Materials Provided

  • One Step Drug Screen Test Cards

  • Package insert

Materials Required but Not Provided

  • Urine specimen collection container

  • Timer

  • External controls

Precautions

  • For healthcare professionals, including professionals at point of care sites.

  • For in vitro diagnostic use only.

  • The drug test card should remain in the sealed pouch until use.

  • Do not use test card after the expiration date printed on the sealed pouch.

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

  • The used drug test card should be discarded according to federal, state, and local regulations.

Storage and Stability

Store as packaged in the sealed pouch at 36–86°F (2–30°C). The test is stable through the expiration date printed on the sealed pouch. The test card must remain in the sealed pouch until use. Do not freeze the drug test cards. Do not use beyond the expiration date.

Specimen Collection, Preparation, and Storage

The urine specimen should 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 36–46°F (2–8°C) for up to 48 hours prior to testing. For prolonged storage, urine specimens may be frozen and stored below −4°F (−20°C). Frozen urine specimens should be thawed and mixed well before testing.

Drug Test Procedure

Refer to diagram below.

Allow the drug test card, urine specimen, and/or controls to reach room temperature (59–86°F or 15–30°C) prior to testing or opening the sealed pouch.

  1. Remove the test card from the sealed pouch and use it as soon as possible.

  2. Remove the cap from the end of the test card.

  3. With arrow(s) pointing toward the urine specimen, immerse the strip(s) of the test card vertically in the urine specimen and hold for at least 10–15 seconds. Immerse only the tip(s) of the strip(s) in the urine sample, to approximately the level of the wavy lines on the strip(s). The plastic test card body should not contact the liquid portion of the urine sample.

  4. Replace the cap and place the drug test card on a dry, non-absorbent, and flat surface.

  5. Start the timer and wait for the colored line(s) to appear.

  6. The results should be read at 5 minutes. Results may be stable for up to 1 hour after test initiation.

Instructions - Drug Test Diagram

Interpretation of Drug Test Results

Refer to diagram below.

  • 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 cutoff levels for a particular drug tested.

    *NOTE:  The shade of the colored lines(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 cutoff 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.

Instructions - Drug Test Results

Quality Control

A procedural control is included in the test. A 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 drug test procedure and to verify proper test performance. Users should follow local, state, and federal guidelines for testing QC materials.

Limitations

  • 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) and liquid chromatography/mass spectrometry (LC/MS) are the preferred confirmatory methods.

  • It is possible that technical or procedural errors, as well as other interfering substances in the urine specimen, may cause erroneous results.

  • 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.

  • A positive test result indicates presence of the drug or its metabolites but does not indicate level of intoxication, administration route, or concentration in urine.

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

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

  • A positive test result may be obtained from certain foods or food supplements.