COCAINE METABOLITE

SPECIFIC PERFORMANCE CHARACTERISTICS

SENSITIVITY

The sensitivity of the AxSYM Cocaine Metabolite assay was calculated to be 30.00 ng/mL. This sensitivity is defined as the lowest measurable concentration which can be distinguished from zero at least 95% confidence.

SPECIFICITY

Cross-reactivity was tested for cocaine metabolites. The following compounds cross-react above the sensitivity (30.00 ng/mL) of the AxSYM Cocaine Metabolite assay:

Test Compound

Concentration

Tested (ng/mL)

Cocaine

10,000

Ecgonine

10,000

The following compounds do not cross-react above the sensitivity (30.00 ng/mL) of the AxSYM Cocaine Metabolite assay (Compounds tested at 100,000 ng/mL, unless otherwise indicated):

Acetaminophen	Melanin
Acetylsalicylic Acid	Meperidine
Alprazolam	Methadone
Amitryptyline	Methadone Primary Metabolite (EDDP)
Amobarbital	d-Methamphetamine
Amoxicillin	3,4-Methylenedioxyamphetamine (MDA)
d,l-amphetamine	3,4-Methylenedioxyethylamphetamine (MDE)
Ampicilin	3,4-Methylenedioxymethamphetamine (MDMA)
Aspartame	Methylphenidate
Benzocaine	Methyprylon
Benzoic Acid	Morphine
Buprenorphine*	Nalidixic Acid*
Butabarbital	Naloxone
Caffeine	Naltrexone
Calcium Hypochlorite	Naproxen*
Chloramphenicol	Niacinamide
Chlordiazepoxide	Nicotine
Chloroquine	Norfloxacin*
Chlorpheniramine*	Oxolinic Acid*
Cholesterol	Oxycodone
Ciprofloxacin*	Oxymorphone*
Cinoxacin*	Penicillin G*
Clindamycin	Phenethylamine
Codeine	Phenobarbital
Diazepam	Phenothiazine
Digoxin	Phentermine
Dihydrocodeine	Phenylbutazone
Dihydromorphine	Phenylpropanolamine*
Diphenhydramine	Phenyltoloxamine
Ecgonine Methyl Ester #	Piromidic Acid*
Ephedrine	Progesterone#
Epinephrine	Promethazine*
Erythromycin*	Prolintane
Estriol	Pseudoephedrine
Fenoprofen*	Quinine
Furosemide*	Salicyclic Acid
Gentisic Acid	Secobarbital
Guaiacol Glyceryl Ether*	Serotonin
Haloperidol	Sulindac
Histamine	Tetracycline
Hydralazine	11-Nor-delta-9-THC-9-carboxylic Acid
Hydrocodone	Theophylline
Hydromorphone	Tolbutamide
Ibuprofen*	Trifluoperazine
Isoproteronol	Trimethoprim
Ketamine*	Tyramine
Ketoprofen	Vincristine*
Lovastatan

# Tested at 10,000 ng/mL

* Tested at 1,000,000 ng/mL

INTERFERENCE

The following compounds added to human urine, resulted in less than 10% error in detecting added drug when assayed with the AxSYM Cocaine Metabolite assay.

Compound	Concentration Tested
Acetone	1	g/dL
Ascorbic Acid	1.5	g/dL
Bilirubin	0.25	mg/dL
Creatinine	500	mg/dL
Ethanol	1	g/dL
Glucose	2	g/dL
Hemoglobin (lysed red blood cells)	115	mg/dL
Oxalic Acid	100	mg/dL
Riboflavin	7.5	mg/dL
Sodium Chloride	6	g/dL
Total Protein	0.05	g/dL
Urea	6	g/dL

The presence of detergents in samples potentially interferes with immunoassay results.

Bleach (hypochlorite) is a strong oxidizing agent. As a consequence, bleach may cause oxidation of some analytes, thus reducing the amount available for analysis. This may result in lower analytic results, regardless of the methodology.

There is the possibility that other substances and/or factors not listed above may interfere with the test and cause false results.

REFERENCE

1. ABBOTT Cocaine Metabolite package insert, October 1997