Microsoft word - r015981 v01.doc

containing a drug concentration less than the cut-off will generate a line in the test INTERPRETATION OF RESULTS
To serve as a procedural control, a colored line will always appear at the control line NEGATIVE:* Two lines appear. One red line should be in the control region (C),
region, indicating that proper volume of specimen has been added and membrane and another apparent red or pink line should be in the test region (T). This negative Ecstasy Test Strip
result indicates that the Methylenedioxymethamphetamine concentration is below REAGENTS
Package Insert
* NOTE: The shade of red in the test line region (T) will vary, but it should be
The test strip contains mouse monoclonal anti-Methylenedioxymethamphetamine considered negative whenever there is even a faint pink line. A rapid, one step test for the qualitative detection of Methylenedioxymethamphetamines antibody-coupled particles and Methylenedioxymethamphetamine-protein conjugate. A goat antibody is employed in the control line system. POSITIVE: One red line appears in the control region (C). No line appears in the
test region (T). This positive result indicates that the Methylenedioxymethamphetamine For healthcare professionals including professionals at point of care sites. PRECAUTIONS
concentration exceeds the detectable level (500 ng/mL). For professional in vitro diagnostic use only. • For healthcare professionals including professionals at point of care sites. INVALID: Control line fails to appear. Insufficient specimen volume or incorrect
For professional in vitro diagnostic use only. Do not use after the expiration date. INTENDED USE
procedural techniques are the most likely reasons for control line failure. Review the • The test strip should remain in the sealed pouch until use. The MDMA One Step Ecstasy Test Strip is a lateral flow chromatographic immunoassay procedure and repeat the test using a new test strip. If the problem persists, • All specimens should be considered potentially hazardous and handled in the for the qualitative detection of Methylenedioxymethamphetamine in human urine at a discontinue using the lot immediately and contact your local distributor. Test Results
• The used test strip should be discarded according to federal, state and local regulations. This assay provides only a preliminary analytical test result. A more specific
alternate chemical method must be used in order to obtain a confirmed
STORAGE AND STABILITY
analytical result. Gas chromatography/mass spectrometry (GC/MS) is the
Store as packaged in the sealed pouch at 2-30°C. The test strip is stable through the preferred confirmatory method. Clinical consideration and professional
expiration date printed on the sealed pouch. The test strip must remain in the sealed judgment should be applied to any drug of abuse test result, particularly when
pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
preliminary positive results are used.
SPECIMEN COLLECTION AND PREPARATION
Urine Assay
Methylenedioxymethamphetamine (ecstasy) is a designer drug first synthesized in The urine specimen must be collected in a clean and dry container. Urine collected at 1914 by a German drug company for the treatment of obesity.3 Those who take the any time of the day may be used. Urine specimens exhibiting visible particles should be drug frequently report adverse effects, such as increased muscle tension and centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing. sweating. MDMA is not clearly a stimulant, although it has, in common with Specimen Storage
amphetamine drugs, a capacity to increase blood pressure and heart rate. MDMA Urine specimens may be stored at 2-8°C for up to 48 hours prior to assay. For long- does produce some perceptual changes in the form of increased sensitivity to light, term storage, specimens may be frozen and stored below -20°C. Frozen specimens difficulty in focusing, and blurred vision in some users. Its mechanism of action is QUALITY CONTROL
should be thawed and mixed before testing. thought to be via release of the neurotransmitter serotonin. MDMA may also release A procedural control is included in the test. A red line appearing in the control dopamine, although the general opinion is that this is a secondary effect of the drug MATERIALS
region (C) is considered an internal positive procedural control. It confirms sufficient (Nichols and Oberlender, 1990). The most pervasive effect of MDMA, occurring in Materials Provided
specimen volume, adequate membrane wicking and correct procedural technique. virtually all people who took a reasonable dose of the drug, was to produce a clenching of the jaws. Methylenedioxymethamphetamine Test Strip yields a Control standards are not supplied with this kit; however it is recommended that positive result when the Methylenedioxymethamphetamine in urine exceeds 500 positive and negative controls be tested as good laboratory practice to confirm the Materials Required But Not Provided
test procedure and to verify proper test performance. PRINCIPLE
LIMITATIONS
1. The MDMA One Step Ecstasy Test Strip provides only a qualitative, preliminary The MDMA One Step Ecstasy Test Strip is an immunoassay based on the principle analytical result. A secondary analytical method must be used to obtain a confirmed of competitive binding. Drugs which may be present in the urine specimen compete DIRECTIONS FOR USE
result. Gas chromatography/mass spectrometry (GC/MS) are the preferred against the drug conjugate for binding sites on the antibody. Allow the test strip, urine specimen, and/or controls to reach room temperature
During testing, a urine specimen migrates upward by capillary action. 2. It is possible that technical or procedural errors, as well as other interfering substances (15-30ºC) prior to testing.
Methylenedioxymethamphetamine, if present in the urine specimen below 500 in the urine specimen may cause erroneous results. 1. Bring the pouch to room temperature before opening it. Remove the test strip from ng/mL, will not saturate the binding sites of antibody-coated particles in the test 3. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous the sealed pouch and use it as soon as possible. strip. The antibody-coated particles will then be captured by immobilized results regardless of the analytical method used. If adulteration is suspected, the test 2. With arrows pointing toward the urine specimen, immerse the test strip Methylenedioxymethamphetamine conjugate and a visible colored line will show up should be repeated with another urine specimen. vertically in the urine specimen for at least 10 to 15 seconds. Do not pass the in the test line region. The colored line will not form in the test line region if the 4. A Positive Result indicates presence of the drug or its metabolites but does not maximum line (MAX) on the test strip when immersing the strip. See the Methylenedioxymethamphetamine level exceeds 500 ng/mL because it will saturate indicate level or intoxication, administration route or concentration in urine. all the binding sites of anti-Methylenedioxymethamphetamine antibodies. 5. A Negative Result may not necessarily indicate drug-free urine. Negative results can 3. Place the test strip on a non-absorbent flat surface, start the timer and wait be obtained when drug is present but below the cutoff level of the test. A drug-positive urine specimen will not generate a colored line in the test line region for the red line(s) to appear. The result should be read at 5 minutes. Do not 6. Test does not distinguish between drugs of abuse and certain medications. because of drug competition, while a drug-negative urine specimen or a specimen 7. A positive test result might be obtained from certain foods or food supplements. PERFORMANCE CHARACTERISTICS
3,4-Methylenedioxyethyl-amphetamine (MDE) Accuracy
Precision
A side-by-side comparison was conducted using the MDMA One Step Ecstasy Test A study was conducted at 3 physician’s offices by untrained operators using 3 Strip and a leading commercially available MDMA rapid test. Testing was different lots of product to demonstrate the within run, between run and between performed on 240 clinical specimens. Ten percent of the positive specimens operator precision. An identical panel of coded specimens containing no employed were either at –25% or +25% level of the cut-off concentration of 500 Methylenedioxymethamphetamine, 25% Methylenedioxymethamphetamine above ng/mL Methylenedioxymethamphetamine. Presumptive positive results were and below the cut-off and 50% Methylenedioxymethamphetamine above and below confirmed by GC/MS. Approximately 10% of the negative clinical samples were the 500 ng/mL cut-off were provided to each site. The results are given below: also confirmed with GC/MS. The following results were tabulated: Methylenedioxymetha
Other MDMA Rapid Test
mphetamine
Chloramphenicol Mephentermine Sulfamethazine concentration (ng/mL)
MDMA One Step
Test Strip
Total Results
% Agreement with this commercial kit
ACON MDMA One Step Ecstasy Test Strips were also tested with 93 MDMA positive and 147 MDMA negative urine samples in a clinical study. Nine of these positive urine Effect of Urinary Specific Gravity
samples in the +/- 25% cutoff range were derived from the concentrated MDMA clinical Fifteen (15) urine samples of normal, high, and low specific gravity ranges were specimens; the rest were true clinical specimens. All positive samples used in this study spiked with 250 ng/mL and 750 ng/mL of Methylenedioxymethamphetamine were confirmed by GC/MS. Negative clinical samples were screened by a commercial respectively. The MDMA One Step Ecstasy Test Strip was tested in duplicate using MDMA rapid test kit. Approximately 10% of these negative samples were confirmed by the fifteen neat and spiked urine samples. The results demonstrate that varying GC/MS. The following results were tabulated. ranges of urinary specific gravity does not affect the test results. Cutoff to
Negative
cutoff to
>+25% cutoff
Effect of the Urinary pH
+25% cutoff
The pH of an aliquoted negative urine pool was adjusted to a pH range of 5 to 9 in 1 Positive 0
pH unit increments and spiked with Methylenedioxymethamphetamine to 250 ng/mL Negative 147
and 750 ng/mL. The spiked, pH-adjusted urine was tested with the MDMA One Step Ecstasy Test Strip in duplicate. The results demonstrate that varying ranges of pH Eighty (80) of these samples were also run using the MDMA One Step Ecstasy Test does not interfere with the performance of the test. Strip by an untrained operator at a different site. Based on GC/MS data, the operator Cross-Reactivity
obtained a statistically similar Positive Agreement, Negative Agreement and Overall A study was conducted to determine the cross-reactivity of the test with compounds Agreement rate as the laboratory personnel. in either drug-free urine or Methylenedioxymethamphetamine positive urine. The Analytical Sensitivity
following compounds show no cross-reactivity when tested with the MDMA One A drug-free urine pool was spiked with Methylenedioxymethamphetamine at the Step Ecstasy Test Strip at a concentration of 100 µg/mL. following concentrations: 0 ng/mL, 250 ng/mL, 375 ng/mL, 500 ng/mL, 625 ng/mL Non Cross-Reacting Compounds
and 750 ng/mL. The result demonstrates >99% accuracy at 50% above and 50% below the cut-off concentration. The data are summarized below: Acetophenetidin Estrone-3-sulfate Perphenazine Methylenedioxymethamp
Visual Result
Percent of
hetamine Concentration
N-Acetylprocainamide Ethyl-p-aminobenzoate Phencyclidine Negative Positive
BIBLIOGRAPHY
1. Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 2nd Ed. Amobarbital Hemoglobin Trans-2-phenylcyclo-propy- 2. Hawks RL, CN Chiang. Urine Testing for Drugs of Abuse. National Institute Ampicillin Hydrochlorothiazide L-Phenylephrine for Drug Abuse (NIDA), Research Monograph 73, 1986 3. A Handbook of Drug and Alcohol Abuse, Gail Winger, Third Edition, Oxford Analytical Specificity
D-Amphetamine Hydrocortisone Phenylpropanolamine The following table lists compounds that are positively detected in urine by the MDMA One Step Ecstasy Test Strip at 5 minutes. Concentration
Compound
D,L-3,4-Methylenedioxymethamphetamine HCI

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