Urine 1-Drug Card - AMPH (Amphetamine) TMS Labs single panel urine AMPH drug card is easy-to-use, very accurate, extremely inexpensive, and FDA-approved testing for amphetamine drug use.

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Drug Screen Test Card Product Information

Cut-off Levels

The One Step Drug Screen Test Card 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.

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.

• 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 card should be discarded according to federal, state and local regulations.

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.

Urine Assay

The urine specimen must be collected in a clean and dry container. Urine collected at any time of the day may be used. Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing.

Urine specimens may be stored at 2-8^°C for up to 48 hours prior to testing. For prolonged storage, specimens may be frozen and stored below -20^°C. Frozen specimens should be thawed and mixed well before testing.

• Test cards

• Package insert

• Specimen collection container

• Timer

• External controls

Quality Control

A procedural control is included in the test. A red line appearing in the control region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

Control standards are not supplied with this kit. However, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance.

Limitations

1. The One Step Drug Screen Test Card provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography and mass spectrometry (GC/MS) is the preferred confirmatory method.

2. There is a possibility that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.

3. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another urine specimen.

4. A Positive result does not indicate level or intoxication, administration route or concentration in urine.

5. A Negative result may not necessarily indicate drug-free urine. Negative results can be obtained when drug is present but below the cut-off level of the test.

6. Test does not distinguish between drugs of abuse and certain medications.

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