Product Manual

QUALITY CONTROL
A procedural control is included in the test. A colored line appearing in the control region
(C) is considered an internal procedural control. It confirms sufficient specimen volume,
adequate membrane wicking and correct procedural technique.
LIMITATIONS
1. The Alere
iScreen
®
OFD Cotinine Test Device 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), gas
chromatography/tandem mass spectrometry (GC/MS/MS) and liquid
chromatography/tandem mass spectrometry (LC/MS/MS) are preferred confirmatory
methods.
2. A positive test result does not indicate the concentration of drug in the specimen or
the route of administration.
3. A negative result may not necessarily indicate a drug-free specimen. Drug may be
present in the specimen below the cutoff level of the assay.
PERFORMANCE CHARACTERISTICS
Accuracy
% Agreement with Commercial Kit
Specimen COT
Positive 97.6%
Negative >99%
Tota l 98 . 9%
% Agreement with LC/MS
Specimen COT
Positive >99%
Negative 97.9%
Tot a l 98 . 6%
Analytical Sensitivity
A PBS pool was spiked with drugs to target concentrations of ± 50% cut-off and ± 25%
cut-off and tested with the Alere
iScreen
®
OFD Cotinine Test Device. The results are
summarized below.
Drug conc.
(Cut-off range)
n
COT
- +
0% Cut-off 90 90 0
-50% Cut-off 90 90 0
-25% Cut-off 90 89 1
Cut-off 90 45 45
+25% Cut-off 90 5 85
+50% Cut-off 90 0 90
Analytical Specificity
The following table lists the concentration of compounds (ng/mL) above which the Alere
iScreen
®
OFD Cotinine Test Device identified positive results at a read time of
10 minutes.
COTININE (COT)
(-) Cotinine 30
S(-)-Nicotine 5,000
Cross-Reactivity
A study was conducted to determine the cross-reactivity of the test with compounds
spiked into drug-free PBS stock. The following compounds demonstrated no false
positive results on the Alere
iScreen
®
OFD Cotinine Test Device when tested with
concentrations up to 10 µg/mL.
Acetaminophen Acetophenetidin
Aminopyrine Amoxicillin
Ampicillin l-Ascorbic acid
Apomorphine Aspartame
Atropine Benzilic acid
Benzoic acid Benzphetamine
Bilirubin d,l-Brompheniramine
Caffeine Cannabidol
Chloralhydrate Chloramphenicol
Chlorothiazide d,l-Chloropheniramine
Chlorpromazine Chloroquine
Cholesterol Clonidine
Creatinine Deoxycorticosterone
Dextromethorphan Diclofenac
Diflunisal Digoxin
Diphenhydramine l-Ψ-Ephedrine
β-Estradiol Estrone-3-sulfate
Ethyl-p-aminobenzoate l-(-)-Epinephrine
Erythromycin Fenoprofen
Furosemide Gentisic acid
Hemoglobin Hydralazine
Hydrochlorothiazide Hydrocortisone
o-Hydroxyhippuric acid p-Hydroxytyramine
Ibuprofen Iproniazid
d,l-Isoproterenol Isoxsuprine
Ketamine Ketoprofen
Labetalol Loperamide
Meperidine Meprobamate
Methylphenidate Nalidixic acid
Naloxone Naltrexone
Naproxen Niacinamide
Nifedipine Norethindrone
d-Norpropoxyphene Noscapine
d,l-Octopamine Oxalic acid
Oxolinic acid Oxymetazoline
Papaverine Penicillin-G
Pentazocine Perphenazine
Phenelzine Trans-2-phenylcyclopropylamine
Phenylpropanolamine Prednisolone
Prednisone d,l-Propranolol
d-Propoxyphene d-Pseudoephedrine
Quinacrine Quinine
Quindine Ranitidine
Salicylic acid Serotonin
Sulfamethazine Sulindac
Tetracycline Tetrahydrocortisone 3-Acetate
Thiamine Thioridazine
d,l-Tyrosine Tolbutamide
Triamterene Trifluoperazine
Trimethoprim d,l-Tryptophan
Tyramine Uric acid
Verapamil Zomepirac
BIBLIOGRAPHY
1. Cone, EJ, “Saliva Testing for Drugs of Abuse,” Ann NY Acad Sci, 1993;694:pp120
Manufactured for Alere Toxicology Services-Products Division
Portsmouth, VA 23704 USA
© 2011 Alere. All rights reserved.
The Alere Logo, Alere and iScreen are trademarks of the Alere group of companies.
DN: 1156050202
Printed in China Eff.Date: 2012-01-30