Urine 3-Drug Combo - COC/MAMP/THC-Sensitivity & Precision

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Drug Screen Test Card with Cup and Adulterations Precision and Analytical Sensitivity

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 ą 50% and ą 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
Amphetamine conc. (ng/mL)	n per site	-	+	-	+	-	+
0	5	5	0	5	0	5	0
500	5	5	0	4	1	5	0
750	5	5	0	1	4	1	4
1250	5	0	5	0	5	0	5
1500	5	0	5	0	5	0	5

BARBITURATES (BAR)

Secobarbital conc. (ng/mL)	n per site	Site A		Site B		Site C
Secobarbital conc. (ng/mL)	n per site	-	+	-	+	-	+
0	5	5	0	5	0	5	0
150	5	4	1	5	0	5	0
225	5	1	4	4	1	5	0
375	5	0	5	0	5	2	3
450	5	0	5	0	5	1	4

BENZODIAZEPINES (BZO)

Oxazepam conc. (ng/mL)	n per site	Site A		Site B		Site C
Oxazepam conc. (ng/mL)	n per site	-	+	-	+	-	+
0	5	5	0	5	0	5	0
150	5	4	1	3	2	4	1
225	5	2	3	4	1	2	3
375	5	0	5	0	5	3	2
450	5	0	5	0	5	1	4

COCAINE (COC)

Benzoylecgonine conc. (ng/mL)	n per site	Site A		Site B		Site C
Benzoylecgonine conc. (ng/mL)	n per site	-	+	-	+	-	+
0	5	5	0	5	0	5	0
150	5	5	0	4	1	5	0
225	5	5	0	1	4	5	0
375	5	1	4	0	5	2	3
450	5	0	5	0	5	1	4

COTININE (COT)

Cotinine conc. (ng/mL)	n per lot	Lot A		Lot B
Cotinine conc. (ng/mL)	n per lot	-	+	-	+
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
Propoxyphene conc. (ng/mL)	n per lot	-	+	-	+	-	+
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
11-nor-09 -THC-9-COOH conc. (ng/mL)	n per site	-	+	-	+	-	+
0	5	5	0	5	0	5	0
25	5	5	0	3	2	5	0
375	5	5	0	2	3	5	0
62.5	5	1	4	1	4	1	4
75	5	0	5	0	5	0	5

METHADONE (MTD)

Methadone conc. (ng/mL)	n per site	Site A		Site B		Site C
Methadone conc. (ng/mL)	n per site	-	+	-	+	-	+
0	5	5	0	5	0	5	0
150	5	5	0	5	0	5	0
225	5	2	3	5	0	4	1
375	5	1	4	2	3	2	3
450	5	0	5	0	5	0	5

METHAMPHETAMINE (mAMP)

Methamphetamine conc. (ng/mL)	n per site	Site A		Site B		Site C
Methamphetamine conc. (ng/mL)	n per site	-	+	-	+	-	+
0	5	5	0	5	0	5	0
500	5	5	0	4	1	5	0
750	5	5	0	4	1	1	4
1250	5	0	5	0	5	3	2
1500	5	0	5	0	5	0	5

Ecstasy (MDMA)

MDMA conc. (ng/mL)	n per site	Site A		Site B		Site C
MDMA conc. (ng/mL)	n per site	-	+	-	+	-	+
0	5	5	0	5	0	5	0
250	5	4	1	5	0	5	0
375	5	4	1	3	2	4	1
625	5	0	5	0	5	1	4
750	5	0	5	0	5	0	5

OPIATE 300 (MOP 300 OR OPI 300)

Morphine conc. (ng/mL)	n per site	Site A		Site B		Site C
Morphine conc. (ng/mL)	n per site	-	+	-	+	-	+
0	5	5	0	5	0	5	0
150	5	4	1	5	0	5	0
225	5	2	3	5	0	5	0
375	5	0	5	0	5	3	2
450	5	0	5	0	5	1	4

OPIATES (OPI 2000)

Morphine conc. (ng/mL)	n per site	Site A		Site B		Site C
Morphine conc. (ng/mL)	n per site	-	+	-	+	-	+
0	5	5	0	5	0	5	0
1000	5	4	1	5	0	5	0
1500	5	4	1	3	2	4	1
2500	5	0	5	0	5	1	4
3000	5	0	5	0	5	0	5

PHENCYCLIDINE (PCP)

Phencyclidine conc. (ng/mL)	n per site	Site A		Site B		Site C
Phencyclidine conc. (ng/mL)	n per site	-	+	-	+	-	+
0	5	5	0	5	0	5	0
12.5	5	4	1	5	0	5	0
18.75	5	2	3	5	0	3	2
31.25	5	1	4	0	5	1	4
37.5	5	1	4	0	5	0	5

TRICYCLIC ANTIDEPRESSANT (TCA)

Phencyclidine conc. (ng/mL)	n per site	Site A		Site B		Site C
Phencyclidine conc. (ng/mL)	n per site	-	+	-	+	-	+
0	5	5	0	5	0	5	0
500	5	5	0	4	1	4	1
750	5	5	0	1	4	3	2
1250	5	0	5	1	4	0	5
1500	5	0	5	0	5	0	5

Analytical Sensitivty

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

Drug Concentration Cut-off Range	n	AMP		BAR		BZO		COC
0% Cut-off	30	30	0	30	0	30	0	30	0
-50% Cut-off	30	30	0	30	0	30	0	30	0
-25% Cut-off	30	30	0	27	3	26	4	30	0
Cut-off	30	18	12	22	8	12	18	4	26
+25% Cut-off	30	1	29	7	23	3	27	0	30
+50% Cut-off	30	0	30	2	28	0	30	0	30

Drug Concentration Cut-off Range	n	THC		MTD		MAMP		MDMA
0% Cut-off	30	30	0	30	0	30	0	30	0
-50% Cut-off	30	30	0	29	1	30	0	30	0
-25% Cut-off	30	12	18	24	6	30	0	26	4
Cut-off	30	1	29	2	28	1	29	4	26
+25% Cut-off	30	1	29	2	28	1	29	4	26
+50% Cut-off	30	0	30	0	30	0	30	0	30

Drug Concentration Cut-off Range	n	OPI		PCP		TCA
0% Cut-off	30	30	0	30	0	30	0
-50% Cut-off	30	30	0	30	0	30	0
-25% Cut-off	30	30	0	19	11	22	8
Cut-off	30	13	17	16	14	12	18
+25% Cut-off	30	4	26	6	24	7	23
+50% Cut-off	30	0	30	0	30	0	30

Analytical Specificity

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
(ą)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
(ą) 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
(ą)-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-tee urine or drug positive urine containing Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, Methylenedioxymethamphetamine, Opiate, Phencyclidine or Tricyclic antidepressants. The following compounds show no cross-reactivity when tested with One Step Drug Screen Test Card at a concentration of 100 gg/mL.

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