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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% cut-off level, was labeled, blinded and tested at each site. The results are given below:
AMPHETAMINE (AMP)
| Amphetamine conc. (ng/mL) |
n per site |
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 |
| 1250 | 15 | 6 | 9 | 4 | 11 | 4 | 11 |
| 1500 | 15 | 2 | 13 | 1 | 14 | 1 | 14 |
BARBITURATES (BAR)
| Secobarbital conc. (ng/mL) |
n per site |
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 | 11 | 8 | 10 | 5 |
| 375 | 15 | 2 | 13 | 5 | 10 | 5 | 10 |
| 450 | 15 | 0 | 15 | 1 | 14 | 1 | 14 |
BENZODIAZEPINES (BZO)
| Oxazepam conc. (ng/mL) |
n per site |
Site A |
Site B | Site C | |||
| - | + | - | + | - | + | ||
| 0 | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| 150 | 15 | 14 | 1 | 14 | 1 | 15 | 0 |
| 225 | 15 | 11 | 4 | 14 | 1 | 14 | 1 |
| 375 | 15 | 0 | 15 | 1 | 14 | 3 | 12 |
| 450 | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
COCAINE (COC)
| Benzoylecgonine conc. (ng/mL) |
n per site |
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.
COTININE (COT)
| Cotinine conc. (ng/mL) |
n per lot |
Lot A |
Lot B | ||
| - | + | - | + | ||
| 0 | 30 | 30 | 0 | 30 | 0 |
| 100 | 30 | 30 | 0 | 30 | 0 |
| 400 | 30 | 0 | 30 | 0 | 30 |
PROPOXYPHENE (PPX)
| Propoxyphene conc. (ng/mL) |
n per lot |
Site A |
Site B | Site C | |||
| - | + | - | + | - | + | ||
| 0 | 45 | 15 | 0 | 15 | 0 | 15 | 0 |
| 150 | 45 | 15 | 0 | 15 | 0 | 14 | 1 |
| 225 | 45 | 10 | 5 | 8 | 7 | 7 | 8 |
| 375 | 45 | 0 | 15 | 0 | 15 | 1 | 14 |
| 450 | 45 | 0 | 15 | 0 | 15 | 0 | 15 |
MARIJUANA (THC)
| 11-nor-09 -THC-9-COOH conc. (ng/mL) |
n per site |
Site A |
Site B | Site C | |||
| - | + | - | + | - | + | ||
| 0 | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| 25 | 15 | 15 | 0 | 15 | 0 | 14 | 1 |
| 375 | 15 | 9 | 6 | 14 | 1 | 9 | 6 |
| 62.5 | 15 | 2 | 13 | 0 | 15 | 0 | 15 |
| 75 | 15 | 0 | 15 | 0 | 15 | 0 | 16 |
METHADONE (MTD)
| Methadone conc. (ng/mL) |
n per site |
Site A |
Site B | Site C | |||
| - | + | - | + | - | + | ||
| 0 | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| 150 | 15 | 12 | 3 | 15 | 0 | 15 | 0 |
| 225 | 15 | 5 | 7 | 14 | 1 | 15 | 0 |
| 375 | 15 | 0 | 15 | 0 | 15 | 1 | 14 |
| 450 | 15 | 1 | 14 | 0 | 15 | 0 | 15 |
METHAMPHETAMINE (mAMP)
| Methamphetamine conc. (ng/mL) |
n per site |
Site A |
Site B | Site C | |||
| - | + | - | + | - | + | ||
| 0 | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| 500 | 15 | 15 | 0 | 14 | 1 | 13 | 2 |
| 750 | 15 | 21 | 4 | 10 | 5 | 10 | 5 |
| 1250 | 15 | 8 | 7 | 4 | 11 | 6 | 9 |
| 1500 | 15 | 1 | 14 | 1 | 14 | 0 | 15 |
Ecstasy (MDMA)
| MDMA conc. (ng/mL) |
n per site |
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 |
OPIATE 300 (MOP 300 OR OPI 300)
|
Morphine |
n per site |
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 |
OPIATES (OPI 2000)
| Morphine conc. (ng/mL) |
n per site |
Site A |
Site B | Site C | |||
| - | + | - | + | - | + | ||
| 0 | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| 1000 | 15 | 15 | 0 | 15 | 0 | 14 | 1 |
| 1500 | 15 | 13 | 2 | 11 | 4 | 7 | 8 |
| 2500 | 15 | 4 | 11 | 1 | 14 | 2 | 13 |
| 3000 | 15 | 0 | 15 | 0 | 15 | 2 | 13 |
Oxycodone (OXY)
| Oxycodone conc. (ng/mL) |
n per site |
Site A |
Site B | Site C | |||
| - | + | - | + | - | + | ||
| 0 | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| 50 | 15 | 15 | 0 | 15 | 0 | 14 | 1 |
| 75 | 15 | 15 | 0 | 14 | 1 | 5 | 10 |
| 125 | 15 | 15 | 0 | 3 | 12 | 2 | 13 |
| 150 | 15 | 0 | 15 | 0 | 15 | 0 | 15 |
PHENCYCLIDINE (PCP)
|
Phencyclidine |
n per site |
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 |
TRICYCLIC ANTIDEPRESSANT (TCA)
| Phencyclidine conc. (ng/mL) |
n per site |
Site A |
Site B | Site C | |||
| - | + | - | + | - | + | ||
| 0 | 15 | 15 | 0 | 15 | 0 | 15 | 0 |
| 500 | 15 | 15 | 0 | 14 | 1 | 14 | 1 |
| 750 | 15 | 11 | 4 | 13 | 2 | 10 | 5 |
| 1250 | 15 | 8 | 7 | 5 | 10 | 1 | 14 |
| 1500 | 15 | 4 | 11 | 0 | 15 | 0 | 15 |
The following table lists the concentration of compounds (ng/mL) that are detected positive in urine by One Step Drug Screen Test Card at 5 minutes.
|
AMPHETAMINE |
ng/mL |
|
D-Amphetamine |
1,000 |
|
D,L-Amphetamine sulfate |
3,000 |
|
L-Amphetamine |
50,000 |
|
(±)3,4-Methylenedioxyamphetamine |
2,000 |
|
Phentermine |
3,000 |
|
BARBITURATES |
|
|
Secobarbital |
300 |
|
Amobarbital |
300 |
|
Alphenol |
150 |
|
Aprobarbital |
200 |
|
Butabarbital |
75 |
|
Butalbital |
2,500 |
|
Butethal |
100 |
|
Cyclopentobarbital |
600 |
|
Pentobarbital |
300 |
|
Phenobarbital |
100 |
|
BENZODIAZEPINES |
|
|
Oxazepam |
300 |
|
Alprazolam |
196 |
|
a-Hydroxyalprazolam |
1,262 |
|
Bromazepam |
1,562 |
|
Chlordiazepoxide |
1,562 |
|
Chlordiazepoxide HCI |
781 |
|
Clobazam |
98 |
|
Clonazepam |
781 |
|
Clorazepate dipotassium |
195 |
|
Delorazepam |
1,562 |
|
Desalkylflurazepam |
390 |
|
Diazepam |
195 |
|
Estazolam |
2,500 |
|
Flunitrazepam |
390 |
|
(±) Lorazepam |
1,562 |
|
RS-Lorazepam glucuronide |
156 |
|
Midazolam |
12,500 |
|
Nitrazepam |
98 |
|
Norchlordiazepoxide |
195 |
|
Nordiazepam |
390 |
|
Oxazepam |
300 |
|
Temazepam |
98 |
|
Triazolam |
2,500 |
|
COCAINE |
|
|
Benzoylecgonine |
300 |
|
Cocaine HCl |
780 |
|
Cocaethylene |
12,500 |
|
Ecgonine HCl |
32,000 |
|
MARIJUANA (THC) |
|
|
11-nor-A9 -THC-9 COOH |
50 |
| Cannabinol |
20,000 |
| 11-nor-A8-THC-9 COOH |
30 |
| A8 -THC |
15,000 |
| A9 -THC |
15,000 |
|
METHADONE |
|
|
Methadone |
300 |
|
Doxylamine |
50,000 |
|
METHAMPHETAMINE |
|
|
D-Methamphetamine |
1,000 |
|
p-Hydroxymethamphetamine |
30,000 |
|
L-Methamphetamine |
8,000 |
|
(±)-3,4-Methylenedioxymethamphetamine |
2,000 |
|
Mephentermine |
50,000 |
|
Ecstasy (MDMA) |
|
|
D,L-3,4-Methylenedioxymethamphetamine (MDMA) |
500 |
|
3,4-Methylenedioxyamphetamine |
3,000 |
|
3,4-Methylenedioxyethyl-amphetamine (MDE) |
300 |
|
OPIATE 300 (MOP) |
|
|
Morphine |
300 |
|
Codeine |
300 |
|
Ethylmorphine |
6,250 |
|
Hydrocodone |
50,000 |
|
Hydromorphone |
3,125 |
|
Levophanol |
1500 |
|
6-Monoacetylmorphine |
400 |
|
Morphine 3-p-D-glucuronide |
1,000 |
|
Norcodeine |
6,250 |
|
Normorphone |
100,000 |
|
Oxycodone |
30,000 |
|
Oxymorphone |
100,000 |
|
Procaine |
15,000 |
|
Thebaine |
6,250 |
|
OPIATES (2000) |
|
|
Morphine |
2,000 |
|
Codeine |
2,000 |
|
Ethylmorphine |
5,000 |
|
Hydrocodone |
12,500 |
|
Hydromorphone |
5,000 |
|
Levophanol |
75,000 |
|
6-Monoacetylmorphine |
5,000 |
|
Morphine 3-p-D-glucuronide |
2,000 |
|
Norcodeine |
12,500 |
|
Normorphone |
50,000 |
|
Oxycodone |
25,000 |
|
Oxymorphone |
25,000 |
|
Procaine |
150,000 |
|
Thebaine |
100,000 |
|
Oxycodone |
|
| Oxycodone | 100 |
| Codeine |
50,000 |
| Dihydrocodeine |
12,500 |
| Ethylmorphine | 25,000 |
| Hydrocodone | 1,562 |
| Hydromorphone | 12,500 |
| Oxymorphone | 1,562 |
| Thebaine | 50,000 |
|
PCP |
|
|
Phencyclidine |
25 |
|
4-Hydroxyphencyclidine |
12,500 |
|
TCA |
|
|
Notriptyline |
1,000 |
|
Nordoxepine |
1,000 |
|
Trimipramine |
3,000 |
|
Amitriptyline |
1,500 |
|
Promazine |
1,500 |
|
Desipramine |
200 |
|
Imipramine |
400 |
|
Clomipramine |
12,500 |
|
Doxepine |
2,000 |
|
Maprotiline |
2,000 |
|
Promethazine |
2,500 |
Effect of Urinary Specific Gravity
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 cut-off 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 the 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 drugs at 50% below and 50% above cut-off levels. The spiked, pH-adjusted urine was tested with One Step Drug Screen Test Card. The results demonstrate that varying ranges of pH does not interfere with the performance of the test.
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 Cocaine, Barbiturates, Benzodiazepine, Amphetamine, Methamphetamine, Marijuana, Methadone, Opiate or Phencyclidine. The following compounds show no cross-reactivity when tested with One Step Drug Screen Test Card at a concentration of 100 pg/mL.

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