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

Specificity

The following table lists compounds that are detected positive in urine by the OXY One Step Oxycodone 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)
Oxycodone 100
Hydrocodone 6,250
Hydromorphone 50,000
Levorphanol 50,000
Naloxone 37,500
Naltrexone 37,500
Oxymorphone 200

Accuracy

A side-by-side comparison was conducted using the OXY One Step Oxycodone Test Strip and a leading commercially available oxycodone rapid test. Testing was performed on 300 clinical specimens. Five percent (5%) of the positive specimens employed were within 75% or 125% of the assay cutoff concentration of 100 ng/mL oxycodone. Presumptive positive results were confirmed by GC/MS. The following results were tabulated:

Methods and Results Other OXY Rapid Test
Pos. Neg. Totals
OXY
One Step
Test Strip
Positive 135 1 136
Negative 5 159 164
Totals 140 160 300
*Agreement 96% 99% 98%

* % Agreement With Other OXY Rapid Test

When compared to the GC/MS lab testing method at the cutoff concentration of 100 ng/mL, the following results were tabulated:

Methods and Results GC/MS
Neg. <−25%
of
Cutoff
−25% of
Cutoff to
Cutoff
Cutoff to
+25% of
Cutoff
>+25%
of
Cutoff
OXY
One Step
Test Strip
Positive 0 0 1 2 133
Negative 147 6 8 0 3
*Agreement 99% (161/162) 98% (135/138)

* Agreement With GC/MS Lab Testing Method. Total Agreement: 99% (296/300)

Eighty (80) of these samples were also run using the OXY One Step Oxycodone Test Strip by an untrained operator at a different site. Based on GC/MS data, the untrained 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 oxycodone at the following concentrations: 0 ng/mL, 50 ng/mL, 75 ng/mL, 100 ng/mL, 125 ng/mL, 150 ng/mL, and 200 ng/mL. The result demonstrates >99% accuracy at 50% and 150% of the cutoff concentration of the assay. The data are summarized below:

Oxycodone
Conc. (ng/mL)
% of
Cutoff
n Visual Result
Neg. Pos.
0 0% 30 30 0
50 −50% 30 30 0
75 −25% 30 30 0
100 Cutoff 30 18 12
125 +25% 30 6 24
150 +50% 30 0 30
200 +100% 30 0 30

Precision

A study was conducted at three independent physician's office sites (A. internal medicine, B. pediatrics, C. general practice) by three independent, untrained, licensed medical assistants using 3 different lots of product and run in 3 consecutive days to demonstrate the within-run, between-run, and between-operator precision. An identical panel of coded specimens containing no oxycodone, oxycodone spiked at levels ±25% of the assay cutoff, and oxycodone spiked at levels ±50% of the 100-ng/mL assay cutoff were provided to each site. The results are given below:

Oxycodone
Conc. (ng/mL)
n Site A Site B Site C
+ + +
0 15 15 0 15 0 15 0
50 15 15 0 15 0 15 0
75 15 14 1 13 2 11 4
125 15 1 14 0 15 0 15
150 15 0 15 0 15 0 15

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 oxycodone-positive urine. The following compounds show no cross-reactivity (were not detected positive) when tested with the OXY One Step Oxycodone Test Strip at concentrations of 100,000 ng/mL.

Non Cross-Reacting Compounds
Acetaminophen; Acetophenetidin; 6-Acetylcodeine; N-Acetylprocainamide; Acetylsalicylic acid; Aminopyrine; Amitryptyline; Amobarbital; Amoxicillin; d-Amphetamine; dl-Amphetamine; l-Amphetamine; Ampicillin; Apomorphine; l-Ascorbic acid; Aspartame; Atropine; Benzilic acid; Benzoic acid; Benzoylecgonine; Benzphetamine; Bilirubin; dl-Brompheniramine; Buspirone; Caffeine; Cannabidiol; Cannabinol; Chloral hydrate; Chloramphenicol; Chlordiazepoxide; Chlorothiazide; dl-Chlorpheniramine; Chlorpromazine; Chloroquine; Cholesterol; Clomipramine; Clonidine; Cocaine; Cortisone; l-Cotinine; Creatinine; Deoxycorticosterone; Dextromethorphan; Diazepam; Diclofenac; Dicyclomine; Diflunisal; Digoxin; Diphenhydramine; 5,5-Diphenylhydantion; Doxylamine; (1R,2S)-l-Ephedrine; l-Epinephrine; B-Estradiol; Estrone 3-sulfate; Ethyl p-aminobenzoate; Erythromycin; Fenoprofen; Furosemide; Gentisic acid; Hemoglobin; Heroin (Diacetylmorphine); Hydralazine; Hydrochlorothiazide; Hydrocortisone; p-Hydroxyamphetamine; o-Hydroxyhippuric acid; p-Hydroxymethamphetamine; p-Hydroxytyramine; Ibuprofen; Iproniazid; dl-Isoproterenol; Isoxsuprine; Ketamine; Ketoprofen; Labetalol; Levorphanol; Loperamide; Maprotiline; Meperidine; Mephentermine; Meprobamate; Methadone; d-Methamphetamine; Methoxyphenamine; dl-3,4-Methylenedioxyamphetamine (MDA); dl-3,4-Methylenedioxymethamphetamine (MDMA); Methylphenidate; 6-Monoacetylmorphine; Morphine; Morphine 3-B-D-glucuronide; Morphine sulfate; Nalidixic acid; Naloxone; Naltrexone; Naproxen; Niacinamide; Nifedipine; Nimesulidate; Norcodeine; Norethindrone; Normorphone; d-Norpropoxyphene; Noscapine; dl-Octopamine; Oxalic acid; Oxazepam; Oxolinic acid; Oxymetazoline; Papaverine; Penicillin-G; Pentazocine hydrochloride; Pentobarbital; Perphenazine; Phencyclidine (PCP); Phenelzine; trans-2-Phenylcyclopropylamine hydrochloride; l-Phenylephrine; B-Phenylethylamine; Phenylpropanolamine; Prednisolone; Prednisone; Procaine; Promazine; Promethazine; dl-Propranolol; d-Propoxyphene; d-Pseudoephedrine; l-Pseudoephedrine; Quinacrine; Quinidine; Quinine; Ranitidine; Salicylic acid; Secobarbital; Serotonin (5-Hydroxytryptamine); Sulfamethazine; Sulindac; Sustiva (Efavirenz); Temazepam; Tetracycline; Tetrahydrocortisone 3-acetate; Tetrahydrocortisone 3-B-D-glucuronide; Tetrahydrozoline; Theophylline; Thiamine; Thioridazine; Tolbutamide; Trazodone; Triamterene; Trifluoperazine; Trimethoprim; Tryptamine; dl-Tryptophan; Tyramine; Uric acid; Verapamil; Zomepirac

Effect of Urinary Specific Gravity

Fifteen (15) urine samples of normal, high, and low specific gravity ranges were spiked with 50 ng/mL and 150 ng/mL of oxycodone, respectively. The OXY One Step Oxycodone 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 oxycodone at levels of 50 ng/mL and 150 ng/mL. The spiked, pH-adjusted urine was tested with the OXY One Step Oxycodone Test Strip in duplicate. The results demonstrate that varying ranges of pH does not interfere with the performance of the test.