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

Specificity

The following table lists compounds that are detected positive in urine by the THC One Step Marijuana 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)
11-nor-delta-9-THC-COOH 50
11-nor-delta-8-THC-COOH 30
delta-9-THC 15,000
delta-8-THC 15,000
Cannabinol 20,000

Accuracy

A 3-way side-by-side comparison was conducted using the THC One Step Marijuana Test Strip and a leading commercially available THC 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 THC Rapid Test
Pos. Neg. Totals
THC
One Step
Test Strip
Positive 140 0 140
Negative 3 157 160
Totals 143 157 300
*Agreement 98% >99% 99%

* % Agreement With Other THC Rapid Test

When compared to GC/MS, the following results were tabulated:

Methods and Results GC/MS
Pos. Neg. Totals
THC
One Step
Test Strip
Positive 135 5 140
Negative 6 154 160
Totals 141 159 300
*Agreement 96% 97% 96%

* % Agreement With GC/MS Lab Testing Method

Point of Care Accuracy

A study was conducted using the same clinical specimens with 10% distribution at 25% above and below the 50-ng/mL cutoff at three geographically distinct point of care sites to determine the accuracy of the THC One Step Marijuana Test Strip in the hands of point of care users. Forty (40) positive specimens and 40 negative specimens were tested on 3 different lots of each product.

The difference in sensitivity and specificity results obtained by the laboratory professional for the same clinical specimens compared to the results obtained by the point of care (untrained) user was insignificant. At a 95% confidence interval, the odds ratio for the point of care user versus the laboratory professional was 1 to 1 for sensitivity and specificity.

Sensitivity

A drug-free urine pool was spiked with 11-nor-delta-9-THC-COOH at the following concentrations: 0 ng/mL, 25 ng/mL, 37.5 ng/mL, 50 ng/mL, 62.5 ng/mL, and 75 ng/mL. The result demonstrates >99% accuracy at 50% above and 50% below the cutoff concentration. The data are summarized below:

11-nor-delta-9-THC-COOH
Conc. (ng/mL)
% of
Cutoff
n Visual Result
Neg. Pos.
0 0% 30 30 0
25 −50% 30 30 0
37.5 −25% 30 12 18
50 Cutoff 30 1 29
62.5 +25% 30 1 29
75 +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, according to GC/MS, no 11-nor-delta-9-THC-COOH, 25% 11-nor-delta-9-THC-COOH above and below the cutoff, and 50% 11-nor-delta-9-THC-COOH above and below the 50-ng/mL cutoff was provided to each site. For the specimens below the −25% cutoff concentration, the 3 sites demonstrated 98% agreement with each other. For the −25% to +25% cutoff specimens, the 3 sites demonstrated 83% agreement with each other. For specimens above the +25% cutoff concentration, the 3 sites demonstrated 94% agreement with each other. For all results, the 3 sites were found to have a 91% agreement with each other.

Non Cross-Reacting Compounds (Cross-Reactivity)

A study was conducted to determine the cross-reactivity of the test with compounds in drug-free urine. The following compounds show no cross-reactivity (were not detected positive) when tested with the THC One Step Marijuana 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; 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; Cocaine hydrochloride; Codeine; Cortisone; l-Cotinine; Creatinine; Deoxycorticosterone; Dextromethorphan; Diazepam; Diclofenac; Diflunisal; Digoxin; Diphenhydramine; Doxylamine; Ecgonine hydrochloride; Ecgonine methyl ester; Erythromycin; B-Estradiol; Estrone 3-sulfate; Ethyl p-aminobenzoate; Fenoprofen; Furosemide; Gentisic acid; Hemoglobin; Hydralazine; Hydrochlorothiazide; Hydrocodone; Hydrocortisone; o-Hydroxyhippuric acid; 3-Hydroxytyramine; Ibuprofen; Imipramine; Iproniazid; l-Isoproterenol; Isoxsuprine; Ketamine; Ketoprofen; Labetalol; Levorphanol; Loperamide; Maprotiline; Meprobamate; Methadone; Methoxyphenamine; d-3,4-Methylenedioxyamphetamine; d-3,4-Methylenedioxymethamphetamine; Methylphenidate; Methyprylon; Morphine 3-B-D-glucuronide; Nalidixic acid; Nalorphine; Naloxone; Naltrexone; Naproxen; Niacinamide; Nifedipine; Norcodeine; Norethindrone; d-Norpropoxyphene; Noscapine; dl-Octopamine; Oxalic acid; Oxazepam; Oxolinic acid; Oxycodone; Oxymetazoline; p-Hydroxymethamphetamine; Papaverine; Penicillin-G; Pentazocine; Pentobarbital; Perphenazine; Phencyclidine; Phenelzine; Phenobarbital; Phentermine; 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; dl-Thyroxine; Tolbutamide; Triamterene; Trifluoperazine; Trimethoprim; Trimipramine; Tryptamine; dl-Tryptophan; Tyramine; dl-Tyrosine; Uric acid; Verapamil; Zomepirac

Effect of Urinary Specific Gravity

Twenty-six (26) urine samples of normal, high, and low specific gravity ranges were spiked with 25 ng/mL and 75 ng/mL of 11-nor-delta-9-THC-COOH, respectively. The THC One Step Marijuana Test Strip was tested in duplicate using the 26 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 11-nor-delta-9-THC-COOH to 25 ng/mL and 75 ng/mL. The spiked, pH-adjusted urine was tested with the THC One Step Marijuana Test Strip in duplicate and interpreted according to the package insert. The results demonstrate that varying ranges of pH does not interfere with the performance of the test.