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.

Specificity

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.

Compound Cutoff (ng/mL)
Methadone 300
Doxylamine 50,000

Accuracy

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
Pos. Neg. Totals
MTD
One Step
Test Strip
Positive 132 0 132
Negative 0 168 168
Totals 132 168 300
*Agreement >99% >99% >99%

* % 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
Pos. Neg. Totals
MTD
One Step
Test Strip
Positive 122 10 132
Negative 1 167 168
Totals 123 177 300
*Agreement 99% 94% 96%

* % Agreement With GC/MS Lab Testing Method

Sensitivity

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:

Methadone
Conc. (ng/mL)
% of
Cutoff
n Visual Result
Neg. Pos.
0 0% 30 30 0
150 −50% 30 30 0
225 −25% 30 25 5
300 Cutoff 30 12 18
375 +25% 30 4 26
450 +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 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:

Methadone
Conc. (ng/mL)
n Site A Site B Site C
+ + +
0 15 15 0 15 0 15 0
150 15 12 3 15 0 15 0
225 15 8 7 14 1 15 0
375 15 0 15 0 15 1 14
450 15 1 14 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 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.