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The RapidSense™ Drugs of Abuse Cocaine (COC) 300 Device is a lateral flow competitive immunoassay intended for the qualitative detection for the cocaine metabolite, benzoylecgonine, in human urine at a cut-off concentration of 300 ng/mL. The assay is intended for use in professional laboratories by healthcare professionals. For In Vitro Diagnostic Use. This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a cocaine metabolite specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.

The RapidSense™ Drugs of Abuse Cocaine (COC) 300 Device is an immunoassay based on the principle of competitive binding. The cocaine metabolite, benzoylecgonine, which may be present in the urine specimen competes against its respective drug conjugate for binding sites on the specific antibody. The assay is a colored-latex particle, monoclonal antibody-based rapid test for the qualitative detection of the cocaine metabolite at a cut-off of 300 ng/mL. The test utilizes the QuantRx patented, one step positive read, competitive immunoassay technology. In the absence of the drug in the urine or if the amount of drug is below cut-off level, the visible test line zone (T) will show a clean negative (no signal on the test band). Drug positive specimens show a blue line in the visible test line zone (T). As an internal procedural control, a red control line appears in the control region (C) to verify that sufficient volume of sample was added and proper flow was obtained. The control line should always appear regardless of the presence of the drug if the assay has been performed properly.

The RapidSense™ Drugs of Abuse Phencyclidine (PCP) 25 Device is a lateral flow competitive immunoassay intended for the qualitative detection for Phencyclidine in human urine at a cut-off concentration of 25 ng/mL. The assay is intended for use in professional laboratories by healthcare professionals. For in vitro diagnostic use. This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method. Tests for PCP cannot distinguish between abused drugs and certain prescribed medications. Certain foods or medications may interfere with tests for PCP and cause false positive results.

The RapidSense™ Drugs of Abuse Phencyclidine (PCP) 25 Device is an immunoassay based on the principle of competitive binding. Phencyclidine which may be present in the urine specimen competes against its respective drug conjugate for binding sites on the specific antibody. The assay is a coloredlatex particle, monoclonal antibody-based rapid test for the qualitative detection of Phencyclidine at a cut-off of 25 ng/mL. The test utilizes the QuantRx patented, one step positive read, competitive immunoassay technology. In the absence of the drug in the urine or if the amount of drug is below cut-off level, the visible test line zone (T) will show a clean negative (no signal on the test band). Drug positive specimens show a blue line in the visible test line zone (T). As an internal procedural control, a red control line appears in the control region (C) to verify that sufficient volume of sample was added and proper flow was obtained. The control line should always appear regardless of the presence of the drug if the assay has been performed properly.

The RapidSense™ Drugs of Abuse Methamphetamine (MET) 1000 Device is a lateral flow competitive immunoassay intended for the qualitative detection of Methamphetamine in human urine at a cut-off concentration of 1000 ng/mL. The assay is intended for use in professional laboratories by healthcare professionals. For in vitro diagnostic use. This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method. Tests for methamphetamine cannot distinguish between abused drugs and certain prescribed medications. Certain foods or medications may interfere with tests for methamphetamine and cause false positive results.

The RapidSense™ Drugs of Abuse Methamphetamine (MET) 1000 Device is an immunoassay based on the principle of competitive binding. Methamphetamine which may be present in the urine specimen competes against its respective drug conjugate for binding sites on the specific antibody. The assay is a colored-latex particle, monoclonal antibody-based rapid test for the qualitative detection of Methamphetamine at a cut-off of 1000 ng/mL. The test utilizes the QuantRx patented, one step positive read, competitive immunoassay technology. In the absence of the drug in the urine or if the amount of drug is below cut-off level, the visible test line zone (T) will show a clean negative (no signal on the test band). Drug positive specimens show a blue line in the visible test line zone (T). As an internal procedural control, a red control line appears in the control region (C) to verify that sufficient volume of sample was added and proper flow was obtained. The control line should always appear regardless of the presence of the drug if the assay has been performed properly.

The QuantRx Female Fertility Test is intended to measure follicle-stimulating hormone (FSH) in urine as an ancillary screen of fertility for home use by women who are attempting to conceive.

The QuantRx Female Fertility Test is a rapid, immunochromatographic assay for the measurement of follicle-stimulating hormone (FSH) in human urine. The test is performed on day 3 of the menstrual cycle by urinating directly on the absorbent tip or by dipping it in a cup of urine, and observing for the formation of colored lines after 10 minutes. A test line of color intensity greater than or equal to the reference line indicates an FSH level of at least 10 mIU/mL is indicative of diminished ovarian reserve, which corresponds to reduced fertility. A test line intensity of less than the reference line is indicative of normal ovarian reserve.