What is a CLIA Waived drug test?
CLIA Waived drug tests are test systems that have been approved for a waiver based on the CLIA 7-point criteria, as well as tests cleared by the FDA for home use, as listed in the CLIA regulations.
Instructions for Use:
Remove test cup from sealed pouch and give to the donor for sample collection.
Ask the donor to provide approximately 30 mL of urine (about 1/3 full).
Read specimen temperature strip within 5 minutes of sample collection. A green dot will indicate the specimen temperature. The temperature of newly collected human urine specimen should read between 90-100 degrees. Please note:
If the temperature is out of range, the specimen should be discarded and a new sample should be collected using a new test cup.
Pull back the tab to expose the test panels and set test device on a flat surface then wait for the colored signals to appear in the test results area. Results should be read after 4 to 5 minutes. Results read after 5 minutes should be considered invalid.
How to Read Drug Test Results:
Negative test results will show two lines – one line in the control region (C) and one line in the test region (T). Please note, even a very faint line in the test region indicates a negative result.
Presumptive positive results will show only one line in the control region (C). If a test fails to show a line in the control region (C), this indicates an invalid test.
Invalid drug test results occur when no line appears in the control region (C). Should this occur, repeat the test with a new panel. If results are still invalid, stop using the test kit and contact the manufacturer.