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CR3 Keyless Split Cup - Urine Drug Test
This Instruction is for use testing of any combination of the following drugs:
AMP/BZO/COC/THC/mAMP/OPI
A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine.
For Professional and In Vitro Diagnostic Use Only.
INTENDED USE
CR3 Keyless Split Specimen Cup is a lateral flow chromatographic immunoassay for the qualitative
detection of multiple drugs and drug metabolites in urine at the following cut-off concentrations:
AMP/BZO/COC/THC/mAMP/OPI
A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine.
For Professional and In Vitro Diagnostic Use Only.
INTENDED USE
CR3 Keyless Split Specimen Cup is a lateral flow chromatographic immunoassay for the qualitative
detection of multiple drugs and drug metabolites in urine at the following cut-off concentrations:
| Test | Calibrator | Cut-off |
| Amphetamine (AMP 300) | D-Amphetamine | 300 ng/ml |
| Benzodiazepines (BZO) | Oxazepam | 200 ng/ml |
| Cocaine (COC 300) | Benzoylecgonine | 300 ng/ml |
| Marijuana (THC 50) | 11-nor-delta 9-THC-9 COOH | 50 ng/ml |
| Methamphetamine (mAMP 300) | D-Methamphetamine | 300 ng/ml |
| Opiate 300 (OPI 300, MOP, MOR) | Morphine | 300 ng/ml |
This assay provides only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.1 Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained.
SUMMARY AND EXPLANATION OF THE TEST
The CR3 Keyless Split Specimen Cup is a competitive immunoassay utilizing highly specific reactions between antibodies and antigens for the detection of multiple drugs and drug metabolites in human urine without the use of an instrument.
PRINCIPLE
The CR3 Keyless Split Specimen Cup is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against their respective drug conjugate for binding sites on their specific antibody. During testing, a urine specimen migrates upward by capillary action. A drug, if present in the urine specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody. The antibody will then react with the drug-protein conjugate and a visible colored line will show up in the test line region of the specific drug strip. The presence of drug above the cut-off concentration will saturate all the binding sites of the antibody. Therefore, the colored line will not form in the test line region. A drug-positive urine specimen will not generate a colored line in the specific test line region of the strip because of drug competition, while a drug-negative urine specimen will generate a line in the test line region
because of the absence of drug competition. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
REAGENTS
The test contains a membrane strip coated with drug-protein conjugates (purified bovine albumin) on the test line, a goat polyclonal antibody against gold-protein conjugate at the control line, and a dye pad which contains colloidal gold particles coated with mouse monoclonal antibody specific to Amphetamine,Cocaine,Methamphetamine,Morphine,THC,Benzodiazepines.
The test is for single use only.
SUMMARY AND EXPLANATION OF THE TEST
The CR3 Keyless Split Specimen Cup is a competitive immunoassay utilizing highly specific reactions between antibodies and antigens for the detection of multiple drugs and drug metabolites in human urine without the use of an instrument.
PRINCIPLE
The CR3 Keyless Split Specimen Cup is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against their respective drug conjugate for binding sites on their specific antibody. During testing, a urine specimen migrates upward by capillary action. A drug, if present in the urine specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody. The antibody will then react with the drug-protein conjugate and a visible colored line will show up in the test line region of the specific drug strip. The presence of drug above the cut-off concentration will saturate all the binding sites of the antibody. Therefore, the colored line will not form in the test line region. A drug-positive urine specimen will not generate a colored line in the specific test line region of the strip because of drug competition, while a drug-negative urine specimen will generate a line in the test line region
because of the absence of drug competition. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
REAGENTS
The test contains a membrane strip coated with drug-protein conjugates (purified bovine albumin) on the test line, a goat polyclonal antibody against gold-protein conjugate at the control line, and a dye pad which contains colloidal gold particles coated with mouse monoclonal antibody specific to Amphetamine,Cocaine,Methamphetamine,Morphine,THC,Benzodiazepines.
The test is for single use only.
