Test Panel Information:

This product provides a preliminary result. For in vitro diagnostic use only. A quantitative analytical method is needed to obtain a confirmed result.

Instructions:

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, Barbiturates, benzodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, Methylenedioxy-methamphetamine, Morphine, Oxycodone, Phencyclidine, Propoxyphene or Tricyclic Antidepressants.

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 card 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.

Specimen Collection and Preparation:
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.
Specimen Storage:
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.

Materials Provided:
Test card
Package Insert
Adulteration Color Chart (when applicable)

Materials Required but not Provided:
Specimen collection container
Timer
External controls

Directions for Use:

Allow the test card, urine specimen, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1. Remove the test card from the sealed pouch and use it as soon as possible. Remove the cap from the end of the test card. With arrows pointing toward the urine specimen, immerse the strip(s) of the test card vertically in the urine specimen for at least 10-15 seconds. Immerse the test card to at least the level of the wavy lines on the strip(s), but not above the arrow(s) on the test card. See Illustration below:

2. Replace cap and place the test card on a non-absorbent flat surface. Start the timer. Read the adulteration strips between 3-5 minutes (when applicable) compare the colors on the adulteration pads to the enclosed color chart. If the specimen indicates adulteration, refer to your Drug Free Policy for guidelines on adulterated specimens. We recommend not to interpret the drug test results and either retest the urine or collect another specimen.

3. The drug strip results should be read at 5 minutes.

Interpretation of Results: (please refer to illustration above)

Negative: Two lines appear. A colored line appears in the control region (C) and a colored line appears in the Test region (T). This negative result means that the concentrations in the urine sample are below the designated cut-off levels for a particular drug tested.

NOTE: The shade of the colored line(s) in the test region (T) may vary. The result should be considered negative whenever there is even a faint line.

Positive: A colored line appears in the control region (C) and NO line appears in the test region (T). The positive result means that the drug concentration in the urine sample is greater than the designated cut-off for a specific drug.

Invalid: No line appears in the control region (C). Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Read the directions again and repeat the test with a new test card. If the result is still invalid, contact your manufacturer.

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 / 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 of 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.