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Drug Testing Products> Technical Report

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WARNINGS AND PRECAUTIONS

  1. For in vitro diagnostic and professional use only.
  2. Do not use the test device beyond the expiration date.
  3. Urine specimens may be infectious; properly handle and dispose of all used reaction devices in a biohazard container.
  4. Visually inspect the foil package to insure it is intact. If the package is not intact, the integrity of DrugCheck 5 TM might be compromised.

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STORAGE AND STABILITY

Store test kit below 28°C (83°F); do not freeze. If stored at 2°-8°C (36°-46°F), allow the test kit to reach room temperature (15°-28°; 59°-83°F) before performing the test. Refer to the expiration date for stability.

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SPECIMEN COLLECTION AND PREPARATION

Fresh urine specimens should be collected directly into the cup and do not require any special handling or pretreatment. No additives or preservatives are required. Note: Urine specimens can be transferred from a urine collection container into DrugCheck 5 TM, if necessary.

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TEST PROCEDURE

  1. Do not break the seal of the pouch until ready to begin testing.
  2. Remove DrugCheck 5 TMfrom the foil pouch.
  3. Collect a urine specimen directly into DrugCheck 5 TM. Ensure the sample is no less than 1/2 oz and does not exceed 2 oz., as indicated by the graduations on the side of DrugCheck 5 TM.
  4. Read the results at 5 minutes. Note: The result must be interpreted at five minutes. Waiting more than five minutes may cause the reading to be inaccurate.

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INTERPRETATIONS OF THE RESULTS


Confirm: A rose-pink band is visible in each control zone. No color band appearing in the appropriate test zone indicates a preliminary positive result for the corresponding drug of that specific test zone. Send urine specimen to a certified laboratory for confirmation.

Negative: A rose-pink band is visible in each control zone and the appropriate test zone, indicating that the concentration of the corresponding drug of that specific test zone is below the detection limit of the test.

Retest: If a color band is not visible in each of the control zones, the test is invalid. Another test should be run to re-evaluate the specimen.

Note: There is no meaning attributed to line color intensity or width.

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QUALITY CONTROL

An internal procedure control has been incorporated into the test to ensure proper kit performance and reliability.

The use of an external control is recommended to verify proper kit performance. Quality control samples should be tested according to quality control requirements established by the testing laboratory.

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LIMITATIONS OF THE TEST

  1. This product is designed to be used for the detection of drugs of abuse and their metabolites in human urine only.
  2. Although the test is very accurate, there is the possibility false results will occur due to the presence of interfering substances in the specimen sample.
  3. The test is a qualitative screening assay and is not suggested for quantitative determination of drug levels in urine, or the level of intoxication.
  4. Adulterants such as bleach or other strong oxidizing agents, when added to urine specimens, can cause erroneous test results regardless of the analysis method used. If adulteration is suspected, obtain another urine specimen.

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