphetamine in the urine sample (consumer) only one control-line appears at the test strip.
This assay provides only a preliminary analytical test result. 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 con-firmatory method by the National Institute on Drug Abuse (NIDA). Clinical consideration and professional judgment should be applied to any methamphetamine test result, particularly when preliminary positive results are indicated.
This product is intended for professional use only. The assay should not be used without proper supervision and is not intended for over the counter sale to lay persons.
(±)-3,4-methylenedioxymethamphetamine (MDMA) is the main component of ecstasy. Ecstasy influences the central nervous system as a stimulant. In addition to psychological addiction, taking ecstasy also causes general unrest, a reduced feeling of hunger and overall feeling of well being. Ecstasy appears in the urine within three hours after administration (any type) and be present for 24-48 hours after the last dose2,3,4. Overdose and extended usage of Ecstasy may lead to substance abuse, which may cause severe and/or permanent damage to the human nervous system. A relatively frequent outcome is physical overexertion resulting in death, due to the elimination of the body’s warning signals.
Maximum expected urine concentrations and the half-life of drugs of abuse and psychotropics
The concentrations are the lowest published concentrations in urine after consumption of respective drugs underneath lethal doses
Times of detection of various drugs of abuse in urine
Accu-Tell ® Rapid MDMA Urine Test is is an immunoassay in which the chemically labelled MDMA (MDMA conjugate) competes with the free MDMA which may be present in urine for limited antibody binding sites. The test device contains membrane strips which are pre-coated with immobilized MDMA conjugate as antigen on the test band (T). A red colored anti-colloidal gold conjugate pad is placed at the right ending of the membrane at the liquid contact site. After soaking it with urine the gold-conjugates move along the membrane chromatographically by capillary action and the antibodies get to the test region. If there is no MDMA molecule in the urine the antibody gold conjugate attaches to the MDMA conjugate to form a visible line. Therefore, the formation of a visible precipitant in the test zone occurs when the test urine is negative for the drug.
If MDMA is present in the urine, the drug antigen competes with the immobilized MDMA conjugate on the test band region for limited antibody sites. In case of sufficient concentration of the drug, it fills the limited antibody binding sites. This will prevent attachment of the colored antibody-colloidal gold conjugate to the MDMA conjugate zone on the test band region. Therefore, absence of the colored band on the test region indicates a positive result. A control band with a different antigen/antibody reaction is also added to the immunochromatographic membrane strip at the control region (C) to indicate that the test has been performed properly.
This control line should always appear, regardless of the presence of MDMA. This means that negative urine will produce two colored bands (non-consumer), and positive urine will produce only one band (consumer). The presence of this colored band in the control region therefore serves as 1) verification that sufficient volume has been added, and 2) that proper flow was obtained.
The test kit is to be stored refrigerated or at room temperature 2-30°C (36-86 °F) in the sealed pouch for the duration of the shelf life.
1. For In Vitro use only.
2. For pro essional use only.
3. Use only once.
4. Fill each sample well only with 3 drops (120-150 μl) urine.
5. Do not use more than the required amount of liquid.
6. Avoid cross-contamination of urine samples by using a new specimen collection container and specimen pipette for each urine sample.
7. Do not touch the reaction zone of the device to avoid contamination.
8. Do not spill the samples into the reaction zone.
9. Use only urine as liquid and no other one instead.
10. Urine specimens may be potentially infectious. Proper handling and disposal methods should be established.
11. Do not use the cassette after expiration date.
12. Do not use the test after damage of the packaging foil.
13. Use test right after unwrapping.
14. Please be aware of the developing time of the test (5 min) before evaluation.
15. Please take the specificity and the cross reactivity into account for evaluation.
16. Store and transport the test device always at 2-30°C (36°-86°F).
Accu-Tell ® Rapid MDMA Urine Test is formulated for use with urine specimens. Fresh urine does not require any special handling or pretreatment. Urine samples should be collected such that testing can be performed as soon as possible after the specimen collection, preferably during the same day. The specimen may be refrigerated at 2-8°C for 2 days, or frozen at -20°C 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.
Note: Urine specimens and all materials coming in contact with them should be handled and disposed of as if capable of transmitting infection. Avoid contact with skin by wearing gloves and proper laboratory attire.
Review “Specimen Collection“ instructions. Test cassette/stip, patient’s samples, and controls should be brought to room temperature (15-30°C) prior to testing. Do not open pouches until ready to perform the assay.
For Test Cassette:
1. Remove the test cassette from its protective pouch (bring the device to room temperature before opening the pouch to avoid condensation of moisture on the membrane). Label the device with patient or control identification.
2. Draw the urine sample to the line marked on the pipette. Dispense 3 drops (or 120 μl) into the sample well. Use a separate pipette and device for each sample or control.
3. Read result between 3 to 15 minutes after the addition of sample. Do not read result after 15 minutes.
For Test Strip:
1. Bring the pouch to room temperature before opening it. Remove the test strip from the sealed pouch and use it as soon as possible.
2. With arrows pointing toward the urine specimen, immerse the test strip vertically in the urine specimen for at least 5 seconds. Do not pass the maximum line on the test strip when immersing the strip.
3. Place the test strip on a non-absorbent flat surface, start the timer and wait for the red line(s) to appear. The result should be read between 3 to 15 minutes after the addition of sample. Do not interpret the result after 15 minutes.
Negative: Two colored lines appear in the viewing window. The line in the test region (T) is the drug probe line; the line on the control region (C) is the control line, which is used to indicate proper performance of the device. The color intensity of the test line may be weaker or stronger than that of the control line.
Positive: Only one colored line appears in the control region (C). The absence of a test line indicates a positive result.
Invalid: No line appears in the control region. Under no circumstances should a positive sample be identified until the control line forms in the viewing area. If the control line does not form, the test result is inconclusive and should be repeated.
Note: A very faint line in the test region indicates that the barbiturate in the sample is near the cut-off level of the test. These samples should be re-tested or confirmed with a more specific method before a positive determination is made.
1. The assay is designed for use with human urine only.
2. A positive result with any of the tests indicates the presence of a drug/metabolite only, and does not indicate or measure intoxication.
3. There is a possibility that technical or procedural errors as well as other substances and factors not listed may interfere with the test and cause false results.
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.
Good laboratory practice recommends the use of control materials to ensure proper kit performance. Quality control specimens are available from commercial sources. When testing the positive and negative controls, use the same assay procedure as with a urine specimen
A. Accuracy
The accuracy of Accu-Tell ® Rapid MDMA Urine Test was compared and checked against a commercially available test with a threshold value of 1000 ng/ml. 100 urine samples taken from volunteer test persons who claim to be non-consumers, was examined under both tests. The results were 100% in agreement.
B. Reproducibility
The reproducibility of Accu-Tell ® Rapid MDMA Urine Test was verified by blind tests performed at a four different locations. All 50 utilized samples with an MDMA concentration of 500 ng/ml yielded a negative result. All 50 samples with a MDMA concentration of 2000 ng/ml yielded a positive result.
C. Precision
Test precision was determined by blind tests with control solutions. Controls with a MDMA concentration of 500 ng/ml should yield a negative result and controls with a MDMA concentration of 1500 ng/ml should provide a positive result.
D. Specificity
The specificity of Accu-Tell ® Rapid MDMA Urine Test was tested with the substances listed below, all of which can be found in a normal urine specimen.
The following compounds with a similar chemical structure yield a positive result at the specified concentration:
With exception of the above, for the respective parameter listed positive-reacting drugs resp. drug metabolites, all following listed compounds reacted negative up to a concentration of 100 μg/ml.
1. Baselt, R.C. Disposition of Toxic Drugs and Chemicals in Man, Biomedical Publications, 1982.
2. Urine Testing for Drugs of Abuse. National Institute on Drug Abuse (NIDA), Research Monograph 73, 1986.
3. Fed. Register, Department of Health and Human Services, Mandatory Guidelines for Federal Workplace Drug Testing Programs, 53, 69, 11970, 1988.
4. McBay, A.J. Clin. Chem. 33, 33B-40B, 1987.
5. Gilman, A.G., & Goodman, L.S. The Pharmacological Basis of Therapeutics, eds. MacMillan Publishing, New York, NY, 1980.
6. Greenblatt, D.J., Shader, R.I.: Benzodiazepines in Clinical Practice. New York, Raven Press, 1974.
7. Harvey, R.A. Champe, P.C.: Lippincott’s illustrated Reviews. Pharmacology, 91-95, 1992.
The above information is just for reference. The actual technical specifications are subject to the insert provided with the product. |
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