One Step COC Urine Test is a lateral flow, one-step immunoassay for the qualitative detection
of benzoylec-gonine (cocaine metabolite) in human urine at a cut-off of 300 ng/mL. This product is used to obtain a visual, qualitative result and is intended for professional use. The assay should not be used without proper supervision and is not intended for over the counter sale to lay persons.
This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromato-graphy/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the National Institute on Drug Abuse (NIDA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
The accuracy of One Step COC Urine Test was evaluated in comparison to a commercially available immunoassay at a cut-off of 300 ng/mL. 120 urine samples, collected from presumed non-user volunteers, have been tested by both procedures with 100% agreement.
In a separate study, 69 urine samples, obtained from a clinical laboratory where they were screened and confirmed as positives by GC/MS, were tested by both One Step COC Urine Test and a commercially available immunoassay. Of the 55 samples with benzoylecgonine concentrations 383 ng/ml, all were found to be positives by both methods (100% agreement). Of the 10 samples with benzoylecgonine concentrations from 200-278 ng/ml, which were identi¬fied as positives by the other commer¬cially available immunoassay, all were determined negatives by One Step COC Urine Test. Of the four samples with benzoylecgonine concen¬trations from 340 to 360 ng/ml, which were identified positives by the commer¬cially available immunoassay, two were deter¬mined positives and two were de¬termined negatives by One Step COC Urine Test. The two negatives showed very faint lines.
The reproducibility of One Step COC Urine Test was evaluated at 4 different sites using blind controls. Of the 60 samples with benzolyecgonine concentrations of 150 ng/mL, all were determined negatives. Of the 60 sam¬ples with a benzoylecgonine con¬cen¬tration of 600 ng/mL, all were deter¬mined as positives.
The precision of One Step COC Urine Test was determined by con¬ducting the test with blind spiked con¬trols. The control at 150 ng/mL should give a negative result and the control at 450 ng/mL should give a positive result.
benzoylec-gonine (ng/mL) No Tested Correct Result % Correct Result
150 50 50 100
450 50 50 100
The specificity for One Step COC Urine Test was tested by adding various drugs, drug metabolites, and other compounds that are likely to be present in urine. All compounds were prepared in drug-free normal human urine.
The following compounds were tested for cross-reactivity in the Accu-Tell® One Step COC Urine Test and found to be posi¬tives if the levels were greater than 300 ng/ml.
The following compounds were found not to cross-react when tested at con¬centrations up to 100 µg/mL.
Acetaminophen, Acetone, Albumin, Ami¬triptyline, Ampicillin, Aspartame, Aspirin, Atropine, Benzocaine, Bilirubin, Caffe¬ine, Chloroquine, (+)-Chlorphenir-amine, (+/-)-Chlorpheniramine, Crea-tine, Dex¬brom¬pheniramine, Dextro¬methor¬phan, 4-Dimethyl-aminoanti¬pyrine, Dopamine, Ecgonine, Ecgonine Methyl Esther, (+/-)-Ephe-drine, (-)-Ephedrine, (+)-Epineph¬rine, Erytro¬mycin, Ethanol, Furosemide, Glucose, Guajacol Glyceryl Ether, Hemo¬globin, Imipramine, (+/-)-Isopro-terenol, Lido¬caine, (1R, 2S)-(-)-N-Methyl-Ephedrine, (+)-Naproxen, (+/-)-Norephedrine, Oxalic Acid, Penicillin-G, Pheniramine, Pheno¬thiazine, L-Phenyl-ephrine, Phenylethyl¬amine, Procaine, Quinidine, Ranitidine, Sodium Chloride, Sulindac, Thiorida¬zine, Trifluorperazine, Trimethobenz¬amide, Tyramine, VitaminC
Contact Name: Karen Liu
Company Name: Accubiotech Co, .ltd
Street Address: Building 10, No.28
Yu Hua Road, Shunyi District,
Beijing 101300, China
Member name: AccuBioTech
Member Since: 15 December 2009
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Business focus: Rapid In Vitro Diagnostic Test Kit
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