The following specifications apply to the MDMA: Ecstasy panel of the One Step Urine Drug Tests. This includes the 1-panel MDMA One Step Ecstasy Drug Test — plus any multi-panel urine drug tests that contain an MDMA panel.

Specificity

The following table lists compounds that are detected positive in urine by the MDMA One Step Ecstasy Test Strip at 5 minutes. Cutoff represents the concentration of each compound required to yield a positive reading, expressed in nanograms of compound per milliliter of urine (ng/mL). A lower cutoff indicates a greater ability to detect the compound.

Compound Cutoff (ng/mL)
3,4-Methylenedioxymethamphetamine (MDMA) 500
3,4-Methylenedioxyamphetamine (MDA) 3,000
3,4-Methylenedioxyethylamphetamine (MDEA) 300

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 (10%) of the positive specimens employed were either at −25% or +25% level of the cutoff concentration of 500 ng/mL MDMA. 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:

Methods and Results Other MDMA Rapid Test
Pos. Neg. Totals
MDMA
One Step
Test Strip
Positive 90 1 91
Negative 0 149 149
Totals 90 150 240
*Agreement >99% 99% >99%

* % Agreement With Other MDMA Rapid Test

The MDMA One Step Ecstasy Test Strips were also tested with 93 MDMA-positive and 147 MDMA-negative urine samples in a clinical study. Nine (9) 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.

Methods and Results Neg. −25% of
Cutoff to
Cutoff
Cutoff to
+25% of
Cutoff
>+25%
of
Cutoff
MDMA One Step Test Strip Pos. 0 3 6 82
Neg. 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 MDMA 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
Conc. (ng/mL)
% of
Cutoff
n Visual Result
Neg. Pos.
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
Conc. (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 (Cross-Reactivity)

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; 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; Codeine; Cortisone; l-Cotinine; Creatinine; Deoxycorticosterone; Dextromethorphan; Diclofenac; Diazepam; Diflunisal; Digoxin; Dicyclomine; Diphenhydramine; 5,5-Diphenylhydantoin; Doxylamine; Ecgonine; Ecgonine methyl ester; (1R,2S)-l-Ephedrine; l-Epinephrine; Erythromycin; B-Estradiol; Estrone 3-sulfate; Ethyl p-aminobenzoate; Fenoprofen; Furosemide; Gentisic acid; Hemoglobin; Hydralazine; Hydrochlorothiazide; Hydrocodone; Hydrocortisone; p-Hydroxyamphetamine; o-Hydroxyhippuric acid; 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; Morphine 3-B-D-glucuronide; 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; Pentobarbital; Perphenazine; Phencyclidine; Phenelzine; Phenobarbital; Phentermine; trans-2-Phenylcyclopropylamine; l-Phenylephrine; B-Phenylethylamine; Phenylpropanolamine; Prednisolone; Prednisone; Procaine; Promazine; Promethazine; dl-Propranolol; d-Propoxyphene; d-Pseudoephedrine; l-Pseudoephedrine; Quinacrine; Quinidine; Quinine; Ranitidine; Salicylic acid; Secobarbital; Serotonin (5-Hydroxytryptamine); Sulfamethazine; Sulindac (Efavirenz); Sustiva; Temazepam; Tetracycline; Tetrahydrocortisone 3-acetate; Tetrahydrocortisone 3-B-D-glucuronide; Tetrahydrozoline; Thebaine; Theophylline; Thiamine; Thioridazine; Tolbutamide; 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 15 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.