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MDMA Test Cassette
Description
One-Step MDMA Test is a one step, lateral flow chromatographic immunoassay for the qualitative detection of MDMA and its metabolites in human urine. The test cut off is 500ng/ml
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One-Step MDMA Test

For in vitro Diagnosis Use

INTENDED USE

·        One-Step MDMA Test is a one step, lateral flow chromatographic immunoassay for the qualitative detection of MDMA and its metabolites in human urine. The test cut off is 500ng/ml.

·        The rapid test provides only a preliminary test result. A more specific alternative chemical method, such as Gas Chromatography/Mass Spectrometry (GC/MS), must be used in order to obtain a confirmed analytical result. The National Institute on Drug Abuse (NIDA) has recommended GC/MS method as the preferred confirmation method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary test result is positive.

SUMMARY

·        MDMA, 3, 4-methylenedioxy-N-methamphetamine, was developed and patented in the early 1900’s as a chemical precursor in the synthesis of pharmaceuticals. Chemically, MDMA is similar to the stimulant amphetamine and the hallucinogen mescaline. MDMA can produce both stimulant and psychedelic effects. MDMA didn’t gain notoriety as an illicit drug until the 1980’s. By 1985, the United States Drug Enforcement Agency placed MDMA on the schedule I list (Drug with a high potential for abuse with no current medical use). Despite the schedule I status, the recent popularity of MDMA as an illicit drug warrants the need for an accurate drug screen specifically designed to detect MDMA.

·        MDMA is taken orally, usually in a tablet or a capsule with 80-150mg. MDMA’s effects last approximately 3 to 6 hours following oral administration, hyperthermia, though confusion, depression, sleep problems, anxiety, and paranoia have been reported to occur even weeks after the drug is taken. MDMA can produce a significant increase in heart rate and blood pressure and a sense of alertness like that associated with amphetamine use. Following a typical dose, 65% of MDMA is excreted unchanged in the urine and up to 7% is demethylated and eliminated in the urine as methylenedioxyamphetamine MDA). Others metabolites including conjugated mono and di-hydroxy derivates of both MDMA and MDA. MDMA is detectable in urine for up to 3 days after use.

·        One step, urine based drug of abuse screening tests are a rapid, visual, sensitive immunoassay test. They are the most widely accepted methods for screening urine for drug of abuse. One-Step MDMA Test is based on the principle of the high affinity and specific antibody and antigen reaction. It can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of MDMA in urine. The test will show a positive result when the MDMA(Ecstasy) in urine reaches 500ng/ml.

PRINCIPLE

·        The Drug screening MDMA test is an immunoassay based on the principle of competitive binding. The drug or the metabolites, which may be present in the urine specimen competes against limited antibody binding sites. During testing, a urine specimen migrates upward by capillary action. MDMA, if present in the urine specimen below 500ng/ml, will not saturate the antibody binding sites. The colored antibody-particles conjugate will then be captured by immobilized MDMA-BTG on membrane and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the MDMA level is at or above 500ng/ml, because it will saturate all antibody’s binding sites.

·        A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug negative urine specimen will generate a line in the test line region because of the absence of drug competition. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.

MATERIALS SUPPLIED

·        25 individually wrapped test which include one disposable pipette each. Each test contains colored anti-MDMA particles pad and MDMA-BTG conjugate coated on the membrane.

·        One instruction sheet.

MATERIAL REQUIRED BUT NOT PROVIDED

·        Specimen collection container

·        Timer

STORAGE AND STABILITY

Store as packaged in the sealed pouch at 4-30°C. The test kit is stable through the expiration date printed on the sealed pouch. The kit must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

PRECAUTIONS

·        For professional and IN VITRO diagnostic use only.

·        The test device should remain in the sealed pouch until use. Do not use after the expiration date.

·        All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.

·        The test device should be discarded in a proper biohazard container after testing

·        Avoid cross-contamination of urine samples by changing a new specimen collection container and specimen pipette for each sample.

SPECIMEN COLLECTION AND HANDLING

The urine specimen must be collected in a clean and dry container. Urine samples should be collected such that testing can be performed as soon as possible after the specimen collection. Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear supernatant for testing.

Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For prolonged storage, specimens may be frozen and stored below -20°C. Refrigerated samples must be equilibrated to room temperature before testing. Frozen specimens should be thawed and mixed before testing.

TEST PROCEDURE

·            Read the instruction sheet carefully before testing. Allow the test device, urine specimen and/or controls to equilibrate to room temperature (15-30°C) prior to testing. Do not open pouches until ready to perform the assay.

·        Bring the pouched devices to room temperature before opening to avoid condensation of moisture on the membrane. Remove the test devices from the sealed pouch and label the device with patient or control number.

·        Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 0.15ml) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See the illustration below.

·        Wait for the red line(s) to appear. The result should be read between 3-8 minutes after the addition of sample. Do not interpret the result after 8 minutes.

INTERPRETATION OF RESULTS

Negative

Two pink-rose lines (bands) are visible in the control ("C") and test ("T") areas of the test window. This negative result indicates that the MDMA concentration is below the detectable level (500ng/ml).The intensity of the test line may be less than that of the control line; this still means negative result.

Positive

The control line appears in the test window, but the test line is not visible. This positive result indicates that the MDMA concentration is at or above the detectable level (500ng/mL).

Invalid

The test is invalid if the control line is not visible at five minutes. The test failed, or the test procedure was not followed properly. Verify the test procedure and repeat the test with a new testing device.

NOTE:  A very faint line on the test region indicates that the MDMA concentration in the sample in near the cut-off level. These samples should be re-tested or confirmed with a more specific method, such as GC/MS.

LIMITATIONS OF PROCEDURE

·        The assay is designed for human urine only.

·        A positive result with any of the test indicates the presence of a drug/metabolite only and does not indicate or measure intoxication. The test result provides only a preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography and mass spectrometry (GC/MS) are the preferred confirmatory methods.

·        It is possible that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results. See SPECIFICITY for list of substances that will produce positive results, or that do not interfere with test performance.

·        Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another urine specimen.

·        Certain medications containing opiates or opiate derivatives may produce a positive result. Additionally, foods and tea containing poppy products may also produce a positive result.

QUALITY CONTROL

·        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 procedural technique. A clear background is required.

·        Control standards are not supplied with this kit; however it is recommended that positive and negative controls be tested as good laboratory testing practice to confirm the test procedure and to verify proper test performance. When testing the positive and negative controls, use the same assay procedure as with a urine specimen.

PERFORMANCE CHARACTERISTICS

Accuracy

·        The cut-off concentration of the One-Step MDMA Test has been set up to 500ng/ml of MDMA in urine.

·        The accuracy of One-Step MDMA Test 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 tested by both procedure with 100% agreement.

·        In a separate study, fifty three (53) urine samples, obtained from a clinical laboratory where they were confirmed as positives by GC/MS, were tested by both One-Step MDMA Test 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 (8) samples with MDMA concentration between 200-400ng/ml, all were determined negatives by both methods (100% agreement).

Reproducibility

The reproducibility of One-Step MDMA Test was evaluated at three different site using blind controls. Of the fifty samples with MDMA concentration of 250ng/ml all were determined negative. Of the fifty samples with MDMA concentration of 1,000ng/ml all were determined positive.

Precision

The precision of the ChemtrueTM One-Step MDMA Test was determined by conducting the test with spiked controls. The control at the 250ng/ml should give a negative result and the control at the 1,000ng/ml should give a positive result.

Concentration (ng/ml)

Test number

Correct result

% Correct result

250

50

50

100

1,000

50

50

100

Specificity

·        The specificity for One-Step MDMA Test was tested by preparing various drug, drug metabolites, and other compounds that are likely to be present in urine. All compounds were prepared in drug-free normal human urine.

·        The following table lists compounds that are positively detected in urine by One-Step MDMA Test at levels equal to or greater than the concentration list below.

Compound             Concentration (ng/ml)                     

MDMA                      500                               

MDA                        2,000                                    

A study was conducted to determine the cross-reactivity of the test with compounds in urine not associated with MDMA. The following compounds show no cross-reactivity when tested at a concentration up to 100 mg/ml.

Acetamidophen

Glucuronide

b-Estradiol

Norpseudoephedrine

Acetylsalicylate

Glutethimide

Estrone-3-sulfate

Noscapine

Aminopyrine

Guaifenesin

Ethyl-p-aminobenzoate

Nylidrin

Amitriptyline

Hippuric acid

Fenoprofen

D,L-Octopamine

Amobarbital

Hydralazine

Furoxmide

Oxalic acid

Amoxapine

Hydrochlorothiazide

Gentisic acid

Oxazepam

Amoxicillin

Hydrocodone

Oxalic acid

Quinine

L-Amphetamine

Hydrocortisone

Oxazepam

Ranitidine

Apomorphine

Hydromorphone

Oxolinic acid

Salicylic acid

Ascorbic acid

O-Hydroxyhippuric acid

Oxycodone

Secobarbital

Aspartame

Ibuprofen

Oxymetazoline

Serotonin

Atropine

Imipramine

Oxymorphone

Sulfamethazine

Benzocaine

Iproniazid

p-Hydroxymethamphetamine

Sulindac

Benzoylecgonine

(-) Isoproterenol

Papaverine

Temazepam

Benzphetamine

Isoxsuprine

Penicillin-G

Tetracycline

Butabarbital

Ketamine

Pentazocaine

Tetrahydrocortisone

Cannabidiol

Ketoprofen

Pentobarbital

Tetrahydrozoline

Chloralhydrate

Labetalol

Perphenazine

D9-THC

Chloramphenicol

Levorphanol

Phencyclidine

Thebaine

Chlordiazepoxide

Lidocaine

Phenelzine

Thiamine

Chlorothiazide

Loperamide

Phendimetrazine

Thioridazine

Chlorpromazine

Loxapine succinate

Phenobarbital

D,L-Thyroxine

Chlorquine

Maprotiline

Phenytoin

Tolbutamide

Cholesterol

Meperidine

L-Phenylethylamine

Tranylcypromine

Clomipramine

Mephentermine

L-Phenylpropanolamine

Triamterene

Clonidine

Meprobamate

Prednisolone

Trifluoperazine

Cocaine

Methadone

Prednisone

Trimethoprim

Cortisone

Methaqualone

Procaine

Trimipramine

(-) Cotinine

Methoxyphenamine

Promazine

D,L-Tryptophan

Creatinine

Methylphenidat

Promethazine

D,L-Tyrosine

Deoxycorticosterone

Methyprylon

D,L-Propanolol

Uric acid

Dextromethorphan

Morphine-3-b-D-glucuronide

Propiomazine

Verapamil

Diazepam

Nalidixic acid

D-Propoxyphene

Zomepirac

Diethylpropion

Nalorphine

D-Pseudoephedrine

Niacinamide

Diflunisal

Naloxone

Quinidine

Nifedipine

Digoxin

Naltrexone

Ecgonine methylester

Norcodein

Diphenhydramine

Naproxen

(+) Ephedrine

Norethindrone

Doxylamine

Noroxymorphone

(±) Ephedrine

D-Norpropoxyp

hene

Ecgonine

 

(-) Ephedrine

 

(-) y Ephedrine

 

Erythromycin

 

 

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