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The LabOne Inc Cocaine Metabolite Micro-Plate Enzyme ImmunoAssay (EIA) is intended for the qualitative detection of cocaine and its metabolite, benzylecgonine, in oral fluid with the Orasure® Oral Specimen Device. It is a screen test with a cutoff set at 10 ng/ml of benzoylecgonine per ml of oral fluid. (See Cross Reactivity section for information on cross-reactivity with cocaine). This test is intended for laboratory use only. For in vitro diagnostic use. The LabOne Inc Cocaine Metabolite Micro-Plate Enzyme ImmunoAssay (ELA) provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain confirmed analytical results a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy/mass spectroscopy (GC/MS/MS) is the recommended confirmatory method. The LabOne Cocaine Metabolite Micro-Plate EIA Calibrators are intended for medical purposes for use with the LabOne Cocaine Metabolite Micro-Plate EIA to establish points of reference that are used in determination of values in the measurement of cocaine metabolite in saliva. The LabOne Cocaine Metabolite Micro-Plate EIA Controls are intended for use as an assayed quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for cocaine metabolite.

LabOne Cocaine Metabolite Micro-Plate ELA is a solid phase competitive enzyme immunoassay for the determination of cocaine metabolites in oral fluid collected with the OraSure® Oral Specimen Collection Device.

LabOne Micro-Plate Cotinine EIA is a competitive micro-plate immunoassay for the qualitative and semi-quantitative determination of cotinine in oral fluid collected with the OraSure® Oral Fluid Specimen Collection Device. LabOne Micro-Plate Cotinine EIA is used as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine. The test is for in Vitro use only. The LabOne Microplate Cotinine Calibrators are a device intended for medical purposes for use with the LabOne Microplate Cotinine assay to establish points of reference that are used in determination of values in the measurement of cotinine in saliva. The LabOne Microplate Cotinine Controls are intended for use as an assayed quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for cotinine.

LabOne Micro-Plate Cotinine EIA is a solid phase competitive enzyme immunoassay for the qualitative and semi-quantitative analysis of cotinine in oral fluid specimens collected with the OraSure® Oral Specimen Collection Device.