Test Procedure

IMPORTANT: Bring refrigerated test device and urine sample to room temperature before test.

  1. Remove contents from the container (box)

  2. Make sure pouch is at room temperature before opening.

  3. Find a well-lit place to observe the color change of the test strip.

  4. Have a watch or timer ready.

  5. Remove test device from the sealed pouch.

  6. Label device with patient or control identification and the date. Use the device as soon as possible.

  7. Remove the cap from the device.

  8. Dip the sample well end of the device into the specimen.

fig1


Note: You must immerse the sample well into the specimen completely and keep the tip of the arrows in the device’s window above the specimen surface.
See Picture to the left.

  1. Start the timer

  1. Remove the device from the specimen after 10 seconds.

11. Replace the cap back onto the device.

12. Set the device on a clean and level surface

13. Read test results on all test strips between 4-7 minutes.

fig2

INTERPRETATION OF RESULTS

Each test strip is labeled with abbreviations for each test. For example, “COC” is an cocaine test. A complete list of abbreviations can be found in the
intended use section of Page 1.

IMPORTANT:

  • Read each test independently.

  • Do not compare color intensity of one test to anther.

  • Do not compare color intensity of the T line to the C line.

  • Do not interpret the results before 4 minutes or after 7 minutes that may introduce a false positive or negative result.

  1. Check that the test is working properly and the test is valid.

The area between the two “C”s next to the window is called the control region, and the area between the two “T”s is called the test region. If the test
works properly, a colored line must appear in the control region (C line). If no C line develops within 4 minutes on a test strip, the test is not working
correctly and the result is considered Invalid. In this case repeat the assay with a new test device. If the test is still invalid, stop
using the test device and contact the manufacturer.

For example, in the test results below, there is no color line in either control region or test region on test 4, and then the test 4 is invalid. While on
test 5, a line appears in the test region (T line) only and there is no C line, therefore test 5 is invalid, too.

fig3

  1. Read the results only if the C line appears within 4 minutes.

Negative:

When both the C line and T line appear on a test, the result indicates that the urine sample is negative for that drug. If the urine sample is negative for
all the drugs tested, no further testing is required.

fig4

Note: Even a very faint T line indicates a negative result.

Preliminary Positive:

If the C line appears and there is no T line, the result indicates that the urine sample may contain the corresponding drug. In this case, follow the
procedure below to send the urine sample to a lab for confirmation. It is possible that more than one test could be preliminary positive.

For example, in the test results showed below, on both Test 2 and Test 3 there is a C line but no T line, the test result is considered preliminary
positive for test 2 and test 3.

fig5

Note: Samples with preliminary positive results must be confirmed by a more specific method.