Toll-Free: (800) 224-7998

One Step Drug Test:  Marijuana and Methamphetamine (Page 2)

2-Panel - THC-mAMP
One Step Marijuana and Methamphetamine Drug Screen Test Card

Page 1

Cross-Reactivity

A study was conducted to determine the cross-reactivity of the test with compounds in either drug-free urine or drug positive urine containing Marijuana or Methamphetamine. The following compounds show no cross-reactivity (were not detected positive) when tested with the One Step Drug Screen Test Card at a concentration of 100,000 ng/ml:

Non Cross-Reacting Compounds
Acetaminophen; Acetophenetidin; N-Acetylprocainamide; Acetylsalicylic acid; Aminopyrine; Amoxicillin; Ampicillin; l-Ascorbic acid; Apomorphine; Aspartame; Atropine; Benzilic acid; Benzoic acid; Benzphetamine (parent compound only); Bilirubin; dl-Brompheniramine; Caffeine; Cannabidiol; Chloral hydrate; Chloramphenicol; Chlorothiazide; dl-Chlorpheniramine; Chlorpromazine; Cholesterol; Clonidine; Cortisone; l-Cotinine; Creatinine; Deoxycorticosterone; Dextromethorphan; Diclofenac; Diflunisal; Digoxin; Diphenhydramine; l-Y-Ephedrine; B-Estradiol; Estrone 3-sulfate; Ethyl p-aminobenzoate; l-Epinephrine; Erythromycin; Fenoprofen; Furosemide; Gentisic acid; Hemoglobin; Hydralazine; Hydrochlorothiazide; Hydrocortisone; o-Hydroxyhippuric acid; p-Hydroxytyramine; Ibuprofen; Iproniazid; dl-Isoproterenol; Isoxsuprine; Ketamine; Ketoprofen; Labetalol; Loperamide; Meperidine; Meprobamate; Methoxyphenamine; Methylphenidate; Nalidixic acid; Naproxen; Niacinamide; Nifedipine; Norethindrone; Noscapine; dl-Octopamine; Oxalic acid; Oxolinic acid; Oxymetazoline; Papaverine; Penicillin-G; Pentazocine hydrochloride; Perphenazine; Phenelzine; trans-2-Phenylcyclopropylamine hydrochloride; Prednisolone; Prednisone; dl-Propranolol; d-Propoxyphene; d-Pseudoephedrine; Quinacrine; Quinine; Quinidine; Ranitidine (parent compound only); Salicylic acid; Serotonin; Sulfamethazine; Sulindac; Tetracycline; Tetrahydrocortisone 3-acetate; Tetrahydrocortisone 3-(B-D-glucuronide); Tetrahydrozoline; Thiamine; Thioridazine; dl-Tyrosine; Tolbutamide; Triamterene; Trifluoperazine; Trimethoprim; Tryptamine; dl-Tryptophan; Uric acid; Verapamil; Zomepirac

Accuracy

Top of Page

A side-by-side comparison was conducted using the One Step Drug Screen Test Card and commercially available drug rapid tests. Testing was performed on approximately 300 specimens per drug type previously collected from subjects presenting for Drug Screen Testing. Presumptive positive results were confirmed by GC/MS. The following compounds were quantified by GC/MS and contributed to the total amount of drugs found in presumptive positive urine samples tested:

Test Compounds Contributed to the Totals of GC/MS
THC 11-nor-D9-THC-9
mAMP Methamphetamine

The following results are tabulated from these clinical studies:

Method GC/MS
Multi-Drug Single-Line Test Card Neg. Neg. (<-25% Cutoff) Near Cutoff Neg. (-25% Cutoff to Cutoff) Near Cutoff Pos. (Cutoff to +25% Cutoff) Pos. (>+25% Cutoff) Agreement with GC/MS
THC Positive 0 13 9 12 106 97%
Negative 150 6 0 2 2 88%
mAMP Positive 0 0 10 9 126 99%
Negative 150 0 4 1 0 94%
% Agreement With Commercial Kit
Results THC mAMP
Positive Agreement 98% 98%
Negative Agreement >99% >99%
Total Results 99% 99%
% Agreement With GC/MS
Results THC mAMP
Positive Agreement 99% 99%
Negative Agreement 88% 94%
Total Results 92% 96%

Forty (40) clinical samples for each drug were run using each of The One Step Drug Screen Test Card by an untrained operator at a Professional Point of Care site. Based on GC/MS data, the operator obtained statistically similar Positive Agreement, Negative Agreement and Overall Agreement rates as trained laboratory personnel.

Sensitivity

Top of Page

A drug-free urine pool was spiked with drugs at concentrations listed. The results are summarized below:

Drug Concentration Cutoff Range n THC mAMP
- + - +
0% Cutoff 30 30 0 30 0
-50% Cutoff 30 30 0 30 0
-25% Cutoff 30 12 18 30 0
Cutoff 30 1 29 18 12
+25% Cutoff 30 1 29 1 29
+50% Cutoff 30 0 30 0 30

Precision

Top of Page

A study was conducted at three physician offices by untrained operators using three different lots of product to demonstrate the within run, between run and between operator precision. An identical panel of coded specimens, containing drugs at the concentration of +/- 50% and +/- 25% cutoff level, was labeled, blinded and tested at each site. The results are given below:

11-nor-D9-THC-9
Concentration (ng/ml)		 n Site A Site B Site C
- + - + - +
0 15 15 0 15 0 15 0
25 15 15 0 15 0 14 1
37.5 15 9 6 14 1 9 6
62.5 15 2 13 0 15 0 15
75 15 0 15 0 15 0 15
Methamphetamine
Concentration (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

Effect of Urinary Specific Gravity

Top of Page

Fifteen (15) urine samples of normal, high, and low specific gravity ranges (1.000-1.037) were spiked with drugs at 50% below and 50% above cutoff levels respectively. The One Step Drug Screen Test Card was tested in duplicate using fifteen drug-free urine and spiked urine samples. The results demonstrate that varying ranges of urinary specific gravity does not affect the test results.

Effect of Urinary pH

Top of Page

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 drugs at 50% below and 50% above cutoff levels. The spiked, pH-adjusted urine was tested with the One Step Drug Screen Test Card. The results demonstrate that varying ranges of pH does not interfere with the performance of the test.

Related Links

Top of Page