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

Specificity

The following table lists compounds that are detected positive in urine by the AMP One Step Amphetamine 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-Amphetamine 1,000
dl-Amphetamine 3,000
l-Amphetamine 50,000
3,4-Methylenedioxyamphetamine (MDA) 2,000
Phentermine 3,000

Accuracy

A side-by-side comparison was conducted using the AMP One Step Amphetamine Test Strip and a leading commercially available AMP 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 amphetamine. Presumptive positive results were confirmed by GC/MS. The following results were tabulated:

Methods and Results Other AMP Rapid Test
Pos. Neg. Totals
AMP
One Step
Test Strip
Positive 141 0 141
Negative 5 154 159
Totals 146 154 300
*Agreement 97% >99% 98%

* % Agreement With Other AMP 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
AMP
One Step
Test Strip
Positive 132 9 141
Negative 4 155 159
Totals 136 164 300
*Agreement 97% 95% 96%

* % Agreement With GC/MS Lab Testing Method

Eighty (80) of these samples were also run using the AMP One Step Amphetamine 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 amphetamine 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:

Amphetamine
Conc. (ng/mL)
% of
Cutoff
n Visual Result
Neg. Pos.
0 0% 30 30 0
500 −50% 30 30 0
750 −25% 30 22 8
1,000 Cutoff 30 12 18
1,250 +25% 30 2 28
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 amphetamine, 25% amphetamine above and below the cutoff, and 50% amphetamine above and below the 1,000 ng/mL cutoff was provided to each site. The results are given below:

Amphetamine
Conc. (ng/mL)
n Site A Site B Site C
+ + +
0 15 15 0 15 0 15 0
500 15 15 0 15 0 14 1
750 15 13 2 11 4 11 4
1,250 15 6 9 4 11 4 11
1,500 15 2 13 1 14 1 14

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 amphetamine-positive urine. The following compounds show no cross-reactivity (were not detected positive) when tested with the AMP One Step Amphetamine 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; Ampicillin; Ascorbic acid; Apomorphine; Aspartame; Atropine; Benzilic acid; Benzoic acid; Benzoylecgonine; Benzphetamine (Parent compound only); Bilirubin; Brompheniramine; Caffeine; Cannabidiol; Cannabinol; Chloral hydrate; Chloramphenicol; Chlordiazepoxide; Chlorothiazide; dl-Chlorpheniramine; Chlorpromazine; Chloroquine; Cholesterol; Clomipramine; Clonidine; Cocaine; Codeine; Cortisone; l-Cotinine; Creatinine; Deoxycorticosterone; Dextromethorphan; Diazepam; Diclofenac; Diflunisal; Digoxin; Diphenhydramine; Doxylamine; Ecgonine; Ecgonine methyl ester; l-Ephedrine; (1R,2S)-l-Ephedrine; Erythromycin; B-Estradiol; Estrone 3-sulfate; Ethyl p-aminobenzoate; Fenfluramine; Fenoprofen; Furosemide; Gentisic acid; Hemoglobin; Hydralazine; Hydrochlorothiazide; Hydrocodone; Hydrocortisone; p-Hydroxyamphetamine; o-Hydroxyhippuric acid; p-Hydroxymethamphetamine; 3-Hydroxytyramine; Ibuprofen; Imipramine; l-Isoproterenol; Isoxsuprine; Ketamine; Ketoprofen; Labetalol; Levorphanol; Loperamide; Maprotiline; Meperedine; Meprobamate; Methadone; d-Methamphetamine; l-Methamphetamine; Methoxyphenamine; 3,4-Methylenedioxyethylamphetamine; d-3,4-Methylenedioxymethamphetamine; Methylphenidate; 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; l-Phenylephrine; B-Phenylethylamine; Phenylpropanolamine; Prednisolone; Prednisone; Procaine; Promazine; Promethazine; dl-Propranolol; d-Propoxyphene; d-Pseudoephedrine; l-Pseudoephedrine; 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; 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 amphetamine, respectively. The AMP One Step Amphetamine 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 amphetamine to 500 ng/mL and 1,500 ng/mL. The spiked, pH-adjusted urine was tested with the AMP One Step Amphetamine Test Strip in duplicate. The results demonstrate that varying ranges of pH does not interfere with the performance of the test.