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

Specificity

The following table lists compounds that are detected positive in urine by the mAMP One Step Methamphetamine 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)
d-Methamphetamine 1,000
p-Hydroxymethamphetamine 30,000
Mephentermine 50,000
l-Methamphetamine 8,000
3,4-Methylenedioxymethamphetamine (MDMA) 2,000

Accuracy

A side-by-side comparison was conducted using the mAMP One Step Methamphetamine Test Strip and a leading commercially available mAMP rapid test. Testing was performed on 300 clinical specimens. Ten percent (10%) of the specimens employed were either at −25% or +25% level of the cutoff concentration of 1,000 ng/mL methamphetamine. Presumptive positive results were confirmed by GC/MS. The following results were tabulated:

Methods and Results Other mAMP Rapid Test
Pos. Neg. Totals
mAMP
One Step
Test Strip
Positive 145 0 145
Negative 3 152 155
Totals 148 152 300
*Agreement 98% >99% 99%

* % Agreement With Other mAMP Rapid Test

When compared to the GC/MS lab testing method at the cutoff concentration of 1,000 ng/mL, the following results were tabulated:

Methods and Results GC/MS
Pos. Neg. Totals
mAMP
One Step
Test Strip
Positive 135 10 145
Negative 1 154 155
Totals 136 164 300
*Agreement 99% 94% 96%

* % Agreement With GC/MS Lab Testing Method

Eighty (80) of these samples were also run using the mAMP One Step Methamphetamine 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 methamphetamine at the following concentrations: 0 ng/mL, 500 ng/mL, 750 ng/mL, 1,000 ng/mL, 1,250 ng/mL, and 1,500 ng/mL. The result demonstrates >99% accuracy at 50% above and 50% below the cutoff concentration. The data are summarized below:

Methamphetamine
Conc. (ng/mL)
% of
Cutoff
n Visual Result
Neg. Pos.
0 0% 30 30 0
500 −50% 30 30 0
750 −25% 30 30 0
1,000 Cutoff 30 18 12
1,250 +25% 30 1 29
1,500 +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 methamphetamine, 25% methamphetamine above and below the cutoff, and 50% methamphetamine above and below the 1,000 ng/mL cutoff was provided to each site. The results are given below:

Methamphetamine
Conc. (ng/mL)
n Site A Site B Site C
+ + +
0 15 15 0 15 0 15 0
500 15 15 0 14 1 13 2
750 15 11 4 10 5 10 5
1,250 15 8 7 4 11 6 9
1,500 15 1 14 1 14 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 methamphetamine-positive urine. The following compounds show no cross-reactivity (were not detected positive) when tested with the mAMP One Step Methamphetamine 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; Ascorbic acid; Aspartame; Atropine; Benzilic acid; Benzoic acid; Benzoylecgonine; Benzphetamine; Bilirubin; Brompheniramine; Caffeine; Cannabidiol; Chloral hydrate; Chloramphenicol; Chlordiazepoxide; Chlorothiazide; dl-Chlorpheniramine; Chlorpromazine; Chloroquine; Cholesterol; Clomipramine; Clonidine; Cocaethylene; Cocaine; Codeine; Cortisone; l-Cotinine; Creatinine; Deoxycorticosterone; Dextromethorphan; Diazepam; Diclofenac; Diflunisal; Digoxin; Diphenhydramine; Doxylamine; Ecgonine; Ecgonine methyl ester; (1R,2S)-l-Ephedrine; l-Epinephrine; Erythromycin; B-Estradiol; Estrone 3-sulfate; Ethyl p-aminobenzoate; Fenfluramine; Fenoprofen; Furosemide; Gentisic acid; Hemoglobin; Hydralazine; Hydrochlorothiazide; Hydrocodone; Hydrocortisone; p-Hydroxyamphetamine; o-Hydroxyhippuric acid; 3-Hydroxytyramine; Ibuprofen; Imipramine; Iproniazid; l-Isoproterenol; Isoxsuprine; Ketamine; Ketoprofen; Labetalol; Levorphanol; Loperamide; Maprotiline; Meperedine; Meprobamate; Methadone; Methoxyphenamine; d-3,4-Methylenedioxyamphetamine; 3,4-Methylenedioxyethylamphetamine; Methylphenidate; Morphine 3-B-D-glucuronide; Nalidixic acid; Naloxone; Naltrexone; Naproxen; Niacinamide; Nifedipine; Norethindrone; d-Norpropoxyphene; Noscapine; dl-Octopamine; Oxalic acid; Oxazepam; Oxolinic acid; Oxycodone; Oxymetazoline; Papaverine; Penicillin-G; 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; 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 500 ng/mL and 1,500 ng/mL of methamphetamine, respectively. The mAMP One Step Methamphetamine 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 methamphetamine to 500 ng/mL and 1,500 ng/mL. The spiked, pH-adjusted urine was tested with the mAMP One Step Methamphetamine Test Strip in duplicate. The results demonstrate that varying ranges of pH does not interfere with the performance of the test.