CLIA Waived One Step Multi 12 Panel Drug Test Dip Card
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
Amphetamine - 1,000ng/mL
Barbiturates - 300ng/mL
Benzodiazepine - 300ng/mL
Cocaine - 300ng/mL
Methamphetamine - 1,000ng/mL
Ecstasy - 500ng/mL
Methadone - 300ng/mL
Opiate - 2,000ng/mL
Oxycodone - 100ng/mL
Phencyclidine - 25ng/mL
Propoxyphene - 300ng/mL
Marijuana - 50ng/mL
Directions for use
Allow the test device, and urine specimen to come to room temperature (15-30 degrees Celsius (59-86 degrees Fahrenheit prior to testing.
- Remove the test device from the foil pouch.
- Remove the cap from the test device. Label the device with patient or control identifications.
- Immerse the absorbent tip into the urine sample for 10-15 seconds. Urine sample should not touch the plastic device.
- Replace the cap over the absorbent tip and lay the device flatly on a non-absorptive clean surface.
- 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 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 dip card should be discarded according to federal, state and local regulations.