The following specifications apply to the PPX: Propoxyphene panel of the One Step Urine Drug Tests. This includes any multi-panel urine drug tests that contain a PPX panel.

Specificity

The following table lists compounds that are detected positive in urine by the PPX One Step Propoxyphene 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)
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:

Methods and Results Other PPX Rapid Test
Pos. Neg. Totals
PPX
One Step
Test Strip
Positive 157 0 157
Negative 0 157 157
Totals 157 157 314
*Agreement >99% >99% >99%

* % Agreement With Other PPX Rapid Test

A clinical study was conducted on 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 cutoff concentration of 300 ng/mL. When compared to the GC/MS analysis data, the following results were tabulated:

Methods and Results GC/MS
Neg. <−50%
of
Cutoff
−50% of
Cutoff to
Cutoff
Cutoff to
+50% of
Cutoff
>+50%
of
Cutoff
PPX
One Step
Test Strip
Positive 0 0 2 7 158
Negative 152 5 18 10 0
*Agreement 99% (175/177) 94% (165/175)

* Agreement With GC/MS Lab Testing Method. Total Agreement: 97% (340/352)

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
Conc. (ng/mL)
% of
Cutoff
n Visual Result
Neg. Pos.
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
Conc. (ng/mL)
n Site A Site B Site C
+ + +
0 15 15 0 15 0 15 0
150 15 15 0 15 0 14 1
225 15 10 5 8 7 7 8
375 15 0 15 0 15 1 14
450 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 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; (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; trans-2-Phenylcyclopropylamine; l-Phenylephrine; B-Phenylethylamine; Phenylpropanolamine; Prednisolone; Prednisone; 5-B-Pregnane-3a,17a,21-triol-20-one; Procaine; Promazine; Promethazine; dl-Propranolol; d-Pseudoephedrine; l-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; 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 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 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.