Specifications: Propoxyphene Panel (PPX)

The below specifications apply to the PPX: Propoxyphene panels of the One Step Drug Tests. This includes any multi-panel drug test containing a PPX panel.

Specificity

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

Compound Cutoff (ng/ml)
d-Propoxyphene 300
d-Norpropoxyphene 300

Accuracy

A side-by-side comparison was conducted using the PPX One Step Propoxyphene Test Strip and a leading commercially available PPX rapid test. Testing was performed on 314 clinical and diluted clinical specimens. Presumptive positive samples were confirmed by GC/MS. The following results were tabulated:

Method Other PPX Rapid Test Total Results
PPX One Step Test Strip Results Positive Negative
Positive 157 0 157
Negative 0 157 157
Total Results 157 157 314
% Agreement With Commercial Kit >99% >99% >99%

A clinical study was conducted with the PPX One Step Propoxyphene Test Strip using 352 clinical and diluted clinical specimens. All specimens containing propoxyphene were analyzed with GC/MS; negative specimens were pooled and analyzed by GC/MS to limit of detection. Approximately 20% of the specimens containing propoxyphene fell between -50% or +50% of the assay cut-off concentration of 300 ng/ml. When compared to the GC/MS analysis data, the following results were tabulated:

Method Negative <-50% Cutoff -50% Cutoff to Cutoff Cutoff to +50% Cutoff >+50% Cutoff Agreement with GC/MS (95% C.I.)*
PPX One Step Test Strip Positive 0 0 2 7 158 94% (90%-97%)
Negative 152 5 18 10 0 99% (96%-99%)

* 95% Confidence Interval

The test comparison data demonstrate that the PPX One Step Propoxyphene Test Strip can qualitatively detect urine Propoxyphene at the cutoff level of 300 ng/ml with a high degree of confidence.

Sensitivity

A drug-free urine pool was spiked with propoxyphene at the following concentrations: 0 ng/ml, 150 ng/ml, 225 ng/ml, 300 ng/ml, 375 ng/ml, 450 ng/ml and 600 ng/ml. The result demonstrates >99% accuracy at 50% above and 50% below the cutoff concentration of 300 ng/ml. The data are summarized below:

Propoxyphene Concentration (ng/ml) Percent of Cutoff n Visual Result
Negative Positive
0 0% 30 30 0
150 -50% 30 30 0
225 -25% 30 24 6
300 Cutoff 30 17 13
375 +25% 30 7 23
450 +50% 30 0 30
600 +100% 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 no Propoxyphene, 25% Propoxyphene above and below the cutoff, and 50% Propoxyphene above and below the 300 ng/ml cutoff were provided to each site. The results are given below:

Propoxyphene Concentration (ng/ml) n Site A Site B Site C
- + - + - +
0 45 15 0 15 0 15 0
150 45 15 0 15 0 14 1
225 45 10 5 8 7 7 8
375 45 0 15 0 15 1 14
450 45 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 or Propoxyphene containing urine samples at +50% and -50% cutoff levels. The following compounds show no cross-reactivity (were not detected positive) when tested with the PPX One Step Propoxyphene Test Strip at a concentration of 100,000 ng/ml.

Non Cross-Reacting Compounds
4-Acetamidophenol; Acetophenetidin; Acetone; N-Acetylprocainamide; Acetylsalicylic acid; Albumin; Aminopyrine; Amitryptyline; Amobarbital; Amoxapine; Amoxicillin; l-Amphetamine; Ampicillin; Apomorphine; Ascorbic acid; Aspartame; Atropine; Benzilic acid; Benzoic acid; Benzoylecgonine; Benzphetamine; Bilirubin; Brompheniramine; Buspirone; Caffeine; Cannabidiol; Chloral hydrate; Chloramphenicol; Chlordiazepoxide; Chloroquine; Chlorothiazide; dl-Chlorpheniramine; Chlorpromazine; Chlorproxithene; Cholesterol; Clomipramine; Clonidine; Cocaethylene; Cocaine hydrochloride; Codeine; Cortisone; l-Cotinine; Creatinine; Deoxycorticosterone; l-Deoxyephedrine; Dextromethorphan; Diazepam; Diclofenac; Diflunisal; Digoxin; 4-Dimethylaminoantipyrine; Diphenhydramine; Doxylamine; Ecgonine hydrochloride; Ecgonine methyl ester; EDDP; EMDP; Ephedrine; l-Y-Ephedrine; (1R,2S)-l-Ephedrine; dl-Epinephrine; Erythromycin; B-Estradiol; Estrone 3-sulfate; Ethanol; Ethyl p-aminobenzoate; Fenfluramine; Fenoprofen; Furosemide; Gentisic acid; d-Glucose; Guaiacol glyceryl ether; Hemoglobin; Hydralazine; Hydrochlorothiazide; Hydrocodone; Hydrocortisone; p-Hydroxyamphetamine; o-Hydroxyhippuric acid; p-Hydroxymethamphetamine; p-Hydroxynorephedrine; 3-Hydroxytyramine; Hydroxyzine; Ibuprofen; Imipramine; Iproniazid; l-Isoproterenol; Isoxsuprine; Ketoprofen; Labetalol; Lidocaine; Lithium carbonate; Loperamide; Maprotiline; Meperedine; Mephentermine; Meprobamate; d-Methamphetamine; l-Methamphetamine; Methaqualone; Methadol; Methoxyphenamine; Methylphenidate; dl-3,4-Methylenedioxyamphetamine; Methyprylon; Nalidixic acid; Naloxone; Naltrexone; a-Naphthaleneacetic acid; Naproxen; Niacinamide; Nifedipine; Nimesulide; Normorphone; Norethindrone; Noscapine; dl-Octopamine; Orphenadrine; Oxalic acid; Oxazepam; Oxolinic acid; Oxycodone; Oxymetazoline; Oxymorphone; Penicillin-G; Pentazocine; Pentobarbital; Perphenazine; Phencyclidine; Phenelzine; Pheniramine; Phenobarbital; Phenothiazine; Phentermine; l-Phenylephrine; B-Phenylethylamine; Phenylpropanolamine; Prednisolone; Prednisone; 5-B-Pregnane3a17a21triol; Procaine; Promazine; Promethazine; dl-Propranolol; d-Pseudoephedrine; Quinacrine; Quinidine; Quinine; Ranitidine; Riboflavin; Salicylic acid; Secobarbital; Serotonin (5-Hydroxytryptamine); Sodium Chloride; Sulfamethazine; Sulindac; Tetracycline; Tetrahydrocortisone 3-acetate; Tetrahydrocortisone 3-(B-D-glucuronide); Tetrahydrozoline; Theophylline; Thiamine; Thioridazine; l-Thyroxine; Tolbutamide; trans-2-Phenylcyclopropylamine; Trazodone; Trimethobenzamide; 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 (1.007 to 1.029) were spiked with 150 ng/ml and 450 ng/ml of Propoxyphene respectively. The PPX One Step Propoxyphene 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 Propoxyphene to 150 ng/ml and 450 ng/ml. The spiked, pH-adjusted urine was tested with the PPX One Step Propoxyphene Test Strip in duplicate. The results demonstrate that varying ranges of pH does not interfere with the performance of the test.