Specifications: Ecstasy Panel (MDMA)

The below specifications apply to the MDMA: Ecstasy panels of the One Step Drug Tests. This includes the 1-panel One Step Ecstasy Drug Test - plus any multi-panel drug test containing an MDMA panel.

Specificity

The following table lists compounds that are positively detected in urine by the MDMA One Step Ecstasy Test Strip at 5 minutes. MDMA is the target compound.

Compound Cutoff (ng/ml)
3,4-Methylenedioxymethamphetamine (MDMA) 500
3,4-Methylenedioxyamphetamine (MDA) 3,000
3,4-Methylenedioxyethylamphetamine (MDEA) 500

Accuracy

A side-by-side comparison was conducted using the MDMA One Step Ecstasy Test Strip and a leading commercially available MDMA rapid test. Testing was performed on 240 clinical specimens. Ten percent of the positive specimens employed were either at -25% or +25% level of the cutoff concentration of 500 ng/ml Methylenedioxymethamphetamine. Presumptive positive results were confirmed by GC/MS. Approximately 10% of the negative clinical samples were also confirmed with GC/MS. The following results were tabulated:

Method Other MDMA Rapid Test Total Results
MDMA One Step Test Strip Results Positive Negative
Positive 90 1 91
Negative 0 149 149
Total Results 90 150 240
% Agreement With Commercial Kit >99% 99% >99%

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 samples in the +/- 25% cutoff range were derived from the concentrated MDMA clinical specimens; the rest were true clinical specimens. All positive samples used in this study were confirmed by GC/MS. Negative clinical samples were screened by a commercial MDMA rapid test kit. Approximately 10% of these negative samples were confirmed by GC/MS. The following results were tabulated.

Method Negative -25% Cutoff to Cutoff Cutoff to +25% Cutoff >+25% Cutoff
MDMA One Step Test Strip Positive 0 3 6 82
Negative 147 2 0 0

Eighty (80) of these samples were also run using the MDMA One Step Ecstasy Test Strip by an untrained operator at a different site. Based on GC/MS data, the operator obtained a statistically similar Positive Agreement, Negative Agreement and Overall Agreement rate as the laboratory personnel.

Sensitivity

A drug-free urine pool was spiked with Methylenedioxymethamphetamine at the following concentrations: 0 ng/ml, 250 ng/ml, 375 ng/ml, 500 ng/ml, 625 ng/ml and 750 ng/ml. The result demonstrates >99% accuracy at 50% above and 50% below the cutoff concentration. The data are summarized below:

MDMA Concentration (ng/ml) Percent of Cutoff n Visual Result
Negative Positive
0 0% 30 30 0
250 -50% 30 30 0
375 -25% 30 26 4
500 Cutoff 30 17 13
625 +25% 30 4 26
750 +50% 30 0 30

Precision

A study was conducted at 3 physician's offices by untrained operators using 3 different lots of product to demonstrate the within run, between run and between operator precision. An identical panel of coded specimens containing no MDMA, 25% MDMA above and below the cutoff and 50% MDMA above and below the 500 ng/ml cutoff were provided to each site. The results are given below:

MDMA Concentration (ng/ml) n Site A Site B Site C
- + - + - +
0 15 15 0 15 0 15 0
250 15 15 0 15 0 15 0
375 15 15 0 15 0 15 0
625 15 6 9 4 11 7 8
750 15 0 15 0 15 0 15

Non Cross-Reacting Compounds

A study was conducted to determine the cross-reactivity of the test with compounds in either drug-free urine or MDMA positive urine. The following compounds show no cross-reactivity (were not detected positive) when tested with the MDMA One Step Ecstasy Test Strip at a concentration of 100,000 ng/ml.

Non Cross-Reacting Compounds
4-Acetamidophenol; Acetophenetidin; N-Acetylprocainamide; Acetylsalicylic acid; Aminopyrine; Amitryptyline; Amobarbital; Amoxicillin; d-Amphetamine; dl-Amphetamine sulfate; l-Amphetamine; Ampicillin; Apomorphine; l-Ascorbic acid; Aspartame; Atropine; Benzilic acid; Benzoic acid; Benzoylecgonine; Benzphetamine; Bilirubin; dl-Brompheniramine; Buspirone; Caffeine; Cannabidiol; Cannabinol; Chloral hydrate; Chloramphenicol; Chlordiazepoxide; Chlorothiazide; dl-Chlorpheniramine; Chlorpromazine; Chloroquine; Cholesterol; Clomipramine; Clonidine; Cocaethylene; Cocaine hydrochloride; Codeine; Cortisone; l-Cotinine; Creatinine; Deoxycorticosterone; Dextromethorphan; Diclofenac; Diazepam; Diflunisal; Digoxin; Dicyclomine; Diphenhydramine; 5,5-Diphenylhydantoin; Doxylamine; Ecgonine hydrochloride; Ecgonine methyl ester; l-pseudo-Ephedrine; (1R,2S)-l-Ephedrine; l-Epinephrine; Erythromycin; B-Estradiol; Estrone 3-sulfate; Ethyl p-aminobenzoate; Fenoprofen; Furosemide; Gentisic acid; Hemoglobin; Hydralazine; Hydrochlorothiazide; Hydrocodone; Hydrocortisone; o-Hydroxyhippuric acid; p-Hydroxyamphetamine; p-Hydroxymethamphetamine; 3-Hydroxytyramine; Ibuprofen; Imipramine; Iproniazid; dl-Isoproterenol; Isoxsuprine; Ketamine; Ketoprofen; Labetalol; Levorphanol; Loperamide; Maprotiline; Meperidine; Mephentermine; Meprobamate; d-Methamphetamine; Methadone; Methoxyphenamine; Methylphenidate; Morphine 3-B-D-glucuronide; Morphine sulfate; Nalidixic acid; Naloxone; Naltrexone; Naproxen; Niacinamide; Nifedipine; Nimesulidate; Norcodeine; Norethindrone; d-Norpropoxyphene; Noscapine; dl-Octopamine; Oxalic acid; Oxazepam; Oxolinic acid; Oxycodone; Oxymetazoline; Papaverine; Penicillin-G; Pentazocine hydrochloride; Pentobarbital; Perphenazine; Phencyclidine; Phenelzine; Phenobarbital; Phentermine; trans-2-Phenylcyclopropylamine hydrochloride; l-Phenylephrine; B-Phenylethylamine; Phenylpropanolamine; Prednisolone; Prednisone; Procaine; Promazine; Promethazine; dl-Propranolol; d-Propoxyphene; d-Pseudoephedrine; Quinacrine; Quinidine; Quinine; Ranitidine; Salicylic acid; Secobarbital; Serotonin (5-Hydroxytryptamine); Sulfamethazine; Sulindac; Sustiva; Temazepam; Tetracycline; Tetrahydrocortisone 3-acetate; Tetrahydrocortisone 3-(B-D-glucuronide); Tetrahydrozoline; Thebaine; Theophylline; Thiamine; Thioridazine; Tolbutamide; trans-2-Phenylcyclopropylamine; Trazodone; Triamterene; Trifluoperazine; Trimethoprim; Trimipramine; Tryptamine; dl-Tryptophan; dl-Tyrosine; Tyramine; Uric acid; Verapamil; Zomepirac

Effect of Urinary Specific Gravity

Fifteen (15) urine samples of normal, high, and low specific gravity ranges were spiked with 250 ng/ml and 750 ng/ml of MDMA respectively. The MDMA One Step Ecstasy Test Strip was tested in duplicate using the fifteen neat and spiked urine samples. The results demonstrate that varying ranges of urinary specific gravity does not affect the test results.

Effect of Urinary pH

The pH of an aliquoted negative urine pool was adjusted to a pH range of 5 to 9 in 1 pH unit increments and spiked with MDMA to 250 ng/ml 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 does not interfere with the performance of the test.