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Products

Multi-Drug Urine Panel
Multi Drug Test Panel

Catalog No.        Product Name                 

ABT-DOA-E53   Multi-10 Drug Test Panel

ABT-DOA-E75   Multi-9 Drug Test Panel

ABT-DOA-E74   Multi-8 Drug Test Panel

ABT-DOA-E73   Multi-7 Drug Test Panel

ABT-DOA-E32   Multi-6 Drug Test Panel

ABT-DOA-E31   Multi-5 Drug Test Panel

ABT-DOA-E45   Multi-4 Drug Test Panel

ABT-DOA-E44   Multi-3 Drug Test Panel

ABT-DOA-E51   Multi-2 Drug Test Panel


INTENDED USE

ACCU-TELL® Rapid Multi-Drug Test Panel(Urine) is a rapid chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites in urine at the following cut-off concentrations:

Test

Calibrator

Cut-off (ng/mL)

Amphetamine (AMP1,000)

d-Amphetamine

1,000

Amphetamine (AMP 500)

d-Amphetamine

500

Amphetamine (AMP 300)

d-Amphetamine

300

Barbiturates (BAR 300)

Secobarbital

300

Barbiturates (BAR 200)

Secobarbital

200

Benzodiazepines (BZO 500)

Oxazepam

500

Benzodiazepines (BZO 300)

Oxazepam

300

Benzodiazepines (BZO 200)

Oxazepam

200

Benzodiazepines (BZO 100)

Oxazepam

100

Buprenorphine (BUP)

Buprenorphine

10

Cocaine (COC 300)

Benzoylecgonine

300

Cocaine (COC150)

Benzoylecgonine

150

Cocaine (COC 100)

Benzoylecgonine

100

Marijuana (THC150)

11-nor-Δ9-THC-9 COOH

150

Marijuana (THC 50)

11-nor-Δ9-THC-9 COOH

50

Marijuana (THC 25)

11-nor-Δ9-THC-9 COOH

25

Methadone (MTD 300)

Methadone

300

Methadone (MTD 200)

Methadone

200

Methamphetamine (MET 1,000)

d-Methamphetamine

1,000

Methamphetamine (MET 500)

d-Methamphetamine

500

Methamphetamine (MET 300)

d-Methamphetamine

300

Methylenedioxymethamphetamine

(MDMA 500)

d,l-Methylenedioxymethamphetamine

500

Methylenedioxymethamphetamine

(MDMA 1,000)

d,l-Methylenedioxymethamphetamine

1,000

Morphine (MOP 300)

Morphine

300

Morphine (MOP 100)

Morphine

100

Methaqualone(MQL)

Methaqualone

300

Opiate (OPI 2,000)

Morphine

2,000

Phencyclidine (PCP)

Phencyclidine

25

Propoxyphene (PPX)

Propoxyphene

300

Tricyclic Antidepressants (TCA)

Nortriptyline

1,000

Tramadol (TML)

Tramadol

100

Ketamine (KET 1,000)

Ketamine

1,000

Ketamine (KET 500)

Ketamine

500

Ketamine (KET 300)

Ketamine

300

Oxycodone (OXY)

Oxycodone

100

Cotinine(COT200)

Cotinine

200

Cotinine(COT100)

Cotinine

100

2-ethylidene-1,5-dimethyl-

3,3-diphenylpyrrolidine (EDDP300)

2-ethylidene-1,5-dimethyl-

3,3-diphenylpyrrolidine

300

2-ethylidene-1,5-dimethyl-

3,3-diphenylpyrrolidine (EDDP100)

2-ethylidene-1,5-dimethyl-

3,3-diphenylpyrrolidine

100

Fentanyl(FYL20)

Norfentanyl

20

Fentanyl(FYL10)

Norfentanyl

10

Synthetic Marijuana (K2-50)

JWH-018JWH-073

50

Synthetic Marijuana (K2-30)

JWH-018JWH-073

30

6-mono-aceto-morphine (6-MAM10)

6-MAM

10

Configurations of ACCU-TELL® Rapid Multi-Drug Test Panel(Urine)come with any combination of the above listed drug analytes. This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

PERFORMANCE CHARACTERISTICS

Accuracy
A side-by-side comparison was conducted using ACCU-TELL® Rapid Multi-Drug Test Panel(Urine) and commercially available drug rapid tests. Testing was performed on approximately 250 specimens per drug type previously collected from subjects presenting for Drug Screen Testing. Presumptive positive results were confirmed by GC/MS.

% Agreement with GC/MS
Clinical samples for each drug were run using each of ACCU-TELL®Rapid Multi-Drug Test Panel(Urine) 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.

Precision
A study was conducted at three hospitals by untrained operators using three different lots of product to demonstrate the within run, between run and between operator precision. An identical card of coded specimens, containing drugs at concentrations of ± 50% and ± 25% cut-off level, was labeled, blinded and tested at each site. The results are given below:

Analytical SpecificityThe following table lists the concentrations of compounds (ng/mL) that are detected as positive in urine by ACCU-TELL® Rapid Multi-Drug Test Panel(Urine)at 5 minutes.

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. ACCU-TELL® Rapid Multi-Drug Test Panel(Urine) was tested in duplicate using fifteen drug-free urine and spiked urine samples. The results demonstrate that varying ranges of urinary specific gravity do not affect the test results.

Effect of 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 the Multi-Drug Rapid Test Panel. The results demonstrate that varying ranges of pH do 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, Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methadone, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Tramadol ,Ketamine ,Phencyclidine, Propoxyphene or Tricyclic Antidepressants. The following compounds show no cross-reactivity when tested with ACCU-TELL® Rapid Multi-Drug Test Panel(Urine) at a concentration of 100 µg/mL.





LIMITATION

1. ACCU-TELL® Rapid Multi-Drug Test Panel(Urine) provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.1,10

2. There is a possibility that technical or procedural errors, as well as interfering substances in the urine specimen may cause erroneous results.

3. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another urine specimen.

4. A positive result does not indicate level or intoxication, administration route or concentration in urine.

5. A negative result may not necessarily indicate drug-free urine. Negative results can be obtained when drug is present but below the cut-off level of the test.

6. This test does not distinguish between drugs of abuse and certain medications.

7. A positive test result may be obtained from certain foods or food supplements.