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  Urine Test Instructions
Specimen Collection and Preparation

Collect the urine sample in the tamper proof urine cup or in a clean and dry container.

Specimens can be collected at any time of the day and can be stored at 2 - 8ºC (36 -46º) for up to 48 hours prior to testing.

  Directions for use with the Single Device Test

Ensure the urine sample and test device are at room temperature. (15-30ºC) (59-86º) prior to testing.

  • When the pouch is at room temperature, remove the test from the sealed pouch and use it as soon as possible after opening.
  • Place the test device on a clean and level surface.
  • Using the pipette supplied, draw up a small quantity of urine and transfer 3 full drops to the specimen well, marked (S), wait a few seconds between drops.
  • Start the timer and wait for the red lines to appear. The results should be read at 5 minutes. Do not interpret the result after 10 minutes.

Line Intensity may vary from drug to drug but ANY line in the test zone (T) should be read as a negative.

  Directions for use with Single Strip Tests
Allow the test strip, urine specimen, and/or controls to equilibrate to room temperature
(15-30ºC) prior to testing. Then:

1. Bring the pouch to room temperature before opening it. Remove the test strip from the sealed pouch and use it as soon as possible.
2. With arrows pointing toward the urine specimen, immerse the test strip vertically in the urine specimen for at least 10-15 seconds. Do not pass the maximum line (MAX) on the test strip when immersing it.
3. Place the tests strip on a non-absorbent flat surface, start the timer and wait for the coloured line(s) to appear. Read results at 5 minutes. Do not interpret the result after 10 minutes.

NEGATIVE: Two lines appear. One coloured line should be in the control line region ( C ), and another apparent coloured line should be in the test line region ( T ). This negative result indicates that the drug tested concentration is below the detectable level. NOTE: The shade of colour in the test line region (T) may vary, but it should be considered negative whenever there is even a faint coloured line.

POSITIVE: One line appears in the control line region (C) No line appears in the test line region (T). This positive result indicates that the drug tested concentration is above the detectable level.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reason for control line failure. Review the procedure and repeat the test with a new test strip. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

  Directions for use with the Multi-Drug Tests

Ensure the urine sample and Multi-Drug Test is at room temperature. (15-30º)(59-86º) prior to testing.

  • Bring the pouch to room temperature before opening it. Remove the test Panel from the sealed pouch and use it as soon as possible.
  • Remove the cap from the end of the test panel, with the arrows pointing to the urine specimen; immerse the test panel vertically into the urine specimen only as far as the maximum level indicator at least to the wavy line. Do not pass the arrows on the test panel when immersing the panel. Immerse for at least 10-15 seconds.
  • Place the test panel on a non-absorbent flat surface, start the timer and wait for the red line(s) to appear. The results should be read at 5 minutes. Do not interpret results after 10 minutes.

Interpretation of Results

NEGATIVE: Two lines adjacent to each drug name appear. One red line should be in the control region (C) of the specific drug test and another apparent red or pink line adjacent to each drug test should be in the test region (T) of the specific drug test.
*NOTE: The shade of red in the test region (T) may vary, but it should be considered negative whenever there is even a faint pink line.

POSITIVE: One red line appears in the control region (C) of the specific drug test. No line appears in the test region (T) of the specific drug test if the test is Positive. The absence of a test line indicates a positive result for that drug. This positive result indicates that the drug concentration is above the detectable level.

INVALID: If the (C) Control panel fails to show a line. The test is invalid due to insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device or panel.

Quality Control

A procedural control is included in the test. A red line appearing in the control region (C) is considered an internal positive 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 testing practice to confirm the test procedure and to verify proper test performance.

Limitations

The multi-drug panel or device (urine) provides only a preliminary analytical result. A more specific chemical method must be used to obtain a confirmed result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.

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 Result does not indicate level or intoxication, administration route or concentration in urine. A negative result may not necessarily indicate drug-free urine. Negative results can be obtained when drug is present but below the cut-off level and the test does not distinguish between drugs of abuse and certain medications.

     
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