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

Specificity

The following table lists compounds that are detected positive in urine by the MOP One Step Opiate 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)
Morphine 300
Codeine 300
Ethylmorphine 6,250
Hydrocodone 50,000
Hydromorphone 3,125
Levorphanol 1,500
6-Monoacetylmorphine 400
Morphine 3-B-D-glucuronide 1,000
Norcodeine 6,250
Normorphone 100,000
Oxycodone 30,000
Oxymorphone 100,000
Procaine 15,000
Thebaine 6,250

Accuracy

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

Methods and Results Other MOP Rapid Test
Pos. Neg. Totals
MOP
One Step
Test Strip
Positive 150 0 150
Negative 0 150 150
Totals 150 150 300
*Agreement >99% >99% >99%

* % Agreement With Other MOP Rapid Test

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

Methods and Results GC/MS
Pos. Neg. Totals
MOP
One Step
Test Strip
Positive 141 9 150
Negative 0 150 150
Totals 141 159 300
*Agreement >99% 94% 97%

* % Agreement With GC/MS Lab Testing Method

Eighty (80) of these samples were also run using the MOP One Step Opiate 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 morphine 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:

Morphine
Conc. (ng/mL)
% of
Cutoff
n Visual Result
Neg. Pos.
0 0% 30 30 0
150 −50% 30 30 0
225 −25% 30 25 5
300 Cutoff 30 17 13
375 +25% 30 1 29
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 were blind labeled and tested at each site. The results are given below:

Morphine
Conc. (ng/mL)
n Site A Site B Site C
+ + +
0 15 15 0 15 0 15 0
150 15 13 2 13 2 15 0
225 15 3 12 7 8 10 5
375 15 0 15 1 14 0 15
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 either drug-free urine or morphine-positive urine. The following compounds show no cross-reactivity (were not detected positive) when tested with the MOP One Step Opiate Test Strip at a concentration of 100,000 ng/mL.

Non Cross-Reacting Compounds
4-Acetamidophenol; 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; Chloral hydrate; Chloramphenicol; Chlordiazepoxide; Chloroquine; Chlorothiazide; dl-Chlorpheniramine; Chlorpromazine; Cholesterol; Clomipramine; Clonidine; Cocaine hydrochloride; Cortisone; l-Cotinine; Creatinine; Deoxycorticosterone; Dextromethorphan; Diazepam; Diclofenac; Diflunisal; Digoxin; Diphenhydramine; Doxylamine; Ecgonine hydrochloride; Ecgonine methyl ester; Erythromycin; B-Estradiol; Estrone 3-sulfate; Ethyl p-aminobenzoate; Fenoprofen; Furosemide; Gentisic acid; Hemoglobin; Hydralazine; Hydrochlorothiazide; 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; Nalidixic acid; Nalorphine; Naloxone; Naltrexone; Naproxen; Niacinamide; Nifedipine; Norethindrone; d-Norpropoxyphene; Noscapine; dl-Octopamine; Oxalic acid; Oxazepam; Oxolinic acid; Oxymetazoline; Papaverine; Penicillin-G; Pentazocine; Pentobarbital; Perphenazine; Phencyclidine; Phenelzine; Phenobarbital; Phentermine; l-Phenylephrine; B-Phenylethylamine; Phenylpropanolamine; Prednisone; d-Propoxyphene; dl-Propranolol; 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 of normal, high, and low specific gravity ranges were spiked with 150 ng/mL and 450 ng/mL of morphine, respectively. The MOP One Step Opiate 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 morphine to 150 ng/mL and 450 ng/mL. The spiked, pH-adjusted urine was tested with the MOP One Step Opiate 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.