Package Insert - US Screening Source

Cocaine HCl 780Cocaethylene 12,500Ecgonine HCl 32,000MARIJUANA (THC)11-nor-∆ 9 -THC-9 COOH 50Cannabinol 20,00011-nor-∆ 8 -THC-9 COOH 30∆ 8 -THC 15,000∆ 9 -THC 15,000METHADONEMethadone 300Doxylamine 50,000METHAMPHETAMINED-Methamphetamine 1,000ρ-Hydroxymethamphetamine 30,000L-Methamphetamine 8,000D,L 3,4-Methylenedioxymethamphetamine 2,000Mephentermine 50,000METHYLENEDIOXYMETHAMPHETAMINE (MDMA)D,L-3,4-Methylenedioxymethamphetamine HCI (MDMA) 5003,4-Methylenedioxyamphetamine HCI (MDA) 3,0003,4-Methylenedioxyethyl-amphetamine (MDE) 300OPIATE 300 (MOP)Morphine 300Codeine 300Ethylmorphine 6,250Hydrocodone 50,000Hydromorphone 3,125Levophanol 15006-Monoacetylmorphine 400Morphine 3-β-D-glucuronide 1,000Norcodeine 6,250Normorphone 100,000Oxycodone 30,000Oxymorphone 100,000Procaine 15,000Thebaine 6,250OPIATES (2000)Morphine 2,000Codeine 2,000Ethylmorphine 5,000Hydrocodone 12,500Hydromorphone 5,000Levophanol 75,0006-Monoacetylmorphine 5,000Morphine 3-β-D-glucuronide 2,000Norcodeine 12,500Normorphone 50,000Oxycodone 25,000Oxymorphone 25,000Procaine 150,000Thebaine 100,000PCPPhencyclidine 254-Hydroxyphencyclidine 12,500TCANotriptyline 1,000Nordoxepine 1,000Trimipramine 3,000Amitriptyline 1,500Promazine 1,500Desipramine 200Imipramine 400Clomipramine 12,500Doxepin 2,000Maprotiline 2,000Promethazine 25,000Effect of Urinary Specific GravityFifteen (15) urine samples of normal, high, and low specific gravity ranges (1.000-1.037) were spiked withdrugs at 50% below and 50% above cut-off levels respectively. The One Step Drug Screen Test Cardwas tested in duplicate using fifteen drug-free urine and spiked urine samples. The results demonstratethat varying ranges of urinary specific gravity does not affect the test results.Effect of the Urinary pHThe pH of an aliquoted negative urine pool was adjusted to a pH range of 5 to 9 in 1 pH unit incrementsand spiked with drugs at 50% below and 50% above cut-off levels. The spiked, pH-adjusted urine wastested with One Step Drug Screen Test Card. The results demonstrate that varying ranges of pH doesnot interfere with the performance of the test.Cross-ReactivityA study was conducted to determine the cross-reactivity of the test with compounds in either drug-freeurine or drug positive urine containing Cocaine, Barbiturates, Benzodiazepine, Amphetamine,Methamphetamine, Marijuana, Methadone, Methylenedioxymethamphetamine, Opiate, Phencyclidine orTricyclic antidepressant. The following compounds show no cross-reactivity when tested with One StepDrug Screen Test Card at a concentration of 100 µg/mL.AcetaminophenAcetophenetidinN-AcetylprocainamideAcetylsalicylic acidAminopyrineAmitryptylineAmoxicillinAmpicillinL-Ascorbic acidApomorphineAspartameAtropineBenzilic acidBenzoic acidBenzphetamineBilirubinD,L – BrompheniramineCaffeineCannabidiolChloralhydrateChloramphenicolChlorothiazideD,L – ChlorpheniramineChlorpromazineChlorquineCholesterolClomipramineClonidineCortisoneL CotinineCreatinineDeoxycorticosteroneDextromethorphanDiclofenacDiflunisalDigoxinDiphenhydramineEcgonine methylesterL -Ψ-EphedrineNon Cross-Reacting CompoundsDoxylamineHydrochlorothiazideHydrocortisoneO-Hydroxyhippuric acidp-Hydroxyamphetamine3-HydroxytyramineIbuprofenImipramineIproniazidD,L – IsoproterenolIsoxsuprineKetamineKetoprofenLabetalolLoperamideMaprotilineMeperidineMeprobamateMethoxyphenamineMethyphenidateNalidixic acidNaloxoneNaltrexoneNaproxenNiacinamideNifedipineNorethindroneD-NorpropoxypheneNoscapineDL-OctopamineOxalic acidOxolinic acidOxymetazolinePapaverinePenicillin-GPentazocine hydrochloridePerphenazinePhenelzineTrans-2-phenylcyclo-propylaminehydrochlorideβ-EstradiolEstrone-3-sulfateEthyl-p-aminobenzoate[1R,2S] (-) Ephedrine(L) – EpinephrineErythromycinFenoprofenFurosemideGentisic acidHemoglobinHydralazineQuinineRanitidineSalicylic acidSerotoninSulfamethazineSulindacTetracyclineTetrahydrocortisone, 3-acetateTetrahydrocortisone 3-(β-D-glucuronide)TetrahydrozolineThiamineThioridazineL-Phenylephrineβ-PhenylethylaminePhenylpropanolaminePrednisolonePrednisonePromazinePromethazineDL-PropranololD-PropoxypheneD-PseudoephedrineQuinacrineQuinidineDL-TyrosineTolbutamideTriamtereneTrifluoperazineTrimethoprimTrimipramineTryptamineDL-TryptophanTyramineUric acidVerapamilZomepiracBIBLIOGRAPHY1. Stewart DJ, Inaba T, Lucassen M, Kalow W. Clin. Pharmacol. Ther. 1979; 25 ed: 464, 264-8.2. Ambre J. J. Anal. Toxicol. 1985; 9:241.3. Hawks RL, Chiang CN. Urine Testing for Drugs of Abuse. National Institute for Drug Abuse (NIDA),Research Monograph 73, 1986.4. Tietz NW. Textbook of Clinical Chemistry. W.B. Saunders Company. 1986; 1735.5. FDA Guidance Document: Guidance for Premarket Submission for Kits for Screening Drugs of Abuseto be Used by the Consumer, 1997.6. Robert DeCresce. Drug Testing in the workplace, 114.7. Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 2nd Ed. Biomedical Publ., Davis, CA.1982; 4878. Winger Gail. A Handbook of Drug and Alcohol Abuse. Third Edition, Oxford Press, 1992, page 146.DN: R0151047-01Eff. Date: 2002-12-12