The following specifications apply to the MTD: Methadone panel of the One Step Urine Drug Tests. This includes the 1-panel MTD One Step Methadone Drug Test — plus any multi-panel urine drug tests that contain an MTD panel.
The following table lists compounds that are detected positive in urine by the MTD One Step Methadone 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.
A side-by-side comparison was conducted using the MTD One Step Methadone Test Strip and a leading commercially available MTD rapid test. Testing was performed on specimens previously collected from subjects presenting for drug screen testing. Presumptive positive results were confirmed by GC/MS. The following results were tabulated:
|Methods and Results||Other MTD Rapid Test|
* % Agreement With Other MTD Rapid Test
When compared to the GC/MS lab testing method at the cutoff concentration of 300 ng/mL, the following results were tabulated:
|Methods and Results||GC/MS|
* % Agreement With GC/MS Lab Testing Method
A drug-free urine pool was spiked with methadone at the following concentrations: 0 ng/mL, 150 ng/mL, 225 ng/mL, 300 ng/mL, 375 ng/mL, and 450 ng/mL. The result demonstrates >99% accuracy at 50% above and 50% below the cutoff concentration. The data are summarized below:
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 methadone, 25% methadone above and below the cutoff, and 50% methadone above and below the 300-ng/mL cutoff was provided to each site. The following results were tabulated:
|n||Site A||Site B||Site C|
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 methadone-positive urine. The following compounds show no cross-reactivity (were not detected positive) when tested with the MTD One Step Methadone Test Strip at a concentration of 100,000 ng/mL.
|Non Cross-Reacting Compounds|
|Acetaminophen; Acetophenetidin; N-Acetylprocainamide; Acetylsalicylic acid; Aminopyrine; Amitryptyline; Amobarbital; Amoxicillin; dl-Amphetamine; Ampicillin; Apomorphine; l-Ascorbic acid; Aspartame; Atropine; Benzilic acid; Benzoic acid; Benzoylecgonine; Benzphetamine; Bilirubin; dl-Brompheniramine; Caffeine; Cannabidiol; Cannabinol; Chloral hydrate; Chloramphenicol; Chlorothiazide; dl-Chlorpheniramine; Chlorpromazine; Chloroquine; Cholesterol; Clomipramine; Clonidine; Cocaethylene; Cocaine; Codeine; Cortisone; l-Cotinine; Creatinine; Deoxycorticosterone; Dextromethorphan; Diazepam; Diclofenac; Diflunisal; Digoxin; Diphenhydramine; EDDP; EMDP; 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; Mephentermine; Maprotiline; Meperidine; Meprobamate; Methamphetamine; Methoxyphenamine; dl-3,4-Methylenedioxyamphetamine; dl-3,4-Methylenedioxymethamphetamine; Morphine; Morphine 3-B-D-glucuronide; Nalidixic acid; Naloxone; Naltrexone; Naproxen; Niacinamide; Nifedipine; 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; Temazepam; Tetracycline; Tetrahydrocortisone 3-acetate; Tetrahydrocortisone 3-B-D-glucuronide; Tetrahydrozoline; Thebaine; Thiamine; Thioridazine; Tolbutamide; Triamterene; Trifluoperazine; Trimethoprim; Trimipramine; Tryptamine; dl-Tryptophan; Tyramine; dl-Tyrosine; Uric acid; Verapamil; Zomepirac|
Effect of Urinary Specific Gravity
Fifteen (15) urine samples of normal, high, and low specific gravity ranges were spiked with methadone to 150 ng/mL and 450 ng/mL, respectively. The MTD One Step Methadone 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 methadone to 150 ng/mL and 450 ng/mL. The spiked, pH-adjusted urine was tested with the MTD One Step Methadone Test Strip in duplicate. The results demonstrate that varying ranges of pH does not interfere with the performance of the test.