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3-Panel - THC-COC-OPI |
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One Step Marijuana, Cocaine, and Opiate
Drug Screen Test Card (Page 2) |
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1 |
| 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, or Opiate. The following compounds show no cross-reactivity when tested with the One Step Drug Screen Test Card at a concentration of 100,000 ng/mL. |
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| 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;
Chloroquine; Cholesterol; Clonidine; Cortisone;
l-Cotinine; Creatinine; Deoxycorticosterone; Dextromethorphan; Diclofenac; Diflunisal; Digoxin; Diphenhydramine;
Ecgonine methyl ester; l-Pseudoephedrine; B-Estradiol; Estrone-3-sulfate;
Ethyl-p-aminobenzoate; [1R,2S] l-Ephedrine; l-Epinephrine;
Erythromycin; Fenoprofen; Furosemide; Gentisic acid; Hemoglobin;
Hydralazine; Hydrochlorothiazide; Hydrocortisone; o-Hydroxyhippuric
acid; p-Hydroxyamphetamine; p-Hydroxytyramine; Ibuprofen;
Iproniazid; dl-Isoproterenol; Isoxsuprine; Ketamine; Ketoprofen;
Labetalol; Loperamide; Meperidine; Meprobamate;
Methoxyphenamine; Methylphenidate; Nalidixic acid; Naloxone; Naltrexone;
Naproxen; Niacinamide; Nifedipine; Norethindrone; d-Norpropoxyphene;
Noscapine; dl-Octopamine; Oxalic acid; Oxolinic acid;
Oxymetazoline; Papaverine; Penicillin-G; Pentazocine hydrochloride;
Perphenazine; Phenelzine; Trans-2-Phenylcyclo-propylamine
hydrochloride; l-Phenylephrine; B-Phenylethylamine;
Phenylpropanolamine; Prednisolone; Prednisone; dl-Propranolol; d-Propoxyphene; d-Pseudoephedrine;
Quinacrine; Quinine; Quinidine; Ranitidine; 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; Tyramine; Uric acid;
Verapamil; Zomepirac |
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. |
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| Test |
Compounds Contributed to the Totals of GC/MS |
| THC |
11-nor-D9-tetrahydrocannabinol-9 carboxylic acid |
| COC |
Benzoylecgonine |
| OPI |
Morphine, Codeine |
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| 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 |
109 |
96% |
| Negative |
150 |
6 |
0 |
0 |
1 |
97% |
| COC |
Positive |
0 |
2 |
15 |
16 |
103 |
96% |
| Negative |
150 |
5 |
7 |
1 |
1 |
90% |
| OPI |
Positive |
0 |
0 |
16 |
18 |
116 |
>99% |
| Negative |
150 |
0 |
0 |
0 |
0 |
90% |
% Agreement With Commercial Kit |
| |
THC |
COC |
OPI |
| Positive Agreement |
98% |
95% |
>99% |
| Negative Agreement |
>99% |
>99% |
>99% |
| Total Results |
99% |
98% |
>99% |
% Agreement With GC/MS |
| |
THC |
COC |
OPI |
| Positive Agreement |
96% |
96% |
>99% |
| Negative Agreement |
97% |
90% |
>90% |
| Total Results |
96% |
93% |
>95% |
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| 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. |
| 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: |
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11-nor-D9-THC-9 COOH
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 |
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| *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 |
| A drug-free urine pool was spiked with drugs at concentrations listed. The results are summarized below. |
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Drug Concentration
Cutoff Range |
n |
THC |
COC |
OPI |
| - |
+ |
- |
+ |
- |
+ |
| 0% Cutoff |
30 |
30 |
0 |
30 |
0 |
30 |
0 |
| -50% Cutoff |
30 |
30 |
0 |
30 |
0 |
30 |
0 |
| -25% Cutoff |
30 |
12 |
18 |
30 |
0 |
30 |
0 |
| Cutoff |
30 |
1 |
29 |
4 |
26 |
13 |
17 |
| +25% Cutoff |
30 |
1 |
29 |
0 |
30 |
4 |
26 |
| +50% Cutoff |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
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| Effect of Urinary Specific Gravity |
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|
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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. |
| 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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| Analytical Specificity:
See Page 1. |
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