Specifications: Benzodiazepines Panel (BZO)

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

Specificity

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

Compound Cutoff (ng/ml)
Oxazepam 300
Alprazolam 196
Bromazepam 1,562
Chlordiazepoxide 1,562
Clobazam 98
Clonazepam 781
Clorazepate dipotassium 195
Delorazepam 1,562
Desalkylflurazepam 390
Diazepam 195
Estazolam 2,500
Flunitrazepam 390
a-Hydroxyalprazolam 1,262
dl-Lorazepam 1,562
RS-Lorazepam glucuronide 156
Midazolam 12,500
Nitrazepam 98
Norchlordiazepoxide 195
Nordiazepam 390
Temazepam 98
Triazolam 2,500

Accuracy

A side-by-side comparison was conducted using the BZO One Step Benzodiazepines Test Strip and a leading commercially available BZO 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:

Method Other BZO Rapid Test Total Results
BZO One Step Test Strip Results Positive Negative
Positive 131 4 135
Negative 14 149 163
Total Results 145 153 298
% Agreement With Commercial Kit 90% 97% 94%

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

Method GC/MS Total Results
BZO One Step Test Strip Results Positive Negative
Positive 131 8 139
Negative 4 157 161
Total Results 135 165 300
% Agreement With GC/MS Analysis 97% 95% 96%

Eighty (80) of these samples were also run using the BZO One Step Benzodiazepines 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 Oxazepam 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:

Oxazepam Concentration (ng/ml) Percent of Cutoff n Visual Result
Negative Positive
0 0% 30 30 0
150 -50% 30 30 0
225 -25% 30 27 3
300 Cutoff 30 11 9
375 +25% 30 5 25
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 containing, according to GC/MS, no Oxazepam, 25% Oxazepam above and below the cutoff and 50% Oxazepam above and below the 300 ng/ml cutoff was provided to each site. The following results were tabulated:

Oxazepam Concentration (ng/ml) n Site A Site B Site C
- + - + - +
0 15 15 0 15 0 15 0
150 15 15 0 13 2 13 2
225 15 6 9 7 8 13 2
375 15 0 15 1 14 3 12
450 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 drug free urine. The following compounds show no cross-reactivity (were not detected positive) when tested with the BZO One Step Benzodiazepines 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 sulfate; Ampicillin; Apomorphine; l-Ascorbic acid; Aspartame; Atropine; Benzilic acid; Benzoic acid; Benzoylecgonine; Benzphetamine; Bilirubin; dl-Brompheniramine; Caffeine; Cannabidiol; Cannabinol; Chloral hydrate; Chloramphenicol; Chloroquine; Chlorothiazide; dl-Chlorpheniramine; Chlorpromazine; Cholesterol; Clomipramine; Clonidine; Cocaethylene; Cocaine; Codeine; Cortisone; l-Cotinine; Creatinine; Deoxycorticosterone; Dextromethorphan; Diclofenac; Diflunisal; Digoxin; Diphenhydramine; Doxylamine; Ecgonine; Ecgonine methyl ester; l-pseudo-Ephedrine; (1R,2S)-l-Ephedrine; l-Epinephrine; Erythromycin; B-Estradiol; Estrone 3-sulfate; Ethyl p-aminobenzoate; Fenoprofen; Furosemide; Gentisic acid; Hemoglobin; Hydralazine; Hydrochlorothiazide; Hydrocodone; Hydrocortisone; o-Hydroxyhippuric acid; p-Hydroxyamphetamine; p-Hydroxymethamphetamine; 3-Hydroxytyramine; Ibuprofen; Imipramine; Iproniazid; dl-Isoproterenol; Isoxsuprine; Ketamine; Ketoprofen; Labetalol; Loperamide; Maprotiline; MDE; Meperidine; Meprobamate; Methadone; l-Methamphetamine; Methoxyphenamine; dl-3,4-Methylenedioxyamphetamine; dl-3,4-Methylenedioxymethamphetamine; Morphine 3-B-D-glucuronide; Morphine sulfate; Nalidixic acid; Naloxone; Naltrexone; Naproxen; Niacinamide; Nifedipine; Norcodeine; Norethindrone; d-Norpropoxyphene; Noscapine; dl-Octopamine; Oxalic acid; Oxolinic acid; Oxycodone; Oxymetazoline; Papaverine; Penicillin-G; Pentazocine; Pentobarbital; Perphenazine; Phencyclidine; Phenelzine; Phenobarbital; Phentermine; 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; Sulfamethazine; Sulindac; 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 150 ng/ml and 450 ng/ml of Oxazepam respectively. The BZO One Step Benzodiazepines 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 Oxazepam to 150 ng/ml and 450 ng/ml. The spiked, pH-adjusted urine was tested with the BZO One Step Benzodiazepines 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.