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Instant Drug Urine Testing

AutoSplit Integrated Drug Test Cup Product Information: Technical Report

Drug Screen Test Card Principle

The AutoSplit Integrated Drug Test 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.

Intended Use

The AutoSplit Integrated Drug Test 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:

The configurations of the One Step Multi-Drug Screen Test Card come with any combination of the above listed drug analytes. This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

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, Phencyclidine, Benzodiazepine, Methadone or Barbiturate.

Precautions

·         For healthcare professionals including professionals at point of care sites.

·         For in vitro diagnostic use only. Do not use after the expiration date.

·         The test panel should remain in the sealed pouch until use.

·         All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.

·         The used test cup should be discarded according to federal, state and local regulations.

Storage and Stability

Store as packaged in the sealed pouch at 2-30^°C. The test strip is stable through the expiration date printed on the sealed pouch. The test strips must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

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NOTE: California Residents - Business and Professions Code 1246.5 Requires That Any Test that has not been approved by the Federal Food and Drug Administration for sale to the public without a prescription as an Over-The-Counter Test kit must be ordered by a Licensed physician acting on a patient's behalf.  All orders for test kits within the state of California

NOTE: New York State Residents New York State health law prohibits the testing of certain specimens collected in or mailed from New York, and prohibits the transmission of data from our laboratory to NY physicians or residents. Therefore, direct receipt of lab results for NY residents is not possible.

International Residents & Orders:  Extra shipping charges may be added for international orders.  Patients will be contacted by e-mail or telephone to approve charges.