Specifications: Oxycodone Panel (OXY)

The below specifications apply to the OXY: Oxycodone panels of the One Step Drug Tests. This includes the 1-panel One Step Oxycodone Drug Test - plus any multi-panel drug test containing an OXY panel.

Specificity

The following table lists compounds that are positively detected in urine by the OXY One Step Oxycodone Test Strip at 5 minutes. Oxycodone is the target compound.

Compound Cutoff (ng/ml)
Oxycodone 100
Naloxone 37,500
Naltrexone 37,500
Levorphanol 50,000
Hydrocodone 6,250
Hydromorphone 50,000
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 (5) percent 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:

Method Other OXY Rapid Test Total Results
OXY One Step Test Strip Results Positive Negative
Positive 142 0 142
Negative 4 154 158
Total Results 146 154 300
% Agreement With Commercial Kit 97% >99% 99%

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

Method GC/MS % Agreement With GC/MS Analysis
OXY One Step Test Strip Results Neg. Near Cutoff Neg. Near Cutoff Pos. Pos.
Positive 0 5 2 135 96%
Negative 147 8 2 1 98%

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 100% accuracy at 50% and 150% of the cutoff concentration of the assay. The data are summarized below:

Oxycodone Concentration (ng/ml) Percent of Cutoff n Visual Result
Negative Positive
0 0% 30 30 0
50 -50% 30 30 0
75 -25% 30 23 7
100 Cutoff 30 13 17
125 +25% 30 8 22
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 three different lots of product and run in three 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 Concentration (ng/ml) n Site A Site B Site C
- + - + - +
0 15 15 0 15 0 15 0
50 15 15 0 15 0 14 1
75 15 15 0 14 1 5 10
125 15 0 15 3 12 2 13
150 15 0 15 0 15 0 15

Non Cross-Reacting Compounds

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; l-pseudo-Ephedrine; B-Estradiol; Estrone 3-sulfate; Ethyl p-aminobenzoate; Erythromycin; Fenoprofen; Furosemide; Gentisic acid; Hemoglobin; Heroin (Diacetylmorphine); Hydralazine; Hydrochlorothiazide; Hydrocortisone; o-Hydroxyhippuric acid; p-Hydroxyamphetamine; p-Hydroxymethamphetamine; p-Hydroxytyramine; Ibuprofen; Iproniazid; dl-Isoproterenol; Isoxsuprine; Ketamine; Ketoprofen; Labetalol; Levorphanol; Loperamide; Maprotiline; Meperidine; Mephentermine; Meprobamate; d-Methamphetamine; Methadone; Methoxyphenamine; dl-3,4-Methylenedioxyamphetamine; dl-3,4-Methylenedioxymethamphetamine; 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; Phenelzine; trans-2-Phenylcyclopropylamine hydrochloride; l-Phenylephrine; B-Phenylethylamine; Phenylpropanolamine; Prednisolone; Prednisone; Procaine; Promazine; Promethazine; dl-Propranolol; d-Propoxyphene; d-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; Tolbutamide; 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 fifteen 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.