The following specifications apply to the OPI: Opiate panel of the One Step Urine Drug Tests. This includes the 1-panel OPI One Step Opiate Drug Test — plus any multi-panel urine drug tests that contain an OPI panel.
The following table lists compounds that are detected positive in urine by the OPI One Step Opiate 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.
A side-by-side comparison was conducted using the OPI One Step Opiate Test Strip and a leading commercially available OPI 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 OPI Rapid Test|
* % Agreement With Other OPI Rapid Test
When compared to the GC/MS lab testing method at the cutoff concentration of 2,000 ng/mL, the following results were tabulated:
|Methods and Results||GC/MS|
* % Agreement With GC/MS Lab Testing Method
Eighty (80) of these samples were also run using the OPI One Step Opiate 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.
A drug-free urine pool was spiked with morphine at the following concentrations: 0 ng/mL, 1,000 ng/mL, 1,500 ng/mL, 2,000 ng/mL, 2,500 ng/mL, and 3,000 ng/mL. The result demonstrates >99% accuracy at 50% above and 50% below the cutoff concentration. The data are summarized below:
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:
|n||Site A||Site B||Site C|
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 morphine-positive urine. The following compounds show no cross-reactivity (were not detected positive) when tested with the OPI One Step Opiate 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; 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; Cortisone; l-Cotinine; Creatinine; Deoxycorticosterone; Dextromethorphan; Diazepam; Diclofenac; Diflunisal; Digoxin; Diphenhydramine; Doxylamine; Ecgonine; Ecgonine methyl ester; Erythromycin; B-Estradiol; Estrone 3-sulfate; Ethyl p-aminobenzoate; Fenoprofen; Furosemide; Gentisic acid; Hemoglobin; Hydralazine; Hydrochlorothiazide; Hydrocortisone; o-Hydroxyhippuric acid; p-Hydroxymethamphetamine; 3-Hydroxytyramine; Ibuprofen; Imipramine; Iproniazid; dl-Isoproterenol; Isoxsuprine; Ketamine; Ketoprofen; Labetalol; Loperamide; Maprotiline; Meperidine; Meprobamate; Methadone; Methoxyphenamine; d-3,4-Methylenedioxyamphetamine; d-3,4-Methylenedioxymethamphetamine; Nalidixic acid; Nalorphine; Naloxone; Naltrexone; Naproxen; Niacinamide; Nifedipine; Norethindrone; d-Norpropoxyphene; Noscapine; dl-Octopamine; Oxalic acid; Oxazepam; Oxolinic acid; Oxymetazoline; Papaverine; Penicillin-G; Pentazocine; Pentobarbital; Perphenazine; Phencyclidine; Phenelzine; Phenobarbital; Phentermine; l-Phenylephrine; B-Phenylethylamine; Phenylpropanolamine; Prednisone; 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; 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 1,000 ng/mL and 3,000 ng/mL of morphine, respectively. The OPI One Step Opiate 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 morphine to 1,000 ng/mL and 3,000 ng/mL. The spiked, pH-adjusted urine was tested with the OPI One Step Opiate 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.