CLIA Waived One Step Multi 10 Panel Drug Test Cup
A rapid one step screening test for the simultaneous, qualitative detection of:
For in vitro diagnostic use only. It is intended for OTC and for prescription use.
Tests & Cut-off levels:
Marijuana - 50ng/mL
Cocaine - 300ng/mL
Opiate - 2,000ng/mL
Methamphetamine - 1,000ng/mL
Benzodiazepine - 300ng/mL
Barbiturate - 300ng/mL
Methadone - 300ng/mL
Oxycodone - 100ng/mL
Buprenorphine - 10ng/mL
Tricyclic - 1,000ng/mL
Directions for use:
Allow the test cup to come to room temperature (15-30 degrees Celsius (59-86 degrees Fahrenheit prior to testing.
- Tear the foil bag open, remove test cup and disposable gloves provided for donor. Label the device with donor information.
- Open test cup lid. Urinary directly into the test cup. Be sure to fill up the test cup with the urine specimen between minimum of 30 mL to maximum of 110 mL (marked on the cup).
- After urine specimen as been collected, close the lid securely and return cup to collection official.
- Collection official use glove provided. Peel off label to repeal test result.
- Read results at 5 minutes.
DO NOT INTERPRET RESULT AFTER 10 MINUTES.
Interpretation of Results:
Negative: 2 lines appear. 1 red line should be in the control region (C), and another apparent red or pink line should be in the test region (T). This negative result indicates that the Cotinine concentration is below the detectable level (300ng/mL).
NOTE: The shade of red in the test line region (T) may vary, but it should be considered negative whenever there is even a faint pink line.
Positive: 1 red line appears in the control region (C). No line appears in the test region (T). This positive result indicates that the Cotinine concentration exceeds the detectable level (300ng/mL).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test using a new test dip card. If the problem persists, discontinue using the lot immediately and contact us.
*For in vitro diagnostic use only. Do not use after the expiration date.
- The test cup 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.