PRINCIPLE One-Step MDMA The Drug screening MDMA test is an immunoassay based on the principle of competitive binding. The drug or the MonlabTest® metabolites, which may be present in the urine specimen

competes against limited antibody binding sites. During Only for professional in vitro diagnostic use. testing, a urine specimen migrates upward by capillary Store at 2 - 30ºC. action. MDMA, if present in the urine specimen below

INTENDED USE 500ng/mL, will not saturate the antibody binding sites. The The One-Step MDMA MonlabTest® is a one step, lateral flow colored antibody-particles conjugate will then be captured chromatographic immunoassay for the qualitative detection by immobilized MDMA-protein on membrane and a visible of MDMA and its metabolites in human urine. The test cut off colored line will show up in the test line region. The colored is 500ng/ml. line will not form in the test line region if the MDMA level is at The rapid test provides only a preliminary test result. A more or above 500ng/ml, because it will saturate all antibody’s specific alternative chemical method, such as Gas binding sites. Chromatography/Mass Spectrometry (GC/MS), must be used A drug-positive urine specimen will not generate a colored in order to obtain a confirmed analytical result. The National line in the test line region because of drug competition; Institute on Drug Abuse (NIDA) has recommended GC/MS while a drug negative urine specimen will generate a line in method as the preferred confirmation method. Clinical the test line region because of the absence of drug consideration and professional judgment should be applied competition. To serve as a procedural control, a colored line to any drug of abuse test result, particularly when will always appear at the control line region if the test has preliminary test result is positive. been performed properly. SUMMARY REAGENTS AND MATERIALS SUPPLIED MDMA, 3, 4-methylenedioxy-N-methamphetamine, was • 20 individually wrapped test strips. developed and patented in the early 1900’s as a chemical • One instruction sheet. precursor in the synthesis of pharmaceuticals. Chemically, MDMA is similar to the stimulant amphetamine and the MATERIAL REQUIRED BUT NOT PROVIDED • hallucinogen mescaline. MDMA can produce both stimulant Specimen collection container • and psychedelic effects. MDMA didn’t gain notoriety as an illicit Timer drug until the 1980’s. By 1985, the United States Drug STORAGE AND STABILITY Enforcement Agency placed MDMA on the schedule I list • Store as packaged in the sealed pouch at 2-30°C. (Drug with a high potential for abuse with no current medical • The test strip must remain in the sealed pouch until use. use). Despite the schedule I status, the recent popularity of DO NOT FREEZE. MDMA as an illicit drug warrants the need for an accurate drug PRECAUTIONS screen specifically designed to detect MDMA. • FOR PROFESSIONAL AND IN VITRO DIAGNOSTIC USE MDMA is taken orally, usually in a tablet or a capsule with ONLY. 80-150mg. MDMA’s effects last approximately 3 to 6 hours • The test device should remain in the sealed pouch until following oral administration, hyperthermia, though confusion, use. Don’t use it after the expiration date. • depression, sleep problems, anxiety, and paranoia have been All specimens should be considered potentially hazardous and handled in the same manner as an reported to occur even weeks after the drug is taken. MDMA infectious agent. can produce a significant increase in heart rate and blood • The test device should be discarded in a proper pressure and a sense of alertness like that associated with biohazard container after testing. amphetamine use. Following a typical dose, 65% of MDMA is • Avoid cross-contamination of urine samples by excreted unchanged in the urine and up to 7% is demethylated changing a new specimen collection container and and eliminated in the urine as methylenedioxyamphetamine specimen pipette for each sample. (MDA). Others metabolites including conjugated mono and SPECIMEN COLLECTIONAND HANDLING di-hydroxy derivates of both MDMA and MDA. MDMA is The urine specimen must be collected in a clean and dry detectable in urine for up to 3 days after use. container. Urine samples should be collected such that One-Step, urine based drug of abuse screening tests are a testing can be performed as soon as possible after the rapid, visual, sensitive immunoassay test. They are the most specimen collection. Urine specimens exhibiting visible widely accepted methods for screening urine for drug of precipitates should be centrifuged, filtered, or allowed to abuse. The One-Step MDMA MonlabTest® is based on the settle to obtain a clear supernatant for testing. principle of the high affinity and specific antibody and Urine specimens may be stored at 4-8°C for up to 48 hours antigen reaction. It can be performed without the use of an prior to testing. For prolonged storage, specimens may be instrument. The test utilizes a monoclonal antibody to frozen and stored below -20°C. Refrigerated samples must selectively detect elevated levels of MDMA in urine. The test be equilibrated to room temperature before testing. Frozen will show a positive result when the MDMA (Ecstasy) in urine specimens should be thawed and mixed before testing. reaches 500ng/ml. 1 Ref: CHEM-7002S-20 Monlab SL Selva de Mar 48 08019 BCN Spain + 34 93 433 58 60 Fax +34 93 436 38 94 [email protected] www.monlab.com Revision: OCTOBER 2013

TEST PROCEDURE • A secondary analytical method must be used to obtain • Review “Specimen collection” instructions. Test strips, a confirmed result. Gas chromatography and mass patient’s samples, and controls should be brought to spectrometry (GC/MS) are the preferred confirmatory room temperature (10-30ºC) prior to testing. Do not methods. open pouches until ready to perform the assay. • It is possible that technical or procedural errors, as well • Remove the test strip from its protective pouch (bring the as other interfering substances in the urine specimen test to room temperature before opening the pouch to avoid may cause erroneous results. See SPECIFICITY for condensation of moisture on the membrane), and label the list of substances that will produce positive results, or strip with patient or control number. that do not interfere with test performance. • Immerse the test strip in the urine sample with the arrow • Adulterants, such as bleach and/or alum, in urine end pointing toward the urine. Do not immerse the strip specimens may produce erroneous results regardless of above the printed MAX line. After a minimum of 15 seconds, the analytical method used. If adulteration is suspected, remove the test strip from the urine and lay fiat on a the test should be repeated with another urine non-absorptive clean surface. Alternatively, the test strip specimen. may be left in the test sample, as long as the strip is not • Certain medications containing opiates or opiate immersed above the MAX line. A separate test strip must be derivatives may produce a positive result. Additionally, for each sample or control. foods and tea containing poppy products may also • Read result between 3 to 8 minutes after the produce a positive result. addition of samples. Do not read result after 8 minutes. QUALITY CONTROL INTERPRETATION OF RESULTS A procedural control is included in the test. A red line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct Negative procedural technique. A clear background is required. Two pink-rose lines (bands) are visible in the control Control standards are not supplied with this kit; however it is (C) and test (T) regions of the viewing area. The recommended that positive and negative controls be tested intensity of the test line may be less than that of the as good laboratory testing practice to confirm the test control line; this still means negative result. procedure and to verify proper test performance. When testing the positive and negative controls, use the same assay procedure as with a urine specimen.

Positive PERFORMANCE CHARACTERISTICS The control line appears in the viewing area, but the Accuracy test line is not visible. The cut-off concentration of the One-Step MDMA MonlabTest® has been set up to 500ng/ml of MDMA in urine. The accuracy of One-Step MDMA MonlabTest® was evaluated in comparison to a commercially available one-step immunoassay. One hundred (100) urine samples

collected from presumed non-user health people have been Invalid tested by both procedures with 100% agreement. The test is invalid if the control line is not visible at five In a separate study, fifty three (53) urine samples, obtained minutes. The test failed, or the test procedure was not from a clinical laboratory where they were confirmed as followed properly. Verify the test procedure and repeat positives by GC/MS, were tested by both One-Step MDMA the test with a new testing device. MonlabTest® and a commercially available one-step immunoassay. Of the forty five (45) samples with MDMA concentration between 600-2600ng/ml, all were found to be

positives by both methods (100% agreement). Of the eight NOTE: A very faint line on the test region indicates that (8) samples with MDMA concentration between the MDMA concentration in the sample in near the cut-off 200-400ng/ml, all were determined negatives by both level. These samples should be re-tested or confirmed with a methods (100% agreement). more specific method, such as GC/MS.

LIMITATIONS OF PROCEDURE Reproducibility • The assay is designed for human urine only. The reproducibility of One-Step MDMA MonlabTest® was • A positive result with any of the test indicates the evaluated at three different site using blind controls. Of the presence of a drug/metabolite only and does not fifty samples with MDMA concentration of 250ng/ml all were indicate or measure intoxication. The test result determined negative. Of the fifty samples with MDMA provides only a preliminary analytical result. concentration of 1,000ng/ml all were determined positive.

2 Ref: CHEM-7002S-20 Monlab SL Selva de Mar 48 08019 BCN Spain + 34 93 433 58 60 Fax +34 93 436 38 94 [email protected] www.monlab.com Revision: OCTOBER 2013

Precision Deoxycorticosterone Methyprylon The precision of the One-Step MDMA MonlabTest® was Dextromethorphan Morphine-3-β-D-glucuronide determined by conducting the test with spiked controls. The Diazepam Nalidixic acid control at the 250ng/ml should give a negative result and the Diethylpropion Nalorphine control at the 1,000ng/ml should give a positive result. Diflunisal Naloxone Concentration Test Correct Correct Digoxin Naltrexone (ng/ml) number result result % Diphenhydramine Naproxen 250 50 50 100 Doxylamine Noroxymorphone 1,000 50 50 100 Ecgonine Norpseudoephedrine Specificity (-) ψ Ephedrine Noscapine The specificity for One-Step MDMA MonlabTest® was tested β-Estradiol Nylidrin by preparing various drug, drug metabolites, and other Estrone-3-sulfate D,L-Octopamine compounds that are likely to be present in urine. All Ethyl-p-aminobenzoate Oxalic acid compounds were prepared in drug-free normal human urine. Fenoprofen Oxazepam The following table lists compounds that are positively Furoxmide Quinine detected in urine by One-Step MDMA MonlabTest® at levels Gentisic acid Ranitidine equal to or greater than the concentration list below. Oxalic acid Salicylic acid Compound Concentration (ng/ml) Oxazepam Secobarbital Oxolinic acid Serotonin MDMA 500 Oxycodone Sulfamethazine MDA 2,000 Oxymetazoline Sulindac Oxymorphone Temazepam A study was conducted to determine the cross-reactivity of p-Hydroxymethamphetamine Tetracycline the test with compounds in urine not associated with MDMA. Papaverine Tetrahydrocortisone The following compounds show no cross-reactivity Penicillin-G Tetrahydrozoline when tested at a concentration up to 100µg/ml. Pentazocaine ∆9-THC Pentobarbital Thebaine Glucuronide Perphenazine Thiamine Acetylsalicylate Glutethimide Phencyclidine Thioridazine Aminopyrine Guaifenesin Phenelzine D,L-Thyroxine Amitriptyline Hippuric acid Phendimetrazine Tolbutamide Amobarbital Hydralazine Phenobarbital Tranylcypromine Amoxapine Hydrochlorothiazide Phenytoin Triamterene Amoxicillin Hydrocodone L-Phenylethylamine Trifluoperazine L-Amphetamine Hydrocortisone L-Phenylpropanolamine Trimethoprim Apomorphine Hydromorphone Prednisolone Trimipramine Ascorbic acid O-Hydroxyhippuric acid Prednisone D,L-Tryptophan Aspartame Ibuprofen Promazine D,L-Tyrosine Atropine Imipramine Promethazine Uric acid Benzocaine Iproniazid D,L-Propanolol Verapamil Benzoylecgonine (-) Isoproterenol Propiomazine Zomepirac Benzphetamine Isoxsuprine D-Propoxyphene Promazine Butabarbital Ketamine D-Pseudoephedrine Promethazine Cannabidiol Ketoprofen Quinidine D,L-Propanolol Chloralhydrate Labetalol Ecgonine methylester Propiomazine Chloramphenicol Levorphanol Erythromycin D-Propoxyphene Chlordiazepoxide Lidocaine D-Norpropoxyp Chlorothiazide Loperamide Chlorpromazine Loxapine succinate REFERENCES 1. Base1t. R, C. Disposition of Toxic Drugs and Chemicals Chlorquine Maprotiline in Man. Biomedical Publications. Davis. CA 1982. Cholesterol Meperidine 2. Urine Testing for Drugs of Abuse. National Institute on Clomipramine Mephentermine Drug Abuse (NIDA). Research Monograph 73, 1986. Clonidine Meprobamate 3. E11enhorn. M. J. And Barce1oux, D. G. Medical Cocaine Methadone Toxicology. E1sevier Science Publishing Company. 1nc Cortisone Methaqualone New York. 1988 (-) Cotinine Methoxyphenamine 4. Fed. Register. Department of Health and Human Creatinine Methylphenidat Services. Mandatory Guidelines for Federal Workplace 3 Ref: CHEM-7002S-20 Monlab SL Selva de Mar 48 08019 BCN Spain + 34 93 433 58 60 Fax +34 93 436 38 94 [email protected] www.monlab.com Revision: OCTOBER 2013

Drug Testing Programs, 53, 69, 11970-11979, 1988 5. Gilman, A, G, and Goodman, L, S, The Pharmacological Basis of Therapeutics. eds. MacMillan Publishing. New York NY, 1980. 6. Gorodetzkym. C, W, Detection of Drugs of Abuse in Biological Fluids. In Martin WR(ed) ：Drug Addiction 1, New York, Spring-Verlag, 1977. 7. Harvey, R, A, Champe, P, C, Lippincotts illustrated Reviews . Pharmacology, 91-95,1992. 8. Hofmann F. E, A, Handbook on Drug and Alcohol Abuse: The Bionedical Aspects. New York, Oxford University Press, 1983. 9. McBay, A, J, Clin. Chem, 22, 33B-4OB,1987

PACKAGING

CHEM-7002S-20 20 MDMA Tests

GRAPHICAL SYMBOLS USED For i n vitro diagnostic Manufacturer use only Don’t re-use Consult instructions

for use Contains sufficient n Keep dry for tests Temperature Catalogue Code limitation

Lot Number Use by

Shanghai Chemtron Biotech Co., Ltd.

European Representative: Shanghai International Holding Corp. GmbH (Europe) Address: Eiffestrasse 80, 20537 Hamburg Germany Tel: 0049-40-2513175 Fax: 0049-40-255726

Agent: Monlab SL Selva de Mar 48 08019 Barcelona-Spain Tel +34 934 335 860 Fax +34 934 363 984

4 Ref: CHEM-7002S-20 Monlab SL Selva de Mar 48 08019 BCN Spain + 34 93 433 58 60 Fax +34 93 436 38 94 [email protected] www.monlab.com Revision: OCTOBER 2013