RU Clean Product Instructions

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INTENDED USE

RU Clean Multi-Drug Tests use immuno-chromatographic urinary assay for the rapid detection of drug of abuse in human urine at cut-off levels specified by SAMHSA.  Each of the test strips has been subjected to strict testing prior to FDA clearance of the individual test strips.  These tests are designed to obtain a visual result and intended for professional use only. They are not intended for Over the Counter (OTC) sale to lay persons.

EXPLANATION OF TEST

The RU Clean Multi-Drug Test is a convenient holder which permits individual tests in one dip into an individual's urine.  It is easy, fast and visually indicates binding results.  Each test strip functions completely independently of the other test strips.  Each individual test employs unique antibodies to selectively identify the individual drug of abuse in overall test sample.

MATERIALS SUPPLIED

1.    (1) RU Clean Multi-Drug Test device.

MATERIALS REQUIRED BUT NOT PROVIDED

1.    Urine specimen collection container.

2.    Timer or clock.

PRECAUTIONS

1.    Avoid cross contamination of urine samples by using a new specimen collection container for each urine sample.

2.    Urine specimens may be potentially infectious. Avoid contact with skin by wearing gloves and proper attire. Properly handle and dispose of all used test devices in an appropriate manner.

3.    Do not use a RU Clean Multi-Drug Test beyond the expiration date imprinted on the outside of the foil pouch.

STORAGE AND STABILITY

The RU Clean Multi-Drug Test can be stored at room temperature or refrigerated with no affect on the expiration date. Do not freeze.

URINE COLLECTION AND PREPARATION

The fresh urine samples should be collected in a clean dry container such that testing may be performed during the same day.  Urine specimen may be refrigerated for 48 hours, or frozen at for longer period of time prior to testing.

Urine specimens that have been refrigerated or frozen must be brought back to room temperature before testing. Urine samples exhibiting visible precipitates should not be used.

TEST PROCEDURE

1.    Do not open foil pouch until ready to begin testing. A refrigerated test device should be allowed to come to room temperature before opening the pouch.

2.    Remove the test device from the sealed foil pouch by tearing along the notch.

3.    Remove the protective cap and immerse the strips in urine with the arrow end pointing towards the urine sample for at least 10 seconds. Introduce the urine to at least the wavy lines.  However,  the urine SHOULD NOT touch the plastic device.

4.    Replace the protective cap over the exposed strips and lay the test device on a clean flat surface. Read the test result at 5 minutes. The results remain stable for at least four hours after the test initiation.

INTERPRETATION OF RESULTS

Negative: Two colored bands appear, one in the control region and one in the test region. A negative result indicates that the free drug is absent or less than the detection level of the test.

Positive: Only one colored band appears in the control region with no apparent band in the test region. A positive result indicates that the free drug is present in the urine at or exceeding the detection level of the test.

Invalid: No band appears in the control region, or a band appears in the test region only. An invalid result may be due to improper assay procedures or damage of the device. The assay is inconclusive and the specimen should be repeated using a new test device.

Notes:

• A visual example is provided at the top of each test device.

• The test band intensity may be weaker or stronger than that of the control band.

PRECISION

The following compounds were found not to have any impact on the negative results when tested at concentrations up to 100,000 ng/ml.

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