Specifications: Methadone Panel (MTD)

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

Specificity

The following table lists compounds that are positively detected in urine by the MTD One Step Methadone Test Strip at 5 minutes. Methadone is the target 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:

Method Other MTD Rapid Test Total Results
MTD One Step Test Strip Results Positive Negative
Positive 132 0 132
Negative 0 168 168
Total Results 132 168 292
% Agreement With Commercial Kit >99% >99% >99%

When compared to the GC/MS lab testing method at the cutoff concentration of 300 ng/ml, the following results were tabulated:

Method GC/MS Total Results
MTD One Step Test Strip Results Positive Negative
Positive 122 10 132
Negative 1 167 168
Total Results 123 177 300
% Agreement With GC/MS Analysis 99% 94% 96%

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 98% accuracy at 50% above and 50% below the cutoff concentration. The data are summarized below:

Methadone Concentration (ng/ml) Percent of Cutoff n Visual Result
Negative Positive
0 0% 30 30 0
150 -50% 30 29 1
225 -25% 30 24 6
300 Cutoff 30 21 9
375 +25% 30 2 28
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 Concentration (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

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 sulfate; 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; 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; Mephentermine; Maprotiline; Meperidine; Meprobamate; Methamphetamine; Methoxyphenamine; dl-3,4-Methylenedioxyamphetamine; dl-3,4-Methylenedioxymethamphetamine; Morphine 3-B-D-glucuronide; Morphine sulfate; 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 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; 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 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 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.