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Detection Levels - Common Illicit Drugs

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Instant Drug Urine Testing

AutoSplit Drug Test Cup Performance Characteristics

Accuracy

A side-by-side comparison was conducted using the One Step Single Drug Test Strip and commercially available drug rapid tests. Testing was performed on approximately 1,700 specimens 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

AMP

Amphetamine

BAR

Secobarbital, Butalbital, Phenobarbital, Pentobarbital

BZO

Oxazepam, Nordiazepam, -OH-Alprazepam, Desaky-frazepam

COC

Benzoylecgonine

THC

11-nor-9-carboxy-delta-9-tetrahydrocanabinol

MTD

Methadone

mAMP

Methamphetamine

OPI

Morphine, Codeine

PCP

Phencyclidine

TCA

Nortrptyline

Information For Drug Cut Off Times

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Forty (40) clinical samples for each drug were run using each of The One Step Single Drug Test Strip 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.

*Note: TCA was based on HP/LC data.

 

Sensitivity and Specificity

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

 

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

 

OPIATE 300 (MOP 300 OR OPI 300)

Morphine
conc. (ng/mL)

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

 

PHENCYCLIDINE (PCP)

Phencyclidine
conc. (ng/mL)

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

 

Analytical Specificity 

The following table lists the concentration of compounds (ng/mL) that are detected positive in urine by AutoSplit Integrated Drug Test Cup 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