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

Specificity

The following table lists compounds that are detected positive in urine by the BUP One Step Buprenorphine 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)
Buprenorphine 10
Buprenorphine 3-B-D-glucuronide 15
Norbuprenorphine 20
Norbuprenorphine 3-B-D-glucuronide 200

Accuracy

Two hundred twenty-six (226) urine samples were obtained and tested with the BUP One Step Buprenorphine Test Strip and by the LC/MS lab testing method. The results are summarized below:

Methods and Results LC/MS
**Neg. <−25%
of
Cutoff
−25% of
Cutoff to
Cutoff
Cutoff to
+25% of
Cutoff
>+25%
of
Cutoff
BUP
One Step
Test Strip
Positive 0 0 0 5 50
Negative 150 15 5 1 0
*Agreement >99% (170/170) 98% (55/56)

* Agreement With LC/MS Lab Testing Method. Total Agreement: >99% (225/226)

** Negative samples were confirmed using LC/MS by pooling these samples into groups of 15.

Sensitivity

A drug-free urine pool was spiked with buprenorphine at the following concentrations: 0 ng/mL, 5 ng/mL, 7.5 ng/mL, 10 ng/mL, 12.5 ng/mL, 15 ng/mL, and 20 ng/mL. The assay cutoff level of 10 ng/mL was selected to correlate with the LC/MS analysis cutoff for buprenorphine. The result demonstrates >99% accuracy at 50% above and 50% below the cutoff concentration. The data are summarized below:

Buprenorphine
Conc. (ng/mL)
% of
Cutoff
n Visual Result
Neg. Pos.
0 0% 90 90 0
5 −50% 90 90 0
7.5 −25% 90 75 15
10 Cutoff 90 60 30
12.5 +25% 90 31 59
15 +50% 90 0 90
20 +100% 90 0 90

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 no buprenorphine, 25% buprenorphine above and below the cutoff, and 50% buprenorphine above and below the 10 ng/mL cutoff was provided to each site. The following results were tabulated:

Buprenorphine
Conc. (ng/mL)
n Site A Site B Site C
+ + +
0 15 15 0 15 0 15 0
5 15 15 0 15 0 15 0
7.5 15 8 7 10 5 9 6
12.5 15 0 15 1 14 0 15
15 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 buprenorphine-positive urine. The following compounds show no cross-reactivity (were not detected positive) when tested with the BUP One Step Buprenorphine Test Strip at a concentration of 100,000 ng/mL.

Non Cross-Reacting Compounds
4-Acetamidophenol; Acetone; Acetophenetidin; Acetylsalicylic acid; Albumin; Aminopyrine; Amitryptyline; Amobarbital; Amoxapine; Amoxicillin; dl-Amphetamine; Ampicillin; Apomorphine; Ascorbic acid; Aspartame; Atropine; Benzilic acid; Benzoic acid; Benzphetamine; Bilirubin; Brompheniramine; Buspirone; Caffeine; Cannabidiol; Cannabinol; Cimetidine; Chloral hydrate; Chloramphenicol; Chlordiazepoxide; Chloroquine; Chlorothiazide; d-Chlorpheniramine; dl-Chlorpheniramine; Chlorpromazine; Chlorproxithene; Cholesterol; Clomipramine; Clonidine; Cortisone; l-Cotinine; Creatinine; Cyclobarbital; Cyclobenzaprine; Deoxycorticosterone; l-Deoxyephedrine; l-Deprenyl; Dextromethorphan; Diazepam; Diclofenac; Diflunisal; Digoxin; 4-Dimethylaminoantipyrine; Diphenhydramine; Dicyclomine; 5,5-Diphenylhydantoin; Disopyramide; Doxylamine; Ecgonine; Ecgonine methyl ester; EDDP; EMDP; Efavirenz; Ephedrine; l-Ephedrine; l-Epinephrine; dl-Epinephrine; Erythromycin; B-Estradiol; Estrone 3-sulfate; Ethanol; Ethyl p-aminobenzoate; Etodolac; Famprofazone; Fenfluramine; Fenoprofen; Fentanyl; Fluoxetine; Furosemide; Gentisic acid; d-Glucose; Guaiacol glyceryl ether; Guaiacol glyceryl ether carbamate; Hemoglobin; Hydralazine; Hydrochlorothiazide; Hydrocodone; Hydrocortisone; Hydromorphone; o-Hydroxyhippuric acid; p-Hydroxymethamphetamine; p-Hydroxynorephedrine; 3-Hydroxytyramine (Dopamine); Hydroxyzine; Ibuprofen; Imipramine; Iproniazid; l-Isoproterenol; Isoxsuprine; Kanamycin; Ketamine; Ketoprofen; Labetalol; Levorphanol; Lidocaine; Lindane; Lithium carbonate; Loperamide; Maprotiline; Meperidine; Meprobamate; l-Methamphetamine; Methaqualone; Methadone; Methoxyphenamine; MDMA; Methylphenidate; Mephentermine; Metoprolol; Morphine; Morphine 3-B-D-glucuronide; Methyprylon; Nalidixic acid; Naloxone; Naltrexone; a-Naphthaleneacetic acid; Naproxen; Niacinamide; Nifedipine; Nimesulide; Norcodeine; Normorphone; Norethindrone; d-Norpropoxyphene; Noscapine; dl-Octopamine; Orphenadrine; Oxalic acid; Oxazepam; Oxolinic acid; Oxycodone; Oxymetazoline; Oxymorphone; Papaverine; Pemoline; Penicillin-G; Pentazocine; Pentobarbital; Perphenazine; Phencyclidine; Phenelzine; Pheniramine; Phenobarbital; Phenothiazine; Phentermine; trans-2-Phenylcyclopropylamine; l-Phenylephrine; B-Phenylethylamine; dl-Phenylpropanolamine; Prednisolone; Prednisone; 5-B-Pregnane-3a,17a,21-triol-20-one; Procaine; Promazine; Promethazine; d-Propoxyphene; dl-Propranolol; d-Pseudoephedrine; Quinacrine; Quinidine; Quinine; Ranitidine; Riboflavin; Salicylic acid; Secobarbital; Serotonin (5-Hydroxytryptamine); Sodium Chloride; Sulfamethazine; Sulindac; Temazepam; Tetracycline; Tetrahydrocortexolone; Tetrahydrocortisone 3-acetate; Tetrahydrozoline; Thebaine; Theophylline; Thiamine; Thioridazine; l-Thyroxine; Tolbutamide; cis-Tramadol; Trazodone; Trimethobenzamide; Triamterene; Trimipramine; Trifluoperazine; Trimethoprim; Tryptamine; dl-Tryptophan; Tyramine; dl-Tyrosine; Uric acid; Verapamil; Zomepirac

Effect of Urinary Specific Gravity

Fifteen (15) urine samples with specific gravity ranges from 1.004 to 1.034 were spiked with buprenorphine to the concentrations of 5 ng/mL, 15 ng/mL, and 20 ng/mL. The BUP One Step Buprenorphine 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 buprenorphine to the concentrations of 5 ng/mL, 15 ng/mL, and 20 ng/mL. The spiked, pH-adjusted urine was tested with the BUP One Step Buprenorphine Test Strip in duplicate. The results demonstrate that varying ranges of pH does not interfere with the performance of the test.