BARBITURATES

SPECIFIC PERFORMANCE CHARACTERISTICS

Sensitivity

The sensitivity of the AxSYM Barbiturates II U assay was calculated to be 60.00 ng/mL. This sensitivity is defined as the lowest measurable concentration which can be distinguished from zero with at least 95% confidence.

Specificity

Cross-reactivity was tested for the commonly used barbiturates and metabolites. The following compounds cross-react above the sensitivity (60.00 ng/mL) of the AxSYM Barbiturates II U assay:

Test Compound	Concentration Tested (ng/mL)
Allobarbital	400
Alphenol	200
Amobarbital	700
Aprobarbital	200
Barbital	2,000
5-ethyl-5-(4-hydroxyphenyl)-barbituric acid	2,000
Brallobarbital	200
Butabarbital	200
Butalbital	200
Butobarbital	400
Cyclopentobarbital	200
Hexobarbital	100,000
Metharbital	1,000,000
Methohexital	1,000,000
Pentobarbital	200
Phenobarbital	200
Talbutal	200
Thiopental	2,000

Cross-reactivity was tested with compounds that have similar chemical structure or are used concurrently. The following compound cross-reacts above the sensitivity (60.00 ng/mL) of the AxSYM Barbiturates II U assay:

Test Compound	Concentration Tested (ng/mL)
Aminoglutethimide	100,000
Dezocine	1,000,000
Glutethimide	10,000
5-(p-Hydroxyphenyl)-5-phenylhydantoin (HPPH)	500,000
Primidone	100,000
Retinoic Acid	1,000,000

The following compounds do not cross-react above the sensitivity (60.00 ng/mL) of the AxSYM Barbiturates II U assay (Compounds tested at 100,000 ng/mL, unless otherwise indicated):

Acetaminophen*	Lovastatan
Acetylsalicylic Acid	Melanin
Alprazolam	Meperidine
Amitryptyline	Methadone
Amoxicillin	Methadone Primary Metabolite (EDDP)
Ampicilin	d-Methamphetamine
Aspartame	d,l-Methamphetamine
Barbituric Acid	3,4-Methylenedioxyamphetamine (MDA)
Benzocaine	3,4-Methylenedioxy-N-Ethylamphetamine (MDE)
Benzoic Acid	3,4-Methylenedioxymethamphetamine (MDMA)
Benzoylecgonine	Methylphenidate
Buprenorphine*	Methyprylon
Caffeine	Morphine
Calcium Hypochlorite	Naloxone
Chloramphenicol	Naltrexone
Chlordiazepoxide	Naproxen*
Chloroquine	Niacinamide
Chlorpheniramine	Nicotine
Cholesterol	Oxycodone
Clindamycin	Oxymorphone
Cocaine	Penicillin G*
Codeine	Phenothiazine
Dextromethorphan	Phenylbutazone
Diazepam	Phenylpropanolamine*
Digoxin	Phenytoin
Dihydrocodeine	Procainimide
Dihydromorphine	Progesterone#
1,3-Dimethylbarbituric Acid	Prolintane
Diphenhydramine*	Promethazine*
Ecgonine	Pseudoephedrine**
Ephedrine**	Quinine
Epinephrine*	Salicyclic Acid
Erythromycin*	Serotonin
Estriol	Sulindac
Fenoprofen*	Tetracycline
Furosemide*	11-Nor-delta-9-THC-9-carboxylic Acid
Gentisic Acid	Theophylline
Guaiacol Glyceryl Ether*	Tolbutamide
Haloperidol	Trifluoperazine
Histamine	Trimethoprim
Hydralazine	Tyramine
Hydrocodone
Hydromorphone
Ibuprofen*
Isoproterenol
Ketamine*
Ketoprofen

# Tested at 10,000 ng/mL

* Tested at 1,000,000 ng/mL

** Tested at 3,000,000 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 Barbiturate II U 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 AxSYM Barbiturates II U package insert, October,1997