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

Specificity

The following table lists compounds that are detected positive in urine by the COC One Step Cocaine 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)
Benzoylecgonine 300
Cocaine 780
Cocaethylene 12,500
Ecgonine 32,000

Accuracy

A side-by-side comparison was conducted by laboratory personnel using the COC One Step Cocaine Test Strip and a commercially available 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 COC Rapid Test
Pos. Neg. Totals
COC
One Step
Test Strip		 Positive 136 0 136
Negative 7 157 164
Totals 143 157 300
*Agreement 95% >99% 98%

* % Agreement With Other COC Rapid Test

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

Methods and Results GC/MS
Pos. Neg. Totals
COC
One Step
Test Strip		 Positive 119 17 136
Negative 5 159 164
Totals 124 176 300
*Agreement 96% 90% 93%

* % Agreement With GC/MS Lab Testing Method

Eighty (80) of these clinical samples were also run using the COC One Step Cocaine 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 benzoylecgonine 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 >99% accuracy at 50% above and 50% below the cutoff concentration. The data are summarized below:

Benzoylecgonine
Conc. (ng/mL)		 % of
Cutoff		 n Visual Result
Neg. Pos.
0 0% 30 30 0
150 −50% 30 30 0
225 −25% 30 30 0
300 Cutoff 30 4 26
375 +25% 30 0 30
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 were blind labeled and tested at each site. The results are given below:

Benzoylecgonine
Conc. (ng/mL)		 n Site A Site B Site C
− + − + − +
0 15 14* 0 15 0 15 0
150 15 14 1 15 0 14 1
225 15 4 11 5 10 8 7
375 15 0 15 0 15 0 15
450 15 0 15 0 15 1 14
Non-Valid 15 15/15 15/15 15/15

*Note: Non-valid results were obtained in this treatment. Non-valid tests were provided as part of this study to ensure that readers would accurately identify non-valid test results.

Non Cross-Reacting Compounds (Cross-Reactivity)

A study was conducted to determine the cross-reactivity of the test with compounds in either drug-negative urine or benzoylecgonine-positive urine. The following compounds show no cross-reactivity (were not detected positive) when tested with the COC One Step Cocaine 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; Ampicillin; Apomorphine; l-Ascorbic acid; Aspartame; Atropine; Benzilic acid; Benzoic acid; Benzphetamine; Bilirubin; dl-Brompheniramine; Caffeine; Cannabidiol; Cannabinol; Chloral hydrate; Chloramphenicol; Chlordiazepoxide; Chlorothiazide; dl-Chlorpheniramine; Chlorpromazine; Chloroquine; Cholesterol; Clomipramine; Clonidine; Codeine; Cortisone; l-Cotinine; Creatinine; Deoxycorticosterone; Dextromethorphan; Diazepam; Diclofenac; Diflunisal; Digoxin; Diphenhydramine; Doxylamine; Ecgonine methyl ester; Erythromycin; B-Estradiol; Estrone 3-sulfate; Ethyl p-aminobenzoate; Fenoprofen; Furosemide; Gentisic acid; Hemoglobin; Hydralazine; Hydrochlorothiazide; Hydrocodone; Hydrocortisone; o-Hydroxyhippuric acid; p-Hydroxymethamphetamine; 3-Hydroxytyramine; Ibuprofen; Imipramine; Iproniazid; dl-Isoproterenol; Isoxsuprine; Ketamine; Ketoprofen; Labetalol; Levorphanol; Loperamide; Maprotiline; Meperidine; Meprobamate; Methadone; Methoxyphenamine; dl-3,4-Methylenedioxyamphetamine; dl-3,4-Methylenedioxymethamphetamine; Morphine; 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; 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; 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 150 ng/mL and 450 ng/mL of benzoylecgonine, respectively. The COC One Step Cocaine 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 benzoylecgonine to 150 ng/mL and 450 ng/mL. The spiked, pH-adjusted urine was tested with the COC One Step Cocaine 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.