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

Specificity

The following table lists compounds that are detected positive in urine by the PCP One Step Phencyclidine 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)
Phencyclidine 25
4-Hydroxy-phencyclidine 12,500

Accuracy

A side-by-side comparison was conducted using the PCP One Step Phencyclidine Test Strip and a leading commercially available PCP rapid test. Testing was performed on 212 clinical specimens. Ten percent (10%) of the specimens employed were either at −25% or +25% level of the cutoff concentration of 25 ng/mL phencyclidine. Presumptive positive results were confirmed by GC/MS. The following results were tabulated:

Methods and Results Other PCP Rapid Test
Pos. Neg. Totals
PCP
One Step
Test Strip
Positive 56 0 56
Negative 1 155 156
Totals 57 155 212
*Agreement 98% >99% >99%

* % Agreement With Other PCP Rapid Test

When compared to the GC/MS lab testing method at the cutoff concentration of 25 ng/mL, the following results were tabulated:

Methods and Results GC/MS
Pos. Neg. Totals
PCP
One Step
Test Strip
Positive 50 5 55
Negative 0 157 157
Totals 50 162 212
*Agreement >99% 97% 98%

* % Agreement With GC/MS Lab Testing Method

Eighty (80) of these samples were also run using the PCP One Step Phencyclidine 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 phencyclidine at the following concentrations: 0 ng/mL, 12.5 ng/mL, 18.75 ng/mL, 25 ng/mL, 31.25 ng/mL, and 37.5 ng/mL. The result demonstrates >99% accuracy at 50% above and 50% below the cutoff concentration. The data are summarized below:

Phencyclidine
Conc. (ng/mL)
% of
Cutoff
n Visual Result
Neg. Pos.
0 0% 30 30 0
12.5 −50% 30 30 0
18.75 −25% 30 19 11
25 Cutoff 30 16 14
31.25 +25% 30 6 24
37.5 +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 no phencyclidine, 25% phencyclidine above and below the cutoff, and 50% phencyclidine above and below the 25 ng/mL cutoff was provided to each site. The following results were tabulated:

Phencyclidine
Conc. (ng/mL)
n Site A Site B Site C
+ + +
0 15 15 0 15 0 15 0
12.5 15 15 0 14 1 14 1
18.75 15 11 4 13 2 10 5
31.25 15 8 7 5 10 1 14
37.5 15 4 11 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 phencyclidine-positive urine. The following compounds show no cross-reactivity (were not detected positive) when tested with the PCP One Step Phencyclidine 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; Ampicillin; Apomorphine; Ascorbic acid; Aspartame; Atropine; Benzilic acid; Benzoic acid; Benzoylecgonine; Benzphetamine; Bilirubin; Brompheniramine; Caffeine; Cannabidiol; Cannabinol; Chloral hydrate; Chloramphenicol; Chlordiazepoxide; Chlorothiazide; dl-Chlorpheniramine; Chlorpromazine; Chloroquine; Cholesterol; Clomipramine; Clonidine; Cocaine; Codeine; Cortisone; l-Cotinine; Creatinine; Deoxycorticosterone; Dextromethorphan; Diazepam; Diclofenac; Diflunisal; Digoxin; Diphenhydramine; Doxylamine; Ecgonine; Ecgonine methyl ester; Erythromycin; B-Estradiol; Estrone 3-sulfate; Ethyl p-aminobenzoate; Fenoprofen; Furosemide; Gentisic acid; Hemoglobin; Hydralazine; Hydrochlorothiazide; Hydrocodone; Hydrocortisone; o-Hydroxyhippuric acid; p-Hydroxymethamphetamine; 3-Hydroxytyramine; Ibuprofen; Imipramine; Iproniazid; dl-Isoproterenol; Isoxsuprine; Ketamine; Ketoprofen; Labetalol; Loperamide; Maprotiline; Meperedine; Meprobamate; Methadone; Methoxyphenamine; d-3,4-Methylenedioxyamphetamine; d-3,4-Methylenedioxymethamphetamine; Morphine; Morphine 3-B-D-glucuronide; Nalidixic acid; Naloxone; Naltrexone; Naproxen; Niacinamide; Nifedipine; Norcodeine; Norethindrone; d-Norpropoxyphene; Noscapine; dl-Octopamine; Oxalic acid; Oxazepam; Oxolinic acid; Oxycodone; Oxymetazoline; Papaverine; Penicillin-G; Pentazocine; Pentobarbital; Perphenazine; Phenelzine; Phenobarbital; Phentermine; l-Phenylephrine; B-Phenylethylamine; Phenylpropanolamine; Prednisolone; Prednisone; Procaine; Promazine; Promethazine; dl-Propranolol; d-Propoxyphene; d-Pseudoephedrine; l-Pseudoephedrine; Quinidine; Quinine; Ranitidine; Salicylic acid; Secobarbital; Serotonin (5-Hydroxytryptamine); Sulfamethazine; Sulindac; Temazepam; 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 with specific gravity ranges from 1.007 to 1.032 were spiked with 12.5 ng/mL and 37.5 ng/mL of phencyclidine, respectively. The PCP One Step Phencyclidine 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 phencyclidine to 12.5 ng/mL and 37.5ng/mL. The spiked, pH-adjusted urine was tested with the PCP One Step Phencyclidine 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.