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One Step Drug Test:  Marijuana, Cocaine, Opiates, Amphetamine, Methamphetamine, Benzodiazepines, Barbiturates, PCP, Ecstasy, Oxycodone, Methadone, and Propoxyphene (Page 2)

12-Panel - THC-COC-OPI-AMP-mAMP-BZO-BAR-PCP-MDMA-OXY-MTD-PPX
One Step Marijuana, Cocaine, Opiates, Amphetamine, Methamphetamine, Benzodiazepines, Barbiturates, PCP, Ecstasy, Oxycodone, Methadone, and Propoxyphene Drug Screen Test Card

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Cross-Reactivity

A study was conducted to determine the cross-reactivity of the test with compounds in either drug-free urine or drug positive urine containing Marijuana, Cocaine, Opiate, Amphetamine, Methamphetamine, Benzodiazepines, Barbiturates, Phencyclidine, MDMA, Oxycodone, Methadone, or Propoxyphene. The following compounds show no cross-reactivity (were not detected positive) when tested with the One Step Drug Screen Test Card at a concentration of 100,000 ng/ml:

Non Cross-Reacting Compounds
Acetaminophen; Acetophenetidin; N-Acetylprocainamide; Acetylsalicylic acid; Aminopyrine; Amoxicillin; Ampicillin; l-Ascorbic acid; Apomorphine; Aspartame; Atropine; Benzilic acid; Benzoic acid; Benzphetamine (parent compound only); Bilirubin; dl-Brompheniramine; Caffeine; Cannabidiol; Chloral hydrate; Chloramphenicol; Chlorothiazide; dl-Chlorpheniramine; Chlorpromazine; Cholesterol; Clonidine; Cortisone; l-Cotinine; Creatinine; Deoxycorticosterone; Dextromethorphan; Diclofenac; Diflunisal; Digoxin; Diphenhydramine; l-Y-Ephedrine; B-Estradiol; Estrone 3-sulfate; Ethyl p-aminobenzoate; l-Epinephrine; Erythromycin; Fenoprofen; Furosemide; Gentisic acid; Hemoglobin; Hydralazine; Hydrochlorothiazide; Hydrocortisone; o-Hydroxyhippuric acid; p-Hydroxytyramine; Ibuprofen; Iproniazid; dl-Isoproterenol; Isoxsuprine; Ketamine; Ketoprofen; Labetalol; Loperamide; Meperidine; Meprobamate; Methoxyphenamine; Methylphenidate; Nalidixic acid; Naproxen; Niacinamide; Nifedipine; Norethindrone; Noscapine; dl-Octopamine; Oxalic acid; Oxolinic acid; Oxymetazoline; Papaverine; Penicillin-G; Pentazocine hydrochloride; Perphenazine; Phenelzine; trans-2-Phenylcyclopropylamine hydrochloride; Prednisolone; Prednisone; dl-Propranolol; d-Pseudoephedrine; Quinacrine; Quinine; Quinidine; Ranitidine (parent compound only); Salicylic acid; Serotonin; Sulfamethazine; Sulindac; Tetracycline; Tetrahydrocortisone 3-acetate; Tetrahydrocortisone 3-(B-D-glucuronide); Tetrahydrozoline; Thiamine; Thioridazine; dl-Tyrosine; Tolbutamide; Triamterene; Trifluoperazine; Trimethoprim; Tryptamine; dl-Tryptophan; Uric acid; Verapamil; Zomepirac

Accuracy

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A side-by-side comparison was conducted using the One Step Drug Screen Test Card and commercially available drug rapid tests. Testing was performed on approximately 300 specimens per drug type previously collected from subjects presenting for Drug Screen Testing. Presumptive positive results were confirmed by GC/MS. The following compounds were quantified by GC/MS and contributed to the total amount of drugs found in presumptive positive urine samples tested:

Test Compounds Contributed to the Totals of GC/MS
THC 11-nor-D9-THC-9
COC Benzoylecgonine
OPI Morphine, Codeine
AMP Amphetamine
mAMP Methamphetamine
BZO Oxazepam; Nordiazepam; a-Hydroxyalprazolam; Desalkylflurazepam
BAR Secobarbital; Butalbital; Phenobarbital; Pentobarbital
PCP Phencyclidine
MDMA MDMA
OXY Oxycodone
MTD Methadone
PPX Propoxyphene

The following results are tabulated from these clinical studies:

Method GC/MS
Multi-Drug Single-Line Test Card Neg. Neg. (<-25% Cutoff) Near Cutoff Neg. (-25% Cutoff to Cutoff) Near Cutoff Pos. (Cutoff to +25% Cutoff) Pos. (>+25% Cutoff) Agreement with GC/MS
THC Positive 0 13 9 12 106 97%
Negative 150 6 0 2 2 88%
COC Positive 0 2 15 16 103 98%
Negative 150 5 7 1 1 91%
OPI Positive 0 0 16 18 116 >99%
Negative 150 0 0 0 0 90%
AMP Positive 0 1 8 18 114 97%
Negative 149 1 5 4 0 95%
mAMP Positive 0 0 10 9 126 99%
Negative 150 0 4 1 0 94%
BZO Positive 0 7 1 5 126 97%
Negative 149 7 1 3 1 95%
BAR Positive 0 0 4 5 117 92%
Negative 150 1 5 1 9 98%
PCP Positive 0 0 6 10 40 >99%
Negative 150 6 0 0 0 96%
MDMA Positive 0 0 3 6 82 >99%
Negative 147 0 2 0 0 98%
OXY Positive 0 0 1 2 133 98%
Negative 147 6 8 0 3 99%
MTD Positive 0 0 10 10 112 99%
Negative 150 17 0 0 1 94%
PPX Positive 0 0 2 5 159 94%
Negative 152 11 12 9 2 99%
% Agreement With Commercial Kit
Results THC COC OPI AMP mAMP BZO
Positive Agreement 98% 95% >99% 97% 98% 90%
Negative Agreement >99% >99% >99% >99% >99% 97%
Total Results 99% 98% >99% 98% 99% 94%
% Agreement With Commercial Kit
Results BAR PCP MDMA OXY MTD PPX
Positive Agreement >99% 98% >99% 96% >99% >99%
Negative Agreement 99% >99% 99% 99% >99% >99%
Total Results 99% 99% 99% 98% >99% >99%
% Agreement With GC/MS
Results THC COC OPI AMP mAMP BZO
Positive Agreement 97% 98% >99% 97% 99% 97%
Negative Agreement 88% 91% 90% 95% 94% 95%
Total Results 91% 94% 95% 96% 96% 96%
% Agreement With GC/MS
Results BAR PCP MDMA OXY MTD PPX
Positive Agreement 92% >99% >99% 98% 99% 94%
Negative Agreement 98% 96% 98% 99% 94% 99%
Total Results 95% 97% 99% 99% 96% 96%

Forty (40) clinical samples for each drug were run using each of The One Step Drug Screen Test Card by an untrained operator at a Professional Point of Care site. Based on GC/MS data, the operator obtained statistically similar Positive Agreement, Negative Agreement and Overall Agreement rates as trained laboratory personnel.

Sensitivity

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A drug-free urine pool was spiked with drugs at concentrations listed. The results are summarized below:

Drug Concentration
Cutoff Range		 n THC COC OPI AMP mAMP BZO
- + - + - + - + - + - +
0% Cutoff 30 30 0 30 0 30 0 30 0 30 0 30 0
-50% Cutoff 30 30 0 30 0 30 0 30 0 30 0 30 0
-25% Cutoff 30 12 18 30 0 30 0 22 8 30 0 27 3
Cutoff 30 1 29 4 26 13 17 12 18 18 12 11 19
+25% Cutoff 30 1 29 0 30 4 26 2 28 1 29 5 25
+50% Cutoff 30 0 30 0 30 0 30 0 30 0 30 0 30
Drug Concentration
Cutoff Range		 n BAR PCP MDMA OXY MTD PPX
- + - + - + - + - + - +
0% Cutoff 30 30 0 30 0 30 0 30 0 30 0 30 0
-50% Cutoff 30 30 0 30 0 30 0 30 0 29 1 30 0
-25% Cutoff 30 27 3 19 11 26 4 30 0 24 6 24 6
Cutoff 30 22 8 16 14 17 13 18 12 21 9 17 13
+25% Cutoff 30 7 23 6 24 4 26 6 24 2 28 7 23
+50% Cutoff 30 2 28 0 30 0 30 0 30 0 30 0 30

Precision

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A study was conducted at three physician offices by untrained operators using three different lots of product to demonstrate the within run, between run and between operator precision. An identical panel of coded specimens, containing drugs at the concentration of +/- 50% and +/- 25% cutoff level, was labeled, blinded and tested at each site. The results are given below:

11-nor-D9-THC-9
Concentration (ng/ml)		 n Site A Site B Site C
- + - + - +
0 15 15 0 15 0 15 0
25 15 15 0 15 0 14 1
37.5 15 9 6 14 1 9 6
62.5 15 2 13 0 15 0 15
75 15 0 15 0 15 0 15
Benzoylecgonine
Concentration (ng/ml)		 n Site A Site B Site C
- + - + - +
0 15 14* 0 15 0 15 0
150 15 14 1 15 0 14 1
225 15 4 11 5 10 8 7
375 15 0 15 0 15 0 15
450 15 0 15 0 15 1 14

*Note: One invalid result was obtained.

Morphine
Concentration (ng/ml)		 n Site A Site B Site C
- + - + - +
0 15 15 0 15 0 15 0
1,000 15 15 0 15 0 14 1
1,500 15 13 2 11 4 7 8
2,500 15 4 11 1 14 2 13
3,000 15 0 15 0 15 2 13
Amphetamine
Concentration (ng/ml)		 n Site A Site B Site C
- + - + - +
0 15 15 0 15 0 15 0
500 15 15 0 15 0 14 1
750 15 13 2 11 4 11 4
1,250 15 6 9 4 11 4 11
1,500 15 2 13 1 14 1 14
Methamphetamine
Concentration (ng/ml)		 n Site A Site B Site C
- + - + - +
0 15 15 0 15 0 15 0
500 15 15 0 14 1 13 2
750 15 11 4 10 5 10 5
1,250 15 8 7 4 11 6 9
1,500 15 1 14 1 14 0 15
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
Secobarbital
Concentration (ng/ml)		 n Site A Site B Site C
- + - + - +
0 15 15 0 15 0 15 0
150 15 13 2 15 0 15 0
225 15 5 10 7 8 10 5
375 15 2 13 5 10 5 10
450 15 0 15 1 14 1 14
Phencyclidine
Concentration (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 4 11 0 15
MDMA
Concentration (ng/ml)		 n Site A Site B Site C
- + - + - +
0 15 15 0 15 0 15 0
250 15 15 0 15 0 15 0
375 15 15 0 15 0 15 0
625 15 6 9 4 11 7 8
750 15 0 15 0 15 0 15
Oxycodone
Concentration (ng/ml)		 n Site A Site B Site C
- + - + - +
0 15 15 0 15 0 15 0
50 15 15 0 15 0 15 0
75 15 14 1 13 2 11 4
125 15 1 14 0 15 0 15
150 15 0 15 0 15 0 15
Methadone
Concentration (ng/ml)		 n Site A Site B Site C
- + - + - +
0 15 15 0 15 0 15 0
150 15 12 3 15 0 15 0
225 15 8 7 14 1 15 0
375 15 0 15 0 15 1 14
450 15 1 14 0 15 0 15
Propoxyphene
Concentration (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

Effect of Urinary Specific Gravity

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Fifteen (15) urine samples of normal, high, and low specific gravity ranges (1.000-1.037) were spiked with drugs at 50% below and 50% above cutoff levels respectively. The One Step Drug Screen Test Card was tested in duplicate using fifteen drug-free urine and spiked urine samples. The results demonstrate that varying ranges of urinary specific gravity does not affect the test results.

Effect of Urinary pH

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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 drugs at 50% below and 50% above cutoff levels. The spiked, pH-adjusted urine was tested with the One Step Drug Screen Test Card. The results demonstrate that varying ranges of pH does not interfere with the performance of the test.

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